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NCT Number: NCT06226610

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

The goal of this study is to test the efficacy of Dupixent in improving post-burn itching symptoms versus the current standard of care.

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location status: Recruiting

Location contact

Anjay Khandelwal, MD

CONTACT

[email protected]

330-543-4649

Anjay Khandelwal, MD

PRINCIPAL_INVESTIGATOR

Jessica Kracker, BSN

CONTACT

[email protected]

330-543-0846

Richard Lou, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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 medical management 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 their own guardian
  • one or more of the following existing disorders: conjunctivitis; any co-existing dermatological 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, deems this study inappropriate for an eligible individual.
  • Persons unable to provide their own consent, including prisoners when their incarcerated status is not itself the focus of study, are routinely excluded from clinical 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 with medications other than Dupixent, and whose perceived benefit could confound our results.
  • We similarly exclude anyone treated for pruritis by laser therapy as their perceived benefit could confound our results.

Treatment and study plan

Dupilumab

Drug

injection every two weeks while on study

Placebo

Other

injection every two weeks while on study

Primary outcomes

  1. Itch Severity Scale (ISS) Scores

    Time frame: 12 WEEKS

    Participants' Itch Severity Scale (ISS) scores will decrease more than 2.0 points after 12 weeks following initiating use of Dupixent

Study contacts

Contact information is provided by the study sponsor or research team.

ANJAY KHANDELWAL, MD

CONTACT

[email protected]

330-543-4649

Jessica Kracker, BSN

CONTACT

[email protected]

330-543-0846

Sponsors and collaborators

Lead sponsor

Akron Children's Hospital

Other

Collaborators

  • Ohio State University
  • Regeneron Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2024
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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