Trials / Recruiting
RecruitingNCT06226610
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
A Phase 2 Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy of Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- Sponsor
- Akron Children's Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this study is to test the efficacy of Dupixent in improving post-burn itching symptoms versus the current standard of care.
Detailed description
Participants will receive six injections of Dupixent or placebo (two 300 mg loading doses and one 300 mg dose every two weeks after that). In addition, participants will be asked to complete questionnaires to determine daily itch severity, quality of life, treatment benefit, physical functioning, and pain interference. Individual participants will require 13 weeks to complete all study visits.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dupilumab | injection every two weeks while on study |
| OTHER | Placebo | injection every two weeks while on study |
Timeline
- Start date
- 2024-11-21
- Primary completion
- 2026-01-31
- Completion
- 2026-12-31
- First posted
- 2024-01-26
- Last updated
- 2025-09-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06226610. Inclusion in this directory is not an endorsement.