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| ID | Type | Description | Link |
|---|---|---|---|
| 77242113PSO3001 | Other Identifier | Janssen Research & Development, LLC | |
| 2023-505120-59-00 | Registry Identifier | EUCT number |
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The purpose of this study is see how effective is JNJ-77242113 in participants with moderate to severe plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-77242113 | Experimental | Adolescent and adult participants will receive JNJ-77242113 from Week 0 through Week 156. At Week 24, adult participants who are psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieve an IGA score of 0 or 1 and have >=2-grade improvement from baseline) will be re-randomized either to continue JNJ-77242113 or to placebo (and will be retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Adult participants identified as both PASI 75 and IGA 0 or 1 score non-responders will continue to receive JNJ-77242113 through Week 52. From Week 52 to Week 156, all adult participants will receive JNJ-77242113. Adolescents will not participate in re-randomization regardless of their PASI score or IGA score at Week 24. Adolescents will continue to receive JNJ-77242113 from Week 0 through Week 156. |
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| Placebo | Experimental | Adolescent and adult participants will receive JNJ-77242113 matching placebo from Week 0 to Week 16. Participants will cross-over to receive JNJ-77242113 from Week 16 through Week 156. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-77242113 | Drug | JNJ-77242113 will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2-Grade Improvement From Baseline at Week 16 | IGA assesses participant's plaque psoriasis.Lesions were graded for induration,erythema and scaling, each using 5 point scale.Induration: 0=no evidence of plaque elevation,1=minimal plaque elevation,=0.25 millimeters(mm);2=mild plaque elevation,=0.5mm;3=moderate plaque elevation,=0.75 mm; 4=severe plaque elevation, greater than(>)1 mm; Erythema:0=no evidence of erythema, hyperpigmentation may be present,1=faint erythema,2=light red coloration,3=moderate red coloration,4=bright red coloration; Scaling:0=no evidence of scaling, 1=minimal; occasional fine scale over <5% of lesion, 2=mild; fine scale dominates,3=moderate; coarse scale predominates, 4=severe; thick, scale predominates. Final IGA score of psoriasis was based upon average of induration, erythema and scaling scores assessed on a 5 point scale:cleared(0),minimal(1), mild(2),moderate(3),or severe(4). Higher score=more severe disease. Baseline:closest measurement taken prior to or at time of first study drug administration date. | Week 16 |
| Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 | Percentage of participants who achieved PASI 90 (at least 90% improvement from baseline in PASI score) response at Week 16 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved IGA Score of 0 at Week 16 | The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 millimeter (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Dermatology Specialists | Phoenix | Arizona | 85006 | United States | ||
| Johnson Dermatology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41191940 | Derived | Bissonnette R, Soung J, Hebert AA, Pink AE, Pinter A, Moore AY, Shi Y, Wang WH, Toth DP, Miller-Kassamali M, Cafone J, Jiang J, Li S, DeKlotz CMC, Nunes F, Lebwohl MG. Oral Icotrokinra for Plaque Psoriasis in Adults and Adolescents. N Engl J Med. 2025 Nov 6;393(18):1784-1795. doi: 10.1056/NEJMoa2504187. |
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The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo to JNJ-77242113 200 mg | Adult participants: Participants received placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0- 16. At Week 16, participants were crossed-over to receive JNJ-77242113 200 milligrams (mg) tablet orally QD through Week 52. Adolescent participants: Participants received placebo matching to JNJ-77242113 tablet orally QD from Week 0- 16. At Week 16, participants were cross-over to receive JNJ-77242113 200 mg tablet orally QD through Week 52. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Placebo-controlled Period(PCP):Week 0-16 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 24, 2023 | Apr 15, 2026 |
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| Placebo |
| Drug |
Placebo will be administered orally |
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| Week 16 |
| Percentage of Participants Who Achieved PASI 75 Response at Week 4 | Percentage of participants who achieved PASI 75 (at least >=75% improvement from baseline in PASI) response at Week 4 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Week 4 |
| Percentage of Participants Who Achieved PASI 90 Response at Week 8 | Percentage of participants who achieved PASI 90 (at least >=90% improvement from baseline in PASI) response at Week 8 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Week 8 |
| Percentage of Participants Who Achieved PASI 75 Response at Week 16 | Percentage of participants who achieved PASI 75 (>=75% improvement from baseline in PASI) response at Week 16 were reported.. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Week 16 |
| Percentage of Participants Who Achieved PASI 100 Response at Week 16 | Percentage of participants who achieved PASI 100 (100% improvement from baseline in PASI) response at Week 16 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Week 16 |
| Percentage of Participants Who Achieved Scalp Specific (ss)-IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline Ss-IGA Score >=2 | The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease. Higher score indicated severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Week 16 |
| Percentage of Participants Who Achieved Psoriasis Symptom and Signs Diary (PSSD) Symptom Score of 0 at Week 8 Among Participants With a Baseline PSSD Symptom Score >0 | PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived first by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Week 8 |
| Percentage of Participants Who Achieved Psoriasis Symptom and Signs Diary (PSSD) Symptom Score of 0 at Week 16 Among Participants With a Baseline PSSD Symptom Score >0 | PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived first by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Week 16 |
| Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in PSSD Itch Score at Week 4 Among Participants With a Baseline PSSD Itch Score >=4 | PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was a self-administered PRO instrument that included 11 items covering symptoms(itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. PSSD itch item score over seven days was averaged into a weekly itch score, ranging from 0 to 10 with higher scores indicating severe disease. Baseline=closest measurement taken prior to or at time of first study drug administration date. | Week 4 |
| Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in PSSD Itch Score at Week 16 Among Participants With a Baseline PSSD Itch Score >=4 | PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was a self-administered PRO instrument that included 11 items covering symptoms(itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. PSSD itch item score over seven days was averaged into a weekly itch score, ranging from 0 to 10 with higher scores indicating severe disease. Baseline=closest measurement taken prior to or at time of first study drug administration date. | Week 16 |
| Percentage of Participants Who Achieved PASI 75 Response at Week 52 Among Participants Randomized at Week 24 and Were PASI 75 Responders at Week 24 | Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Week 52 among participants randomized at Week 24 and were PASI 75 responders at Week 24 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. Baseline=closest measurement taken prior to or at time of first study drug administration date. | Week 52 |
| Percentage of Participants Who Achieved PASI 90 Response at Week 52 Among Participants Randomized at Week 24 and Were PASI 90 Responders at Week 24 | Percentage of participants who achieved PASI 90 (at least >=90% improvement from baseline in PASI) response at Week 52 among participants randomized at Week 24 and were PASI 90 responders at Week 24 were reported. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. Baseline=closest measurement taken prior to or at time of first study drug administration date. | Week 52 |
| Time to Loss of PASI 75 Among Participants Randomized at Week 24 and Were PASI 75 Responders at Week 24 | Time to loss of PASI 75 response was defined as time from re-randomization at Week 24 to visit of loss of PASI 75 response. Loss of PASI 75 response was defined as less than (<)75% improvement in PASI from Week 24 up to Week 52 in an adult participant who had achieved >=75% improvement in PASI from baseline at Week 24. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. | Week 24 up to Week 52 |
