JNJ-77242113 for Plaque Psoriasis

(FRONTIER 2 Trial)

No longer recruiting at 85 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Janssen Research & Development, LLC

Must not be taking: Biologics, Experimental therapies

Disqualifiers: Hepatitis B, Hepatitis C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 36 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the long-term effectiveness of JNJ-77242113, an experimental treatment, for individuals with moderate-to-severe plaque psoriasis, a skin condition causing red, scaly patches. Participants will receive varying doses to determine the most effective one. Those who participated in a previous study with this treatment and believe they might benefit from continued participation would be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.

Will I have to stop taking my current medications?

The trial requires you to stop using topical treatments that could affect psoriasis, except for nonmedicated emollients and salicylic acid shampoos, before starting the study. The protocol does not specify about other medications, so it's best to discuss with the study team.

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

Research has shown that JNJ-77242113 is generally safe based on previous studies. In all tested groups, side effects were mild or moderate. Importantly, no serious side effects or deaths were linked to the treatment. This suggests that participants usually tolerate JNJ-77242113 well. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about JNJ-77242113 for treating moderate-to-severe plaque psoriasis because it offers a novel approach compared to traditional treatments like topical corticosteroids, phototherapy, and biologics targeting TNF-alpha or IL-17. JNJ-77242113 acts differently by targeting specific pathways, potentially leading to more precise and effective symptom control. Additionally, the treatment is available in multiple dosing regimens, including once or twice daily options, providing flexibility and potentially increasing adherence and effectiveness. These features make JNJ-77242113 a promising candidate for improving patient outcomes in psoriasis management.

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

Research has shown that JNJ-77242113 effectively treats moderate-to-severe plaque psoriasis. In earlier studies, this treatment outperformed a placebo in reducing skin symptoms. Specifically, it helped 72% of patients achieve clear skin on the scalp and 85% on the genitals. JNJ-77242113 targets a part of the immune system involved in inflammation, calming the overactive immune response that causes psoriasis symptoms. Overall, JNJ-77242113 has shown promising results for people with hard-to-treat psoriasis. Participants in this trial will receive different dosages of JNJ-77242113 to further evaluate its effectiveness and safety. ^{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

Agree not to receive a live virus or live bacterial vaccination during the study, or within 4 weeks after the last administration of study intervention

Must have completed the Week 16 visit in Protocol 77242113PSO2001

In the opinion of the investigator, may benefit from inclusion in this long term extension (LTE) study

Exclusion Criteria

Has received any live virus or bacterial vaccination within 12 weeks before the first administration of study intervention

Currently has hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or has other clinically active liver disease, or tests positive for HBsAg or anti-HCV

Was permanently discontinued from study intervention in Protocol 77242113PSO2001 for any reason

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-77242113

How Is the Trial Designed?

Group I: Group 6: JNJ-77242113 Dose 3 QD Experimental Treatment 1 Intervention

Participants originally randomized to placebo in originating Study 77242113PSO2001 will receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study.

Group II: Group 5: JNJ-77242113 Dose 3 BID Experimental Treatment 1 Intervention

Participants originally randomized to JNJ-77242113 Dose 3 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 BID from Week 0 through Week 36 in this study.

Group III: Group 4: JNJ-77242113 Dose 1 Twice Daily (BID) Experimental Treatment 1 Intervention

Participants originally randomized to JNJ-77242113 Dose 1 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 BID from Week 0 through Week 36 in this study.

Group IV: Group 3: JNJ-77242113 Dose 3 QD Experimental Treatment 1 Intervention

Participants originally randomized to JNJ-77242113 Dose 3 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study.

Group V: Group 2: JNJ-77242113 Dose 2 QD Experimental Treatment 1 Intervention

Participants originally randomized to JNJ-77242113 Dose 2 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 2 QD from Week 0 through Week 36 in this study.

Group VI: Group 1: JNJ-77242113 Dose 1 Once Daily (QD) Experimental Treatment 1 Intervention

Participants originally randomized to JNJ-77242113 Dose 1 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 QD from Week 0 through Week 36 in this study.

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. 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 ...

8. medchemexpress.com medchemexpress.com/icotrokinra.html?srsltid=AfmBOoqx--ysFtc67EuQl-sE3FlE4bLyGh5P19LD2bo8b55QN8v7e51B

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 ...