(281) 713-2962
800 Rockmead Drive, Suite 155
Kingwood, TX 77339
[email protected]
Efficacy and Safety Study of OATD-01 in Patients With Active Pulmonary Sarcoidosis
Status: Recruiting
Location: Molecure Investigative Site
Conditions: Molecure Investigative Site
City/State:
Birmingham, Alabama
Kansas City, Kansas
Baltimore, Maryland
Rochester, Minnesota
Cleveland, Ohio
Philadelphia, Pennsylvania
Charleston, South Carolina
Contact Information:
Theodoros Charitos, MD
+48789125928
[email protected]
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.
Detailed Description:
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 stratification of the study population based on previous treatment status for sarcoidosis (previously treated/treatment-naïve) will be applied for statistical analysis without limitation for the ratio between the subject groups. Double-blind conditions will be kept for the whole treatment duration.