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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-004320-16 | EudraCT Number | ||
| 77242113PSO2002 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate long-term clinical response of JNJ-77242113 treatment 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 this study evaluates JNJ-77242113 as options of advanced therapies in moderate to severe plaque psoriasis. This is a long-term extension study of JNJ-77242113 in eligible participants who have completed the Week 16 visit of the originating Study 77242113PSO2001. The total duration of this study will be up to 40 weeks which will include a 36-week treatment period, and a 4-week safety follow-up period after the last study intervention administration. Safety will be assessed by adverse events (AEs), clinical safety laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: JNJ-77242113 Dose 1 Once Daily (QD) | Experimental | Participants originally randomized to JNJ-77242113 Dose 1 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 QD from Week 0 through Week 36 in this study. |
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| Group 2: JNJ-77242113 Dose 2 QD | Experimental | Participants originally randomized to JNJ-77242113 Dose 2 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 2 QD from Week 0 through Week 36 in this study. |
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| Group 3: JNJ-77242113 Dose 3 QD | Experimental | Participants originally randomized to JNJ-77242113 Dose 3 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study. |
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| Group 4: JNJ-77242113 Dose 1 Twice Daily (BID) | Experimental | Participants originally randomized to JNJ-77242113 Dose 1 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 BID from Week 0 through Week 36 in this study. |
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| Group 5: JNJ-77242113 Dose 3 BID | 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 Greater Than or Equal to (>=) 75 Percent (%) Improvement From Baseline in Psoriasis Area Severity Index Score (PASI-75) at LTE Week 36 | Percentage of participants who achieved >=75% improvement from baseline in PASI score at LTE Week 36 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, 4=very severe) and extent of involvement from 0 (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 more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study. | Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved at Least 90% Improvement From Baseline in PASI Score (PASI-90) at LTE Week 36 | Percentage of participants who achieved >=90% improvement from baseline in PASI score at LTE Week 36 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In 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, 4=very severe) and extent of involvement from 0 (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 more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Skin Institute | Sacramento | California | 95815 | United States | ||
| Renstar Medical Research |
| 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. | |
| 39971605 |
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The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Total of 227 participants entered study 77242113PSO2002 (long-term extension [LTE]) after completing originating study 77242113PSO2001 (NCT05223868) Week 16. Per plan, data collected from Week 0 of originating study was analyzed for efficacy while data from Week 0 of current study (referred as LTE Week 0) was analyzed for safety.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Then JNJ-77242113 100 mg QD | Participants originally randomized to placebo in originating study (77242113PSO2001) received JNJ-77242113 100 milligrams (mg) tablet orally once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 6, 2022 | Apr 15, 2026 |
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Participants originally randomized to JNJ-77242113 Dose 3 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 BID from Week 0 through Week 36 in this study.
|
| Group 6: JNJ-77242113 Dose 3 QD | Experimental | Participants originally randomized to placebo in originating Study 77242113PSO2001 will receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study. |
|
| Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline) |
| Percentage of Participants Who Achieved 100% Improvement From Baseline in PASI Score (PASI-100) at LTE Week 36 | Percentage of participants who achieved 100% improvement from baseline in PASI score at LTE Week 36 was reported. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1=slight, 2=moderate, 3=severe and 4=very severe) and extent of involvement from 0 (no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range on a scale of 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study. | Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline) |
| Change From Baseline in PASI Total Score at LTE Week 36 | Change from baseline in PASI total score at LTE Week 36 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 first study drug administration date in 77242113PSO2001 study. | Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline) |
| Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at LTE Week 36 | 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). A higher score indicated more severe disease. | At LTE Week 36 (52 weeks from originating study baseline) |
| Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at LTE Week 36 | Change from baseline in PSSD symptoms scores at LTE Week 36 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: 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 scales for severity. Items were averaged on the daily symptom score when at least 3 items (>=50 percentage of 5 items) on these scales were 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. Baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study. | Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline) |
| Change From Baseline in PSSD Signs Score at LTE Week 36 | Change from baseline in PSSD sign scores at LTE Week 36 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 were 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 first study drug administration date in 77242113PSO2001 study. | Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline) |
