M15-998: Risankizumab compared to placebo in PsA patients (Bio-IR)

  • Research type

    Research Study

  • Full title

    A Phase 3, Randomized, Double-Blind Study Comparing Risankizumab to Placebo in Subjects with Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or intolerance to Biologic Therapy(ies)

  • IRAS ID

    257478

  • Contact name

    Hasan Tahir

  • Contact email

    hasan.tahir@bartshealth.nhs.uk

  • Sponsor organisation

    AbbVie Ltd

  • Eudract number

    2017-002464-40

  • Clinicaltrials.gov Identifier

    NCT03671148

  • 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 150 mg for the treatment of signs and symptoms of psoriatic arthritis (PsA) in patients with moderately to severely active PsA. 50% of patients will have not responded to treatment (after at least 12 weeks of therapy) or shown intolerance to 1 or 2 biologic therapies (Bio-IR). The remaining patients on the study will have not responded to treatment (after at least 12 weeks of therapy) or shown intolerance to at least 1 conventional synthetic Disease Modifying Anti-Rheumatic Drug (csDMARD). The study will include approximately 420 subjects in 170 sites globally.

    Patients in this phase 3, randomised, double-blind, placebo-controlled study 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/0352

  • Date of REC Opinion

    2 Jul 2019

  • REC opinion

    Further Information Favourable Opinion