| Time to Loss of PASI 90 Among Participants Randomized at Week 24 and Were PASI 90 Responders at Week 24 | The time to loss of PASI 90 response was defined as the time from re-randomization at Week 24 to the visit of loss of PASI 90 response. Loss of PASI 90 response is defined as <90% improvement in PASI from Week 24 up to Week 52 in an adult participant who had achieved >=90% improvement in PASI from baseline at Week 24. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. | Week 24 up to Week 52 |
| Change From Baseline in Body Surface Area (BSA) at Week 16 | A BSA was commonly used measure of severity of skin disease. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). BSA was assessed using hand print method where the surface area of the participant's hand including the palm and all 5 digits was used as a guide to estimate 1% BSA. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Baseline (Week 0), Week 16 |
| Change From Baseline in PASI Total Score at Week 16 | Change from baseline in PASI total score at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Baseline (Week 0), Week 16 |
| Percent Change From Baseline in PASI Total Score at Week 16 | Percent change from baseline in PASI total score at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Baseline (Week 0), Week 16 |
| Percentage of Participants Who Achieved Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 and a >=2-Grade Improvement in Genital Psoriasis From Baseline at Week 16 Among Participants With a Baseline sPGA-G Score >=2 | Percentage of participants achieving a sPGA-G Score of 0 or 1 and at least a 2-grade improvement in genital psoriasis from baseline at Week 16 among participants with a baseline sPGA-G score >=2 was reported. The sPGA-G was a 6-point scale to assess the severity of genital psoriasis at a given time point. The sPGA-G evaluates erythema, plaque elevation, and scale of genital psoriatic lesions. The severity of genital psoriasis was assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5). Higher score indicates more severity. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Week 16 |
| Percentage of Participants Achieving a Physician's Global Assessment of Hands and Feet (Hf-PGA) Score of 0 or 1 and at Least a 2-grade Improvement at Week 16 Among Participants With a Baseline Hf-PGA Score >=2 | Percentage of participants achieving a hf-PGA score of 0 or 1 and at least a 2-grade improvement at Week 16 among participants with a baseline hf-PGA score >=2 was reported. The hf-PGA assesses the severity of hand and foot psoriasis using a 5-point scale to score the plaques on the hands and feet. hf-PFA was categorized from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Higher score indicates more severity. Meeting the hf-PGA 0 or 1 criteria defined as having an hf-PGA score of clear (0) or almost clear (1) and a >=2-grade improvement from baseline. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Week 16 |
| Percent Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 16 Among Participants With Baseline mNAPSI Score >0 | The mNAPSI was an index used for assessing and grading the severity of nail psoriasis. Each of the participant's ten fingernails are evaluated on 7 features. The first three features are each scored from 0 to 3 in severity and were 1 = onycholysis and oil-drop dyschromia, 2 = pitting, and 3 = nail plate crumbling. The next four features was each scored 0 (absent) or 1 (present), and are (1) leukonychia, (2) splinter hemorrhages (3) nail bed hyperkeratosis, and (4) red spots in the lunula. Each fingernail is rated for the presence and severity of seven features to give a total fingernail score of 0-13 (0= no involvement, 13 = greatest involvement). The total mNAPSI score is the sum of the 10 fingernail scores (range 0-130; 0= no involvement, 130= greatest involvement). The higher the score the more severe the nail bed psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Baseline (Week 0), Week 16 |
| Percentage of Participants Who Achieved Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16 Among Participants With a Baseline f-PGA Score >=2 | Percentage of participants who achieved f-PGA score of 0 or 1 at Week 16 was reported. f-PGA 0 or 1 criteria was defined as an f-PGA score of clear (0) or minimal (1). The f-PGA is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe. The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4= severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Week 16 |
| Change From Baseline in PSSD Symptom Score at Week 16 | PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms(itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Baseline (Week 0), Week 16 |
| Change From Baseline in PSSD Sign Score at Week 16 | PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms(itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (>=50% of 6 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Baseline (Week 0), Week 16 |
| Percentage of Participants Achieving PSSD Sign Score of 0 at Week 16 Among Participants With Baseline PSSD Sign Score >0 | PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (>=50% of 6 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Week 16 |
| Percentage of Participants Achieving Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 Score of 0 or 1 at Week 16 Among Participants With Baseline GenPS-SFQ Item 2 Score >=2 and a Baseline sPGA-G Score >=3 | Percentage of participants achieving GenPs-SFQ Item 2 score of 0 or 1 at Week 16 among participants with baseline GenPS-SFQ Item 2 score >=2 and a baseline sPGA-G score >=3 was reported. GenPs-SFQ was a 2-item participant-reported instrument used to assess the impact of genital psoriasis on the frequency of sexual activity in the last 7 days. Item 1 assesses overall frequency of sexual activity in the last 7 days (none/ zero, once, or 2 or more times), and item 2 assesses how frequently genital psoriasis symptoms have limited the frequency of sexual activity in the last 7 days (0 = never, 1 = rarely, 2 = sometimes, 3 = often, or 4 = always). Lower scores of item 2 indicated less limitation of sexual activity due to genital psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Week 16 |
| Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 Among Participants With a Baseline DLQI Score >1 | The DLQI was a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Week 16 |
| Change From Baseline in Total DLQI Score at Week 16 | Change from baseline in total DLQI score at Week 16 was reported. The DLQI was a dermatology specific health related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Baseline (Week 0), Week 16 |
| Adult Participants: Change From Baseline in Domain Scores of the Patient-reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16 | PROMIS-29, 29-item generic HRQoL survey, assesses each 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; ability to participate in social roles and activities) with 4 questions and pain intensity. Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often and 5=always). Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain). Higher score= worst pain. Each domain included 4 items, plus a single pain intensity item totaling 29 items. Raw score of each PROMIS domain was converted into a standardized score with mean of 50; standard deviation (SD) of 10 (T-Score). Higher PROMIS T score=more of concept being measured that is, higher scores in anxiety, depression, fatigue, pain interference, sleep disturbance= worse symptoms, higher scores in physical function, social roles=better functioning. Baseline: closest measurement taken prior to/at the time of first study drug administration date. | Baseline (Week 0), Week 16 |
| Adolescent Participants: Percentage of Participants Achieving Children's Dermatology Life Quality Index (CDLQI) Score of 0 or 1 at Week 16 Among Participants With a Baseline CDLQI Score >1 | The CDLQI was an adapted version of the DLQI for the pediatric population and was utilized in the adolescent population in this study. The CDLQI is a 10-item instrument that has 4 item response options and a recall period of 1 week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children. The instrument is designed for use in children, is self-explanatory and can be simply handed to the participant who asked to fill it in with the help of the child's parent or caregiver. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Week 16 |
| Adolescent Participants: Change From Baseline in CDLQI at Week 16 | The CDLQI was an adapted version of the DLQI for the pediatric population and was utilized in the adolescent population in this study. The CDLQI is a 10-item instrument that has 4 item response options and a recall period of 1 week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children. The instrument is designed for use in children, is self-explanatory and can be simply handed to the participant who asked to fill it in with the help of the child's parent or caregiver. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Baseline (Week 0), Week 16 |
