M16-766 Plaque Psoriasis
Research type
Research Study
Full title
Protocol M16-766: A Multicenter, Randomized, Open Label, Efficacy Assessor-Blinded Study of Risankizumab Compared to Secukinumab for the Treatment of Adult Subjects with Moderate to Severe Plaque Psoriasis who are Candidates for Systemic Therapy
IRAS ID
247706
Contact name
Richard Warren
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2017-004932-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 25 days
Research summary
Psoriasis is a chronic inflammatory disease in which skin cells build up and develop scaly red and white patches on the skin. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. Despite the availability of various psoriasis therapies, many patients do not respond adequately to these treatments, or gradually lose response over time.
Risankizumab is an investigational drug being developed to help treat patients with inflammatory diseases such as psoriasis. Secukinumab is a drug that is already approved and available to treat patients who have psoriasis. This study will evaluate how well risankizumab works within the body and how safe it is compared to secukinumab for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy. Around 310 participants at approximately 80 sites worldwide will be included.
This open-label study will examine the effect of 150 mg risankizumab every 12 weeks vs. 300 mg secukinumab every 4 weeks.
There are 2 study groups and 155 patients will be randomly assigned to each group:
• Group 1 will receive 2 injections of active secukinumab (300 mg total dosage) subcutaneously (administered under the skin) at Weeks 0, 1, 2, 3, and 4, and every 4 weeks thereafter until the last dose at Week 48.
• Group 2 will receive 2 injections of active risankizumab (150 mg total dosage) subcutaneously at Weeks 0, 4, and then every 12 weeks thereafter until the last dose at Week 40.An independent assessor who does not know which group each patient is in will assess how effective the treatments have been.
Participation could last up to 72 weeks in total. Patients will have approximately 18 study visits to the research centre.
REC name
London - Central Research Ethics Committee
REC reference
18/LO/1219
Date of REC Opinion
20 Aug 2018
REC opinion
Further Information Favourable Opinion