Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic

Last updated: September 16, 2025
Sponsor: Akron Children's Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Hives (Urticaria)

Rash

Skin Wounds

Treatment

Dupilumab

Placebo

Clinical Study ID

NCT06226610
2024-002
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

• Persons 18-60 year old with post-burn hypertrophic scars of any size which required grafting or epidermal autografting for an acute burn injury, with continued complaint of pruritus due to inadequate relief from standard of care (medical management by antihistamine and neuroleptic medications) after at least four weeks and are a minimum of four weeks after their last grafting surgery, and who speak English sufficient to participate in the study.

Exclusion

Exclusion Criteria:

  • Currently taking Dupixent for any other diagnosis

  • known allergy to Dupixent

  • pregnant and or lactating mothers

  • anyone treated for pruritus using laser therapy

  • currently receiving adequate relief for pruritis under standard of care medicalmanagement by antihistamine or neuroleptic medications

  • Currently taking steroids

  • persons with developmental delays or otherwise unable to complete measures

  • prisoners or anyone otherwise unable to give their own consent or who is not theirown guardian

  • one or more of the following existing disorders: conjunctivitis; any co-existingdermatological condition except burns; any type of cancer; requiring dialysis;chronic Stage 3 or higher kidney disease; biliary disorder; gall bladder disorder;or another renal or hepatic disorder which, in the opinion of study physician, deemsthis study inappropriate for an eligible individual.

  • Persons unable to provide their own consent, including prisoners when theirincarcerated status is not itself the focus of study, are routinely excluded fromclinical trials at this site

  • We further exclude persons with other dermatological conditions (other than burn) ,which may have pruritis or pain associated with them and who may be treated withmedications other than Dupixent, and whose perceived benefit could confound ourresults.

  • We similarly exclude anyone treated for pruritis by laser therapy as their perceivedbenefit could confound our results.

Study Design

Total Participants: 46
Treatment Group(s): 2
Primary Treatment: Dupilumab
Phase: 2
Study Start date:
November 21, 2024
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Akron Children's Hospital

    Akron, Ohio 44308
    United States

    Site Not Available

  • Akron Children's Hospital

    Akron 5145476, Ohio 5165418 44308
    United States

    Active - Recruiting

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