Deucravacitinib for Psoriatic Arthritis

Recruiting in Palo Alto (17 mi)

+312 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Bristol-Myers Squibb

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new medication called deucravacitinib to help people with active Psoriatic Arthritis. It aims to reduce joint pain and swelling by blocking harmful signals in the body. The study includes people who haven't tried biologic treatments or need an alternative to TNFα inhibitors. Deucravacitinib is an emerging treatment option for Psoriatic Arthritis, showing promise in recent studies.

Eligibility Criteria

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

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

I have been diagnosed with psoriatic arthritis for at least 3 months.

I have active arthritis with at least 3 swollen and 3 tender joints.

I have active psoriasis or a history of it.

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.

I have taken approved or experimental drugs for PsA or PsO.

I have an autoimmune condition like lupus or multiple sclerosis.

Participant Groups

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.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: DeucravacitinibExperimental Treatment1 Intervention

Group II: ApremilastExperimental Treatment1 Intervention

Group III: PlaceboPlacebo Group2 Interventions

Deucravacitinib is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Sotyktu for: