Actively Recruiting
Efficacy and Safety Study of OATD-01 in Patients With Active Pulmonary Sarcoidosis
Led by Molecure S.A. · Updated on 2025-12-12
96
Participants Needed
28
Research Sites
179 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efficacy and Safety Study of OATD-01 in Patients With Active Pulmonary Sarcoidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects with active symptomatic pulmonary sarcoidosis diagnosed per ATS guidelines
- Treatment-naïve or previously treated with no recruitment cap
- Parenchymal pulmonary involvement confirmed by [18F]FDG PET/CT imaging
You will not qualify if you...
- Need for immediate start of standard therapy for pulmonary sarcoidosis
- Active cardiac or neurological sarcoidosis
- History of or active Löfgren syndrome
- Significant lung diseases other than sarcoidosis (e.g., tuberculosis, asthma, COPD, interstitial lung disease, lung cancer)
- Any current inflammatory or immunological systemic disease other than sarcoidosis
- Use of systemic or inhaled sarcoidosis therapies recently, except corticosteroids (within 3 months) or immunosuppressants/anti-TNF agents (within 4 months)
- Systemic treatment needed for extrapulmonary sarcoidosis (e.g., neurological involvement)
- Heart conditions including QTcF prolongation, arrhythmias (except non-sustained supraventricular arrhythmia), severe heart failure, myocardial hypertrophy, or left ventricle ejection fraction below 50%
- Known neurosarcoidosis, small fiber neuropathy, or conditions causing primary ataxia
- Abnormal lab values including bilirubin, liver enzymes, alkaline phosphatase, creatinine clearance, low calcium, or marked fasting hyperglycemia
- Uncontrolled diabetes with plasma glucose over 8.3 mmol/L or contraindications to [18F]FDG PET procedure
- Known HIV, hepatitis B or C infection
- Severe uncontrolled systemic diseases or other conditions compromising safety or participation
- Current smoking of more than 5 cigarettes or use of nicotine alternatives daily
- Use of prohibited medications including drugs causing QT prolongation, thiazide diuretics, strong CYP3A4 inhibitors or inducers, strong inhibitors of P-glycoprotein or BCRP, drugs sensitive to certain transporters, pirfenidone, and nintedanib
AI-Screening
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Trial Site Locations
Total: 28 locations
1
Molecure Investigative Site
Birmingham, Alabama, United States, 35209
Withdrawn
2
Molecure Investigative Site
Kansas City, Kansas, United States, 66062
Withdrawn
3
Molecure Investigative Site
Baltimore, Maryland, United States, 21224
Actively Recruiting
4
Molecure Investigative Site
Rochester, Minnesota, United States, 55905
Withdrawn
5
Molecure Investigative Site
Cleveland, Ohio, United States, 44195
Actively Recruiting
6
Molecure Investigative Site
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
7
Molecure Investigative Site
Charleston, South Carolina, United States, 29425
Actively Recruiting
8
Molecure Investigative Site
Vejle, Denmark, 7100
Withdrawn
9
Molecure Investigative Site
Bobigny, France, 93000
Withdrawn
10
Molecure Investigative Site
Montpellier, France, 34295
Actively Recruiting
11
Molecure Investigative Site
Paris, France, 75013
Actively Recruiting
12
Molecure Investigative Site
Paris, France, 75015
Actively Recruiting
13
Molecure Investigative Site
Essen, Germany, 45239
Actively Recruiting
14
Molecure Investigative Site
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
15
Molecure Investigative Site
Mainz-GE, Germany, 55131
Actively Recruiting
16
Molecure Investigative Site
Corfu, Greece, 49100
Withdrawn
17
Molecure Investigative Site
Heraklion, Greece, 71500
Actively Recruiting
18
Molecure Investigative Site
Pátrai, Greece, 26500
Actively Recruiting
19
Molecure Investigative Site
Thessaloniki, Greece, 57010
Actively Recruiting
20
Molecure Investigative Site
Nieuwegein, Netherlands, 3435 CM
Actively Recruiting
21
Molecure Investigative Site
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
22
Molecure Investigative Site
Bergen, Norway, 5009
Actively Recruiting
23
Molecure Investigative Site
Oslo, Norway, 1478
Actively Recruiting
24
Molecure Investigative Site
Birmingham, United Kingdom, B15 2GW
Actively Recruiting
25
Molecure Investigative Site
Cambridge, United Kingdom, CB2 0AY
Withdrawn
26
Molecure Investigative Site
Edinburgh, United Kingdom, EH16 4SA
Actively Recruiting
27
Molecure Investigative Site
London, United Kingdom, SE5 9RS
Actively Recruiting
28
Molecure Investigative Site
London, United Kingdom, SW3 6JY
Actively Recruiting
Research Team
T
Theodoros Charitos, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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