Recruiting
Phase 2

Dupixent

Sponsor:

Akron Children's Hospital

Code:

NCT06226610

Conditions

Pruritis

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Dupilumab

Placebo

Study Details

Brief 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.

Conditions

Pruritis

Study ID

NCT06226610

Start date

Nov 21, 2024

Status verified date

Dec, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jan 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Dupilumab

injection every two weeks while on study

Placebo

injection every two weeks while on study

Primary outcome measure

  • Itch Severity Scale (ISS) Scores [ Time Frame: 12 WEEKS ]

Central Contacts and Locations

Central contacts

Locations

Akron Children's Hospital

Recruiting

Akron, Ohio, United States, 44308

Contacts

Principal Investigator:

Anjay Khandelwal, MD

More Information

Sponsor

Akron Children's Hospital

Last update posted

Sep 19, 2025

Last verified

Dec, 2024

Keywords

  • Itching, itch

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Akron Children's Hospital on 2025-09-19.