Efficacy and Safety Study of OATD-01 in Patients With Active Pulmonary Sarcoidosis
NCT ID: NCT06205121
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
96 participants
INTERVENTIONAL
2024-03-21
2027-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active Arm
Subjects will receive OATD-01 as 25mg film-coated tablets for oral administration once daily for 12 weeks
OATD-01
OATD-01 is an oral inhibitor of chitinase-1 (CHIT1)
Placebo Arm
Subjects will receive placebo as film-coated tablets for oral administration once daily for 12 weeks
Placebo
Matching placebo tablets
Interventions
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OATD-01
OATD-01 is an oral inhibitor of chitinase-1 (CHIT1)
Placebo
Matching placebo tablets
Eligibility Criteria
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Inclusion Criteria
* Treatment-naïve or previously treated (no recruitment cap)
* Parenchymal pulmonary involvement on \[18F\]FDG PET/CT
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Molecure S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Piotr Iwanowski, MD
Role: STUDY_CHAIR
CMO
Locations
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Molecure Investigative Site
Birmingham, Alabama, United States
Molecure Investigative Site
Kansas City, Kansas, United States
Molecure Investigative Site
Baltimore, Maryland, United States
Molecure Investigative Site
Rochester, Minnesota, United States
Molecure Investigative Site
Cleveland, Ohio, United States
Molecure Investigative Site
Philadelphia, Pennsylvania, United States
Molecure Investigative Site
Charleston, South Carolina, United States
Molecure Investigative Site
Vejle, , Denmark
Molecure Investigative Site
Bobigny, , France
Molecure Investigative Site
Montpellier, , France
Molecure Investigative Site
Paris, , France
Molecure Investigative Site
Paris, , France
Molecure Investigative Site
Essen, , Germany
Molecure Investigative Site
Freiburg im Breisgau, , Germany
Molecure Investigative Site
Mainz-GE, , Germany
Molecure Investigative Site
Corfu, , Greece
Molecure Investigative Site
Heraklion, , Greece
Molecure Investigative Site
Pátrai, , Greece
Molecure Investigative Site
Thessaloniki, , Greece
Molecure Investigative Site
Nieuwegein, , Netherlands
Molecure Investigative Site
Rotterdam, , Netherlands
Molecure Investigative Site
Bergen, , Norway
Molecure Investigative Site
Oslo, , Norway
Molecure Investigative Site
Birmingham, , United Kingdom
Molecure Investigative Site
Cambridge, , United Kingdom
Molecure Investigative Site
Edinburgh, , United Kingdom
Molecure Investigative Site
London, , United Kingdom
Molecure Investigative Site
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2023-506642-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OATD-01-C-03
Identifier Type: -
Identifier Source: org_study_id
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