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
Summary of Research
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 Pulmunary 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 18 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.Summary of Results
One patient took part and completed the study.
Seven important changes in study conduct, called deviations, have occurred during the study period of this single patient. Of these, 3 deviations were of failure to perform safety laboratory sampling and analyses at protocol defined timepoints, 2 deviations were of failure to perform in-clinic spirometry at protocol defined timepoints and 2 deviations were of any Good Clinical Practice (GCP) non-compliance that met the definition of a major protocol deviation.
The patient received selnoflast (200 mg BID) orally every day. Study drug administration on Days 1, 7, 14, 21, and 28 were at the study center under supervision of site staff. A total of 6 doses out of 56 doses were missed during the blinded treatment phase of the study.
Analysis for efficacy endpoints were not meaningful with one patient and are hence not performed for this study.
Key safety findings were as follows:
- No adverse events (AEs), deaths and serious AEs were reported.
- No clinically meaningful difference from baseline was observed in respiratory rate, blood pressure, pulse rate, and temperature.
- No clinically meaningful shifts from baseline were observed in laboratory parameters
- The electrocardiogram (ECG) data showed no clinically significant trends post-baseline versus baseline in mean ECG parameters.The Sponsor decided to discontinue the study to re-evaluate strategy and development of selnoflast in COPD. Efficacy and PK analysis were not performed. Overall, there were no unexpected safety findings. There was no impact on the study due to COVID-19 pandemic.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
22/LO/0091
Date of REC Opinion
27 Apr 2022
REC opinion
Further Information Favourable Opinion