Efficacy and Safety Study of OATD-01 in Patients With Active Pulmonary Sarcoidosis
Trial Parameters
Brief Summary
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.
Eligibility Criteria
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, interstitial lung disease, lung cancer) or any current inflammatory or immunological systemic disease other than sarcoidosis * Potentially effective systemic or inhaled pharmacological (including investigational) therapy for sarcoidosis (whether pulmonary or other disease), with the exception of any of the following: 1. corticosteroids received not later than 3 months prior to enrolment 2. immunosuppr