A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis

Conditions

• Plaque Psoriasis

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• JNJ-77242113 — DRUG
  JNJ-77242113 will be administered orally.
• Matching Placebo to JNJ-77242113 — DRUG
  Matching placebo will be administered orally.
• Ustekinumab — DRUG
  Ustekinumab will be administered subcutaneously.
• Matching Placebo to Ustekinumab — DRUG
  Matching placebo will be administered subcutaneously.

Study Details

The main purpose of this study is to assess how well JNJ-77242113 works when compared to placebo and ustekinumab in participants with moderate to severe plaque psoriasis.

Key Dates

Start date

Apr 15, 2025

Status verified

Jun 2026

Primary completion

Nov 17, 2025

Completion

Aug 20, 2027

Study Design

Enrollment

752 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1: JNJ 77242113
  Participants will receive JNJ-77242113 once daily from Week 0 through Week 104. All participant will receive ustekinumab matching placebo at Week 0, 4 and 16 to maintain the blind.
• Placebo Comparator: Arm 2: Placebo
  Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for ustekinumab at Week 0, 4 and 16 and JNJ-77242113 from Week 16 through Week 104.
• Active Comparator: Arm 3: Ustekinumab
  Participants will receive Ustekinumab at Week 0, Week 4, and Week 16 followed by JNJ-77242113 once daily from Week 28 through Week 104. Participants will receive both Ustekinumab and placebo for JNJ-77242113 to maintain the blind through Week 28.

Primary Outcome Measure

JNJ-77242113 and Placebo Group: Percentage of Participants with Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater than or Equal to (>=) 2 Grade Improvement from Baseline at Week 16 [ Time Frame: Week 16 ]

Locations (48)

Find similar trials in Birmingham, AL

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