POETYK PsA-2 - Deucravacitinib in patients with PsA (IM011-055)
Research type
Research Study
Full title
POETYK PsA-2 (055) - A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Participants with Active Psoriatic Arthritis (PsA) who are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or had Previously Received TNFα Inhibitor Treatment
IRAS ID
1003828
Contact name
Head of Global Clinical Trial Submission Unit
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2020-005099-36
Clinicaltrials.gov Identifier
Research summary
This is a phase 3 trial in adults with psoriatic arthritis (PsA) who only receive non-steroidal anti-inflammatory (like ibuprofen) and biologic disease-modifying anti-rheumatic drugs to treat their condition, and whose treatment has been unsuccessful with tumour necrosis factor inhibitors. 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, compared to placebo or apremilast. There are three parts to this study (screening, treatment and follow-up). The screening part of the study 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. It is divided into 2 parts, 16-week placebo-controlled treatment is followed by the 36 weeks active treatment period.
During the first part patients will be randomised (3:3:1) to either 6 mg deucravacitinib once a day, placebo or 30mg apremilast twice a day. At Week 16, patients taking 6 mg deucravacitinib will continue the same treatment during the 36-week Active Treatment Period. Those randomised to placebo, will be reallocated to 6 mg deucravacitinib and those taking 30 mg apremilast twice daily, will continue taking that same dose.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 52week treatment period (or if the patient comes off treatment earlier), patients will enter the follow-up period lasting 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 complete health related questionnaires; undergo blood tests; physical examinations (blood pressure and heart rate), chest x-rays and an ECG.
The study is funded by Bristol Myers Squibb.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
21/SC/0270
Date of REC Opinion
9 Nov 2021
REC opinion
Further Information Favourable Opinion