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

<bold>Introduction:</bold> 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 (<ext-link>NCT05314517</ext-link>) assessing the effect of namilumab in patients with chronic pulmonary sarcoidosis. <bold>Methods:</bold> 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. <bold>Results:</bold> 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. <bold>Conclusion:</bold> 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.