JNJ-77242113 for Plaque Psoriasis
(ICONIC-LEAD Trial)

Recruiting in Palo Alto (17 mi)

+202 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called JNJ-77242113 to see if it helps people with moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches. The study aims to find out if this new treatment can improve symptoms for those who have not responded well to other treatments.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for adolescents and adults with moderate to severe plaque psoriasis, who have had the condition for at least 6 months. They should need phototherapy or systemic treatment and have a significant area of their body affected. Women able to bear children must test negative for pregnancy.

Inclusion Criteria

Your skin has a lot of psoriasis, with a score of 12 or more on a scale that measures its severity.

Your overall skin condition is rated as moderate or worse by the study doctor at the beginning of the trial.

If you are a woman who could become pregnant, you need to have a negative pregnancy test before starting the study.

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Exclusion Criteria

You are allergic to JNJ-77242113 or any of the substances it contains.

My psoriasis is not the plaque type but another form like guttate or pustular.

My psoriasis started or got worse after taking certain medications.

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Treatment Details

Interventions

JNJ-77242113 (Monoclonal Antibodies)

Trial OverviewThe study is testing JNJ-77242113's effectiveness against placebo in participants with plaque psoriasis. It aims to see if this new medication can improve skin conditions compared to no active treatment.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment2 Interventions

Adolescent and adult participants will receive JNJ-77242113 matching placebo from Week 0 to Week 16. Participants will cross-over to receive JNJ-77242113 from Week 16 through Week 156.

Group II: JNJ-77242113Experimental Treatment1 Intervention

Adolescent and adult participants will receive JNJ-77242113 from Week 0 through Week 156. At Week 24, adult participants who are psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieve an IGA score of 0 or 1 and have \>=2-grade improvement from baseline) will be re-randomized either to continue JNJ-77242113 or to placebo (and will be retreated with JNJ-77242113 upon loss of \>=50% of their Week 24 PASI improvement). Adult participants identified as both PASI 75 and IGA 0 or 1 score non-responders will continue to receive JNJ-77242113 through Week 52. From Week 52 to Week 156, all adult participants will receive JNJ-77242113. Adolescents will not participate in re-randomization regardless of their PASI score or IGA score at Week 24. Adolescents will continue to receive JNJ-77242113 from Week 0 through Week 156.