M16-011: Risankizumab compared to placebo in PsA patients (DMARD-IR)
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Study Comparing Risankizumab to Placebo in Subjects with Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy
IRAS ID
256743
Contact name
Hasan Tahir
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2017-002465-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 7 months, 7 days
Research summary
Psoriatic Arthritis (PsA) is a type of arthritis which develops in some people with the skin condition psoriasis. It is caused by the body’s immune system mistakenly attacking healthy joint tissue causing inflammation, joint damage, disability, and a reduced life expectancy. Currently patients have a range of options for treatment but these do not always have the desired or prolonged effect over the length of a patient’s life.
Risankizumab is an investigational drug being developed to help treat patients with inflammatory diseases such as psoriatic arthritis (PsA). The purpose of this study is to look at the effectiveness and safety of risankizumab (150mg) for the treatment of signs and symptoms of PsA in patients with moderately to severely active PsA who do not respond to treatment after at least 12 weeks of therapy or for patients who cannot take 1 or more conventional (traditional) synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARD). The study will include approximately 880 subjects in 270 sites globally.
This is a phase 3, randomised, double-blind, placebo-controlled study. Patients will be randomised in a 1:1 ratio to either risankizumab (150 mg subcutaneous injection) or placebo. After week 24 all patients will receive risankizumab. An independent assessor who does not know which group each patient is in will assess how effective the treatments have been.
Patients could be in the study for up to 233 weeks, including:
• Screening Period - about 35 days (5 weeks)
• Period 1 –Treatment period from Baseline/Day 1 to Week 24 (about 6 months)
• Period 2 – Treatment period from Week 24 through Week 208 (about 3 ½ years)
• Follow-up Period - 20 weeks (5 months)REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
19/LO/0351
Date of REC Opinion
3 Jul 2019
REC opinion
Further Information Favourable Opinion