JNJ-77242113 for Plaque Psoriasis

Recruiting at 197 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

774 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to see how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.

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.

What data supports the effectiveness of the drug Deucravacitinib for treating plaque psoriasis?

Deucravacitinib has been shown to be effective in treating moderate to severe plaque psoriasis, with over 50% of patients experiencing a significant reduction in symptoms after 16 weeks of treatment. It works by specifically targeting and inhibiting a protein involved in the inflammation process, which helps reduce the symptoms of psoriasis. ^{1 2 3 4 5}

Is deucravacitinib safe for humans?

Deucravacitinib has been tested in clinical trials and shown to be generally safe for humans. Common side effects include upper respiratory infections, increased blood enzyme levels, and mild skin issues like acne. No serious adverse events were reported in early human studies. ^{1 2 3 4 6}

How is the drug Deucravacitinib unique for treating plaque psoriasis?

Deucravacitinib is unique because it is a first-in-class, highly selective oral drug that targets the TYK2 enzyme, which plays a role in the immune response involved in psoriasis. Its allosteric mechanism of action, which stabilizes an inhibitory interaction within the enzyme, sets it apart from other treatments, potentially offering a better safety profile and long-term efficacy. ^{1 2 3 5 7}

Research Team

Janssen Research & Development, LLC Clinicaltrial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Deucravacitinib: First Approval. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

SOTYKTUTM (Deucravacitinib 6-mg Tablets)- A New Agent for the Management of Adult Plaque Psoriasis. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Deucravacitinib in moderate-to-severe psoriasis. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Matching-Adjusted Indirect Comparison of the Long-Term Efficacy of Deucravacitinib Versus Adalimumab for Moderate to Severe Plaque Psoriasis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

First-in-human study of deucravacitinib: A selective, potent, allosteric small-molecule inhibitor of tyrosine kinase 2. [2023]

7. England 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. [2023]