Deucravacitinib for Psoriatic Arthritis

(COMBo Trial)

Overseen By Aleuna Lee, PhD, CCRC

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Texas Southwestern Medical Center

Must be taking: Anti-TNF

Must not be taking: TYK2, JAK inhibitors

Disqualifiers: Severe cardiovascular, hepatic, renal, others

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

Compensation: Varies

Number of Visits: 5

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding deucravacitinib, a new potential drug, to current treatments can better manage symptoms and improve the quality of life for people with psoriatic arthritis. The trial will compare deucravacitinib with a placebo, both alongside standard anti-TNF treatments, which help reduce inflammation. Individuals with psoriatic arthritis who experience noticeable skin plaques or joint pain, despite stable anti-TNF therapy, might be suitable candidates for this trial. As a Phase 4 trial, this research seeks to understand how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

You may not need to stop your current medications. The trial allows the use of certain medications like csDMARDs, NSAIDs, and oral glucocorticoids if they have been stable for a specific period before starting the trial. However, some medications must not have been used for a certain time before the trial begins.

What is the safety track record for deucravacitinib?

Research has shown that deucravacitinib is generally well-tolerated by people with psoriatic arthritis. In one study, patients who took deucravacitinib for up to 52 weeks continued to benefit, with most side effects being mild to moderate. Common side effects included minor infections and headaches, while serious side effects were rare. This suggests that the treatment is safe for most people.

Since the FDA has already approved deucravacitinib for other conditions, like psoriasis, additional evidence supports its safety. This indicates that it has undergone thorough testing and is considered safe for treating other diseases. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for psoriatic arthritis, which often includes anti-TNF therapies like adalimumab or etanercept, deucravacitinib offers a fresh approach by targeting the TYK2 enzyme, part of the JAK family involved in inflammation. This new mechanism can potentially provide relief for patients who don't respond well to existing treatments. Researchers are excited about deucravacitinib because it offers a unique method of action and is administered orally, which can be more convenient compared to the injections required for many current therapies.

What evidence suggests that adding deucravacitinib to PsA treatment could be effective?

Research has shown that deucravacitinib effectively treats psoriatic arthritis. One study found that 54.2% of patients taking deucravacitinib experienced at least a 20% improvement in symptoms after 16 weeks. This improvement persisted for a year, demonstrating long-term effectiveness. In this trial, participants will receive either deucravacitinib combined with an established standard of care anti-TNF or a placebo combined with the anti-TNF. Patients also showed better skin condition scores, regardless of other medications used. Overall, deucravacitinib has proven effective and safe for managing psoriatic arthritis symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

Joseph F. Merola, MD MMSc

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with Psoriatic Arthritis who are currently under treatment but still have symptoms. Participants should be adults willing to add a new medication, deucravacitinib, or a placebo to their regimen.

Inclusion Criteria

I have psoriasis covering more than 3% of my body or PsA with significant joint symptoms despite ongoing treatment.

I am currently taking up to 1 csDMARD, NSAID, or oral glucocorticoid.

I am on a stable dose of prednisone or its equivalent, not exceeding 15 mg daily.

Exclusion Criteria

Recent herpes zoster or herpes simplex infection

I have a history of fibromyalgia or similar joint conditions.

History of prior allergic reaction or intolerance to deucravacitinib

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive deucravacitinib in combination with anti-TNF therapy or placebo for Psoriatic Arthritis

48 weeks

Regular visits at baseline, weeks 5, 12, 24, and 48

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 the effectiveness of deucravacitinib when added to existing Psoriatic Arthritis treatments. It's designed to see if this combination can better manage symptoms and improve quality of life compared to current therapies alone.

How Is the Trial Designed?

Group I: established standard of care anti-TNF plus deucravacitinib Experimental Treatment 1 Intervention

Deucravacitinib will be administered in tablet form. Anti-TNF will be administered by injection.

Group II: established standard of care anti-TNF plus placebo Placebo Group 1 Intervention

Placebo will be administered in tablet form. Anti-TNF will be administered by injection.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Citations

1.

empr.com

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

Week 52 Data Confirm Deucravacitinib Efficacy in Psoriatic ...

Findings showed a significantly greater percentage of deucravacitinib-treated patients achieved ACR20 response at week 16 compared with those ...

2.

ccjm.org

ccjm.org/page/acr-2025/deucravacitinib

Deucravacitinib has favorable safety, sustained efficacy ...

Deucravacitinib has favorable safety, sustained efficacy through 52 weeks in adults with active psoriatic arthritis, phase 3 data show | Cleveland Clinic ...

3.

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%; ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12450178/

Efficacy and Safety of Deucravacitinib, a Selective ...

PASI scores: Patients with or without background csDMARD use showed similar improvements in PASI scores with deucravacitinib at both doses. Of ...

5.

acrabstracts.org

acrabstracts.org/abstract/efficacy-and-safety-of-deucravacitinib-up-to-week-52-a-multicenter-randomized-double-blind-placebo-controlled-phase-3-study-in-patients-with-active-psoriatic-arthritis-who-are-naive-to-biologic-d/

Efficacy and Safety of Deucravacitinib up to Week 52

1 Responses continued to improve through W24 and were maintained with deucravacitinib through W52; similar results were seen for ACR 50/70 ( ...

6.

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 who are ...