NCT06205121

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Molecure S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Sarcoidosis

Interventions

Type	Name	Description
DRUG	OATD-01	OATD-01 is an oral inhibitor of chitinase-1 (CHIT1)
DRUG	Placebo	Matching placebo tablets

Timeline

• Start date: 2024-03-21
• Primary completion: 2027-08-01
• Completion: 2027-09-01
• First posted: 2024-01-12
• Last updated: 2025-12-12

Locations

28 sites across 8 countries: United States, Denmark, France, Germany, Greece, Netherlands, Norway, United Kingdom

Regulatory

• FDA-regulated drug study