BP43098 A Study to Assess the Safety of RO7486967 in Patients with COPD
Research type
Research Study
Full title
PHASE Ib, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE SAFETY OF RO7486967 IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE
IRAS ID
303650
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceuticals Division, PDR
Contact email
Sponsor organisation
F. Hoffman-La Roche Ltd.
Eudract number
2021-000558-25
Duration of Study in the UK
0 years, 8 months, 15 days
Research summary
This is a Phase Ib, randomised, double-blind, placebo-controlled, parallel-group clinical trial with the purpose of testing the safety of a study drug called RO7486967 to find out what effects, good or bad, it has on study participants and their Chronic Obstructive Pulmonary Disease (COPD).
This research study is sponsored by F. Hoffmann-La Roche Ltd., who will be responsible for funding the study and for covering the cost of all study procedures.
RO7486967 is a small chemical molecule that can inhibit the formation of protein complexes known as inflammasomes, which could worsen the inflammation of a participant's lung.
Approximately 40 participants will take part in the study in the UK and 106 worldwide.
RO7486967 is an experimental drug, which means Health Authorities like the MHRA in the United Kingdom have not approved RO7486967 for the treatment of any diseases.REC name
London - West London & GTAC Research Ethics Committee
REC reference
21/LO/0758
Date of REC Opinion
1 Nov 2021
REC opinion
Unfavourable Opinion