Deucravacitinib for Psoriatic Arthritis

Recruiting at 61 trial locations

Overseen By First line of the email MUST contain the NCT# and Site#

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Bristol-Myers Squibb

Disqualifiers: Other JIA, Uveitis, 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: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness and safety of a new treatment, Deucravacitinib, for children with juvenile psoriatic arthritis, a condition causing joint pain and swelling. The trial will compare this medication to a placebo, a look-alike substance with no active ingredients, to determine its efficacy. Children diagnosed with juvenile psoriatic arthritis, experiencing arthritis in at least three joints, and not responding well to other treatments for at least three months may be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Deucravacitinib is likely to be safe for humans?

Research has shown that deucravacitinib has been tested for safety in treating plaque psoriasis and psoriatic arthritis. In these studies, the side effects of deucravacitinib were predictable and manageable, with no new safety issues identified.

For individuals with moderate to severe plaque psoriasis, long-term use of deucravacitinib was generally well-tolerated, meaning most did not experience severe or unexpected side effects. Similarly, studies on psoriatic arthritis confirmed previous findings, indicating it is generally safe for individuals with this condition.

Overall, the evidence supports that deucravacitinib is a well-tolerated treatment, with no new safety concerns emerging from recent studies. ^{1 2 3 4 5}

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

Deucravacitinib is unique because it targets the TYK2 enzyme, a key player in the inflammatory process of psoriatic arthritis. Unlike current treatments, which often involve TNF inhibitors or IL-17 blockers, this oral medication offers a novel mechanism of action by selectively inhibiting TYK2. Researchers are excited about Deucravacitinib because it may provide an effective option with potentially fewer side effects and more convenient oral administration compared to injectable biologics.

What evidence suggests that Deucravacitinib might be an effective treatment for juvenile psoriatic arthritis?

Research has shown that Deucravacitinib, which participants in this trial may receive, can help treat psoriatic arthritis. In studies, 28.8% of patients taking Deucravacitinib experienced a 50% improvement in their symptoms, compared to 16.3% of those taking a placebo. Additionally, 40.9% of patients saw a 75% improvement in their skin symptoms, while only 15.4% of those on a placebo did. Deucravacitinib blocks TYK2, a protein involved in inflammation, which helps reduce the symptoms of psoriatic arthritis. Overall, the evidence supports its potential benefits for people with this condition. ^{2 3 6 7 8}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for children with Juvenile Psoriatic Arthritis (JPsA) who have at least three joints affected by arthritis. They should have tried a medication for JPsA for three months without success or experienced issues with it.

Inclusion Criteria

I have been diagnosed with Juvenile Psoriatic Arthritis.

I have arthritis in three or more joints.

I have tried a treatment for JPsA for 3 months with little to no success.

Exclusion Criteria

My arthritis is specifically diagnosed as JPsA, not another type of JIA.

Participants must not have been diagnosed with JPsA before 5 years of age

Other protocol-defined Inclusion/Exclusion criteria apply.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Deucravacitinib or placebo to evaluate drug levels, efficacy, and safety

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Deucravacitinib

Trial Overview The study tests Deucravacitinib, a new drug, against a placebo to check its levels in the body, effectiveness, and safety in treating juvenile psoriatic arthritis.

How Is the Trial Designed?

Group I: Arm A Experimental Treatment 1 Intervention

Group II: Arm B Placebo Group 2 Interventions

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Published Research Related to This Trial

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]

Deucravacitinib, an oral medication for moderate to severe plaque psoriasis, demonstrated higher PASI 75 response rates compared to apremilast and methotrexate across all time points in a network meta-analysis of 47 randomized controlled trials.

Long-term efficacy of deucravacitinib was comparable to first-generation biologics like adalimumab and ustekinumab, making it a viable oral treatment option for patients seeking effective psoriasis management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-, Mid-, and Long-Term Efficacy of Deucravacitinib Versus Biologics and Nonbiologics for Plaque Psoriasis: A Network Meta-Analysis. Armstrong, AW., Warren, RB., Zhong, Y., 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 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, an oral tyrosine kinase 2 inhibitor, showed significant improvements in psoriasis symptoms and quality of life as early as Week 4 in a 12-week Phase 2 trial involving adults with moderate to severe plaque psoriasis.

Patients experienced better quality of life alongside clinical improvements, indicating that as psoriasis symptoms improved, so did their overall well-being, suggesting that deucravacitinib could be a promising new treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial. Thaçi, D., Strober, B., Gordon, KB., et al.[2022]

Citations

1. news.bms.com news.bms.com/news/details/2025/Bristol-Myers-Squibb-Presents-Two-Late-Breaking-Presentations-Demonstrating-Sotyktu-deucravacitinib-Efficacy-in-Psoriatic-Arthritis-and-Systemic-Lupus-Erythematosus/default.aspx

Corporate news details New data showed ACR20 responses (at least a 20 percent improvement in signs and symptoms of disease) achieved at Week 16 (Sotyktu, 54.2%; ...

2. psoriasis-hub.com psoriasis-hub.com/medical-information/deucravacitinib-for-psoriatic-arthritis-52-week-results-from-the-phase-iii-poetyk-psa-2-trial

52-week results from the phase III POETYK PsA-2 trial Clinical responses, including ACR50 (28.8% vs 16.3%), ACR70 (10.6% vs 5.4%), and PASI75 (40.9% vs 15.4%), were higher with deucravacitinib vs ...

3. academic.oup.com academic.oup.com/rheumatology/article/64/5/2557/7826634

Deucravacitinib, a selective, TYK2 inhibitor, in psoriatic arthritis These results suggest that the MDA response achieved with deucravacitinib is comprehensive across an array of its component outcomes in PsA.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40616721/

Efficacy and Safety of Deucravacitinib, a Selective, ... Introduction: This study aimed to evaluate the influence of background conventional synthetic disease-modifying antirheumatic drug (csDMARD) use on efficacy and ...

5. empr.com empr.com/reports/week-52-data-confirm-deucravacitinib-efficacy-in-psoriatic-arthritis/

Week 52 Data Confirm Deucravacitinib Efficacy in Psoriatic ... The primary endpoint was the proportion of participants achieving American College of Rheumatology improvement of 20% (ACR20) response at week ...

6. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2827130

Safety and Efficacy of Deucravacitinib in Moderate to ... The results of this analysis further support the long-term safety and efficacy of deucravacitinib for patients with moderate to severe plaque psoriasis.

7. rheumatologyadvisor.com rheumatologyadvisor.com/news/deucravacitinib-under-review-for-active-psoriatic-arthritis/

Deucravacitinib Under Review for Active Psoriatic Arthritis The safety profile of deucravacitinib was consistent with previous studies; no new safety signals were identified. “There is a significant ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04908189

NCT04908189 | A Study to Determine the Efficacy and ... The purpose of this study is to evaluate the safety and efficacy of deucravacitinib versus placebo for the treatment of participants with active PsA.