Efficacy and Safety Study of OATD-01 in Patients With Active Pulmonary Sarcoidosis
ConditionPulmonary Sarcoidosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMolecure S.A.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- OATD-01
- Placebo
Treatment groups
96 Participants
are divided into 2 treatment groupsLocations
28Denmark
Molecure Investigative Site7100, Vejle Denmark
France
Molecure Investigative Site93000, Bobigny France
Molecure Investigative Site34295, Montpellier France
Molecure Investigative Site75013, Paris France
Sponsors and collaborators
Molecure S.A.
Lead sponsor
Source ClinicalTrials.gov