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Tests treatment safety and results for Pulmonary Sarcoidosis
Official title Efficacy and Safety Study of OATD-01 in Patients With Active Pulmonary Sarcoidosis
ClinicalTrials.gov ID: NCT06205121
What this study is testing
What is OATD-01?
OATD-01 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for pulmonary sarcoidosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male and female people 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
You likely can't join if
- 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...
- Potentially effective systemic or inhaled pharmacological (including investigational) therapy for sarcoidosis (whether pulmonary or other disease)...
- corticosteroids received not later than 3 months prior to enrolment
See the full eligibility criteria
- Male and female people 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
- 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...
- Potentially effective systemic or inhaled pharmacological (including investigational) therapy for sarcoidosis (whether pulmonary or other disease), with the exception of any of the following:
- corticosteroids received not later than 3 months prior to enrolment
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Kansas City, Kansas, United States
- Baltimore, Maryland, United States
- Rochester, Minnesota, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Charleston, South Carolina, United States
- Vejle, Denmark
- Bobigny, France
- Montpellier, France
- Paris, France
- Essen, Germany
- Freiburg im Breisgau, Germany
- Mainz-GE, Germany
- Corfu, Greece
- Heraklion, Greece
- Pátrai, Greece
- Thessaloniki, Greece
- Nieuwegein, Netherlands
- Rotterdam, Netherlands
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Kansas City, Kansas, United States; Baltimore, Maryland, United States; Rochester, Minnesota, United States; Cleveland, Ohio, United States; Philadelphia, Pennsylvania, United States and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.