| Adolescent Participants: Change From Baseline in Domain Scores of the PROMIS-25 Pediatric Score at Week 16 | The PROMIS-25 was utilized in the adolescent population and is a 25-item generic HRQoL survey. Six PROMIS domains (physical function mobility, anxiety, depressive symptoms, fatigue, peer relationships, pain interference) are each assessed with 4 questions. Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often, 5=always). Higher score=worst pain. Raw scores for each domain were converted to T-scores using standardized score with a mean of 50 and a standard deviation (SD) of 10 with an observed range 20 to 80. For anxiety, depressive symptoms, fatigue, and pain interference, a negative change indicates an improvement while for physical function mobility and peer relationships, a positive change indicates an improvement. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Baseline (Week 0), Week 16 |
| Percentage of Participants Who Achieved an IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Week 52 | IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0=no evidence of plaque elevation, 1=minimal plaque elevation, =0.25mm; 2=mild plaque elevation, =0.5 mm; 3=moderate plaque elevation, =0.75mm;4=severe plaque elevation, >1 mm; Erythema: 0=no evidence of erythema, hyperpigmentation may be present, 1=faint erythema, 2=light red coloration, 3=moderate red coloration, 4=bright red coloration; Scaling: 0=no evidence of scaling, 1=minimal; occasional fine scale over less than 5% of lesion, 2=mild; fine scale dominates,3 =moderate; coarse scale predominates, 4 =severe; thick, scale predominates.Final IGA score of psoriasis was based upon average of induration,erythema and scaling scores assessed on a 5 point scale: cleared(0),minimal(1),mild(2),moderate (3), or severe (4).Higher score=more severe disease. Baseline: closest measurement taken prior to or at time of first study drug administration date. | Week 52 |
| Percentage of Participants Achieving IGA Score of 0 at Week 52 Among Participants Who Were IGA 0 Responders at Week 24 | The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease. | Week 52 |
| Percentage of Participants Achieving PASI 100 Response at Week 52 Among PASI 100 Responders at Week 24 | Percentage of participants achieving PASI 100 (100% improvement from baseline in PASI) response at Week 52 among PASI 100 responders at Week 24 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. | Week 52 |
| Time to Loss of IGA Response of 0 or 1 | The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease. | Week 24 up to Week 52 |
| Adolescent Participants: Percentage of Participants With IGA Score of 0 or 1 and a >=2-grade Improvement From Baseline at Week 52 | IGA assesses participant's plaque psoriasis. Lesions were graded for induration,erythema and scaling,each using 5 point scale. Induration: 0=no evidence of plaque elevation, 1=minimal plaque elevation,=0.25mm; 2=mild plaque elevation,=0.5 mm; 3=moderate plaque elevation,= 0.75 mm; 4=severe plaque elevation, >1mm; Erythema: 0=no evidence of erythema, hyperpigmentation may be present, 1=faint erythema, 2=light red coloration, 3=moderate red coloration, 4=bright red coloration; Scaling:0=no evidence of scaling, 1=minimal; occasional fine scale over less than 5% of lesion, 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared(0), minimal(1), mild(2), moderate(3), or severe(4). Higher score=more severe disease. Baseline:closest measurement taken prior to or at time of first study drug administration date. | Week 52 |
| Adolescent Participants: Percentage of Participants Who Achieved PASI 75 Response at Week 52 | Percentage of participants who achieved PASI 75 (>=75% improvement in PASI from baseline) response at Week 52 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. Baseline:closest measurement taken prior to or at time of first study drug administration date. | Week 52 |
| Adolescent Participants: Percentage of Participants Who Achieved PASI 90 Response at Week 52 | Percentage of participants who achieved PASI 90 (at least >=90% improvement in PASI from baseline) response at Week 52 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. Baseline: closest measurement taken prior to or at time of first study drug administration date. | Week 52 |
| Number of Participants With Treatment-emergent Adverse Events (AEs) | From Week 0 up to Week 160 |
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | From Week 0 up to Week 160 |
| Fort Smith |
| Arkansas |
| 72916 |
| United States |
| First OC Dermatology | Fountain Valley | California | 92708 | United States |
| Center for Dermatology Clinical Research | Fremont | California | 94538 | United States |
| Integrative Skin Science and Research | Sacramento | California | 95815 | United States |
| Rady Childrens Hospital San Diego | San Diego | California | 92123 | United States |
| Southern California Dermatology | Santa Ana | California | 92701 | United States |
| Clinical Science Institute | Santa Monica | California | 90403 | United States |
| Bioclinical Research Alliance Inc. | Miami | Florida | 33155 | United States |
| Ziaderm Research LLC | North Miami Beach | Florida | 33162 | United States |
| Forcare Clinical Research Inc | Tampa | Florida | 33613 | United States |
| Skin Care Physicians of Georgia | Macon | Georgia | 31217 | United States |
| Arlington Dermatology | Rolling Meadows | Illinois | 60008 | United States |
| Endeavor Health | Skokie | Illinois | 60077 | United States |
| Dundee Dermatology | West Dundee | Illinois | 60118 | United States |
| Dawes Fretzin Clinical Research Group LLC | Indianapolis | Indiana | 46250 | United States |
| Indiana Clinical Trial Center | Plainfield | Indiana | 46168 | United States |
| Qualmedica Research | Owensboro | Kentucky | 42301 | United States |
| Dermatology and Advanced Aesthetics | Lake Charles | Louisiana | 70605 | United States |
| Allcutis Research 1 | Beverly | Massachusetts | 01915 | United States |
| Michigan Center of Medical Research | Clarkston | Michigan | 48346 | United States |
| Minnesota Clinical Study Center | New Brighton | Minnesota | 55112 | United States |
| Skin Specialists | Omaha | Nebraska | 68144 | United States |
| Allcutis Research | Portsmouth | New Hampshire | 03801 | United States |
| Schweiger Dermatology Group | East Windsor | New Jersey | 08520 | United States |
| Icahn School of Medicine at Mt. Sinai | New York | New York | 10029 | United States |
| Wilmington Dermatology Center | Wilmington | North Carolina | 28405 | United States |
| Oakview Dermatology | Athens | Ohio | 45701 | United States |
| Optima Research | Boardman | Ohio | 44512 | United States |
| Dermatologists of Central States LLC | Fairborn | Ohio | 45324 | United States |
| Central Sooner Research | Oklahoma City | Oklahoma | 73170 | United States |
| Oregon Medical Research Center | Portland | Oregon | 97201 | United States |
| Oregon Dermatology and Research Center | Portland | Oregon | 97210 | United States |
| The Pennsylvania Centre for Dermatology, LLC | Exton | Pennsylvania | 19341 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| Arlington Research Center, Inc. | Arlington | Texas | 76011 | United States |
| The University of Texas Health Science Center at Houston | Bellaire | Texas | 77401 | United States |
| Center for Clinical Studies 1 | Houston | Texas | 77004 | United States |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | United States |
| Center for Clinical Studies | Webster | Texas | 77598 | United States |
| Springville Dermatology CCT Research | Springville | Utah | 84663 | United States |
| Virginia Dermatology Skin Cancer Center Pllc | Norfolk | Virginia | 23502 | United States |
| Frontier Derm Partners CRO, LLC | Mill Creek | Washington | 98012 | United States |
| Premier Clinical Research | Spokane | Washington | 99202 | United States |
| ARCIS Salud SRL Aprillus asistencia e investigacion | Buenos Aires | C1406AGA | Argentina |
| Centro Privado de Medicina Familiar | Buenos Aires | C1417EYG | Argentina |
| Derma Internacional S A | Buenos Aires | C1426 | Argentina |
| Psoriahue | CABA | C1425DKG | Argentina |
| Centro de Investigaciones Medicas Mar Del Plata | Mar del Plata | B7600FYK | Argentina |
| Instituto De Especialidades De La Salud SRL | Rosario | S2000DBS | Argentina |
| MR Medicina Reumatologica | San Fernando | B1646 | Argentina |
| Dr Rodney Sinclair Pty Ltd | East Melbourne | 3002 | Australia |
| The Alfred Hospital | Melbourne | 3004 | Australia |
| Kingsway Dermatology & Aesthetics | Miranda | 2228 | Australia |
| ISHI dermatology | Mitcham | 3132 | Australia |
| Royal Melbourne Hospital | Parkville | 3050 | Australia |
| Veracity Clinical Research | Woolloongabba | 4102 | Australia |
| Dermatology Research Institute Inc | Calgary | Alberta | T2J 7E1 | Canada |
| Rejuvenation Dermatology Clinic Edmonton Downtown | Edmonton | Alberta | T5J 3S9 | Canada |
| Dr. Chih ho Hong Medical | Surrey | British Columbia | V3R 6A7 | Canada |
| Mediprobe Research Inc. | London | Ontario | N5X 2P1 | Canada |
| Dr Wei Jing Loo Medicine Professional Corporation | London | Ontario | N6H 5L5 | Canada |
