JNJ-77242113 for Plaque Psoriasis

Recruiting in Palo Alto (17 mi)

+136 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Janssen Research & Development, LLC

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of the study is to evaluate how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.

Research Team

Janssen Research & Development, LLC Clinicaltrial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for individuals with moderate to severe plaque psoriasis who have had the condition for at least 26 weeks and are candidates for phototherapy or systemic treatment. They must have a PASI score of 12 or more, an IGA of 3 or higher, and psoriasis affecting at least 10% of their body surface area.

Inclusion Criteria

I am eligible for light therapy or medication for my plaque psoriasis.

Total psoriasis area and severity index (PASI) >=12 at screening and baseline

Total investigator global assessment (IGA) >=3 at screening and baseline

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Exclusion Criteria

My psoriasis is not the plaque type.

I haven't had major surgery in the last 8 weeks and don't plan any during the study.

I do not have severe or worsening health issues in any part of my body.

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Treatment Details

Interventions

JNJ-77242113 (Monoclonal Antibodies)

Trial OverviewThe study tests the effectiveness of JNJ-77242113 in treating plaque psoriasis compared to a placebo and another medication called deucravacitinib. Participants will be randomly assigned to receive either JNJ-77242113, its matching placebo, deucravacitinib, or its matching placebo.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: JNJ-77242113Experimental Treatment2 Interventions

Participants will receive JNJ-77242113 from Week 0 through Week 156 and deucravacitinib matching placebo from Week 0 through Week 24.

Group II: DeucravacitinibActive Control3 Interventions

Participants will receive deucravacitinib from Week 0 through Week 24 and matching placebo for JNJ-77242113 from Week 0 through Week 24 and JNJ-77242113 from Week 24 through Week 156.

Group III: PlaceboPlacebo Group3 Interventions

Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for deucravacitinib from Week 0 through Week 24 and JNJ-77242113 from Week 16 through Week 156.