MSB11022 in Moderate to Severe Chronic Plaque Psoriasis
Research type
Research Study
Full title
A randomised, double-blind, confirmatory trial to evaluate the efficacy, safety and immunogenicity of MSB11022 compared with European Union-Approved Humira in subjects with moderate to severe chronic plaque psoriasis.
IRAS ID
197371
Contact name
Anthony Bewley
Contact email
Sponsor organisation
Merck KGaA
Eudract number
2015-003287-37
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
This is a phase 3 study testing the investigational drug MSB11022 in patients with moderate to severe chronic plaque psoriasis. The main purpose of the study is to find out if MSB11022 is as effective and safe as EU-approved Humira.
Half the subjects will be chosen randomly to receive MSB11022 and the other half will receive EU-approved Humira as a sub cutaneous (under the skin) injection for a double-blind 15 week treatment period. After completion of this treatment period, eligible subjects will be able to enter a 37 week double blind extension phase. Double blind means that neither the subject or doctor will know which study drug they have been randomised to. The subjects initially randomised to the EU-approved Humira arm will be re-randomised to receive either MSB11022 or EU-approved Humira.
Assessments include medical history, physical examination, skin examination, demographic data, Quality of Life questionnaires, chest x-ray, electrocardiogram (ECG), vital signs, urine and blood tests, subject diaries and PASI (Psoriasis Area Severity Index) and PGA (Physicians' Global Assessment)assessments.
Approximately 406 subjects worldwide will be randomised; this includes 8 subjects from the UK. The planned trial duration per subject is approximately 60 weeks: a 4-week screening period, a core treatment period up to Week 16, an additional 37-week extended treatment period for subjects who achieve PASI 50 at Week 16 and a Safety Follow-up visit 4 weeks after the last dose. The research is anticipated to last until September 2017.
REC name
London - Central Research Ethics Committee
REC reference
16/LO/0340
Date of REC Opinion
8 Apr 2016
REC opinion
Further Information Favourable Opinion