RESOLVE-LUNG, a multinational, randomized, placebo-controlled Phase II trial of namilumab, an anti-GMCSF monoclonal antibody, in chronic pulmonary sarcoidosis: trial design and patient characteristics
Bildiriler > Özet Bildiri
Yazarlar: Bernt Van Den Blink, Chantal Petit, Hayes M. Dansky, Min Lin, Nesrin MOĞULKOÇ BISHOP, Rohit Gupta, Sibel Atis Nayci, Julien Guiot, James Galloway, Robert P. Baughman, Theodore F. Reiss, Bernt van den Blink
Sarcoidosis and other granulomatous ILD/DPLD, , , Uluslararası, Özet Bildiri, ss OA955-OA955
DOI: 10.1183/13993003.congress-2024.oa955
Özet
Introduction: Granulocyte-macrophage colony-stimulating factor (GMCSF) is thought to play a key role in the granulomatous response in sarcoidosis. Here we report the study design and blinded patient characteristics of the RESOLVE-LUNG trial ( NCT05314517 ) assessing the effect of namilumab in patients with chronic pulmonary sarcoidosis. Methods: Up to 100 patients were to be enrolled and randomized to receive namilumab 150mg or placebo administered s.c. every 4 weeks for 22 weeks, followed by an optional 26-weeks open label extension. Eligible patients must be ≥18 years, have a biopsy proven history of sarcoidosis ≥6 months, have evidence of active pulmonary disease based on HRCT, PET/CT or defined clinical criteria, and agree to taper their oral corticosteroid (OCS) and stop their immunosuppressive therapy (IST). The primary endpoint is the proportion of subjects with a rescue event. Secondary endpoints include time to rescue, OCS use, change from baseline in percentage predicted FVC and the King Sarcoidosis Questionnaire Lung domain score. Results: The majority of patients enrolled were above 50 years of age, male, Caucasian, and treated with OCS and/or IST, with methotrexate being the most commonly used IST. Most patients had mild to moderate pulmonary function impairment and a Medical Research Council dyspnea score of 2. Correlation analyses among selected baseline pulmonary endpoints will be presented. Conclusion: RESOLVE-LUNG, one of the largest Phase II trials in chronic sarcoidosis aims to investigate the efficacy and safety profile of namilumab in chronic pulmonary sarcoidosis.