JNJ-77242113 for Plaque Psoriasis

(FRONTIER 1 Trial)

No longer recruiting at 110 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Janssen Research & Development, LLC

Must not be taking: IL-23R agents, IL-17 agents

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 aims to determine the effectiveness of different doses of the experimental treatment JNJ-77242113 for individuals with moderate-to-severe plaque psoriasis. Participants will receive either the treatment or a placebo (a substance with no active drug) to compare outcomes. The trial targets individuals who have had plaque psoriasis for at least six months and need more than topical treatments. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before starting. If you've used specific psoriasis treatments like IL-23R, IL-17, IL-12/23, or TNF-alpha therapies, you need to stop them at least 12 weeks or 5 half-lives before the trial. B cell-depleting agents must be stopped 26 weeks prior.

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

Research has shown that JNJ-77242113 is generally well-tolerated, meaning most people experience no major problems with it. In earlier studies, side effects were mostly mild or moderate. Importantly, no serious side effects or deaths were linked to this treatment. These findings suggest that JNJ-77242113 is likely safe. While these results are encouraging, discussing any concerns with a doctor before joining a clinical trial is always advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for psoriasis?

Researchers are excited about JNJ-77242113 for moderate-to-severe plaque psoriasis because it offers a potentially new approach to treatment. Unlike the common therapies that often target immune system components like TNF-alpha or IL-17, JNJ-77242113 may work through a different mechanism that could provide relief for patients who don't respond well to existing treatments. Additionally, the study includes multiple dosing regimens (once or twice daily), which could help tailor treatment plans to individual needs and improve patient outcomes. This flexibility and potential new mechanism bring hope for more effective management of psoriasis.

What evidence suggests that this trial's treatment could be effective for plaque psoriasis?

Research has shown that JNJ-77242113 could be a promising treatment for moderate-to-severe plaque psoriasis. In earlier studies, it proved more effective than a placebo, reducing psoriasis symptoms better than no treatment. Specifically, one study found that JNJ-77242113 successfully cleared skin in hard-to-treat areas like the scalp and genitals, with high rates of improvement. This treatment is a targeted oral peptide, which blocks certain proteins that cause inflammation in psoriasis. Overall, these early results suggest JNJ-77242113 could be an effective option for those with severe psoriasis. Participants in this trial will receive different doses of JNJ-77242113 or a placebo to further evaluate its effectiveness. ^{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

You have a BSA greater than or equal to 10% at screening and baseline.

Participant has a total Psoriasis area and severity index (PASI) >=12 at screening and baseline

Participant has a total Investigator global assessment (IGA) >=3 at screening and baseline

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

≤ 4 weeks

Treatment

Participants receive JNJ-77242113 or placebo for 16 weeks to evaluate efficacy and safety in moderate-to-severe plaque psoriasis

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

How Is the Trial Designed?

Group I: Group 5: JNJ-77242113 Dose 3 BID and Placebo Experimental Treatment 2 Interventions

Participants will receive JNJ-77242113 Dose 3 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Group II: Group 4: JNJ-77242113 Dose 1 Twice Daily (BID) and Placebo Experimental Treatment 2 Interventions

Participants will receive JNJ-77242113 Dose 1 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Group III: Group 3: JNJ-77242113 Dose 3 QD and Placebo Experimental Treatment 2 Interventions

Participants will receive JNJ-77242113 Dose 3 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Group IV: Group 2: JNJ-77242113 Dose 2 QD and Placebo Experimental Treatment 2 Interventions

Participants will receive JNJ-77242113 Dose 2 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Group V: Group 1: JNJ-77242113 Dose 1 Once Daily (QD) and Placebo Experimental Treatment 2 Interventions

Participants will receive JNJ-77242113 Dose 1 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Group VI: Group 6: Placebo Placebo Group 1 Intervention

Participants will receive placebo BID 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. 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 ...

3. 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 ...

4. 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 ...

5. 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 ...

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 ...