| Percentage of Participants Who Achieved PSSD Symptoms Score Equal (=) 0 at LTE Week 36 Among Participants With a Baseline (Week 0 of the Originating Study) Symptoms 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 symptom score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is 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 first study drug administration date in 77242113PSO2001 study. | Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline) |
| Percentage of Participants Achieving PSSD Signs Score=0 at Week 36 Among Participants With a Baseline (Week 0 of the Originating Study) Signs 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 is 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 first study drug administration date in 77242113PSO2001 study. | Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline) |
| Number of Participants With Treatment-emergent Adverse Events (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 AE that occurred after receiving the treatment in originating study (77242113PSO2001). TEAEs and TESAEs that occurred during this study are reported. | From LTE Week 0 up to LTE Week 40 |
| Ocala |
| Florida |
| 34470 |
| United States |
| Forcare Clinical Research Inc | Tampa | Florida | 33613 | United States |
| Arlington Dermatology | Rolling Meadows | Illinois | 60008 | United States |
| Indiana Clinical Trial Center | Plainfield | Indiana | 46168 | 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 |
| Center for Clinical Studies | Webster | Texas | 77598 | 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 | N8T 1E6 | Canada |
| Innovaderm Research Inc. | Montreal | Quebec | H2H2B5 | 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 |
| ISA - Interdisciplinary Study Association GmbH | Berlin | 10789 | Germany |
| CRS Clinical Research Services Berlin GmbH | Berlin | 13627 | 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 |
| Gemeinschaftspraxis Scholz/Sebastian/Schilling | Mahlow | 15831 | Germany |
| Hautarztpraxis | Witten | 58453 | Germany |
| 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 |
| 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. 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 | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 10048 | Taiwan |
| Chang-Gung Memorial Hospital, LinKou Branch | Taoyuan | 333 | Taiwan |
| Guys and St Thomas NHS Foundation Trust | London | SE1 9RT | United Kingdom |
| University Hospital Southampton NHS Foundation Trust | Southampton | SO16 6YD | United Kingdom |
| Derived |
| LaRoche JK, Lanier J, Alvarenga R, Collins M, Costelloe T, Chiau A, Whetherly H, De Soete W, Faludi J, Rens K. Climate footprint of industry-sponsored in-human clinical trials: life cycle assessments of clinical trials spanning multiple phases and disease areas. BMJ Open. 2025 Feb 19;15(2):e085364. doi: 10.1136/bmjopen-2024-085364. |
| FG001 |
| JNJ-77242113 25 mg QD |
Participants received JNJ-77242113 25 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| FG002 | JNJ-77242113 50 mg QD | Participants received JNJ-77242113 50 mg tablet orally QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| FG003 | JNJ-77242113 25 mg BID | Participants received JNJ-77242113 25 mg tablet orally twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 36 in this LTE study. |
| FG004 | JNJ-77242113 100 mg QD | Participants received JNJ-77242113 100 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| FG005 | JNJ-77242113 100 mg BID | Participants received JNJ-77242113 100 mg tablet BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 36 in this LTE study. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Then JNJ-77242113 100 mg QD | Participants originally randomized to placebo in originating study (77242113PSO2001) received JNJ-77242113 100 milligrams (mg) tablet orally once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| BG001 | JNJ-77242113 25 mg QD | Participants received JNJ-77242113 25 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| BG002 | JNJ-77242113 50 mg QD | Participants received JNJ-77242113 50 mg tablet orally QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| BG003 | JNJ-77242113 25 mg BID | Participants received JNJ-77242113 25 mg tablet orally twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 36 in this LTE study. |
| BG004 | JNJ-77242113 100 mg QD | Participants received JNJ-77242113 100 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| BG005 | JNJ-77242113 100 mg BID | Participants received JNJ-77242113 100 mg tablet BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 36 in this LTE study. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants Who Achieved Greater Than or Equal to (>=) 75 Percent (%) Improvement From Baseline in Psoriasis Area Severity Index Score (PASI-75) at LTE Week 36 | Percentage of participants who achieved >=75% improvement from baseline in PASI score at LTE Week 36 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, 4=very severe) and extent of involvement from 0 (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 more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study. | Full analysis set (FAS) included randomized participants who received at least one dose of study intervention in the originating study (77242113PSO2001) for participants initially randomized to JNJ-77242113, and participants who crossed over and received JNJ-77242113 for participants initially randomized to placebo. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline) |
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| Secondary | Percentage of Participants Who Achieved at Least 90% Improvement From Baseline in PASI Score (PASI-90) at LTE Week 36 | Percentage of participants who achieved >=90% improvement from baseline in PASI score at LTE Week 36 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In 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, 4=very severe) and extent of involvement from 0 (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 more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study. | FAS included randomized participants who received at least one dose of study intervention in the originating study (77242113PSO2001) for participants initially randomized to JNJ-77242113, and participants who crossed over and received JNJ-77242113 for participants initially randomized to placebo. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline) |
