NCT06205121 · Molecure S.A.
Efficacy and Safety Study of OATD-01 in Patients With Active Pulmonary Sarcoidosis
What this study is about
This is a Phase 2, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment, adaptive, conducted at multiple hospitals study to evaluate the effectiveness, safety, tolerability, how the drug affects the body (PD), and how the drug moves through the body (PK) of OATD-01 in the treatment of subjects with active pulmonary sarcoidosis.
View original scientific description
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.
Interventions
DRUG
OATD-01
OATD-01 is an oral inhibitor of chitinase-1 (CHIT1)
DRUG
Placebo
Matching placebo tablets
Primary outcome measures
Response to treatment
Time frame: After 12 weeks of treatment, i.e. from baseline (randomization) visit to End-of-Treatment (EOT) visit.
Response classed as Complete response, Partial response, Stable disease and Progressive disease based on Standard Uptake Volume (SUV) changes in the uptake for {18F\]FDG-PET/CT above the background (pulmonary parenchyma /ascending aorta) in pulmonary target lesions and any new lesions.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male and female subjects with active symptomatic pulmonary sarcoidosis, (definite diagnosis of active pulmonary sarcoidosis per ATS guidelines)
- Treatment-naïve or previously treated (no recruitment cap)
- Parenchymal pulmonary involvement on \[18F\]FDG PET/CT
Exclusion criteria
- Requirement for immediate start of standard of care therapy for pulmonary sarcoidosis
- Active cardiac or neuro- sarcoidosis
- History of/active Löfgren syndrome
- Clinically significant lung disease other than sarcoidosis (e.g. tuberculosis, asthma, Chronic Obstructive Pulmonary Disease, interstitial lung disease, lung cancer) or any current inflammatory or immunological systemic disease other than sarcoidosis
- Potentially effective systemic or inhaled pharmacological (including investigational) therapy for sarcoidosis (whether pulmonary or other disease), with the exception of any of the following: 1. corticosteroids received not later than 3 months prior to enrolment 2. imm
Where
- Birmingham, Alabama
- Kansas City, Kansas
- Baltimore, Maryland
- Rochester, Minnesota
- Cleveland, Ohio
- Philadelphia, Pennsylvania
- Charleston, South Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 12, 2025 · Source of record for eligibility and locations