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 — DRUG
    injection every two weeks while on study
  • Placebo — OTHER
    injection 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 - Dupixent
    Two 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 - Placebo
    Two 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

Locations (1)

FacilityCityStateZIPSite coordinators
Akron Children's HospitalAkronOhio44308
Anjay Khandelwal, MD
330-543-4649
Jessica Kracker, BSN
330-543-0846
Anjay Khandelwal, MD (PRINCIPAL_INVESTIGATOR)
Richard Lou, MD (SUB_INVESTIGATOR)

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