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| Secondary | Percentage of Participants Who Achieved 100% Improvement From Baseline in PASI Score (PASI-100) at LTE Week 36 | Percentage of participants who achieved 100% improvement from baseline in PASI score at LTE Week 36 was reported. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1=slight, 2=moderate, 3=severe and 4=very severe) and extent of involvement from 0 (no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range on a scale of 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study. | FAS included randomized participants who received at least one dose of study intervention in the originating study (77242113PSO2001) for participants initially randomized to JNJ-77242113, and participants who crossed over and received JNJ-77242113 for participants initially randomized to placebo. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline) |
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| Secondary | Change From Baseline in PASI Total Score at LTE Week 36 | Change from baseline in PASI total score at LTE Week 36 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 first study drug administration date in 77242113PSO2001 study. | FAS was used. Here, 'N' (Overall number of participants analyzed) signifies number of participants with non-missing data for this outcome measure after applying predefined intercurrent event rules. Participants with missing assessments were not included, as no further imputation was applied for missing data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline) |
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| Secondary | Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at LTE Week 36 | 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). A higher score indicated more severe disease. | FAS included randomized participants who received at least one dose of study intervention in the originating study (77242113PSO2001) for participants initially randomized to JNJ-77242113, and participants who crossed over and received JNJ-77242113 for participants initially randomized to placebo. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | At LTE Week 36 (52 weeks from originating study baseline) |
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| Secondary | Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at LTE Week 36 | Change from baseline in PSSD symptoms scores at LTE Week 36 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: 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 scales for severity. Items were averaged on the daily symptom score when at least 3 items (>=50 percentage of 5 items) on these scales were 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. Baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study. | FAS was used. Here, 'N' (Overall number of participants analyzed) signifies number of participants with non-missing data for this outcome measure after applying predefined intercurrent event rules. Participants with missing assessments were not included, as no further imputation was applied for missing data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline) |
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| Secondary | Change From Baseline in PSSD Signs Score at LTE Week 36 | Change from baseline in PSSD sign scores at LTE Week 36 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 were 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 first study drug administration date in 77242113PSO2001 study. | FAS was used. Here, 'N' (Overall number of participants analyzed) signifies number of participants with non-missing data for this outcome measure after applying predefined intercurrent event rules. Participants with missing assessments were not included, as no further imputation was applied for missing data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline) |
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| Secondary | Percentage of Participants Who Achieved PSSD Symptoms Score Equal (=) 0 at LTE Week 36 Among Participants With a Baseline (Week 0 of the Originating Study) Symptoms 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 symptom score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is 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 first study drug administration date in 77242113PSO2001 study. | FAS: randomized participants who received at least 1 dose of study intervention in originating study (77242113PSO2001) for participants initially randomized to JNJ-77242113, and participants who crossed over and received JNJ-77242113 for participants initially randomized to placebo and had baseline PSSD (Week 0 of originating study) symptom score >=1. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline) |
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| Secondary | Percentage of Participants Achieving PSSD Signs Score=0 at Week 36 Among Participants With a Baseline (Week 0 of the Originating Study) Signs 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 is 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 first study drug administration date in 77242113PSO2001 study. | FAS: randomized participants who received at least 1 dose of study intervention in originating study (77242113PSO2001) for participants initially randomized to JNJ-77242113, and participants who crossed over and received JNJ-77242113 for participants initially randomized to placebo and had baseline (Week 0 of originating study) PSSD sign score >=1. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. | Posted | Number | Percentage of participants | Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline) |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (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 AE that occurred after receiving the treatment in originating study (77242113PSO2001). TEAEs and TESAEs that occurred during this study are reported. | LTE safety analysis set included randomized participants in study 77242113PSO2001 who entered the LTE study 77242113PSO2002 and received at least one dose of study intervention (including a partial dose) during the 77242113PSO2002 study period. | Posted | Count of Participants | Participants | From LTE Week 0 up to LTE Week 40 |
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From LTE Week 0 up to LTE Week 40
Safety analysis were based on LTE safety analysis set which included randomized participants in study 77242113PSO2001 who entered the LTE study 77242113PSO2002 and received at least one dose of study intervention (including a partial dose) during the 77242113PSO2002 study period.
