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Monoclonal Antibodies

JNJ-77242113 for Plaque Psoriasis

Phase 3

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Candidate for phototherapy or systemic treatment for plaque psoriasis

Be older than 18 years old

Must not have

Nonplaque form of psoriasis (e.g., erythrodermic, guttate, or pustular)

Major surgical procedure within 8 weeks before screening or planned during study participation period

Timeline

Screening 3 days

Treatment Varies

Follow Up from week 24 through week 156

Awards & highlights

Pivotal Trial

Summary

This trial aims to see how well JNJ-77242113 works for people with moderate to severe plaque psoriasis when compared to a placebo and deucravacitinib.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects may include typical drug reactions such as nausea, headache, possible skin irritation at the application site if topical, fatigue, and any specific risks associated with immune-modulating treatments like increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My psoriasis is not the plaque type.

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

Timeline

Screening ~ 3 days14 visits

Treatment ~ Varies

Follow Up ~ from week 24 through week 156

Screening ~ 3 days

Treatment ~ Varies

Follow Up ~from week 24 through week 156

This trial's timeline: 3 days for screening, Varies for treatment, and from week 24 through week 156 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16

JNJ-77242113 and Placebo Group: Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2 Grade Improvement From Baseline at Week 16

Secondary study objectives

Change From Baseline in Body Surface Area (BSA) at Week 16

Change from Baseline in PASI Score at Week 16

JNJ-77242113 and Deucravacitinib Group: : Percentage of Participants Achieving an IGA Score of 0 or 1 and >=2 Grade Improvement From Baseline at Weeks 16 and 24

+31 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

JNJ-77242113

2022

Completed Phase 2

~640

0 / 3Eligibility criteria met