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NCT06205121 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of OATD-01 in Patients With Active Pulmonary Sarcoidosis
A Phase 2 study of Pulmonary Sarcoidosis, sponsored by Molecure S.A..
- Recruiting
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
- 20
- Study locations
NCT06205121: Recruiting Phase 2 study of Pulmonary Sarcoidosis, sponsored by Molecure S.A..
NCT06205121 is a Phase 2 study of Pulmonary Sarcoidosis that is actively recruiting participants, run by Molecure S.A.. The registered enrollment target is 96 participants, below the 796-participant average among 5 other Pulmonary Sarcoidosis trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06205121, a Phase 2 study of Pulmonary Sarcoidosis, is actively recruiting participants, sponsored by Molecure S.A..
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Response classed as Complete response, Partial response, Stable disease and Progressive disease based on Standard Uptake Volume (SUV) changes in the uptake for {18F\]FDG-PET/CT above the background (pulmonary parenchyma /ascending aorta) in pulmonary target lesions and any new lesions.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG OATD-01
Study Locations (20)
Other
- Molecure Investigative Site - Vejle
- Molecure Investigative Site - Bobigny
- Molecure Investigative Site - Montpellier
- Molecure Investigative Site - Paris
- Molecure Investigative Site - Paris
- Molecure Investigative Site - Essen
- Molecure Investigative Site - Freiburg im Breisgau
- Molecure Investigative Site - Mainz-GE
- Molecure Investigative Site - Corfu
- Molecure Investigative Site - Heraklion
- Molecure Investigative Site - Pátrai
- Molecure Investigative Site - Thessaloniki
- Molecure Investigative Site - Nieuwegein
Alabama
- Molecure Investigative Site - Birmingham
Kansas
- Molecure Investigative Site - Kansas City
Maryland
- Molecure Investigative Site - Baltimore
Minnesota
- Molecure Investigative Site - Rochester
Ohio
- Molecure Investigative Site - Cleveland
Pennsylvania
- Molecure Investigative Site - Philadelphia
South Carolina
- Molecure Investigative Site - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2024-03-21 |
| Est. Completion | 2027-09 |
| Phase | Phase 2 |
What NCT06205121 shows while recruiting
NCT06205121 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 796-participant average among 5 other Pulmonary Sarcoidosis trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Pulmonary Sarcoidosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06205121 names 20 study sites across 8 states, led by Other, Alabama, Kansas.
Frequently Asked Questions
What is clinical trial NCT06205121 about?
NCT06205121 is a clinical study titled "Efficacy and Safety Study of OATD-01 in Patients With Active Pulmonary Sarcoidosis". 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.
What is the current status of trial NCT06205121?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2024-03-21. Estimated completion is 2027-09.
What conditions does trial NCT06205121 study?
This clinical trial studies the following conditions: Pulmonary Sarcoidosis.
What interventions are being tested in trial NCT06205121?
The interventions under investigation include: Placebo (DRUG), OATD-01 (DRUG).
Who is sponsoring clinical trial NCT06205121?
This trial is sponsored by Molecure S.A., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06205121 being conducted?
This trial has 20 study locations across Alabama, Kansas, Maryland, Minnesota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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