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RecruitingNCT06226610Updated Oct 28, 2026

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

A Phase 2 interventional study of Dupilumab and Placebo in Pruritis, sponsored by Akron Children's Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Akron Children's Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 11 months later.
Updated Oct 28, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Pruritis

Browse trials for

Keywords

  • Itching, itch
03

In context

Pruritus

490 studies on the registry are indexed under Pruritus; 93 are open to participants now.

This study's planned enrollment of 46 is below the median of 60 across 422 interventional studies indexed under Pruritus.

Browse Pruritus studies →

Lead sponsor

Akron Children's Hospital is the lead sponsor of 33 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
46 participants (estimated)

Study 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.

    Drug: Dupilumab

  • 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.

    Other: Placebo

Interventions

  • DrugDupilumab

    injection every two weeks while on study

  • OtherPlacebo

    injection every two weeks while on study

06

What researchers measure

Primary outcomes

  1. Itch Severity Scale (ISS) Scores

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

    Time frame: 12 WEEKS

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Jan 31, 2026→Dec 31, 2027
Oct 28, 2026
Study completion
Dec 31, 2026→Dec 31, 2027
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    Primary completion Jan 31, 2026→Dec 31, 2027
    Study completion Dec 31, 2026→Dec 31, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06226610
Lead sponsor
Akron Children's Hospital
Collaborators
Regeneron Pharmaceuticals, Ohio State University
Responsible party
Sponsor
First posted
Jan 26, 2024
Start date
Nov 21, 2024
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 28, 2026

Study contacts

ANJAY KHANDELWAL, MD
Contact
akhandelwal@akronchildrens.org
330-543-4649
Jessica Kracker, BSN
Contact
jkracker@akronchildrens.org
330-543-0846

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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