| Ryan Clinical Research Inc | Newmarket | Ontario | L3Y 5G8 | Canada |
| Canadian Dermatology Center | Toronto | Ontario | M3B 0A7 | Canada |
| Toronto Research Centre | Toronto | Ontario | M3H 5Y8 | Canada |
| FACET Dermatology | Toronto | Ontario | M4C 1L1 | Canada |
| XLR8 Medical Research | Windsor | Ontario | N8T 1E6 | Canada |
| Innovaderm Research Inc. | Montreal | Quebec | H2X 2V1 | Canada |
| China Japan Friendship Hospital | Beijing | 100013 | China |
| Beijing Friendship Hospital Capital Medical University | Beijing | 100050 | China |
| Peking University Third Hospital | Beijing | 100191 | China |
| The Affiliated Hospital of Bengbu Medical College | Bengbu | 233099 | China |
| Hosp. of Chengde Medical University | Chengde | 067030 | China |
| Chengdu Second People's Hospital | Chengdu | 610017 | China |
| The First Hospital of Jiaxing | Jiaxing | 314001 | China |
| Qilu Hospital of Shandong University | Jinan | 250012 | China |
| Dermatology Hospital of Jiangxi Province | Nanchang | 330000 | China |
| Nanyang First People's Hospital | Nanyang | 473004 | China |
| Shanghai skin disease hospital | Shanghai | 200443 | China |
| Northeast International Hospital | Shenyang | 110016 | China |
| Union Hospital Tongji Medical College of Huazhong University of Science and Technology | Wuhan | 430022 | China |
| The Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an | 710004 | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | 212001 | China |
| Hopital Prive d'Antony | Antony | 92160 | France |
| Centre Hospitalier Victor Dupouy | Argenteuil | 95107 | France |
| Fachklinik Bad Bentheim | Bad Bentheim | 48455 | Germany |
| Charite - Campus Mitte | Berlin | 10117 | Germany |
| Universitatsklinikum Bonn | Bonn | 53127 | Germany |
| Klinische Forschung Dresden GmbH | Dresden | 01069 | Germany |
| Hautzentrum Dulmen | Dülmen | 48249 | Germany |
| Privatpraxis Dr. Hilton & Partner | Düsseldorf | 40212 | Germany |
| Universitaetsklinikum Frankfurt | Frankfurt am Main | 60590 | Germany |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | 79104 | Germany |
| Derma-Study-Center Friedrichshafen GmbH | Friedrichshafen | 88045 | Germany |
| Universitaetsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Hautarztpraxis | Mahlow | 15831 | Germany |
| Universitaetsklinikum Muenster | Münster | 48149 | Germany |
| Klinikum Oldenburg | Oldenburg | 26133 | Germany |
| Hautarztpraxis Mortazawi | Remscheid | 42897 | Germany |
| Universitaetsklinik Tuebingen | Tübingen | 72076 | Germany |
| Hautarztpraxis 2 | Witten | 58453 | Germany |
| CentroDerm GmbH | Wuppertal | 42287 | Germany |
| Pecsi Tudomanyegyetem | Borgyogyaszati Klinika | 7632 | Hungary |
| Obudai Egeszsegugyi Centrum Kft | Budapest | 1036 | Hungary |
| Derma-B Kft | Debrecen | 4031 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4032 | Hungary |
| Somogy Varmegyei Kaposi Mor Oktato Korhaz | Kaposvár | 7400 | Hungary |
| SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika | Szeged | 6720 | Hungary |
| Allergo-Derm Bakos Kft. | Szolnok | 5000 | Hungary |
| Medmare Egeszsegugyi Es Szolgaltato Bt. | Veszprém | 8200 | Hungary |
| Azienda Di Rilievo Nazionale E Di Alta Specializzazione | Palermo | 90127 | Italy |
| Azienda Ospedaliero Universitaria di Parma | Parma | 43126 | Italy |
| Policlinico Tor Vergata | Roma | 00133 | Italy |
| Istituto Clinico Humanitas | Rozzano | 20089 | Italy |
| Teikyo University Hospital | Itabashi Ku | 173 8606 | Japan |
| Hospital of the University of Occupational and Environmental Health | Kitakyushu-shi | 807-8556 | Japan |
| Mito Kyodo General Hospital | Mito | 310 0015 | Japan |
| Nagoya City University Hospital | Nagoya | 467 8602 | Japan |
| Kindai University Hospital | Osaka Sayama Shi | 589 8511 | Japan |
| Tohoku University Hospital | Sendai | 980 8574 | Japan |
| Tokyo Medical University Hospital | Shinjuku | 160 0023 | Japan |
| Mie University Hospital | Tsu | 514 8507 | Japan |
| Osteo-Medic s.c A. Racewicz, J Supronik | Bialystok | 15-351 | Poland |
| Specderm Poznanska sp j | Bialystok | 15-375 | Poland |
| Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska | Elblag | 82 300 | Poland |
| Centrum Medyczne dr Rajzer Sp z o o | Krakow | 30 438 | Poland |
| Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna | Krakow | 30-002 | Poland |
| Centrum Medyczne Promed | Krakow | 31-411 | Poland |
| Dermed Centrum Medyczne Sp z o o | Lodz | 90-265 | Poland |
| Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna | Lodz | 90-338 | Poland |
| Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C | Osielsko | 86031 | Poland |
| SOLUMED Centrum Medyczne | Poznan | 60 529 | Poland |
| Clinical Research Center sp z o o MEDIC R s k | Poznan | 61 731 | Poland |
| Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna | Warsaw | 01 817 | Poland |
| Klinika Ambroziak Dermatologia | Warsaw | 02 953 | Poland |
| DERMMEDICA Sp.z o.o. | Wroclaw | 51 503 | Poland |
| Wro Medica | Wroclaw | 51 685 | Poland |
| Centrum Medyczne Oporow | Wroclaw | 52 416 | Poland |
| Korea University Ansan Hospital | Ansan-si | 15355 | South Korea |
| Chosun university hospital | Gwangju | 61453 | South Korea |
| CHA Bundang Medical Center, CHA University | Gyeonggi-do | 13496 | South Korea |
| Hallym University Sacred Heart Hospital | Gyeonggi-do | 14068 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Hosp. Univ. Fundacion Alcorcon | Alcorcón | 28922 | Spain |
| Hosp. Gral. Univ. Dr. Balmis | Alicante | 03010 | Spain |
| Hosp Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hosp. de La Santa Creu I Sant Pau | Barcelona | 08041 | Spain |
| Hosp. Univ. de Basurto | Bilbao | 48013 | Spain |
| Grupo Dermatologico Y Estetico Pedro Jaen | Madrid | 28002 | Spain |
| Hosp. Gral. Univ. Gregorio Maranon | Madrid | 28007 | Spain |
| Hosp. Univ. Son Espases | Palma de Mallorca | 07120 | Spain |
| Hosp. Clinico Univ. de Santiago | Santiago de Compostela | 15706 | Spain |
| Hosp. Virgen Macarena | Seville | 41009 | Spain |
| Hosp. de Manises | Valencia | 46940 | Spain |
| National Taiwan University Hospital Hsin Chu Branch | Hsinchu | 30059 | Taiwan |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 83301 | Taiwan |
| National Taiwan University Hospital | Taipei | 10048 | Taiwan |
| Mackay Memorial Hospital | Taipei | 10449 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Linkou Chang Gung Memorial Hospital | Taoyuan | 33382 | Taiwan |
| Hacettepe University Medical Faculty | Ankara | 06230 | Turkey (Türkiye) |
| Gazi University Medical Faculty | Ankara | 06560 | Turkey (Türkiye) |
| Erciyes University Medical Faculty | Kayseri | 38039 | Turkey (Türkiye) |
| Ondokuz Mayis University | Samsun | 55270 | Turkey (Türkiye) |
| London North West University Healthcare NHS Trust | Harrow | HA1 3UJ | United Kingdom |
| Guys and St Thomas NHS Foundation Trust | London | SE1 9RT | United Kingdom |
| Royal Berkshire Hospital | Reading | RG1 5AN | United Kingdom |
| Salford Royal Hospital | Salford | M6 8HD | United Kingdom |
| FG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| After PCP: Weeks 16-24 |
|
|
| Randomized Withdrawal (RWD): Weeks 24-52 |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo to JNJ-77242113 200 mg | Adult participants: Participants received placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0- 16. At Week 16, participants were crossed-over to receive JNJ-77242113 200 milligrams (mg) tablet orally QD through Week 52. Adolescent participants: Participants received placebo matching to JNJ-77242113 tablet orally QD from Week 0- 16. At Week 16, participants were cross-over to receive JNJ-77242113 200 mg tablet orally QD through Week 52. |
| BG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2-Grade Improvement From Baseline at Week 16 | IGA assesses participant's plaque psoriasis.Lesions were graded for induration,erythema and scaling, each using 5 point scale.Induration: 0=no evidence of plaque elevation,1=minimal plaque elevation,=0.25 millimeters(mm);2=mild plaque elevation,=0.5mm;3=moderate plaque elevation,=0.75 mm; 4=severe plaque elevation, greater than(>)1 mm; Erythema:0=no evidence of erythema, hyperpigmentation may be present,1=faint erythema,2=light red coloration,3=moderate red coloration,4=bright red coloration; Scaling:0=no evidence of scaling, 1=minimal; occasional fine scale over <5% of lesion, 2=mild; fine scale dominates,3=moderate; coarse scale predominates, 4=severe; thick, scale predominates. Final IGA score of psoriasis was based upon average of induration, erythema and scaling scores assessed on a 5 point scale:cleared(0),minimal(1), mild(2),moderate(3),or severe(4). Higher score=more severe disease. Baseline:closest measurement taken prior to or at time of first study drug administration date. | Full analysis set (FAS) included all participants who were randomized at Week 0 in the study. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of Participants | Week 16 |
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| Primary | Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 | Percentage of participants who achieved PASI 90 (at least 90% improvement from baseline in PASI score) response at Week 16 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Full analysis set (FAS) included all participants who were randomized at Week 0 in the study. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Who Achieved IGA Score of 0 at Week 16 | The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 millimeter (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease. | Full analysis set (FAS) included all participants who were randomized at Week 0 in the study. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Who Achieved PASI 75 Response at Week 4 | Percentage of participants who achieved PASI 75 (at least >=75% improvement from baseline in PASI) response at Week 4 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Full analysis set (FAS) included all participants who were randomized at Week 0 in the study. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 4 |
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| Secondary | Percentage of Participants Who Achieved PASI 90 Response at Week 8 | Percentage of participants who achieved PASI 90 (at least >=90% improvement from baseline in PASI) response at Week 8 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Full analysis set (FAS) included all participants who were randomized at Week 0 in the study. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 8 |
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| Secondary | Percentage of Participants Who Achieved PASI 75 Response at Week 16 | Percentage of participants who achieved PASI 75 (>=75% improvement from baseline in PASI) response at Week 16 were reported.. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Full analysis set (FAS) included all participants who were randomized at Week 0 in the study. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Who Achieved PASI 100 Response at Week 16 | Percentage of participants who achieved PASI 100 (100% improvement from baseline in PASI) response at Week 16 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Full analysis set (FAS) included all participants who were randomized at Week 0 in the study. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Who Achieved Scalp Specific (ss)-IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline Ss-IGA Score >=2 | The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease. Higher score indicated severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Analysis population only included all participants who were randomized at Week 0 in the study and had baseline ss-IGA Score >=2. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Who Achieved Psoriasis Symptom and Signs Diary (PSSD) Symptom Score of 0 at Week 8 Among Participants With a Baseline PSSD Symptom Score >0 | PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived first by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Analysis population only included all participants who were randomized at Week 0 in the study and had baseline PSSD Symptom Score >0. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 8 |
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| Secondary | Percentage of Participants Who Achieved Psoriasis Symptom and Signs Diary (PSSD) Symptom Score of 0 at Week 16 Among Participants With a Baseline PSSD Symptom Score >0 | PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived first by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Analysis population only included all participants who were randomized at Week 0 in the study and had baseline PSSD Symptom Score >0. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in PSSD Itch Score at Week 4 Among Participants With a Baseline PSSD Itch Score >=4 | PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was a self-administered PRO instrument that included 11 items covering symptoms(itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. PSSD itch item score over seven days was averaged into a weekly itch score, ranging from 0 to 10 with higher scores indicating severe disease. Baseline=closest measurement taken prior to or at time of first study drug administration date. | Analysis population only included all participants who were randomized at Week 0 in the study and had baseline PSSD itch score >=4. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 4 |
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| Secondary | Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in PSSD Itch Score at Week 16 Among Participants With a Baseline PSSD Itch Score >=4 | PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was a self-administered PRO instrument that included 11 items covering symptoms(itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. PSSD itch item score over seven days was averaged into a weekly itch score, ranging from 0 to 10 with higher scores indicating severe disease. Baseline=closest measurement taken prior to or at time of first study drug administration date. | Analysis population only included all participants who were randomized at Week 0 in the study and had baseline PSSD itch score >=4. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Who Achieved PASI 75 Response at Week 52 Among Participants Randomized at Week 24 and Were PASI 75 Responders at Week 24 | Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Week 52 among participants randomized at Week 24 and were PASI 75 responders at Week 24 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. Baseline=closest measurement taken prior to or at time of first study drug administration date. | Analysis population included participants who were re-randomized at Week 24 and were PASI 75 responders at Week 24. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 52 |
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| Secondary | Percentage of Participants Who Achieved PASI 90 Response at Week 52 Among Participants Randomized at Week 24 and Were PASI 90 Responders at Week 24 | Percentage of participants who achieved PASI 90 (at least >=90% improvement from baseline in PASI) response at Week 52 among participants randomized at Week 24 and were PASI 90 responders at Week 24 were reported. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. Baseline=closest measurement taken prior to or at time of first study drug administration date. | Analysis population included participants who were re-randomized at Week 24 and were PASI 90 responders at Week 24. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 52 |
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| Secondary | Time to Loss of PASI 75 Among Participants Randomized at Week 24 and Were PASI 75 Responders at Week 24 | Time to loss of PASI 75 response was defined as time from re-randomization at Week 24 to visit of loss of PASI 75 response. Loss of PASI 75 response was defined as less than (<)75% improvement in PASI from Week 24 up to Week 52 in an adult participant who had achieved >=75% improvement in PASI from baseline at Week 24. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. | Analysis population included participants who were re-randomized at Week 24 and were PASI 75 responders at Week 24. | Posted | Median | Inter-Quartile Range | Weeks | Week 24 up to Week 52 |
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| Secondary | Time to Loss of PASI 90 Among Participants Randomized at Week 24 and Were PASI 90 Responders at Week 24 | The time to loss of PASI 90 response was defined as the time from re-randomization at Week 24 to the visit of loss of PASI 90 response. Loss of PASI 90 response is defined as <90% improvement in PASI from Week 24 up to Week 52 in an adult participant who had achieved >=90% improvement in PASI from baseline at Week 24. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. | Analysis population included participants who were re-randomized at Week 24 and were PASI 90 responders at Week 24. | Posted | Median | Inter-Quartile Range | Weeks | Week 24 up to Week 52 |
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| Secondary | Change From Baseline in Body Surface Area (BSA) at Week 16 | A BSA was commonly used measure of severity of skin disease. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). BSA was assessed using hand print method where the surface area of the participant's hand including the palm and all 5 digits was used as a guide to estimate 1% BSA. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | FAS included all participants who were randomized at Week 0 in the study. Here, 'N' (overall number of participants analyzed) signifies number of participants with non-missing data for this outcome measure after applying predefined intercurrent event rules. Participants with missing assessments were not included, as no further imputation was applied for missing data. | Posted | Mean | Standard Deviation | Percentage of BSA | Baseline (Week 0), Week 16 |
