JNJ-77242113 for Plaque Psoriasis

(ICONIC-ASCEND Trial)

Recruiting at 115 trial locations

Overseen By Study Contact

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

675 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for people with moderate to severe plaque psoriasis, which means they have a lot of skin area affected and it's quite serious. They should be candidates for light therapy or systemic treatment and haven't started the study treatment before.

Inclusion Criteria

My psoriasis is severe, with a PASI score of 12 or more.

I have been diagnosed with plaque psoriasis, with or without psoriatic arthritis.

My body surface area is at least 10% affected.

Treatment Details

Interventions

• JNJ-77242113
• Ustekinumab

Trial Overview The trial tests JNJ-77242113 against a placebo and Ustekinumab to see which is better at treating plaque psoriasis. Participants will randomly receive either the new drug, its placebo, Ustekinumab, or its placebo.

Participant Groups

Group I: Arm 1: JNJ 77242113 Experimental Treatment 2 Interventions

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.

Group II: Arm 3: Ustekinumab Active Control 3 Interventions

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.

Group III: Arm 2: Placebo Placebo Group 3 Interventions

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.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires