WA29249 - Lebrikizumab in mild to moderate Asthma - STRETTO
Research type
Research Study
Full title
A phase III, randomized, double-blind, placebo controlled study to evaluate the efficacy and safety of Lebrikizumab in adult patients with mild-to-moderate asthma
IRAS ID
180492
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division, PDR
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2013-004625-81
Duration of Study in the UK
0 years, 7 months, 28 days
Research summary
This Phase III study is designed to assess the efficacy and safety of lebrikizumab in adult patients with mild-to-moderate asthma treated with SABA (short acting β-agonists) therapy alone.
After a successful screening period lasting 2 weeks, patients will be allocated equally to one of 3 arms: blinded lebrikizumab (125mg), blinded placebo or open label Singulair 10mg (comparator).
Patients who are allocated to receive blinded study drug (lebrikizumab or placebo) will receive three doses during the 12 week treatment period. The first dose will be administered on Day 1, the second dose will be administered 4 weeks later (+/- 3 days), and the third (and final) dose will be administered 4 weeks after that, at Week 8 (+/- 3 days). The primary endpoint will be assessed at Week 12. Patients who are allocated to receive open-label treatment with Singulair will be required to take orally 1 tablet (10 mg) of Singulair daily in the evening for the duration of the 12-week treatment period.
Following completion or withdrawal from the treatment phase of the study, all patients will enter an 8-week, Safety Follow-Up Period. Safety will be assessed throughout the study.
Patients who experience treatment failure should enter the Safety Follow-Up Period and be managed according to standard of care.
Approximately 300 patients will be recruited globally with 15 patients in the UK in 1 site.
This study is sponsored by Roche Products Ltd in the UK.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
15/NW/0428
Date of REC Opinion
23 Jun 2015
REC opinion
Further Information Favourable Opinion