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| Secondary | Change From Baseline in PASI Total Score at Week 16 | Change from baseline in PASI total score at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | FAS included all participants who were randomized at Week 0 in the study. Here, 'N' (overall number of participants analyzed) signifies number of participants with non-missing data for this outcome measure after applying predefined intercurrent event rules. Participants with missing assessments were not included, as no further imputation was applied for missing data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Week 0), Week 16 |
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| Secondary | Percent Change From Baseline in PASI Total Score at Week 16 | Percent change from baseline in PASI total score at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | FAS included all participants who were randomized at Week 0 in the study. Here, 'N' (overall number of participants analyzed) signifies number of participants with non-missing data for this outcome measure after applying predefined intercurrent event rules. Participants with missing assessments were not included, as no further imputation was applied for missing data. | Posted | Mean | Standard Deviation | Percent change | Baseline (Week 0), Week 16 |
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| Secondary | Percentage of Participants Who Achieved Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 and a >=2-Grade Improvement in Genital Psoriasis From Baseline at Week 16 Among Participants With a Baseline sPGA-G Score >=2 | Percentage of participants achieving a sPGA-G Score of 0 or 1 and at least a 2-grade improvement in genital psoriasis from baseline at Week 16 among participants with a baseline sPGA-G score >=2 was reported. The sPGA-G was a 6-point scale to assess the severity of genital psoriasis at a given time point. The sPGA-G evaluates erythema, plaque elevation, and scale of genital psoriatic lesions. The severity of genital psoriasis was assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5). Higher score indicates more severity. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Analysis population only included all participants who were randomized at Week 0 in the study and had baseline sPGA-G score >=2. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Achieving a Physician's Global Assessment of Hands and Feet (Hf-PGA) Score of 0 or 1 and at Least a 2-grade Improvement at Week 16 Among Participants With a Baseline Hf-PGA Score >=2 | Percentage of participants achieving a hf-PGA score of 0 or 1 and at least a 2-grade improvement at Week 16 among participants with a baseline hf-PGA score >=2 was reported. The hf-PGA assesses the severity of hand and foot psoriasis using a 5-point scale to score the plaques on the hands and feet. hf-PFA was categorized from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Higher score indicates more severity. Meeting the hf-PGA 0 or 1 criteria defined as having an hf-PGA score of clear (0) or almost clear (1) and a >=2-grade improvement from baseline. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Analysis population only included all participants who were randomized at Week 0 in the study and had baseline hf-PGA score >=2. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percent Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 16 Among Participants With Baseline mNAPSI Score >0 | The mNAPSI was an index used for assessing and grading the severity of nail psoriasis. Each of the participant's ten fingernails are evaluated on 7 features. The first three features are each scored from 0 to 3 in severity and were 1 = onycholysis and oil-drop dyschromia, 2 = pitting, and 3 = nail plate crumbling. The next four features was each scored 0 (absent) or 1 (present), and are (1) leukonychia, (2) splinter hemorrhages (3) nail bed hyperkeratosis, and (4) red spots in the lunula. Each fingernail is rated for the presence and severity of seven features to give a total fingernail score of 0-13 (0= no involvement, 13 = greatest involvement). The total mNAPSI score is the sum of the 10 fingernail scores (range 0-130; 0= no involvement, 130= greatest involvement). The higher the score the more severe the nail bed psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Analysis population only included all participants who were randomized at Week 0 in the study and had baseline mNAPSI score >0. Here, 'N' (overall number of participants analyzed) signifies number of participants with non-missing data for this outcome measure after applying predefined intercurrent event rules. Participants with missing assessments were not included, as no further imputation was applied for missing data. | Posted | Mean | Standard Deviation | Percent change | Baseline (Week 0), Week 16 |
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| Secondary | Percentage of Participants Who Achieved Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16 Among Participants With a Baseline f-PGA Score >=2 | Percentage of participants who achieved f-PGA score of 0 or 1 at Week 16 was reported. f-PGA 0 or 1 criteria was defined as an f-PGA score of clear (0) or minimal (1). The f-PGA is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe. The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4= severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Analysis population only included all participants who were randomized at Week 0 in the study and who had baseline f-PGA score >=2. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Change From Baseline in PSSD Symptom Score at Week 16 | PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms(itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | FAS included all participants who were randomized at Week 0 in the study. Here, 'N' (overall number of participants analyzed) signifies number of participants with non-missing data for this outcome measure after applying predefined intercurrent event rules. Participants with missing assessments were not included, as no further imputation was applied for missing data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Week 0), Week 16 |
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| Secondary | Change From Baseline in PSSD Sign Score at Week 16 | PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms(itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (>=50% of 6 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | FAS included all participants who were randomized at Week 0 in the study. Here, 'N' (overall number of participants analyzed) signifies number of participants with non-missing data for this outcome measure after applying predefined intercurrent event rules. Participants with missing assessments were not included, as no further imputation was applied for missing data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Week 0), Week 16 |
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| Secondary | Percentage of Participants Achieving PSSD Sign Score of 0 at Week 16 Among Participants With Baseline PSSD Sign Score >0 | PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (>=50% of 6 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Analysis population included all participants who were randomized at Week 0 in the study and had baseline PSSD sign score >0. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Achieving Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 Score of 0 or 1 at Week 16 Among Participants With Baseline GenPS-SFQ Item 2 Score >=2 and a Baseline sPGA-G Score >=3 | Percentage of participants achieving GenPs-SFQ Item 2 score of 0 or 1 at Week 16 among participants with baseline GenPS-SFQ Item 2 score >=2 and a baseline sPGA-G score >=3 was reported. GenPs-SFQ was a 2-item participant-reported instrument used to assess the impact of genital psoriasis on the frequency of sexual activity in the last 7 days. Item 1 assesses overall frequency of sexual activity in the last 7 days (none/ zero, once, or 2 or more times), and item 2 assesses how frequently genital psoriasis symptoms have limited the frequency of sexual activity in the last 7 days (0 = never, 1 = rarely, 2 = sometimes, 3 = often, or 4 = always). Lower scores of item 2 indicated less limitation of sexual activity due to genital psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Analysis population only included all participants who were randomized at Week 0 in the study and had baseline GenPS-SFQ Item 2 score >=2 and baseline sPGA-G Score >=3. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 Among Participants With a Baseline DLQI Score >1 | The DLQI was a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Analysis population included all participants who were randomized at Week 0 in the study and had baseline DLQI score >1. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Change From Baseline in Total DLQI Score at Week 16 | Change from baseline in total DLQI score at Week 16 was reported. The DLQI was a dermatology specific health related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | FAS included all participants who were randomized at Week 0 in the study. Here, 'N' (overall number of participants analyzed) signifies number of participants with non-missing data for this outcome measure after applying predefined intercurrent event rules. Participants with missing assessments were not included, as no further imputation was applied for missing data. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline (Week 0), Week 16 |