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 Then JNJ-77242113 100 mg QD | Participants originally randomized to placebo in originating study (77242113PSO2001) received JNJ-77242113 100 milligrams (mg) tablet orally once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. | 0 | 35 | 1 | 35 | 14 | 35 |
| EG001 | JNJ-77242113 25 mg QD | Participants received JNJ-77242113 25 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. | 0 | 35 | 0 | 35 | 13 | 35 |
| EG002 | JNJ-77242113 50 mg QD | Participants received JNJ-77242113 50 mg tablet orally QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. | 0 | 39 | 2 | 39 | 15 | 39 |
| EG003 | JNJ-77242113 25 mg BID | Participants received JNJ-77242113 25 mg tablet orally twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 36 in this LTE study. | 0 | 40 | 3 | 40 | 17 | 40 |
| EG004 | JNJ-77242113 100 mg QD | Participants received JNJ-77242113 100 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. | 0 | 40 | 2 | 40 | 20 | 40 |
| EG005 | JNJ-77242113 100 mg BID | Participants received JNJ-77242113 100 mg tablet BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 36 in this LTE study. | 0 | 38 | 1 | 38 | 15 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary Artery Disease | Cardiac disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Ventricular Dysfunction | Cardiac disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
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| Ligament Injury | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Non-systematic Assessment |
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| Foot Deformity | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | Non-systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Tonsillar Hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Meniscus Injury | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 26.0 | Non-systematic Assessment |
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| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 26.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 26.0 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Head Dermatology | Janssen Research and Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 15, 2022 | Apr 15, 2026 | SAP_001.pdf |
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| France |
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| Germany |
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| Japan |
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| Poland |
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| Korea, South |
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| Spain |
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| Taiwan |
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| United Kingdom |
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| United States |
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| OG001 | JNJ-77242113 25 mg QD | Participants received JNJ-77242113 25 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG002 | JNJ-77242113 50 mg QD | Participants received JNJ-77242113 50 mg tablet orally QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG003 | JNJ-77242113 25 mg BID | Participants received JNJ-77242113 25 mg tablet orally twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG004 | JNJ-77242113 100 mg QD | Participants received JNJ-77242113 100 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG005 | JNJ-77242113 100 mg BID | Participants received JNJ-77242113 100 mg tablet BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 36 in this LTE study. |
|
|
| OG001 | JNJ-77242113 25 mg QD | Participants received JNJ-77242113 25 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG002 | JNJ-77242113 50 mg QD | Participants received JNJ-77242113 50 mg tablet orally QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG003 | JNJ-77242113 25 mg BID | Participants received JNJ-77242113 25 mg tablet orally twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG004 | JNJ-77242113 100 mg QD | Participants received JNJ-77242113 100 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG005 | JNJ-77242113 100 mg BID | Participants received JNJ-77242113 100 mg tablet BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 36 in this LTE study. |
|
|
| OG001 | JNJ-77242113 25 mg QD | Participants received JNJ-77242113 25 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG002 | JNJ-77242113 50 mg QD | Participants received JNJ-77242113 50 mg tablet orally QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG003 | JNJ-77242113 25 mg BID | Participants received JNJ-77242113 25 mg tablet orally twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG004 | JNJ-77242113 100 mg QD | Participants received JNJ-77242113 100 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG005 | JNJ-77242113 100 mg BID | Participants received JNJ-77242113 100 mg tablet BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 36 in this LTE study. |
