IM011-1130 Safety Study of Deucravacitinib vs Ustekinumab in Participants with Psoriasis (PRAGMATYK)
Research type
Research Study
Full title
A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants with Moderate-to-Severe Plaque Psoriasis (PRAGMATYK)
IRAS ID
1012641
Contact name
Silvia Morine-nagy
Contact email
Sponsor organisation
Bristol-Myers Squibb Services Unlimited Company
Eudract number
2023-503766-24
Clinicaltrials.gov Identifier
Research summary
This study is a randomised, open-label, active-comparator, long-term safety study. The study will assess the cardiovascular safety of long-term use of study drug, deucravacitinib in comparison to ustekinumab in participants with moderate to severe plaque psoriasis.
Deucravacitinib is a first-in-class oral medication approved to treat adults with plaque psoriasis in adults who are candidates for systemic therapy. Deucravacitinib binds and alters the TYK 2 receptor thereby blocking the signaling of certain cytokine proteins involved in the inflammation process of psoriasis.
Ustekinumab is already approved for treatment of plaque psoriasis. Ustekinumab is a monoclonal antibody that works by targeting and blocking specific proteins (interleukin-12 and interleukin-23) involved in inflammation. It is administered by subcutaneous injection.
This study will take place in various locations around the world. Participants will go through different stages: screening (up to 28 days), treatment (up to 5 years) and follow up. This study will have two treatment groups, participants will be randomised at a 1:1 ratio to either the deucravacitinib or Ustekinumab treatment group. Participants will be centrally randomised, stratified by history of cardiovascular events using interactive response technology. Participants assigned to the deucravacitinib treatment group will take the study drug orally daily. Participants assigned to the Ustekinumab group will be given the comparator by subcutaneous injection on day 1, 4 and then every 12 weeks thereafter.
Participants must be aged 40 years old or over with moderate to severe plaque psoriasis and have at least one cardiovascular disease risk factor. Factors could include but are not limited to; smoking, hypertension, type 1 or 2 diabetes, obesity and coronary heart disease.
Approximately 4,055 participants will be enrolled worldwide to achieve 3,040 randomised to treatment.REC name
Wales REC 5
REC reference
25/WA/0265
Date of REC Opinion
15 Oct 2025
REC opinion
Further Information Favourable Opinion