MedTrace Logo

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

NCT06205121 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-12-12

No results posted yet for this study

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.

Conditions

  • Pulmonary Sarcoidosis

Interventions

DRUG

OATD-01

OATD-01 is an oral inhibitor of chitinase-1 (CHIT1)

DRUG

Placebo

Matching placebo tablets

Sponsors & Collaborators

  • Molecure S.A.

    lead INDUSTRY

Principal Investigators

  • Piotr Iwanowski, MD · CMO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-21
Primary Completion
2027-08-31
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • France
  • Germany
  • Greece
  • Netherlands
  • Norway
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06205121 on ClinicalTrials.gov