JNJ-77242113 for Plaque Psoriasis

(SUMMIT Trial)

No longer recruiting at 50 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new pill, JNJ-77242113, to evaluate its effectiveness for individuals with moderate-to-severe plaque psoriasis, a skin condition that causes red, scaly patches. The study compares this treatment to a placebo (a pill with no active medicine) to assess its effectiveness. Participants will take the pill once daily for 16 weeks. It suits those who have had plaque psoriasis for at least six months and have large affected skin areas. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in psoriasis care.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that JNJ-77242113 was safe in earlier studies. Most side effects were mild to moderate. Importantly, no serious side effects or deaths were linked to the treatment. This indicates that patients generally tolerated the treatment well, which is a positive sign for its safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for moderate-to-severe plaque psoriasis, which often include biologics or topical therapies, JNJ-77242113 uses a novel approach by being delivered as a delayed-release oral tablet. Researchers are excited about JNJ-77242113 because it targets specific pathways involved in psoriasis more directly, potentially reducing inflammation with fewer side effects. This new mechanism of action could offer a more convenient and less invasive option for patients, with the potential for improved long-term management of their condition.

What evidence suggests that JNJ-77242113 could be an effective treatment for plaque psoriasis?

Research has shown that JNJ-77242113, a treatment still under trial, outperformed a placebo for individuals with moderate-to-severe plaque psoriasis. Participants in this trial may receive JNJ-77242113 at one of two different doses or a placebo. Earlier studies demonstrated significant improvements, with 72% of patients with scalp psoriasis and 85% with genital psoriasis experiencing positive results. Additionally, JNJ-77242113 reduced intestinal inflammation in animal studies, supporting its potential effectiveness. These findings suggest that JNJ-77242113 could offer meaningful relief for those dealing with challenging psoriasis symptoms. ^{2 3 6 7 8}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-77242113
• Placebo

How Is the Trial Designed?

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+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

1. investor.jnj.com investor.jnj.com/investor-news/news-details/2025/Icotrokinra-long-term-results-affirm-promise-of-targeted-oral-peptide-with-high-rates-of-durable-skin-clearance-and-favorable-safety-profile-in-difficult-to-treat-scalp-and-genital-psoriasis/default.aspx

Icotrokinra long-term results affirm promise of targeted oral ... In areas of high impact, 72% of patients with scalp psoriasis and 85% with genital psoriasis treated with icotrokinra achieved site-specific ...

2. jnj.com jnj.com/media-center/press-releases/icotrokinra-maintains-standout-combination-of-therapeutic-benefit-and-a-favorable-safety-profile-in-once-daily-pill-through-28-weeks-in-ulcerative-colitis

Icotrokinra maintains standout combination of therapeutic ... Building on 12-week findings, icotrokinra demonstrated clinically meaningful outcomes at Week 28 with 31.7% of patients achieving clinical ...

3. nature.com nature.com/articles/s41598-024-67371-5

JNJ-77242113, a highly potent, selective peptide targeting ... JNJ-77242113 demonstrated efficacy at low oral doses in a rat model of intestinal inflammation despite relatively low systemic exposures (Table ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38324484/

An Oral Interleukin-23-Receptor Antagonist Peptide for ... ... JNJ-77242113 showed greater efficacy than placebo in patients with moderate-to-severe plaque psoriasis. (Funded by Janssen Research and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05357755

A Study of JNJ-77242113 for the Treatment of Moderate- ... The purpose of the study is to evaluate the efficacy of an oral tablet formulation of JNJ-77242113 compared with placebo in participants with moderate-to-severe ...

6. jnj.com jnj.com/media-center/press-releases/icotrokinra-delivered-an-industry-leading-combination-of-significant-skin-clearance-with-demonstrated-tolerability-in-a-once-daily-pill-in-phase-3-topline-results

Icotrokinra delivered an industry-leading combination of ... Safety data was found to be consistent with the Phase 2 FRONTIER 1 and 2 ... About Icotrokinra (JNJ-77242113, JNJ-2113) Investigational ...

7. medchemexpress.com medchemexpress.com/icotrokinra.html?srsltid=AfmBOorEHVsl1BGRRr0YJfAC9JsUOmqEvTGBKid3qZOidxf-UPyYdIks

Icotrokinra (JNJ-77242113) | IL-23 Receptor Antagonist Icotrokinra (Synonyms: JNJ-77242113; JNJ-2113; PN-235). Cat. No.: HY ... SAFETY DATA SHEET (SDS). English - EN (252 KB) Français - FR (252 KB) Deutsch ...

8. jaad.org jaad.org/article/S0190-9622(24)03152-9/fulltext

FRONTIER-2: A phase 2b, long-term extension, dose- ... Higher response rates were observed among patients receiving higher doses of JNJ-77242113, with 79% of those in the highest dose group (100 mg ...