Phase 2
N=255
A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis
Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT05223868 ↗Enrolled (actual)
255
Serious AEs
1.2%
Results posted
Dec 2025
Primary outcome: Primary: Percentage of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 16 — 9.3; 37.2; 58.1; 51.2 Percentage of participants — p==0.002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- JNJ-77242113 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 16 |
9.3; 37.2; 58.1; 51.2; 65.1; 78.6 | =0.002 sig |
| SECONDARY Change From Baseline in PASI Total Score at Week 16 |
-3.59; -12.76; -14.56; -12.73; -13.99; -17.44 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved at Least 90% Improvement From Baseline in PASI (PASI-90) at Week 16 |
2.3; 25.6; 51.2; 26.8; 46.5; 59.5 | =0.002 sig |
| SECONDARY Percentage of Participants Who Achieved 100% Improvement From Baseline in PASI (PASI-100) at Week 16 |
0; 11.6; 25.6; 9.8; 23.3; 40.5 | =0.021 sig |
| SECONDARY Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 |
11.6; 39.5; 58.1; 51.2; 62.8; 64.3 | =0.003 sig |
| SECONDARY Percentage of Participants Who Achieved an IGA Score of Cleared (0) at Week 16 |
0; 16.3; 34.9; 14.6; 27.9; 45.2 | =0.006 sig |
| SECONDARY Change From Baseline in Body Surface Area (BSA) at Week 16 |
-2.4; -11.9; -15.3; -13.3; -14.6; -21.0 | <0.001 sig |
| SECONDARY Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at Week 16 |
-0.8; -35.8; -36.7; -34.0; -29.4; -44.0 | <0.001 sig |
| SECONDARY Change From Baseline in PSSD Signs Score at Week 16 |
-6.2; -38.6; -42.7; -41.8; -41.9; -51.1 | <0.001 sig |
| 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 |
0; 16.3; 23.8; 17.1; 27.9; 26.2 | =0.006 sig |
| SECONDARY Percentage of Participants Who Achieved PSSD Sign Score = 0 at Week 16 Among Participants With a Baseline Sign Score >=1 |
0; 2.3; 14.0; 9.8; 16.3; 14.3 | =0.317 |
| 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 |
2.4; 27.9; 37.2; 30.0; 55.8; 43.9 | =0.001 sig |
| SECONDARY Change From Baseline in Domain Scores of the Patient-Reported Outcomes Measurement Information System (PROMIS-29) at Week 16 |
-1.04; 2.30; 5.81; 4.55; 3.10; 5.81 | =0.002 sig |
| SECONDARY Percentage of Participants Who Achieved at Least a 5-point Improvement From Baseline in Each PROMIS-29 Domain at Week 16 |
11.6; 23.3; 41.9; 36.6; 37.2; 40.5 | =0.160 |
| SECONDARY Number of Participants With Treatment-emergent Adverse Event (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
22; 20; 26; 20; 19; 26 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Participant has a diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 6 months prior to the first administration of study intervention
- Participant be a candidate for phototherapy or systemic treatment for plaque psoriasis
- Participant has a total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline
- Participant has a total Psoriasis area and severity index (PASI) >=12 at screening and baseline
- Participant has a total Investigator global assessment (IGA) >=3 at screening and baseline
Exclusion Criteria
- Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
- Participant has current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
- Participant have previously received any other therapeutic agent directly targeted to interleukin 23 receptor (IL-23R) (including but not limited to guselkumab, tildrakizumab, or risankizumab)
- Participant has received any therapeutic agent directly targeted to interleukin 17 receptor (IL-17) or interleukin 12/23 receptor (IL-12/23) (including but not limited to secukinumab, ixekizumab, brodalumab, or ustekinumab) or has received anti-tumor necrosis factor [TNF]-alpha biologic therapy (including, but not limited to adalimumab) within 12 weeks or 5 half-lives, whichever is longer, of the first administration of study intervention
- Participant has received agents that deplete B cells (including, but not limited to, rituximab, or alemtuzumab) within 26 weeks of the first administration of study intervention
Data sourced from ClinicalTrials.gov (NCT05223868). 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.