Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003700-41 | EudraCT Number | ||
| 77242113PSO2001 | Other Identifier | Janssen Research & Development, LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Th purpose of the study is to evaluate the dose response of JNJ-77242113 in efficacy at Week 16 in participants with moderate-to-severe plaque psoriasis.
The populations of people living with moderate to severe psoriasis is approximately 3.5 billion which are mostly managed with topical and conventional therapies. JNJ-77242113, investigational drug, targets the immune responses in the body and skin which impacts diseases, such as psoriasis and psoriatic arthritis (PsA) and this study evaluates JNJ-77242113 as options of advanced therapies in moderate to severe plaque psoriasis. The total duration of this study is up to 24 weeks which includes a screening period of less than or equal to (<=) 4 weeks, a 16-week treatment period, and a 4-week safety follow-up period. Safety will be assessed by adverse events (AEs), clinical safety laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: JNJ-77242113 Dose 1 Once Daily (QD) and Placebo | Experimental | Participants will receive JNJ-77242113 Dose 1 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens. |
|
| Group 2: JNJ-77242113 Dose 2 QD and Placebo | Experimental | Participants will receive JNJ-77242113 Dose 2 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens. |
|
| Group 3: JNJ-77242113 Dose 3 QD and Placebo | Experimental | Participants will receive JNJ-77242113 Dose 3 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens. |
|
| Group 4: JNJ-77242113 Dose 1 Twice Daily (BID) and Placebo | Experimental | Participants will receive JNJ-77242113 Dose 1 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens. |
|
| Group 5: JNJ-77242113 Dose 3 BID and Placebo | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-77242113 | Drug | JNJ-77242113 tablet will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 16 | Percentage of participants who achieved PASI-75 score (greater than or equal to [>=] 75% improvement from baseline in PASI) 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | ||
| Pacific Skin Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41424381 | Derived | Strawn D, Krueger JG, Bissonnette R, Eyerich K, Ferris LK, Paller AS, Pinter A, Richards D, Chen EY, Paget K, Horowitz D, Parast R, Rusbuldt JJ, Sendecki J, Bhagat S, Tomsho LP, Chou CH, Polak ME, Keyes BE, Bozenhardt E, Xiong Y, Zhou W, DeKlotz C, Newbold P, Waterworth DM, Miller M, Ota T, Yang YW, Leung MW, Miller LS, Cuff CA, McRae B, Ruane D, Kannan AK. Icotrokinra induces early and sustained pharmacodynamic responses in phase IIb study of patients with moderate-to-severe psoriasis. JCI Insight. 2025 Dec 22;10(24):e193563. doi: 10.1172/jci.insight.193563. eCollection 2025 Dec 22. | |
| 38324484 |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ- 77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in long-term extension (LTE) study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 12, 2022 | Dec 9, 2025 |
Not provided
Not provided
Not provided
Not provided
Participants will receive JNJ-77242113 Dose 3 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens. |
|
| Group 6: Placebo | Placebo Comparator | Participants will receive placebo BID from Week 0 through Week 16. |
|
| Placebo | Drug | Placebo tablet will be administered orally. |
|
| Baseline (Week 0), Week 16 |
| Percentage of Participants Who Achieved at Least 90% Improvement From Baseline in PASI (PASI-90) at Week 16 | Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) 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 100% Improvement From Baseline in PASI (PASI-100) at Week 16 | Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) 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 was 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 an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) 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 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 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 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). Higher score indicated more severe disease. | At Week 16 |
| Percentage of Participants Who Achieved an IGA Score of Cleared (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 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. | At Week 16 |
| 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) and Week 16 |
| Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at Week 16 | Change from baseline in PSSD symptoms scores at Week 16 was reported. PSSD was a patient-reported outcome (PRO) questionnaire designed to measure severity of psoriasis symptoms and signs for the assessment of treatment benefit. 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. Items were averaged on the daily symptom score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value was converted into 0-100 scoring, such that symptom score = average value*10, where, 0= least severe and 100= most 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. | Baseline (Week 0) and Week 16 |
| Change From Baseline in PSSD Signs Score at Week 16 | Change from baseline in PSSD sign scores at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 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. Items were averaged on the daily sign score when at least 3 items (>=50 percentage of 6 items) on these scales are answered. The average value was converted into 0-100 scoring, such that sign score = average value*10, where, 0= least severe and 100= most 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. | Baseline (Week 0) and Week 16 |
