Efficacy and Safety Study of OATD-01 in Patients With Active Pulmonary Sarcoidosis

Efficacy and Safety Study of OATD-01 in Patients With Active Pulmonary Sarcoidosis

Status: Recruiting

Conditions: Sarcoidosis


Molecure Investigative Site


Birmingham, Alabama

Kansas City, Kansas

Baltimore, Maryland

Rochester, Minnesota

Cleveland, Ohio

Philadelphia, Pennsylvania

Charleston, South Carolina

Contact Information:

Theodoros Charitos, MD
[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.

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Contact Us

(281) 713-2962
800 Rockmead Drive, Suite 155
Kingwood, TX 77339
[email protected]

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