Clinical trial NCT06226610: Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pruritis
Keywords: Itching, itch
Lead sponsor: Akron Children's Hospital
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
name: Ohio State University
First posted: 2024-01-26
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a dual-arm, two-site, randomized, placebo-controlled interventional Phase 2 randomized controlled clinical trial to estimate the potential effect size of Dupixent on improving post-burn pruritus symptoms. N=46 participants will be enrolled at a 1:1 intervention:control ratio.
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Itch Severity Scale (ISS) Scores
timeFrame: 12 WEEKS
Secondary outcomes:
Other outcomes:
Locations:
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
Study officials:
References: