JNJ-77242113 for Plaque Psoriasis

Not currently recruiting at 226 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 aims to evaluate the effectiveness of a new treatment, JNJ-77242113, for individuals with moderate to severe plaque psoriasis. Participants will receive either JNJ-77242113, another drug called deucravacitinib (also known as Sotyktu or BMS-986165), or a placebo (a substance with no active drug). The trial targets those who have had plaque psoriasis for at least six months and have significant skin involvement that might require light therapy or other medication. The goal is to compare the effectiveness of JNJ-77242113 with the other options. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to the advancement of new treatment options.

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 is generally well-tolerated. In previous studies, about half of the patients taking JNJ-77242113 experienced some unwanted effects, similar to those taking a placebo. Importantly, no major safety issues were reported.

For deucravacitinib, studies have indicated a consistent safety record over several years. Side effects are usually manageable, and the treatment does not cause unexpected problems. Overall, previous research has shown both treatments in the trial to be safe, with side effects similar to those of other psoriasis treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about JNJ-77242113 for plaque psoriasis because it offers a unique mechanism of action compared to current treatments. Most psoriasis treatments, like biologics, target specific proteins in the immune system, but JNJ-77242113 is designed to modulate the JAK pathway, which plays a crucial role in the immune response. This could potentially offer a new way to manage psoriasis symptoms more effectively. Additionally, the treatment's long-term administration plan aims to provide sustained results, which is an attractive feature for managing this chronic condition.

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

Research has shown that JNJ-77242113, one of the treatments studied in this trial, holds promise for treating moderate to severe plaque psoriasis. In one study, 84.1% of patients achieved almost clear skin. Another study found that higher doses of JNJ-77242113 led to better results, with 79% of patients in the highest dose group showing significant improvement. Earlier trials demonstrated that JNJ-77242113 outperformed a placebo. This treatment targets specific proteins involved in inflammation, which may explain its effectiveness in clearing skin symptoms. Overall, the evidence supports its potential benefits for people 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 people with moderate to severe plaque psoriasis who need phototherapy or systemic treatment. They should have had psoriasis, possibly with arthritis, for at least 6 months and it must cover more than 10% of their body surface area.

Inclusion Criteria

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

My psoriasis is severe, covering a large area of my body.

I have been diagnosed with plaque psoriasis for at least 6 months.

Exclusion Criteria

I do not have severe or worsening problems with my kidneys, liver, heart, blood vessels, lungs, stomach, hormones, nerves, blood, joints, mind, or metabolism.

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

My psoriasis is not the plaque type but another form like guttate or pustular.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

24 weeks

Extended Treatment

Participants continue receiving JNJ-77242113 for long-term efficacy and safety assessment

From 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

• Deucravacitinib
• JNJ-77242113

Trial Overview

The study tests the effectiveness of JNJ-77242113 against a placebo and another drug called Deucravacitinib in treating plaque psoriasis. Participants will be randomly assigned to receive one of these treatments.

How Is the Trial Designed?

Group I: JNJ-77242113 Experimental Treatment 3 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 4 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.

Deucravacitinib is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Sotyktu for:

• Moderate to severe plaque psoriasis

Approved in European Union as Sotyktu for:

• Moderate to severe plaque psoriasis

Approved in Canada as Sotyktu for:

• Moderate to severe plaque psoriasis

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

Deucravacitinib is a first-in-class oral TYK2 inhibitor that works by stabilizing an inhibitory interaction within the TYK2 enzyme, which is important for treating various immune-mediated diseases.

It received its first approval in the USA on September 9, 2022, for adults with moderate-to-severe plaque psoriasis, and has since been approved in Japan for multiple forms of psoriasis, indicating its efficacy and safety in managing these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deucravacitinib: First Approval. Hoy, SM.[2022]

In a study involving 100 healthy volunteers, deucravacitinib was found to be rapidly absorbed with a half-life of 8-15 hours, showing a favorable pharmacokinetic profile and no serious adverse events, indicating good safety.

