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Recruiting NCT06226610

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

Phase II Interventional Pruritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dupilumab, Placebo.
Who it may be relevant to
Registry conditions: Pruritis. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Drug Dupilumab
    injection every two weeks while on study
  • Other Placebo
    injection every two weeks while on study

Primary outcome measures

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Akron Children's Hospital — Akron

Identifiers

NCT: NCT06226610 · 2024-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