CIM003JG - CIM331 v Placebo in Atopic Dermatitis Patients
Research type
Research Study
Full title
A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF CIM331 IN ATOPIC DERMATITIS PATIENTS WHO ARE INADEQUATELY CONTROLLED BY OR INTOLERANT TO TOPICAL THERAPY
IRAS ID
139107
Contact name
Anthony Bewley
Contact email
Sponsor organisation
Chugai Pharma Europe Ltd.
Eudract number
2013-002470-46
ISRCTN Number
N/A
Research summary
Atopic dermatitis is associated with skin barrier dysfunction and skin dryness caused by abnormalities of the outer skin layer. It is triggered by an immune response to certain substances and by mechanical irritation. Itching (pruritus) is the most characteristic symptom. It is an unpleasant sensation that results in considerable reduction in patient quality of life, such as by disturbing sleep and scratching that is known to make the dermatitis worse.
This study is being carried out to see if a new investigational drug called CIM331 is safe and effective in treating patients with moderate to severe atopic dermatitis. As well as assessing how well the study drug works, this study will look at which dose works best in treating atopic dermatitis.
This study will consist of 2 parts. Part A will be a randomised, double-blind, placebo-controlled, parallel assignment design (Weeks 0 to 12). Participants will be randomised in a 1:1:1:1:1 ratio to varying doses of CIM331 (4 active treatment groups) and placebo. CIM331 or placebo will be injected subcutaneously. Part B will be a double-blind extension phase in which patients will continue to receive treatment with CIM331 for a further 52 weeks (Weeks 12 to 64). In Part B, participants who were randomised to the placebo group in Part A will be re randomised to one of CIM331 treatment groups. Participants who were randomised to active treatment in Part A will be re-allocated to the same dose in Part B. A safety follow-up visit will be performed 12 weeks after the last dose of study drug.
Approximately 250 participants in approximately 48 study centres in 5 countries will take part in this study.
REC name
London - Riverside Research Ethics Committee
REC reference
13/LO/1752
Date of REC Opinion
10 Dec 2013
REC opinion
Favourable Opinion