Deucravacitinib effectively inhibited key immune pathways (IL-12/IL-23 and type I IFN) in a dose-dependent manner, suggesting its potential as a therapeutic option for various immune-mediated diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-human study of deucravacitinib: A selective, potent, allosteric small-molecule inhibitor of tyrosine kinase 2. Catlett, IM., Aras, U., Hansen, L., et al.[2023]

Deucravacitinib is an oral small molecule that specifically inhibits TYK2, showing promising safety and efficacy for treating moderate to severe plaque psoriasis.

In phase III clinical trials, over 50% of patients taking deucravacitinib 6 mg daily achieved a significant reduction in psoriasis severity (≥75% improvement) at 16 weeks, compared to only 9-13% on placebo and 35-41% on another treatment, apremilast.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deucravacitinib in moderate-to-severe psoriasis. Vu, A., Maloney, V., Gordon, KB.[2022]

Deucravacitinib (SOTYKTUTM) is an effective oral treatment for moderate to severe plaque psoriasis, with up to 58.4% of patients showing symptom improvement by week 16 in phase 3 trials involving 840 participants.

The drug has a favorable safety profile, with common side effects like upper respiratory infections and herpes simplex infections occurring at manageable rates, and its selectivity may enhance long-term safety compared to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SOTYKTUTM (Deucravacitinib 6-mg Tablets)- A New Agent for the Management of Adult Plaque Psoriasis. Gupta, AK., Wang, T., Vincent, K., et al.[2023]

In a long-term study involving 674 patients, deucravacitinib showed significantly higher efficacy than adalimumab, with 67.2% of patients achieving a 75% reduction in psoriasis severity (PASI 75) at 112 weeks compared to 54.0% for adalimumab.

Deucravacitinib maintained stable response rates over two years, while adalimumab's effectiveness declined, suggesting that deucravacitinib may offer a more consistent long-term treatment option for moderate-to-severe plaque psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Matching-Adjusted Indirect Comparison of the Long-Term Efficacy of Deucravacitinib Versus Adalimumab for Moderate to Severe Plaque Psoriasis. Armstrong, AW., Park, SH., Patel, V., et al.[2023]

In a phase 3 trial involving 66 Japanese patients with moderate to severe plaque psoriasis, deucravacitinib showed significantly higher efficacy compared to placebo and apremilast, with 78.1% of patients achieving a ≥75% reduction in PASI score at Week 16.

The safety profile of deucravacitinib was comparable to that of placebo and apremilast, with similar incidence rates of adverse events, and the most common side effect being nasopharyngitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the selective TYK2 inhibitor, deucravacitinib, in Japanese patients with moderate to severe plaque psoriasis: Subgroup analysis of a randomized, double-blind, placebo-controlled, global phase 3 trial. Imafuku, S., Tada, Y., Hippeli, L., et al.[2023]

Deucravacitinib, a selective tyrosine kinase 2 inhibitor, was found to be safe and well tolerated in a study involving 40 healthy Chinese subjects, with no serious adverse events reported.

The drug showed rapid absorption and a dose-dependent increase in systemic exposure, indicating that it effectively reaches the bloodstream and maintains consistent pharmacokinetics across different doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects. Jing, S., Lin, Y., Dockens, R., et al.[2023]

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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 ...

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The hypothesis of this study is that an oral tablet formulation of JNJ-77242113 will result in superior efficacy compared with placebo as determined by the ...

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In areas of high impact, 72% of patients with scalp psoriasis and 85% with genital psoriasis treated with icotrokinra achieved site-specific ...

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In one study, a majority of people taking SOTYKTU saw 75% CLEARER SKIN at Week 16 vs those taking placebo (53% vs 9%).

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NCT06979453 | A Study to Evaluate the Efficacy, Safety ...

A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis ( ...