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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 (±30 minutes prior to dosing), day 29 (24 hours relative to dosing on day 28), and day 78 (approximately same time as day 29 collection)

Awards & highlights

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (±30 minutes prior to dosing), day 29 (24 hours relative to dosing on day 28), and day 78 (approximately same time as day 29 collection)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (±30 minutes prior to dosing), day 29 (24 hours relative to dosing on day 28), and day 78 (approximately same time as day 29 collection)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (±30 minutes prior to dosing), day 29 (24 hours relative to dosing on day 28), and day 78 (approximately same time as day 29 collection) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Changes in Serum Chemokine Levels

Changes in Serum Cytokine Levels

Changes in Serum Serum Amyloid A (SAA) Levels

Other study objectives

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 Aqueous Fluid Chemokine Levels

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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. DF-003 will be administered PO with approximately 240 mL of water in the morning once daily for 28 consecutive days.

0 / 6Eligibility criteria met