POETYK PsA-1 - Deucravacitinib in naive patients with PsA (IM011-054)
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Psoriatic Arthritis who are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs
IRAS ID
1003827
Contact name
Head of the Global Submission Management - Clinical Trials
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2020-005097-10
Clinicaltrials.gov Identifier
Research summary
This is a phase 3 trial in adults with psoriatic arthritis (PsA) who have not already received treatment with a biologic disease-modifying anti-rheumatic drug. PsA is a type of arthritis that affects some people with the skin condition, psoriasis. This study will test an investigational study drug, called deucravacitinib (BMS 986165) to see if it is a safe and effective treatment. This study will test deucravacitinib (taken orally at a dose of 6 mg once a day) compared to placebo.
There are three parts to this study (screening, treatment and follow-up).
The screening part will help ensure the study is appropriate for the patient. It can last up to 28 days. If eligible patients will enter a 52-Week Treatment Period. The treatment period is split into the 16 week placebo-controlled part followed by the 36 weeks active treatment part.
During the placebo-controlled part, patients will be randomised (1:1) to either deucravacitinib or matching placebo.
At Week 16, patients randomised to deucravacitinib will continue taking that same dose of deucravacitinib (6 mg) during the 36-week Active Treatment Period. Those randomised to placebo, will be reallocated to 6 mg deucravacitinib during the 36-week Active Treatment Period.If the patient’s PsA flares up or does not improve the study doctor may give another treatment on top of the study treatment or may discontinue study treatment altogether. After the 52 week treatment period (or if the patient comes off treatment earlier), patients will enter the follow-up period. Patients will be followed for 4 weeks after their last dose of study treatment and will visit the hospital once.
Patients will attend about 15 visits to the hospital. They will undergo blood tests; physical examinations including vital signs (such as blood pressure and heart rate), x-rays to the chest, hands and feet, an ECG and asked to complete some health related questionnaires.
The study is funded by Bristol Myers Squibb.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
21/SC/0307
Date of REC Opinion
21 Oct 2021
REC opinion
Further Information Favourable Opinion