Efficacy and Safety of OATD-01 Compared to Placebo in Adults With Active Pulmonary Sarcoidosis: A 12-Week Randomized, Double-Blind, Placebo-Controlled Multicenter Study

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of OATD-01 in treating adults with active pulmonary sarcoidosis, a condition marked by inflammation in the lungs. This Phase 2 study will involve participants who have a confirmed diagnosis based on American Thoracic Society criteria and active lung involvement shown by specialized imaging. Participants may be treatment-naïve or previously treated but currently not receiving therapy. Participants will be randomly assigned to receive either OATD-01 tablets or placebo tablets once daily for 12 weeks, without knowing which treatment they receive. The study includes a double-blind design and stratifies participants based on their prior treatment status. The aim is to compare the effects of OATD-01 against placebo during this treatment period. During the study, participants will undergo various assessments including lung function tests, imaging scans, quality of life and fatigue questionnaires, laboratory tests, vital sign monitoring, and heart function evaluations. Safety will be closely monitored through adverse event recording and specific evaluations up to 30 days after treatment ends. The primary outcome is the response to treatment after 12 weeks, with additional measures collected throughout the study to assess inflammation, lung function, and overall health.

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