A study to see the effect of OC000459 in people with eczema
Research type
Research Study
Full title
A STUDY OF THE EFFECT OF OC000459 ON SIGNS & SYMPTOMS IN SUBJECTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS: A RANDOMISED DOUBLE BLIND PLACEBO CONTROLLED PARALLEL GROUP STUDY
IRAS ID
132123
Contact name
Michael Cork
Contact email
Sponsor organisation
Atopix Therpeutics Ltd
Eudract number
2013-001924-20
ISRCTN Number
na
Clinicaltrials.gov Identifier
na
Research summary
A randomised, double blind, placebo controlled, parallel group study to identify the effect of OC000459 50mg given once a day orally in comparison to placebo on the severity and extent of Atopic Dermatitis (AD) for 26 weeks in subjects with active moderate to severe AD. There is an unmet need for safe, oral, maintenance therapy for AD. Approximately 200 subjects will be randomised and each treatment arm will consist of approximately 100 subjects. Males and females aged 18 to 40 years with previously clinically confirmed AD are eligible. It is a multicentre study conducted in approximately 20 specialist dermatology centres in Europe.
The study will last a total of 32 weeks. Following 2 weeks of OC000459/placebo treatment, topical therapy will be withdrawn. Subjects will continue on either OC000459 or placebo. They will then be permitted to use standardised topical rescue medication in the event of a flare in their AD. Throughout this period subjects will use their usual emollients (except clinic days).
After the randomised 26 week study period is completed there will be a 4 week follow up period during which all subjects will be permitted to use their emollients and the standard rescue medication, as required, but no study medication is given. There will be a final follow up visit four weeks after the last dose of study medication.
At clinic visits their AD will be assessed by examination and by the use of various questionnaires. Between clinic visits they will complete a daily diary recording their use of medication and the status of their AD. If subjects experience a flare between scheduled clinic visits they will be asked to attend clinic for an unscheduled visit to assess their flare and further visits, if necessary, to assess progress.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
13/EM/0248
Date of REC Opinion
24 Jul 2013
REC opinion
Further Information Favourable Opinion