| Percentage of Participants Who Achieved PSSD Symptoms Score Equal to (=) 0 at Week 16 Among Participants With a Baseline Symptoms Score Greater Than or Equal to (>=) 1 | The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. 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. Items were averaged on the daily symptom score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value was converted into 0-100 scoring, such that symptom score = average value*10, where, 0= least severe and 100= most 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. | Baseline (Week 0), Week 16 |
| Percentage of Participants Who Achieved PSSD Sign Score = 0 at Week 16 Among Participants With a Baseline Sign Score >=1 | The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. 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. Items were averaged on the daily sign score when at least 3 items (>=50 percentage of 6 items) on these scales are answered. The average value was converted into 0-100 scoring, such that sign score = average value*10, where, 0= least severe and 100= most 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. | Baseline (Week 0) , Week 16 |
| Percentage of Participants Who Achieved a Dermatological Life Quality Index (DLQI) of 0 or 1 at Week 16 Among Participants With Baseline DLQI Score Greater Than (>) 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. | Baseline (Week 0), Week 16 |
| Change From Baseline in Domain Scores of the Patient-Reported Outcomes Measurement Information System (PROMIS-29) 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 i.e. 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) and Week 16 |
| Percentage of Participants Who Achieved at Least a 5-point Improvement From Baseline in Each PROMIS-29 Domain 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, 5=always). Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain). Higher score=worst pain. Each domain includes 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; SD of 10 (T-Score). Higher PROMIS T-score= more of the concept being measured i.e. higher scores in anxiety, depression, fatigue, pain interference and sleep disturbance) indicated worse symptoms, higher scores in physical function and social roles= better functioning. Baseline: closest measurement taken prior to/at the time of first study drug administration date. | Baseline (Week 0), Week 16 |
| Number of Participants With Treatment-emergent Adverse Event (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect. TEAE was defined as any event that occurred at or after the initial administration of study agent. | From Week 0 through Week 20 |
| Sacramento |
| California |
| 95815 |
| United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| Forcare Clinical Research Inc | Tampa | Florida | 33613 | United States |
| Atlanta Dermatology, Vein & Research Center | Alpharetta | Georgia | 30022 | United States |
| Arlington Dermatology | Rolling Meadows | Illinois | 60008 | United States |
| Dawes Fretzin Clinical Research Group LLC | Indianapolis | Indiana | 46250 | United States |
| Indiana Clinical Trial Center | Plainfield | Indiana | 46168 | United States |
| DermAssociates, PC | Rockville | Maryland | 20850 | United States |
| Hamzavi Dermatology | Fort Gratiot | Michigan | 48059 | United States |
| Vivida Dermatology | Las Vegas | Nevada | 89119 | United States |
| Windsor Dermatology, PC | East Windsor | New Jersey | 08520 | United States |
| Oregon Dermatology and Research Center | Portland | Oregon | 97210 | United States |
| University of Pittsburgh Department of Dermatology | Pittsburgh | Pennsylvania | 15213 | United States |
| Modern Research Associates | Dallas | Texas | 75231 | United States |
| Center for Clinical Studies | Houston | Texas | 77004 | United States |
| Austin Institute for Clinical Research | Pflugerville | Texas | 78660 | United States |
| Center for Clinical Studies | Webster | Texas | 77598 | United States |
| Virginia Clinical Research | Norfolk | Virginia | 23502 | United States |
| Dermatology Associates | Seattle | Washington | 98101 | United States |
| Premier Clinical Research | Spokane | Washington | 99202 | United States |
| Dermatrials Research | Hamilton | Ontario | L8N 1Y2 | Canada |
| Alliance Clinical Trials | Waterloo | Ontario | N2J 1C4 | Canada |
| XLR8 Medical Research | Windsor | Ontario | N8W 1E6 | Canada |
| Innovaderm Research | Montreal | Quebec | H2X 2V1 | Canada |
| Centre Hospitalier Le Mans | Le Mans | 72037 | France |
| Hopital Charles Nicolle | Rouen | 76031 | France |
| HIA Sainte Anne | Toulon | 83800 | France |
| Fachklinik Bad Bentheim | Bad Bentheim | 48455 | Germany |
| Charite - Universitaetsmedizin Berlin (CCM) | Berlin | 10117 | Germany |
| Rothhaar Studien GmbH | Berlin | 10783 | Germany |
| ISA - Interdisciplinary Study Association GmbH | Berlin | 10789 | Germany |
| Niesmann & Othlinghaus GbR | Bochum | 44793 | Germany |
| Rosenpark Research GmbH | Darmstadt | 64283 | Germany |
| Universitatsklinikum Frankfurt | Frankfurt am Main | 60590 | Germany |
| Derma-Study-Center Friedrichshafen GmbH | Friedrichshafen | 88045 | Germany |
| MensingDerma research GmbH | Hamburg | 22391 | Germany |
| Universitaetsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitatsklinikum Schleswig Holstein Kiel | Kiel | 24105 | Germany |
| Universitatsklinikum Leipzig AOR | Leipzig | 04103 | Germany |
| Dermatologische Gemeinschaftspraxis | Mahlow | 15831 | Germany |
| Hautarztpraxis | Witten | 58453 | Germany |
| Yamanashi Prefectural Central Hospital | Kofu | 400-8506 | Japan |
| Miyata Dermatology Clinic | Matsudo | 271-0092 | Japan |
| Takagi Dermatological Clinic | Obihiro-shi | 080-0013 | Japan |
| Kume Clinic | Sakai | 593 8324 | Japan |
| Sapporo Skin Clinic | Sapporo | 060 0063 | Japan |
| Shizuoka General Hospital | Shizuoka | 420-8527 | Japan |
| Shirasaki Dermatology Clinic | Takaoka | 933-0871 | Japan |
| Kumamoto Kenhoku Hospital | Tamana | 865-0005 | Japan |
| Toyama Prefectural Central Hospital | Toyama | 930 8550 | Japan |
| Nomura Dermatology Clinic | Yokohama | 221 0825 | Japan |
| Nzoz Zdrowie Osteo-Medic | Bialystok | 15-351 | Poland |
| Dermed Centrum Medyczne Sp z o o | Lodz | 90-265 | Poland |
| Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C | Osielsko | 86031 | Poland |
| Klinika Ambroziak Estederm Sp. z o.o | Warsaw | 02-953 | Poland |
| Wro Medica | Wroclaw | 51-685 | Poland |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | 13620 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Konkuk University Medical Center | Seoul | 05030 | South Korea |
| KyungHee University Hospital | Seoul | 102-1703 | South Korea |
| Hosp. Univ. Germans Trias I Pujol | Barcelona | 08916 | Spain |
| Hosp. Univ. 12 de Octubre | Madrid | 28041 | Spain |
| Hosp. Provincial de Pontevedra | Pontevedra | 36001 | Spain |
| Hosp. Univ. I Politecni La Fe | Valencia | 46026 | Spain |
| Hosp. de Manises | Valencia | 46940 | Spain |
| Chang Gung Memorial Hospital | Kaohsiung City | 83342 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 70403 | Taiwan |
| National Taiwan University Hospital | Taipei | 10048 | Taiwan |
| Chang-Gung Memorial Hospital, LinKou Branch | Taoyuan | 333 | Taiwan |
| Castle Hill Hospital | Cottingham | HU16 5JQ | United Kingdom |
| Russell's Hall Hospital | Dudley | DY1 2HQ | United Kingdom |
| Guys and St Thomas NHS Foundation Trust | London | SE1 9RT | United Kingdom |
| University Hospital Southampton NHS Foundation Trust | Southampton | SO16 6YD | United Kingdom |
| Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital | Wakefield | WF1 4DG | United Kingdom |
| Derived |
| Bissonnette R, Pinter A, Ferris LK, Gerdes S, Rich P, Vender R, Miller M, Shen YK, Kannan A, Li S, DeKlotz C, Papp K. An Oral Interleukin-23-Receptor Antagonist Peptide for Plaque Psoriasis. N Engl J Med. 2024 Feb 8;390(6):510-521. doi: 10.1056/NEJMoa2308713. |
| FG001 | JNJ-77242113 25 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| FG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| FG003 | JNJ-77242113 25 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| FG004 | JNJ-77242113 100 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| FG005 | JNJ-77242113 100 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ- 77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in long-term extension (LTE) study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| BG001 | JNJ-77242113 25 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| BG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| BG003 | JNJ-77242113 25 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| BG004 | JNJ-77242113 100 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| BG005 | JNJ-77242113 100 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 16 | Percentage of participants who achieved PASI-75 score (greater than or equal to [>=] 75% improvement from baseline in PASI) 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. | Full analysis set (FAS) included all randomized participants who received at least 1 administration of study intervention. | Posted | Number | Percentage of participants | Baseline (Week 0), Week 16 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 randomized participants who received at least 1 administration of study intervention. Here, 'N' (overall number of participants analyzed) signifies the number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Week 0), Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved at Least 90% Improvement From Baseline in PASI (PASI-90) at Week 16 | Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) 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 randomized participants who received at least 1 administration of study intervention. | Posted | Number | Percentage of participants | Baseline (Week 0), Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved 100% Improvement From Baseline in PASI (PASI-100) at Week 16 | Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) 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 was 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 randomized participants who received at least 1 administration of study intervention. | Posted | Number | Percentage of participants | Baseline (Week 0), Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) 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 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 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 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). Higher score indicated more severe disease. | FAS included all randomized participants who received at least 1 administration of study intervention. | Posted | Number | Percentages of participants | At Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved an IGA Score of Cleared (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 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. | FAS included all randomized participants who received at least 1 administration of study intervention. | Posted | Number | Percentage of participants | At Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 randomized participants who received at least 1 administration of study intervention. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percentage of BSA | Baseline (Week 0) and Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at Week 16 | Change from baseline in PSSD symptoms scores at Week 16 was reported. PSSD was a patient-reported outcome (PRO) questionnaire designed to measure severity of psoriasis symptoms and signs for the assessment of treatment benefit. 