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

Pulmonary Sarcoidosis Clinical Trial

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of a 12-week Administration of OATD-01, an Oral Inhibitor of Chitinase-1 (CHIT1), for the Treatment of Active Pulmonary Sarcoidosis (the KITE Study)

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Pulmonary Sarcoidosis
• Sarcoidosis
• Sarcoidosis, Pulmonary

• NCT number: NCT06205121
• Study type: Interventional
• Source: Molecure S.A.
• Contact: Theodoros Charitos, MD
• Phone: +48789125928
• Email: t.charitos@molecure.com
• Status: Recruiting
• Phase: Phase 2
• Start date: March 21, 2024
• Completion date: March 2026