Only 120 spots left

~120 spots leftby Jan 2026

Deucravacitinib for Psoriasis

Recruiting in Palo Alto (17 mi)

+76 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Bristol-Myers Squibb

Disqualifiers: Non-plaque psoriasis, others

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to measure the safety and effectiveness of deucravatinib in participants with non-pustular palmoplantar psoriasis and genital psoriasis.

Will I have to stop taking my current medications?

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

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

Deucravacitinib has been shown to be effective in treating moderate to severe plaque psoriasis, with up to 58.4% of patients experiencing symptom improvement in clinical trials. It was also more effective than placebo and another drug, apremilast, in reducing psoriasis severity in Japanese patients.¹ ² ³ ⁴ ⁵

What is known about the safety of Deucravacitinib (Sotyktu) in humans?

Deucravacitinib (Sotyktu) has been tested in humans and is generally considered safe, with common side effects including upper respiratory infections, increased blood enzyme levels, and mild skin issues like acne. In studies, no serious adverse events were reported, and the frequency of side effects was similar to those taking a placebo (a harmless pill used for comparison).¹ ² ³ ⁶ ⁷

How is the drug deucravacitinib different from other psoriasis treatments?

Deucravacitinib is unique because it is an oral medication that specifically targets TYK2, a protein involved in the immune response, using an allosteric mechanism (binding to a different site than the active site). This selectivity may offer a better safety profile compared to other treatments, and it has shown significant effectiveness in reducing psoriasis symptoms in clinical trials.¹ ² ⁵ ⁸ ⁹

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults with moderate-to-severe non-pustular palmoplantar and genital psoriasis, who have not improved with at least one topical therapy. Participants should have stable plaque psoriasis without significant flares or changes in the last 6 months and be suitable for phototherapy or systemic treatment.

Inclusion Criteria

My doctor thinks I should get light or drug treatment.

I have had stable psoriasis on my hands and/or feet for at least 6 months.

My psoriasis is moderate to severe, with a score of 3 or more.

See 7 more

Exclusion Criteria

Other protocol-defined inclusion/exclusion criteria apply.

I have a type of psoriasis that is not plaque psoriasis.

Treatment Details

Interventions

Deucravacitinib (Janus Kinase (JAK) Inhibitor)

Trial OverviewThe study tests deucravacitinib's safety and effectiveness against a placebo in treating non-pustular palmoplantar and genital psoriasis. It aims to see if this medication can help manage symptoms better than no active treatment.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DeucravacitinibExperimental Treatment1 Intervention

Group II: Placebo followed by DeucravacitinibPlacebo Group2 Interventions

Deucravacitinib is already approved in Canada for the following indications:

Approved in Canada as Sotyktu for:

Moderate to severe plaque psoriasis

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:

Virginia Clinical ResearchNorfolk, VA

Wake Forest University School Of MedicineWinston-Salem, NC

Medical Dermatology Specialists - PhoenixPhoenix, AZ

Dawes Fretzin Clinical Research Group, LLC (DFCRG)Indianapolis, IN

More Trial Locations

Loading ...

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2731

Patients Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]