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. Items were averaged on the daily symptom score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value was converted into 0-100 scoring, such that symptom score = average value*10, where, 0= least severe and 100= most 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. | FAS included all randomized participants who received at least 1 administration of study intervention. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Week 0) and Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in PSSD Signs Score at Week 16 | Change from baseline in PSSD sign scores at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 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. Items were averaged on the daily sign score when at least 3 items (>=50 percentage of 6 items) on these scales are answered. The average value was converted into 0-100 scoring, such that sign score = average value*10, where, 0= least severe and 100= most 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. | FAS included all randomized participants who received at least 1 administration of study intervention. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Week 0) and Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved PSSD Symptoms Score Equal to (=) 0 at Week 16 Among Participants With a Baseline Symptoms Score Greater Than or Equal to (>=) 1 | The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. 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. Items were averaged on the daily symptom score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value was converted into 0-100 scoring, such that symptom score = average value*10, where, 0= least severe and 100= most 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 included all randomized participants who received at least 1 administration of study intervention and had baseline PSSD symptom score >=1. | Posted | Number | Percentage of participants | Baseline (Week 0), Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved PSSD Sign Score = 0 at Week 16 Among Participants With a Baseline Sign Score >=1 | The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. 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. Items were averaged on the daily sign score when at least 3 items (>=50 percentage of 6 items) on these scales are answered. The average value was converted into 0-100 scoring, such that sign score = average value*10, where, 0= least severe and 100= most 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 included all randomized participants who received at least 1 administration of study intervention and had baseline PSSD sign score >=1. | Posted | Number | Percentage of participants | Baseline (Week 0) , Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a Dermatological Life Quality Index (DLQI) of 0 or 1 at Week 16 Among Participants With Baseline DLQI Score Greater Than (>) 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 randomized participants who received at least 1 administration of study intervention and had baseline DLQI score >1. | Posted | Number | Percentage of participants | Baseline (Week 0), Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Domain Scores of the Patient-Reported Outcomes Measurement Information System (PROMIS-29) 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 i.e. 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 randomized participants who received at least 1 administration of study intervention. Here 'N' (overall number of participants analyzed) referred to the number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Week 0) and Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved at Least a 5-point Improvement From Baseline in Each PROMIS-29 Domain 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, 5=always). Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain). Higher score=worst pain. Each domain includes 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; SD of 10 (T-Score). Higher PROMIS T-score= more of the concept being measured i.e. higher scores in anxiety, depression, fatigue, pain interference and sleep disturbance) indicated worse symptoms, higher scores in physical function and social roles= better functioning. Baseline: closest measurement taken prior to/at the time of first study drug administration date. | FAS included all randomized participants who received at least 1 administration of study intervention. | Posted | Number | Percentage of participants | Baseline (Week 0), Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Event (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect. TEAE was defined as any event that occurred at or after the initial administration of study agent. | The safety analyses set included all randomized participants who received at least 1 administration of study intervention. | Posted | Count of Participants | Participants | From Week 0 through Week 20 |
|
From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration 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 | Participants with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ- 77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in long-term extension (LTE) study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. | 0 | 43 | 0 | 43 | 10 | 43 |
| EG001 | JNJ-77242113 25 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. | 0 | 43 | 0 | 43 | 10 | 43 |
| EG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. | 0 | 43 | 1 | 43 | 15 | 43 |
| EG003 | JNJ-77242113 25 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. | 0 | 41 | 0 | 41 | 12 | 41 |
| EG004 | JNJ-77242113 100 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. | 0 | 43 | 2 | 43 | 8 | 43 |
| EG005 | JNJ-77242113 100 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. | 0 | 42 | 0 | 42 | 10 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Infected Cyst | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | 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 and Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 15, 2022 | Dec 9, 2025 | SAP_001.pdf |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| France |
|
| Germany |
|
| Japan |
|
| Korea, South |
|
| Poland |
|
| Spain |
|
| Taiwan |
|
| United Kingdom |
|
| United States |
|
| OG004 |
| JNJ-77242113 100 mg QD |
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG005 | JNJ-77242113 100 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| <0.001 |
Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not. |
| Superiority |
| Cochran-Mantel-Haenszel | <0.001 | Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not. | Superiority |
| Cochran-Mantel-Haenszel | <0.001 | Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not. | Superiority |
| Cochran-Mantel-Haenszel | <0.001 | Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not. | Superiority |
| OG001 | JNJ-77242113 25 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG003 | JNJ-77242113 25 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG004 | JNJ-77242113 100 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG005 | JNJ-77242113 100 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
|
|
|
| OG001 | JNJ-77242113 25 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG003 | JNJ-77242113 25 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG004 | JNJ-77242113 100 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG005 | JNJ-77242113 100 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
|
|
|
| OG001 | JNJ-77242113 25 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG003 | JNJ-77242113 25 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG004 | JNJ-77242113 100 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG005 | JNJ-77242113 100 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
|
|
|
| OG001 | JNJ-77242113 25 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG003 | JNJ-77242113 25 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG004 | JNJ-77242113 100 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG005 | JNJ-77242113 100 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
|
|
|
| OG001 | JNJ-77242113 25 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG003 | JNJ-77242113 25 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG004 | JNJ-77242113 100 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG005 | JNJ-77242113 100 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
|
|
|
| OG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG003 | JNJ-77242113 25 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG004 | JNJ-77242113 100 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG005 | JNJ-77242113 100 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
|
|
|
| OG001 | JNJ-77242113 25 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG003 | JNJ-77242113 25 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG004 | JNJ-77242113 100 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG005 | JNJ-77242113 100 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
|
|
|
| OG001 | JNJ-77242113 25 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG003 | JNJ-77242113 25 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG004 | JNJ-77242113 100 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG005 | JNJ-77242113 100 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
|
|
|
| OG001 | JNJ-77242113 25 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG003 | JNJ-77242113 25 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG004 | JNJ-77242113 100 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG005 | JNJ-77242113 100 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
|
|
|
| OG001 | JNJ-77242113 25 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG003 | JNJ-77242113 25 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG004 | JNJ-77242113 100 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG005 | JNJ-77242113 100 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
|
|
|
| OG001 | JNJ-77242113 25 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG003 | JNJ-77242113 25 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG004 | JNJ-77242113 100 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG005 | JNJ-77242113 100 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
|
|
|
| OG001 | JNJ-77242113 25 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG003 | JNJ-77242113 25 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG004 | JNJ-77242113 100 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG005 | JNJ-77242113 100 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
|
|
|
| OG001 | JNJ-77242113 25 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG003 | JNJ-77242113 25 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG004 | JNJ-77242113 100 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG005 | JNJ-77242113 100 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
|
|
|
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
| OG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG003 | JNJ-77242113 25 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG004 | JNJ-77242113 100 mg QD | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
| OG005 | JNJ-77242113 100 mg BID | Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16. |
|
|