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| Secondary | Adult Participants: Change From Baseline in Domain Scores of the Patient-reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16 | PROMIS-29, 29-item generic HRQoL survey, assesses each 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; ability to participate in social roles and activities) with 4 questions and pain intensity. Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often and 5=always). Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain). Higher score= worst pain. Each domain included 4 items, plus a single pain intensity item totaling 29 items. Raw score of each PROMIS domain was converted into a standardized score with mean of 50; standard deviation (SD) of 10 (T-Score). Higher PROMIS T score=more of concept being measured that is, higher scores in anxiety, depression, fatigue, pain interference, sleep disturbance= worse symptoms, higher scores in physical function, social roles=better functioning. Baseline: closest measurement taken prior to/at the time of first study drug administration date. | FAS included all adult participants who were randomized at Week 0 in the study. Here, 'N' (overall number of participants analyzed) signifies number of participants with non-missing data for this outcome measure after applying predefined intercurrent event rules. Participants with missing assessments were not included, as no further imputation was applied for missing data. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline (Week 0), Week 16 |
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| Secondary | Adolescent Participants: Percentage of Participants Achieving Children's Dermatology Life Quality Index (CDLQI) Score of 0 or 1 at Week 16 Among Participants With a Baseline CDLQI Score >1 | The CDLQI was an adapted version of the DLQI for the pediatric population and was utilized in the adolescent population in this study. The CDLQI is a 10-item instrument that has 4 item response options and a recall period of 1 week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children. The instrument is designed for use in children, is self-explanatory and can be simply handed to the participant who asked to fill it in with the help of the child's parent or caregiver. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Analysis population only included all participants who were randomized at Week 0 in the study and had baseline CDLQI score >1. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Adolescent Participants: Change From Baseline in CDLQI at Week 16 | The CDLQI was an adapted version of the DLQI for the pediatric population and was utilized in the adolescent population in this study. The CDLQI is a 10-item instrument that has 4 item response options and a recall period of 1 week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children. The instrument is designed for use in children, is self-explanatory and can be simply handed to the participant who asked to fill it in with the help of the child's parent or caregiver. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | FAS included all adolescent participants who were randomized at Week 0 in the study. Here, 'N' (overall number of participants analyzed) signifies number of participants with non-missing data for this outcome measure after applying predefined intercurrent event rules. Participants with missing assessments were not included, as no further imputation was applied for missing data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Week 0), Week 16 |
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| Secondary | Adolescent Participants: Change From Baseline in Domain Scores of the PROMIS-25 Pediatric Score at Week 16 | The PROMIS-25 was utilized in the adolescent population and is a 25-item generic HRQoL survey. Six PROMIS domains (physical function mobility, anxiety, depressive symptoms, fatigue, peer relationships, pain interference) are each assessed with 4 questions. Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often, 5=always). Higher score=worst pain. Raw scores for each domain were converted to T-scores using standardized score with a mean of 50 and a standard deviation (SD) of 10 with an observed range 20 to 80. For anxiety, depressive symptoms, fatigue, and pain interference, a negative change indicates an improvement while for physical function mobility and peer relationships, a positive change indicates an improvement. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | FAS included all adolescent participants who were randomized at Week 0 in the study. Here, 'N' (overall number of participants analyzed) signifies number of participants with non-missing data for this outcome measure after applying predefined intercurrent event rules. Participants with missing assessments were not included, as no further imputation was applied for missing data. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline (Week 0), Week 16 |
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| Secondary | Percentage of Participants Who Achieved an IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Week 52 | IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0=no evidence of plaque elevation, 1=minimal plaque elevation, =0.25mm; 2=mild plaque elevation, =0.5 mm; 3=moderate plaque elevation, =0.75mm;4=severe plaque elevation, >1 mm; Erythema: 0=no evidence of erythema, hyperpigmentation may be present, 1=faint erythema, 2=light red coloration, 3=moderate red coloration, 4=bright red coloration; Scaling: 0=no evidence of scaling, 1=minimal; occasional fine scale over less than 5% of lesion, 2=mild; fine scale dominates,3 =moderate; coarse scale predominates, 4 =severe; thick, scale predominates.Final IGA score of psoriasis was based upon average of induration,erythema and scaling scores assessed on a 5 point scale: cleared(0),minimal(1),mild(2),moderate (3), or severe (4).Higher score=more severe disease. Baseline: closest measurement taken prior to or at time of first study drug administration date. | Analysis population included participants who were re-randomized at Week 24 and were IGA 0 or 1 responder at Week 24. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 52 |
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| Secondary | Percentage of Participants Achieving IGA Score of 0 at Week 52 Among Participants Who Were IGA 0 Responders at Week 24 | The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease. | Analysis population included participants who were re-randomized at Week 24 and were IGA 0 responder at Week 24. Here, 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 52 |
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| Secondary | Percentage of Participants Achieving PASI 100 Response at Week 52 Among PASI 100 Responders at Week 24 | Percentage of participants achieving PASI 100 (100% improvement from baseline in PASI) response at Week 52 among PASI 100 responders at Week 24 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. | Analysis population included participants who were re-randomized at Week 24 and were PASI 100 responder at Week 24. Here, 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 52 |
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| Secondary | Time to Loss of IGA Response of 0 or 1 | The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease. | Analysis population included participants who were re-randomized at Week 24 and were IGA 0 or 1 responder at Week 24. | Posted | Median | Inter-Quartile Range | Weeks | Week 24 up to Week 52 |
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| Secondary | Adolescent Participants: Percentage of Participants With IGA Score of 0 or 1 and a >=2-grade Improvement From Baseline at Week 52 | IGA assesses participant's plaque psoriasis. Lesions were graded for induration,erythema and scaling,each using 5 point scale. Induration: 0=no evidence of plaque elevation, 1=minimal plaque elevation,=0.25mm; 2=mild plaque elevation,=0.5 mm; 3=moderate plaque elevation,= 0.75 mm; 4=severe plaque elevation, >1mm; Erythema: 0=no evidence of erythema, hyperpigmentation may be present, 1=faint erythema, 2=light red coloration, 3=moderate red coloration, 4=bright red coloration; Scaling:0=no evidence of scaling, 1=minimal; occasional fine scale over less than 5% of lesion, 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared(0), minimal(1), mild(2), moderate(3), or severe(4). Higher score=more severe disease. Baseline:closest measurement taken prior to or at time of first study drug administration date. | FAS included all adolescent participants who were randomized at Week 0 in the study. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 52 |
