Phase 2
N=227
A Long-term Extension Study of JNJ-77242113 in Participants With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT05364554 ↗Enrolled (actual)
227
Serious AEs
4.0%
Results posted
Jun 2026
Primary outcome: 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 — 65.7; 48.8; 69.8; 58.5 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- JNJ-77242113 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
65.7; 48.8; 69.8; 58.5; 65.1; 76.2 | — |
| SECONDARY Percentage of Participants Who Achieved at Least 90% Improvement From Baseline in PASI Score (PASI-90) at LTE Week 36 |
57.1; 27.9; 41.9; 36.6; 51.2; 64.3 | — |
| SECONDARY Percentage of Participants Who Achieved 100% Improvement From Baseline in PASI Score (PASI-100) at LTE Week 36 |
34.3; 14.0; 20.9; 17.1; 25.6; 40.5 | — |
| SECONDARY Change From Baseline in PASI Total Score at LTE Week 36 |
-14.15; -13.55; -14.45; -13.24; -15.81; -18.46 | — |
| SECONDARY Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at LTE Week 36 |
65.7; 37.2; 60.5; 46.3; 60.5; 73.8 | — |
| SECONDARY Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at LTE Week 36 |
-29.5; -30.1; -35.2; -31.2; -29.4; -47.7 | — |
| SECONDARY Change From Baseline in PSSD Signs Score at LTE Week 36 |
-42.8; -35.2; -39.2; -36.6; -43.1; -53.1 | — |
| 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 |
34.3; 18.6; 21.4; 17.1; 30.2; 26.2 | — |
| 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 |
22.9; 16.3; 11.6; 12.2; 14.0; 16.7 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
23; 18; 19; 27; 27; 19 | — |
Summary
The purpose of this study is to evaluate long-term clinical response of JNJ-77242113 treatment in participants with moderate-to-severe plaque psoriasis.
Eligibility Criteria
Inclusion Criteria
- Must have completed the Week 16 visit in Protocol 77242113PSO2001
- In the opinion of the investigator, may benefit from inclusion in this long term extension (LTE) study
- Must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study
- Must agree to discontinue all topical therapies that could affect psoriasis or the psoriasis area severity index (PASI) or investigator's global assessment (IGA) evaluation, other than nonmedicated emollient and salicylic acid shampoos, prior to first administration of study intervention
- Agree not to receive a live virus or live bacterial vaccination during the study, or within 4 weeks after the last administration of study intervention
Exclusion Criteria
- Was permanently discontinued from study intervention in Protocol 77242113PSO2001 for any reason
- Has received any biologic therapy or experimental therapy since completion of the originating study, 77242113PSO2001
- Has received any live virus or bacterial vaccination within 12 weeks before the first administration of study intervention
- Has received the bacille Calmette-Guerin (BCG) vaccine within 12 months of the first administration of study intervention
- Currently has hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or has other clinically active liver disease, or tests positive for HBsAg or anti-HCV
Data sourced from ClinicalTrials.gov (NCT05364554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.