JNJ-77242113 for Plaque Psoriasis

Not currently recruiting at 166 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must not be taking: Beta blockers, Calcium channel blockers, Lithium

Disqualifiers: Nonplaque psoriasis, Severe organ disturbances, others

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

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of a new treatment, JNJ-77242113, for individuals with moderate to severe plaque psoriasis, compared to a placebo and another drug, deucravacitinib. Plaque psoriasis is a skin condition characterized by red, scaly patches. Participants will receive one of these treatments to assess their impact on the condition over time. Suitable candidates have had plaque psoriasis for at least six months and require light therapy or medication for management. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if your psoriasis is drug-induced, you may not be eligible to participate.

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

Research has shown that JNJ-77242113 has generally been well-tolerated in past studies. One study demonstrated that the treatment helped clear skin in adults with moderate-to-severe plaque psoriasis for up to 52 weeks, indicating its effectiveness and manageability over time. Another study found that patients receiving higher doses had better responses, with no major safety issues reported. Although specific side effects are not detailed, the treatment's presence in a late phase of trials suggests strong evidence supporting its safety in humans. ^{1 2 3 4 5}

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

Unlike many treatments for plaque psoriasis, which often include topical therapies or biologics targeting specific immune system proteins, JNJ-77242113 offers a novel approach by directly targeting a different part of the immune response. This medication is unique because it works by modulating a specific set of immune pathways, potentially providing relief for patients who do not respond well to existing therapies. Researchers are excited about JNJ-77242113 because it has the potential to offer longer-lasting effects with a different safety profile compared to current options. By exploring this new mechanism of action, JNJ-77242113 could pave the way for more personalized and effective treatment strategies for individuals with plaque psoriasis.

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

Research has shown that JNJ-77242113, which participants in this trial may receive, may effectively treat moderate to severe plaque psoriasis. In studies, it outperformed a placebo, helping many patients achieve clearer skin. Specifically, one study found that 84.1% of patients had mostly clear skin, according to the Investigator's Global Assessment. The treatment blocks a specific part of the immune system involved in inflammation, which can help reduce psoriasis symptoms. Overall, early results suggest that JNJ-77242113 could be a strong option for those with plaque psoriasis. ^{6 7 8 9 10}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinicaltrial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for individuals with moderate to severe plaque psoriasis who have had the condition for at least 26 weeks and are candidates for phototherapy or systemic treatment. They must have a PASI score of 12 or more, an IGA of 3 or higher, and psoriasis affecting at least 10% of their body surface area.

Inclusion Criteria

I am eligible for light therapy or medication for my plaque psoriasis.

Total psoriasis area and severity index (PASI) >=12 at screening and baseline

Total investigator global assessment (IGA) >=3 at screening and baseline

Exclusion Criteria

My psoriasis is not the plaque type.

I haven't had major surgery in the last 8 weeks and don't plan any during the study.

I do not have severe or worsening health issues in any part of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive JNJ-77242113, placebo, or deucravacitinib for the treatment of moderate to severe plaque psoriasis

24 weeks

Regular visits as per study protocol

Long-term Treatment

Participants continue receiving JNJ-77242113 for extended treatment

Week 24 through Week 156

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-77242113

Trial Overview The study tests the effectiveness of JNJ-77242113 in treating plaque psoriasis compared to a placebo and another medication called deucravacitinib. Participants will be randomly assigned to receive either JNJ-77242113, its matching placebo, deucravacitinib, or its matching placebo.

How Is the Trial Designed?

Group I: JNJ-77242113 Experimental Treatment 2 Interventions

Participants will receive JNJ-77242113 from Week 0 through Week 156 and deucravacitinib matching placebo from Week 0 through Week 24.

Group II: Deucravacitinib Active Control 3 Interventions

Participants will receive deucravacitinib from Week 0 through Week 24 and matching placebo for JNJ-77242113 from Week 0 through Week 24 and JNJ-77242113 from Week 24 through Week 156.

Group III: Placebo Placebo Group 3 Interventions

Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for deucravacitinib from Week 0 through Week 24 and JNJ-77242113 from Week 16 through Week 156.

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

Published Research Related to This Trial

In a real-world study of 1756 patients with moderate-to-severe plaque-type psoriasis, secukinumab demonstrated high treatment retention rates of 88.0% after 1 year, 76.4% after 2 years, and 60.5% after 3 years, indicating its effectiveness in long-term management.

The safety profile of secukinumab remained consistent with previous findings, showing low rates of serious adverse events such as inflammatory bowel disease (0.3%) and candida infections (3.1%), suggesting it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab demonstrated sustained retention, effectiveness and safety in a real-world setting in patients with moderate-to-severe plaque psoriasis: long-term results from an interim analysis of the SERENA study. Augustin, M., Sator, PG., von Kiedrowski, R., et al.[2022]

Citations

1. jnj.com jnj.com/media-center/press-releases/icotrokinra-results-show-75-of-adolescents-with-plaque-psoriasis-achieved-completely-clear-skin-and-demonstrate-favorable-safety-profile-in-a-once-daily-pill

Icotrokinra results show 75% of adolescents with plaque ... In the study, 84.1% of adolescent patients treated with once daily icotrokinra achieved an Investigator's Global Assessment (IGA)b score of 0/1 ...

2. 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 ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2504187?rss=searchAndBrowse

Oral Icotrokinra for Plaque Psoriasis in Adults and ... Icotrokinra (JNJ-77242113) is a targeted oral peptide that selectively blocks the interleukin-23 receptor. This mechanism of inhibiting the ...

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. 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 ...

6. 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 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05223868

A Study of JNJ-77242113 in Participants With Moderate-to- ... Th purpose of the study is to evaluate the dose response of JNJ-77242113 in efficacy at Week 16 in participants with moderate-to-severe plaque psoriasis.

8. jnj.com jnj.com/media-center/press-releases/new-data-shows-jnj-2113-the-first-and-only-investigational-targeted-oral-peptide-maintained-skin-clearance-in-moderate-to-severe-plaque-psoriasis-through-one-year

New data shows JNJ-2113, the first and only ... In FRONTIER 2, JNJ-2113 maintained high rates of skin clearance through 52 weeks in adults with moderate-to-severe plaque PsO.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0190962224031529

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 twice daily) ...

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

JNJ-77242113, a highly potent, selective peptide targeting ... Descriptive statistics were used to describe demographic and safety data. Data availability. The data sharing policy of Janssen ...