Recruiting
Phase 2

OATD-01

Sponsor:

Molecure S.A.

Code:

NCT06205121

Conditions

Pulmonary Sarcoidosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

OATD-01

Placebo

Study Details

Brief 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

Study ID

NCT06205121

Start date

Mar 21, 2024

Status verified date

Aug, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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. immunosuppressants or anti-Tumor Necrosis Factor (TNF) agents (or other anti-inflammatory/anti-fibrotic treatment) received not later than 4 months prior to enrolment
  • Systemic treatment indication being an extrapulmonary location of sarcoidosis (e.g., neurological)
  • Heart conditions: QTcF interval prolongation, cardiac arrhythmia (other than non-sustained supraventricular arrhythmia), heart failure (New York Heart Association class III or IV) and/or known myocardial hypertrophy or Left Ventricle Ejection Fraction \<50% in the cardiac MRI
  • Known neurosarcoidosis or small fiber neuropathy or medical conditions causing primary ataxia
  • Lab abnormalities: Abnormal bilirubin, transaminases, alkaline phosphatase (ALP), Creatinine clearance (CrCL) Hypokalemia hypocalcemia (\<2.1 mmol/L), marked fasting hyperglycemia at screening
  • Uncontrolled diabetes at Screening with plasma glucose exceeding 8.3 mmol/L, or other contraindication to \[18F\]FDG administration and/or PET procedure (including body temperature \>37°C and any metabolic disease affecting the energy metabolism of muscles) as described in the PET protocol
  • Known positivity for Human Immunodeficiency Virus (HIV 1/2 antibodies), hepatitis B virus (HBV), or hepatitis C virus (HCV), or detected at screening
  • Severe, uncontrolled systemic disease (e.g., cardiovascular, pulmonary, thyroid, renal or metabolic disease) at Screening, or other condition, which in the opinion of the investigator, would compromise the safety of the subject or the subject's ability to participate in the study
  • Current smoker of \>5 cigarettes or e-cigarettes per day or user of nicotine-releasing alternatives (patches, chewing gums etc)
  • Prohibited medications: Current treatment with drug with QT prolongation effect, thiazide diuretics, strong CYP3A4 inhibitors and/or inducers, P-glycoprotein and/or BCRP strong inhibitors, drugs that are sensitive substrates of OCT1, MATE1, MATE2K, OAT3 with a narrow therapeutic index, pirfenidone and nintedanib.

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active Arm

Subjects will receive OATD-01 as 25mg film-coated tablets for oral administration once daily for 12 weeks

placebo comparator: Placebo Arm

Subjects will receive placebo as film-coated tablets for oral administration once daily for 12 weeks

Interventions

OATD-01

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

Placebo

Matching placebo tablets

Primary outcome measure

  • Response to treatment [ Time Frame: After 12 weeks of treatment, i.e. from baseline (randomization) visit to End-of-Treatment (EOT) visit. ]

Central Contacts and Locations

Central contacts

Locations

Molecure Investigative Site

Recruiting

Baltimore, Maryland, United States, 21224

Molecure Investigative Site

Recruiting

Cleveland, Ohio, United States, 44195

Molecure Investigative Site

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Molecure Investigative Site

Recruiting

Charleston, South Carolina, United States, 29425

More Information

Sponsor

Molecure S.A.

Last update posted

Jul 30, 2026

Last verified

Aug, 2025

Keywords

  • Pulmonary Sarcoidosis
  • Sarcoidosis
  • Chitinase

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Molecure S.A. on 2026-07-30.