Repurposing Dupilumab for Management of Pruritic Genetic Inflammatory Skin Disorders
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- Northwestern University
- Study ID
- NCT05649098
- Phase
- EARLY_PHASE1
- Status
- Recruiting
Conditions
- Skin Diseases
Eligibility Criteria
- Sex
- ALL
- Age
- 6 Months - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Dupilumab — DRUGThe treatment period will include a 16-week open-label phase and a 20-month long-term extension phase for those who qualify and wish to continue.
Study Details
Severe itch is a common symptom of many genetic skin disorders and leads to a negative impact on patient quality of life. The investigators hypothesize that: a) intervention with dupilumab will improve itch in patients with pruritic genetic inflammatory skin disorders, even those not recognized to be Th2-driven; and b) the administration of dupilumab will be well-tolerated, regardless of underlying genetic skin disorder. The total clinical study duration will be 26 months (104 Weeks). The treatment period will include a 16-week open-label phase and a 20-month long-term extension phase for those who qualify and wish to continue.
Key Dates
- Start date
- Jun 12, 2023
- Status verified
- Apr 2026
- Primary completion
- Jun 30, 2031
- Completion
- Jun 1, 2032
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Open-Label Dupilumab
Primary Outcome Measure
Change in Itch [ Time Frame: 16 weeks ]
Central Contacts
- Northwestern Dermatology CTU312-227-6817
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | Dermatology CTU Amy Paller (PRINCIPAL_INVESTIGATOR) |
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