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Active Arm for Sarcoidosis

Phase 2

Recruiting

Research Sponsored by Molecure S.A.

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.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response to treatment

Secondary outcome measures

Adverse events

Electrocardiography

Electrocardiography - specific parameters

+14 more

Trial 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

Do I qualify?Apply below to find out

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many distinct clinics is this experimental investigation currently being conducted?

"At the moment, this research is operational at 10 distinct sites. Among these are facilities located in Philadelphia, Charleston, and Kansas City along with several other locations. It is advisable to opt for a clinic nearby to reduce travel obligations when joining the study."

Answered by AI

What is the upper limit for the number of participants involved in this research endeavor?

"Affirmative, data from clinicaltrials.gov highlights the ongoing patient recruitment for this trial. Initially shared on March 1st, 2024, with the most recent update also made on that date. The study aims to enroll a total of 98 participants distributed among 10 different sites."

Answered by AI

Are there any available positions for participants in this research study?

"Indeed, the details on clinicaltrials.gov highlight that this clinical investigation is actively seeking volunteers. The trial was initially posted on March 1st, 2024, with the latest update also dated as March 1st, 2024. A total of 98 participants are sought across a network of 10 sites."

Answered by AI

Has the Active Arm treatment been given clearance by the FDA?

"The safety assessment for the Active Arm intervention was rated as 2 by our team at Power, reflecting a Phase 2 trial status where some safety data is available but efficacy evidence is lacking."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy and Safety Study of OATD-01 in Patients With Active Pulmonary Sarcoidosis

2024. "Efficacy and Safety Study of OATD-01 in Patients With Active Pulmonary Sarcoidosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06205121.

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