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This study will open for enrollment soon. Please contact the study team for more information and check back frequently.
DF-003-1002 (ROSAH Syndrome) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an experimental drug called DF-003 is a safe and effective option for people with ROSAH Syndrome.
What is the Condition Being Studied?
ROSAH Syndrome (Retinal dystrophy, Optic Nerve edema, Splenomegaly, Anhidrosis, and Migraine Headache)
Who Can Participate in the Study?
Adults ages 18-65 who:
- Are diagnosed with ROSAH Syndrome
- Have active inflammation inside the eye
For more information, contact the study team at DEC_ResearchAdmin@dm.duke.edu.
Age Group
Adults
What is Involved?
If you choose to join this study, you will get a study drug dose of 140 mg on 3 consecutive days to begin the study drug regimen. After these 3 doses, you will get a daily dose of 45 mg. The study drug regimen lasts for 28 days.
Your total participation in the study will last around 19 weeks.
Study Details
Full Title
A Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered DF-003 in ROSAH Syndrome Patients - DF-003-1002
Principal Investigator
Ophthalmologist
Protocol Number
IRB:
PRO00116009
NCT:
NCT06395285
Phase
Phase
I
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon