28689 Phase III Study of Lebrikizumab in Uncontrolled Asthma Patients
Research type
Research Study
Full title
A Phase III, Randomized, Double-Blind, Placebo Controlled Study To Assess The Efficacy and Safety of Lebrikizumab in Patients With Uncontrolled Asthma who are on Inhaled Corticosteroids and a Second Controller Medication.
IRAS ID
138254
Contact name
Ian Sabroe
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2013-000176-15
Clinicaltrials.gov Identifier
Research summary
Asthma is an inflammatory disease of the airways that leads to recurrent episodes of wheezing, breathlessness, chest tightness, and coughing. Uncontrolled asthma accounts for a major proportion of the overall burden of asthma.
Some patients’ asthma remains poorly controlled despite treatment with higher doses of inhaled corticosteroids and additional controller therapies. This study will evaluate the efficacy and safety of lebrikizumab (study drug) in patients with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid therapy and at least one second controller medication. Approximately 1050 participants will take part in this study and will be in the study for up to 124 weeks.
The study consists of:
•Screening period: To see if the participant is suitable.
•Placebo-controlled period: after starting treatment, participants return for visits every 4 weeks until Week 52.
•Active treatment extension: participants return for study visits every 4 weeks for a maximum of 52 weeks.
•Safety follow up period: following the active treatment extension, participants return to the clinic for 3 visits over 20 weeks. No study drug will be administered.Participants who provide written consent and meet all eligibility criteria will be randomly assigned in a 1:1:1 ratio to one of the following:
Group 1: lebrikizumab at a high dose every 4 weeks.
Group 2: lebrikizumab at a low dose every 4 weeks.
Group 3: placebo every 4 weeks.After 52 weeks, participants will enter the active treatment extension where Groups 1 & 2 continue on their originally assigned treatment, Group 3 will be assigned to either high or low dose lebrikizumab every 4 weeks (1 in 2 chance of receiving either dose).
The study involves procedures including (but not limited to): Chest–X-ray at screening, physical exams, ECG (electrical activity of heart), vital signs, blood and urine tests, Spirometry (breathing test) and questionnaires.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
13/YH/0320
Date of REC Opinion
21 Oct 2013
REC opinion
Favourable Opinion