Home › Trials › NCT06205121

Evaluating OATD-01 for treating 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)

Phase 2 Interventional Molecure S.A. · NCT06205121

This study is testing a new treatment called OATD-01 to see if it helps adults with active pulmonary sarcoidosis feel better over 12 weeks.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment96 (estimated)
Ages18 Years and up
SexAll
SponsorMolecure S.A. Industry-sponsored
Locations28 sites (Birmingham, Alabama and 27 other locations)
Trial IDNCT06205121 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical trial is designed to assess the efficacy and safety of OATD-01 in patients with active pulmonary sarcoidosis. Participants, aged 18 and older, will be randomized to receive either OATD-01 or a placebo for a duration of 12 weeks. The study will utilize imaging techniques to confirm the diagnosis and will stratify participants based on their previous treatment history. The trial aims to maintain double-blind conditions throughout the treatment period to ensure unbiased results.

Who should consider this trial

Good fit: Ideal candidates include adults with active symptomatic pulmonary sarcoidosis who are either treatment-naïve or have previously been treated but are currently untreated.

Not a fit: Patients requiring immediate standard care therapy for pulmonary sarcoidosis or those with other significant lung diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from active pulmonary sarcoidosis.

How similar studies have performed: While this approach is novel in the context of OATD-01, similar studies targeting pulmonary sarcoidosis have shown promise in evaluating new treatments.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pulmonary SarcoidosisSarcoidosisChitinase
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.