GB001 in adult subjects with moderate to severe asthma
Research type
Research Study
Full title
A Phase 2b, randomized, double-blind, placebo-controlled, dose-ranging, multi-center study to evaluate the efficacy and safety of GB001 as maintenance therapy in adult subjects with moderate to severe asthma
IRAS ID
252761
Contact name
Dinesh Saralaya
Contact email
Sponsor organisation
GB001, Inc.
Eudract number
2018-002242-36
Duration of Study in the UK
1 years, 6 months, 11 days
Research summary
There are several medications that are taken daily to control the symptoms of moderate to severe asthma. However, sometimes asthma remains difficult to control and patients continue to have symptoms and asthma attacks. The key goal in managing asthma control is to improve symptoms and decrease asthma attacks.
This study, sponsored by GB001, Inc., will test the effects of a new medicine called GB001 on asthma symptoms and also will see if GB001 can reduce asthma attacks. The safety of GB001 will also be tested.
GB001 is a medication that is taken once a day by mouth. GB001 may decrease swelling in the lungs that causes asthma symptoms and asthma attacks.
This study will compare GB001 and placebo (a medicine that looks like the study medicine but doesn’t contain the actual medicine), taken by mouth at bedtime. GB001 or placebo will be added to participants’ normal asthma medications. There will be 3 groups of participants who will receive GB001 (3 different doses) and one group that will receive placebo. These groups will be chosen randomly by a computer.
There may be 10 visits to attend during which various tests, questionnaires and lung tests will be carried out. The study medication will be taken for a total of 24 weeks. Participants will be asked to complete an electronic diary each morning at home.
Participants who complete this study will have participated in this study for up to 34 weeks. This will include a screening visit, 24-week treatment period and a follow up visit.
At the end of the study, eligible participants may be able to continue to receive treatment with GB001.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
18/YH/0392
Date of REC Opinion
15 Nov 2018
REC opinion
Further Information Favourable Opinion