Phase 2 N=89 Randomized Double-blind Treatment

A Study of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis

Plaque Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT05357755 ↗

Enrolled (actual)

Serious AEs

2.3%

Results posted

May 2026

Primary outcome: Primary: Percentages of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 16 — 4.2; 41.9; 73.5 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: Mar 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentages of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 16	4.2; 41.9; 73.5	=0.002 sig
SECONDARY Change From Baseline in PASI Total Score at Week 16	-4.30; -11.56; -16.84	=0.002 sig
SECONDARY Percentages of Participants Who Achieved at Least 90% Improvement From Baseline in PASI (PASI 90) Score at Week 16	0; 25.8; 52.9	=0.007 sig
SECONDARY Percentages of Participants Who Achieved 100% Improvement From Baseline in PASI (PASI 100) Score at Week 16	0; 9.7; 23.5	=0.125
SECONDARY Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16	4.2; 41.9; 73.5	=0.002 sig
SECONDARY Percentages of Participants Who Achieved an IGA Score of Cleared (0) at Week 16	0; 12.9; 29.4	=0.071
SECONDARY Percent Change From Baseline in Psoriasis-Affected Body Surface Area (BSA) at Week 16	-0.9; -14.9; -20.1	<0.001 sig
SECONDARY Number of Participants With 1 or More Treatment-emergent Adverse Events (TEAEs)	14; 13; 20	—
SECONDARY Number of Participants With Serious TEAEs	0; 0; 2	—

Summary

The purpose of the study is to evaluate the efficacy of an oral tablet formulation of JNJ-77242113 compared with placebo in participants with moderate-to-severe plaque psoriasis.

Eligibility Criteria

Inclusion Criteria

Participant has a diagnosis of plaque psoriasis, with or without psoriatic arthritis, for at least 26 weeks prior to the first administration of study intervention
Participant has a total Body Surface Area (BSA) greater than or equal to (>=) 10 percentage (%) at screening and baseline
Participant has a total Psoriasis Area and Severity Index (PASI) >= 12 at screening and baseline
Participant has a total Investigator's Global Assessment (IGA) >= 3 at screening and baseline
Participant be a candidate for phototherapy or systemic treatment for plaque psoriasis

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 (including but not limited to guselkumab, tildrakizumab, or risankizumab)
Participant has received any therapeutic agent directly targeted to interleukin 17 (IL-17), interleukin 17 receptor (IL-17R) or interleukin 12/23 (IL-12/23) (including but not limited to secukinumab, ixekizumab, brodalumab, or ustekinumab) or has received biological therapy targeting tumor necrosis factor (TNF) (including, but not limited to adalimumab, infliximab, or etanercept) within 12 weeks or 5 half-lives, whichever is longer, of the first administration of study intervention
Participant has received proton pump inhibitors (including but not limited to omeprazole, esomeprazole, lansoprazole, rabeprazole, pantoprazole, dexlansoprazole, or zegerid) within 1 week of first administration of study intervention

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05357755). 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.