A Phase II study of CMK389 in patients with pulmonary sarcoidosis
Research type
Research Study
Full title
A subject and investigator blinded, randomized, placebo-controlled, repeat-dose, multicenter study to investigate efficacy, safety, and tolerability of CMK389 in patients with chronic pulmonary sarcoidosis
IRAS ID
279463
Contact name
Robina Coker
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2018-000381-11
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 25 days
Research summary
This is a proof of concept study in which the subject and investigator are both blinded to the treatment assigned. It is a randomised, placebo-controlled, parallel-group, repeat-dose, multicentre, non-confirmatory study of the safety and efficacy of CMK389 administered intravenously every 4 weeks for a total of 4 doses in adults with chronic pulmonary sarcoidosis. Approximately 66 patients will be randomised in a 1:1 ratio to receive either CMK389 or placebo (in this case 5% dextrose). The expected total duration of participation for men and women of non-child bearing potential is approximately 38 weeks. For women of child-bearing potential the expected duration of participation is approximately 62 weeks. Patients will visit the study site up to 12 times during the course of the study and protocol assessments will include assessment of lung function, FDG-PET/CT blood and urine sampling, chest x-ray, scans, physical examination and a questionnaire.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
20/WM/0312
Date of REC Opinion
14 Jan 2021
REC opinion
Further Information Favourable Opinion