|
|
| OG001 | JNJ-77242113 25 mg QD | Participants received JNJ-77242113 25 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG002 | JNJ-77242113 50 mg QD | Participants received JNJ-77242113 50 mg tablet orally QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG003 | JNJ-77242113 25 mg BID | Participants received JNJ-77242113 25 mg tablet orally twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG004 | JNJ-77242113 100 mg QD | Participants received JNJ-77242113 100 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG005 | JNJ-77242113 100 mg BID | Participants received JNJ-77242113 100 mg tablet BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 36 in this LTE study. |
|
|
| OG001 | JNJ-77242113 25 mg QD | Participants received JNJ-77242113 25 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG002 | JNJ-77242113 50 mg QD | Participants received JNJ-77242113 50 mg tablet orally QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG003 | JNJ-77242113 25 mg BID | Participants received JNJ-77242113 25 mg tablet orally twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG004 | JNJ-77242113 100 mg QD | Participants received JNJ-77242113 100 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG005 | JNJ-77242113 100 mg BID | Participants received JNJ-77242113 100 mg tablet BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 36 in this LTE study. |
|
|
| OG001 | JNJ-77242113 25 mg QD | Participants received JNJ-77242113 25 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG002 | JNJ-77242113 50 mg QD | Participants received JNJ-77242113 50 mg tablet orally QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG003 | JNJ-77242113 25 mg BID | Participants received JNJ-77242113 25 mg tablet orally twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG004 | JNJ-77242113 100 mg QD | Participants received JNJ-77242113 100 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG005 | JNJ-77242113 100 mg BID | Participants received JNJ-77242113 100 mg tablet BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 36 in this LTE study. |
|
|
Participants originally randomized to placebo in originating study (77242113PSO2001) received JNJ-77242113 100 milligrams (mg) tablet orally once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study.
| OG001 | JNJ-77242113 25 mg QD | Participants received JNJ-77242113 25 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG002 | JNJ-77242113 50 mg QD | Participants received JNJ-77242113 50 mg tablet orally QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG003 | JNJ-77242113 25 mg BID | Participants received JNJ-77242113 25 mg tablet orally twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG004 | JNJ-77242113 100 mg QD | Participants received JNJ-77242113 100 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG005 | JNJ-77242113 100 mg BID | Participants received JNJ-77242113 100 mg tablet BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 36 in this LTE study. |
|
|
Participants originally randomized to placebo in originating study (77242113PSO2001) received JNJ-77242113 100 milligrams (mg) tablet orally once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study.
| OG001 | JNJ-77242113 25 mg QD | Participants received JNJ-77242113 25 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG002 | JNJ-77242113 50 mg QD | Participants received JNJ-77242113 50 mg tablet orally QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG003 | JNJ-77242113 25 mg BID | Participants received JNJ-77242113 25 mg tablet orally twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG004 | JNJ-77242113 100 mg QD | Participants received JNJ-77242113 100 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG005 | JNJ-77242113 100 mg BID | Participants received JNJ-77242113 100 mg tablet BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 36 in this LTE study. |
|
|
Participants received JNJ-77242113 25 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG002 | JNJ-77242113 50 mg QD | Participants received JNJ-77242113 50 mg tablet orally QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG003 | JNJ-77242113 25 mg BID | Participants received JNJ-77242113 25 mg tablet orally twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG004 | JNJ-77242113 100 mg QD | Participants received JNJ-77242113 100 mg tablet orally QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 36 in this LTE study. |
| OG005 | JNJ-77242113 100 mg BID | Participants received JNJ-77242113 100 mg tablet BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 36 in this LTE study. |
|
|