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DF-003 for ROSAH Syndrome

Phase 1
Waitlist Available
Led By Kathleen Digre
Research Sponsored by Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men must agree to use highly effective contraception
Signs of uveitis in the eye
Must not have
Subjects with certain infections including hepatitis and HIV
Subjects on disallowed therapies or recent investigational treatments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, 2, 8(±2), 15(±2), 22(±2), 28(±2), 29(±2)
Awards & highlights

Summary

This trial is testing a new medication called DF-003 to see if it is safe and effective for treating ROSAH syndrome.

Who is the study for?
This trial is for individuals with ROSAH syndrome, a condition that affects the skin. Participants must meet certain health criteria to join, but specific inclusion and exclusion details are not provided.
What is being tested?
The study tests different doses of an oral medication called DF-003 to see how safe it is and how the body responds to it in patients with ROSAH syndrome.
What are the potential side effects?
Potential side effects are not listed, but generally could include reactions at varying levels of severity related to skin, digestion, or overall health due to the new medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use effective birth control methods.
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I have signs of inflammation in my eye.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have hepatitis or HIV.
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I am not currently on any treatments that are not allowed in the study.
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I am currently pregnant, breastfeeding, or planning to become pregnant.
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I have a history of heart rhythm problems or significant heart disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, 2, 8(±2), 15(±2), 22(±2), 28(±2), 29(±2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, 2, 8(±2), 15(±2), 22(±2), 28(±2), 29(±2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency and Severity of Serious Adverse Events (SAEs) (Local and Systemic) as Assessed by CTCAE v5.0
Frequency and Severity of Treatment-Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
Secondary outcome measures
Area Under the Concentration-Time Curve (AUC) of DF-003 from time zero to infinity (AUC0-inf)
Area Under the Concentration-Time Curve (AUC) of DF-003 from time zero to the time of the last quantifiable concentration (AUC0-last)
Area Under the Concentration-Time Curve (AUC) of DF-003 from time zero to time t (AUC0-t)
+7 more
Other outcome measures
Change in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Scores
Change in Headache Impact Test-6 (HIT-6) Scores
Changes in Eye Anterior Chamber Vitreous Fluid Chemokine and Cytokine Levels

Trial Design

1Treatment groups
Experimental Treatment
Group I: DF-003Experimental Treatment1 Intervention
Oral (PO) doses of 140 mg DF-003 on Days 1, 2, and 3 followed by a maintenance dose of 45 mg DF-003 once daily (QD) starting on Day 4 through Day 28.

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Who is running the clinical trial?

Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm)Lead Sponsor
1 Previous Clinical Trials
96 Total Patients Enrolled
Kathleen DigrePrincipal InvestigatorUniversity of Utah (Moran Eye Center)
Oleg AlekseevPrincipal InvestigatorDuke University (Duke Eye Center)
~8 spots leftby Aug 2025
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