Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Part of paid clinical trials in Akron, Ohio.
- Sponsor
- Akron Children's Hospital
- Study ID
- NCT06226610
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Pruritis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Not accepted
Interventions
- Dupilumab — DRUGinjection every two weeks while on study
- Placebo — OTHERinjection every two weeks while on study
Study Details
The goal of this study is to test the efficacy of Dupixent in improving post-burn itching symptoms versus the current standard of care.
Key Dates
- Start date
- Nov 21, 2024
- Status verified
- Dec 2024
- Primary completion
- Jan 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 46 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: ARM 1 - DupixentTwo subcutaneous injection of 300mg Dupixent at visit 1 and every two weeks (+/- 2 days) for a total of 6 administrations. Injections may be administered in the thigh, lower abdomen or upper arm. The initial dose (two 300 mg doses) will be given in two different injection sites. There are not restriction or guidance regarding dose administration related to meals. No dose modifications will occur during study participation.
- Placebo Comparator: ARM 2 - PlaceboTwo subcutaneous injection of the placebo at visit 1 and every two weeks (+/- 2 days) for a total of 6 administrations. Injections may be administered in the thigh, lower abdomen or upper arm. The initial dose (two doses) will be given in two different injection sites. There are not restriction or guidance regarding dose administration related to meals. No dose modifications will occur during study participation.
Primary Outcome Measure
Itch Severity Scale (ISS) Scores [ Time Frame: 12 WEEKS ]
Central Contacts
- ANJAY KHANDELWAL, MD330-543-4649
- Jessica Kracker, BSN330-543-0846
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Akron Children's Hospital | Akron | Ohio | 44308 | Anjay Khandelwal, MD (PRINCIPAL_INVESTIGATOR) Richard Lou, MD (SUB_INVESTIGATOR) |
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