Deucravacitinib for Psoriatic Arthritis

Not currently recruiting at 337 trial locations

Overseen By BMS Study Connect Contact Center www.BMSStudyConnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bristol-Myers Squibb

Must not be taking: Biologics

Disqualifiers: Nonplaque psoriasis, Lupus, Fibromyalgia, 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: 2

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, deucravacitinib, to determine its effectiveness for people with active psoriatic arthritis (PsA), a condition causing joint pain and skin issues. The study compares deucravacitinib to a placebo and another drug, apremilast, to assess safety and effectiveness. It seeks participants who have had PsA for at least three months, exhibit active symptoms like swollen and tender joints, and have a history of plaque psoriasis. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance 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 whether you need to stop taking your current medications. However, it mentions that participants should not have received biologic therapy for PsA or PsO, which might imply some restrictions on certain medications.

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

Research has shown that deucravacitinib has been tested for safety in treating conditions like psoriatic arthritis. In earlier studies, most patients tolerated deucravacitinib well. Common side effects included headaches and upper respiratory infections, but these were not severe for most individuals.

The FDA is reviewing deucravacitinib for treating active psoriatic arthritis, indicating promise in earlier research. This review process confirms that the treatment has passed initial safety checks for human use. Overall, while some side effects have been noted, research supports that deucravacitinib is relatively safe for many patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for psoriatic arthritis, which typically involve drugs like methotrexate or biologics such as TNF inhibitors, Deucravacitinib offers a fresh approach by targeting the TYK2 enzyme. This enzyme plays a crucial role in the inflammatory pathways associated with psoriatic arthritis. By specifically inhibiting TYK2, Deucravacitinib may offer more precise control over inflammation with potentially fewer side effects. Researchers are excited because this novel mechanism could lead to improved outcomes for patients who don't respond well to existing therapies.

What evidence suggests that this trial's treatments could be effective for psoriatic arthritis?

Research has shown that deucravacitinib, one of the treatments in this trial, holds promise for treating psoriatic arthritis (PsA). Studies have found that it significantly improves symptoms in people with active PsA, even for those who haven't tried biologic treatments before. A year-long study confirmed its effectiveness and safety. These findings suggest that deucravacitinib could be a helpful option for managing PsA symptoms. Participants in this trial may receive deucravacitinib, a placebo, or apremilast as part of the study's treatment arms. ^{1 2 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 people with active Psoriatic Arthritis (PsA) who are either new to biologic treatments or have tried TNFα inhibitors before. They must have had PsA for at least 3 months, with ≥3 swollen and tender joints, an active psoriasis skin lesion or a history of plaque psoriasis, and meet specific medical criteria. Those with non-plaque psoriasis types, other joint diseases like rheumatoid arthritis, fibromyalgia, or certain autoimmune conditions cannot join.

Inclusion Criteria

Your level of high sensitivity C-reactive protein (hsCRP) is 3 mg/L or higher at the screening.

I have active psoriasis or a history of it.

I have finished a year-long treatment in a previous study phase.

Exclusion Criteria

I have a history of or currently have an inflammatory joint disease other than Psoriatic Arthritis.

I have been diagnosed with active fibromyalgia.

I do not have plaque psoriasis currently.

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 for the treatment of active Psoriatic Arthritis

16 weeks

Visits at Weeks 2, 4, 8, 12, 16

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term extension

The long-term extension period will provide additional long-term safety and efficacy information

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Deucravacitinib
• Placebo

Trial Overview The study tests the safety and effectiveness of Deucravacitinib compared to a placebo in treating Psoriatic Arthritis. Participants will be randomly assigned to receive either Deucravacitinib or a placebo. The trial includes those new to biologic drugs as well as patients previously treated with TNFα inhibitors.

How Is the Trial Designed?

Group I: Deucravacitinib Experimental Treatment 1 Intervention

Group II: Apremilast Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 2 Interventions

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?

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 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, 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, 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]

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 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]

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 from the pivotal Phase 3 POETYK PsA-1 trial demonstrated that Sotyktu improved and maintained meaningful clinical responses, ...

2. dermatologytimes.com dermatologytimes.com/view//view/new-52-week-data-reinforce-deucravacitinib-s-benefits-for-psoriatic-arthritis-and-sle

New 52-Week Data Reinforce Deucravacitinib's Benefits ... Bristol Myers Squibb reveals promising data on deucravacitinib's efficacy for psoriatic arthritis and systemic lupus erythematosus, highlighting ...

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

Week 52 Data Confirm Deucravacitinib Efficacy in Psoriatic ... Deucravacitinib was found to be efficacious through 52 weeks in patients with active psoriatic arthritis (PsA) who are naïve to biologic ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06869551

NCT06869551 | A Study to Evaluate the Drug Levels ... The purpose of this study is to evaluate the drug levels, efficacy, and safety of Deucravacitinib (BMS-986165) in pediatric participants with juvenile psoriatic ...

5. 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 ...

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

Safety and Efficacy of Deucravacitinib in Moderate to ... Efficacy outcomes included 75% or greater or 90% or greater reduction from baseline in Psoriasis Area and Severity Index (PASI 75/90) and static ...

7. 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.

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

Deucravacitinib Under Review for Active Psoriatic Arthritis The FDA has accepted for review the sNDA for deucravacitinib for the treatment of adults with active psoriatic arthritis.