M19-164 Plaque Psoriasis
Research type
Research Study
Full title
M19-164: A Phase 3b, multicenter, interventional, open-label study of adult subjects with moderate to severe plaque psoriasis who have a suboptimal response to secukinumab or ixekizumab and are switched to risankizumab.
IRAS ID
270912
Contact name
Richard Warren
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2019-000904-14
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 17 days
Research summary
Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. Despite the availability of various psoriasis therapies, many patients do not respond adequately to these treatments, or gradually lose response over time.
Risankizumab is a drug developed to treat patients with inflammatory diseases such as psoriasis. Secukinumab and Ixekizumab are drugs that are already approved and available to treat patients who have psoriasis. This study will evaluate whether adult patients with moderate to severe plaque psoriasis that have not responded adequately to Secukinumab or Ixekizumab will benefit from a switch to risankizumab.
Around 250 participants at approximately 9 countries worldwide will be included.
Subjects will receive two 75mg injections of risankizumab (150 mg total dosage) subcutaneously (administered under the skin) at Weeks 0, 4 and every 12 weeks thereafter until the last dose at Week 40. Subjects will then be followed up via telephone call, 20 weeks after their last dose.
Participation could last up to 64 weeks in total. Patients will have approximately 8 study visits to the research centre.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
19/NE/0328
Date of REC Opinion
26 Nov 2019
REC opinion
Further Information Favourable Opinion