1311.14 BI655066 v placebo in patients with uncontrolled severe asthma
Research type
Research Study
Full title
A phase IIa, randomized, double-blind, placebo controlled, parallel group study to assess the safety and efficacy of subcutaneously administered BI 655066 as add-on therapy over 24 weeks in patients with severe persistent asthma.
IRAS ID
178583
Contact name
Dave Singh
Contact email
Sponsor organisation
Boehringer Ingelheim Ltd
Eudract number
2014-004932-20
Duration of Study in the UK
1 years, 6 months, 12 days
Research summary
This is a randomized, double-blind, placebo controlled, parallel group, multicenter study to assess the efficacy and safety of BI 655066, an IL-23p19 monoclonal antibody, compared to placebo, in patients with severe persistent asthma. BI 655066 will be administered via subcutaneous injection once every 4 weeks (Week 0, 4, 8, 12, 16, and 20) during the 24-week treatment period. The treatment period will be followed by a 16-week follow-up period.
After signing the informed consent at the initial visit, patients will enter a screening period which should last for up to 4 weeks unless extension of the screening period is necessary under certain circumstances. Patients who qualify to participate in the study will be randomized into a 24-week treatment period in which they will receive either 90 mg BI 655066 or a matching placebo. Patients will be evaluated for an additional 16 weeks following completion of the randomized treatment period. An interim analysis is planned when the last patient completes the 24-week treatment period. Treatment groups will remain blinded until the 16-week follow-up period is completed.
All patients will receive an asthma monitor/electronic diary (E-diary) which has an electronic peak flow meter and an electronic diary. The asthma monitor will be dispensed at the screening visit (Visit 1B), and patients will be required to use the device twice daily (morning and evening) to answer questions related to rescue medication use, asthma controller medication use, and also measure Peak Expiratory Flow (PEF). In addition, patients will complete the first five questions in the Asthma Control Questionnaire (ACQ5) in the E-diary once a week.Sub studies:
Pharmacokinetics sub-study (40 patients globally); bronchoscopy sub-study (50 patients globally); pharmacogenomic sub-study from only patients who sign a seperate consent for this sub-study, and will receive at least one dose of study medication.REC name
North West - Haydock Research Ethics Committee
REC reference
15/NW/0507
Date of REC Opinion
20 Jul 2015
REC opinion
Favourable Opinion