Molecure S.A.
This is a Phase 2, randomized, double-blind, placebo-controlled, adaptive, multicenter study to evaluate the efficacy, safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of OATD-01 in the treatment of subjects with active pulmonary sarcoidosis.
Adult subjects (≥ 18 years of age) diagnosed with symptomatic pulmonary sarcoidosis and active granulomatous process captured by \[18F\]Fluorodeoxyglucose Positron emission tomography/computed tomography (\[18F\]FDG PET/CT) imaging, treatment-naïve or previously treated but currently untreated, will be enrolled in the study. The diagnosis of pulmonary sarcoidosis will be based on the diagnostic criteria for pulmonary sarcoidosis recommended by the American Thoracic Society (ATS, 2020). Subjects will be randomized in a 1:1 ratio to receive either OATD-01 or placebo for 12 weeks. A stratificati…
Inclusion Criteria: * Male and female subjects with active symptomatic pulmonary sarcoidosis, (definite diagnosis of active pulmonary sarcoidosis per ATS guidelines) * Treatment-naïve or previously treated (no recruitment cap) * Parenchymal pulmonary involvement on \[18F\]FDG PET/CT Exclusion Criteria: * Requirement for immediate start of standard of care therapy for pulmonary sarcoidosis * Active cardiac or neuro- sarcoidosis * History of/active Löfgren syndrome * Clinically significant lung disease other than sarcoidosis (e.g. tuberculosis, asthma, Chronic Obstructive Pulmonary Disease, i…
OATD-01 is an oral inhibitor of chitinase-1 (CHIT1)
Matching placebo tablets