A Study of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis

(SUMMIT Trial)

Recruiting at 49 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Janssen Research & Development, LLC

Must not be taking: Interleukin inhibitors, TNF blockers, PPIs

Disqualifiers: Nonplaque psoriasis, Drug-induced psoriasis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

90 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. Specifically, if you are on medications targeting interleukin 17, interleukin 23, or tumor necrosis factor, you must stop them at least 12 weeks before starting the trial. Also, you should not take proton pump inhibitors within 1 week of starting the trial.

What is the purpose of this trial?

This trial is testing a new pill called JNJ-77242113 to see if it can better treat moderate-to-severe plaque psoriasis. The pill aims to calm the immune system, which helps reduce skin problems caused by psoriasis.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

Inclusion Criteria

Participant has a total Body Surface Area (BSA) greater than or equal to (>=) 10 percentage (%) at screening and baseline

You have been diagnosed with plaque psoriasis (a skin condition) with or without psoriatic arthritis for at least 26 weeks before starting the study.

Participant has a total Psoriasis Area and Severity Index (PASI) >= 12 at screening and baseline

Exclusion Criteria

Participant has current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)

Participant have previously received any other therapeutic agent directly targeted to interleukin 23 (including but not limited to guselkumab, tildrakizumab, or risankizumab)

Participant has received any therapeutic agent directly targeted to interleukin 17 (IL-17), interleukin 17 receptor (IL-17R) or interleukin 12/23 (IL-12/23) (including but not limited to secukinumab, ixekizumab, brodalumab, or ustekinumab) or has received biological therapy targeting tumor necrosis factor (TNF) (including, but not limited to adalimumab, infliximab, or etanercept) within 12 weeks or 5 half-lives, whichever is longer, of the first administration of study intervention

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment

Participants receive JNJ-77242113 or placebo once daily for 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• JNJ-77242113
• Placebo

Participant Groups

Group I: Group 2: JNJ-77242113 Dose 2 Experimental Treatment 1 Intervention

Participants will receive JNJ-77242113 Dose 2 as delayed release tablets orally once daily from Week 0 through Week 16.

Group II: Group 1: JNJ-77242113 Dose 1 Experimental Treatment 1 Intervention

Participants will receive JNJ-77242113 Dose 1 as delayed release tablets orally once daily from Week 0 through Week 16.

Group III: Group 3: Placebo Placebo Group 1 Intervention

Participants will receive oral dose of matching placebo once daily from Week 0 through Week 16.

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