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| Secondary | Adolescent Participants: Percentage of Participants Who Achieved PASI 75 Response at Week 52 | Percentage of participants who achieved PASI 75 (>=75% improvement in PASI from baseline) response at Week 52 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. Baseline:closest measurement taken prior to or at time of first study drug administration date. | FAS included all adolescent participants who were randomized at Week 0 in the study. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 52 |
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| Secondary | Adolescent Participants: Percentage of Participants Who Achieved PASI 90 Response at Week 52 | Percentage of participants who achieved PASI 90 (at least >=90% improvement in PASI from baseline) response at Week 52 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. Baseline: closest measurement taken prior to or at time of first study drug administration date. | FAS included all adolescent participants who were randomized at Week 0 in the study. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Week 52 |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (AEs) | Not Posted | Apr 2028 | From Week 0 up to Week 160 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | Not Posted | Apr 2028 | From Week 0 up to Week 160 | Participants |
Placebo-controlled period (PCP): Weeks 0-16; After PCP: Weeks 16-24; Randomized Withdrawal (RWD) period: Weeks 24-52
Safety analysis set included all randomized participants who took at least 1 dose of study intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (PCP Week 0-16) | Adult participants: Participants received placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0- 16. Adolescent participants: Participants received placebo matching to JNJ-77242113 tablet orally QD from Week 0- 16. | 0 | 228 | 6 | 228 | 31 | 228 |
| EG001 | JNJ-77242113 200 mg (PCP Week 0-16) | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 16. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 16. | 0 | 456 | 6 | 456 | 59 | 456 |
| EG002 | Placebo to JNJ-77242113 200 mg (After PCP Week 16-24) | Adult participants: At Week 16, participants were crossed-over to receive JNJ-77242113 200 mg tablet orally QD through Week 24. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 16- 24. | 0 | 213 | 1 | 213 | 11 | 213 |
| EG003 | JNJ-77242113 200 mg (After PCP Week 16-24) | Adult participants: Participants received JNJ-77242113 200 mg tablet QD daily from Week 16- 24. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 16- 24. | 0 | 437 | 5 | 437 | 17 | 437 |
| EG004 | Placebo to JNJ-77242113 200 mg (Week 24-52) | Participants received JNJ-77242113 200 mg QD from Week 24 up to Week 52. | 0 | 212 | 3 | 212 | 39 | 212 |
| EG005 | Responders: JNJ-77242113 200 mg to Placebo (RWD Week 24-52) | Adults who were PASI 75 or IGA 0 or 1 responders at Week 24 were re-randomized to placebo matching to JNJ-77242113 tablet orally QD. Upon loss of >=50% Week 24 PASI improvement, participants were retreated with JNJ-77242113 200 mg tablet orally QD up to Week 52. | 0 | 172 | 2 | 172 | 10 | 172 |
| EG006 | Responders: JNJ-77242113 200 mg (RWD Week 24-52) | Adults who were PASI 75 or IGA 0 or 1 responders at Week 24 were re-randomized to continue JNJ-77242113 200 mg QD up to Week 52. | 0 | 168 | 3 | 168 | 29 | 168 |
| EG007 | JNJ-77242113 200 mg (Week 24-52) | Adults who are both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD from Week 24 up to Week 52. Adolescents received JNJ-77242113 200 mg tablet orally QD from Week 24 up to Week 52. | 0 | 96 | 2 | 96 | 20 | 96 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Anal Fistula | Gastrointestinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Acute Cholecystitis Necrotic | Hepatobiliary disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Gastroenteritis Bacterial | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Clavicle Fracture | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Craniofacial Fracture | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Lumbar Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Pelvic Fracture | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Adenocarcinoma of Colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Status Migrainosus | Nervous system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Subarachnoid Haemorrhage | Nervous system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Aortic Aneurysm | Vascular disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Hypertensive Urgency | Vascular disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Poor Peripheral Circulation | Vascular disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Varicose Vein | Vascular disorders | MedDRA Version 27.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Head Dermatology | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 12, 2024 | Apr 15, 2026 | SAP_001.pdf |
Not provided
| Pregnancy |
|
| Protocol Violation |
|
| Withdrawal by Subject |
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| Non-compliance with study schedule |
|
| Other |
|
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Canada |
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| China |
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| Germany |
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| Hungary |
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| Italy |
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| Japan |
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| Korea, Republic of |
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| Poland |
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| Spain |
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| Taiwan |
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| Turkey |
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| United Kingdom |
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| United States |
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| Argentina |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | Responders: JNJ-77242113 200 mg (RWD Week 24-52) | Adults who were PASI 75 or IGA 0 or 1 responders at Week 24 were re-randomized to continue JNJ-77242113 200 mg tablet orally QD up to Week 52. |
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| OG001 | Responders: JNJ-77242113 200 mg (RWD Week 24-52) | Adults who were PASI 75 or IGA 0 or 1 responders at Week 24 were re-randomized to continue JNJ-77242113 200 mg tablet orally QD up to Week 52. |
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| OG001 |
| Responders: JNJ-77242113 200 mg (RWD Week 24-52) |
Adults who were PASI 75 or IGA 0 or 1 responders at Week 24 were re-randomized to continue JNJ-77242113 200 mg tablet orally QD up to Week 52. |
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| OG001 |
| Responders: JNJ-77242113 200 mg (RWD Week 24-52) |
Adults who were PASI 75 or IGA 0 or 1 responders at Week 24 were re-randomized to continue JNJ-77242113 200 mg tablet orally QD up to Week 52. |
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Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 |
| JNJ-77242113 200 mg |
Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | Responders: JNJ-77242113 200 mg (RWD Week 24-52) | Adults who were PASI 75 or IGA 0 or 1 responders at Week 24 were re-randomized to continue JNJ-77242113 200 mg tablet orally QD up to Week 52. |
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| OG001 | Responders: JNJ-77242113 200 mg (RWD Week 24-52) | Adults who were PASI 75 or IGA 0 or 1 responders at Week 24 were re-randomized to continue JNJ-77242113 200 mg tablet orally QD up to Week 52. |
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| OG001 | Responders: JNJ-77242113 200 mg (RWD Week 24-52) | Adults who were PASI 75 or IGA 0 or 1 responders at Week 24 were re-randomized to continue JNJ-77242113 200 mg tablet orally QD up to Week 52. |
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Adults who were PASI 75 or IGA 0 or 1 responders at Week 24 were re-randomized to continue JNJ-77242113 200 mg tablet orally QD up to Week 52. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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| OG001 | JNJ-77242113 200 mg | Adult participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 24. At Week 24, participants who were psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieved an IGA score of 0 or 1 and had greater than or equal to [>=]2-grade improvement from baseline) were re-randomized either to continue JNJ-77242113 or to placebo (and were retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Participants who were both PASI 75 non-responders and IGA 0 or 1 non-responders at Week 24 continued to receive JNJ-77242113 200 mg tablet orally QD through Week 52. Adolescent participants: Participants received JNJ-77242113 200 mg tablet orally QD from Week 0- 52. Per plan, adolescent participants were not re-randomized regardless of their PASI score or IGA score at Week 24. |
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