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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-lead-ecg measured at screening and over 12 weeks of treatment or study participation - at randomization visit, at week 2 of treatment, week 4, week 8, week 12 (eot) and any fup visits. 2-week 24-h-ecg recordings at weeks 0, 4 and 8 post randomization.
Summary
This trial is testing a new drug called OATD-01 to see how well it works in treating people with active pulmonary sarcoidosis. It is a Phase 2 study, meaning it is
Who is the study for?
This trial is for men and women with active symptomatic pulmonary sarcoidosis, which means they have lung inflammation that can be seen on a special type of scan. It's open to those who haven't been treated before or have had previous treatments.
What is being tested?
The study tests OATD-01 against a placebo to see if it's effective and safe for treating pulmonary sarcoidosis. Participants won't know which one they're getting, and the effects on the body will be closely monitored.
What are the potential side effects?
While specific side effects are not listed here, common ones in trials like this may include nausea, headaches, possible allergic reactions, or other symptoms related to the lungs since it targets pulmonary conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-lead-ecg measured at screening and over 12 weeks of treatment or study participation - at randomization visit, at week 2 of treatment, week 4, week 8, week 12 (eot) and any fup visits. 2-week 24-h-ecg recordings at weeks 0, 4 and 8 post randomization.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-lead-ecg measured at screening and over 12 weeks of treatment or study participation - at randomization visit, at week 2 of treatment, week 4, week 8, week 12 (eot) and any fup visits. 2-week 24-h-ecg recordings at weeks 0, 4 and 8 post randomization.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Response to treatment
Secondary study objectives
Adverse events
Electrocardiography
Electrocardiography - specific parameters
+14 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active ArmExperimental Treatment1 Intervention
Subjects will receive OATD-01 as 25mg film-coated tablets for oral administration once daily for 12 weeks
Group II: Placebo ArmPlacebo Group1 Intervention
Subjects will receive placebo as film-coated tablets for oral administration once daily for 12 weeks
Find a Location
Who is running the clinical trial?
Molecure S.A.Lead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
Samson Fung, MDStudy ChairCMO
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