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

NCT06226610 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2024-002
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Keywords

Itching, itch

Outcome Measures

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

  12 WEEKS

Study Arms (2)

ARM 1 - Dupixent

ACTIVE COMPARATOR

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

ARM 2 - Placebo

PLACEBO COMPARATOR

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

Dupilumab DRUG

injection every two weeks while on study

ARM 1 - Dupixent

Placebo OTHER

injection every two weeks while on study

ARM 2 - Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akron Children's Hospital: lead
• Regeneron Pharmaceuticals: collaborator
• Ohio State University: collaborator

Study Sites (1)

Akron Children's Hospital

Akron, Ohio, 44308, United States

RECRUITING

MeSH Terms

Conditions

Pruritus

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

ANJAY KHANDELWAL, MD

CONTACT

330-543-4649; akhandelwal@akronchildrens.org

Jessica Kracker, BSN

CONTACT

330-543-0846; jkracker@akronchildrens.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The study sponsor will supply all study drug (including placebo) as blinded kits. Study staff, investigators, and participants will be blinded to which treatment condition a participant has been randomized to. Note that the drug manufacturer will email codes to the pharmacists (who are unblinded) identifying the appropriate study drug for a particular participant. It is possible that participants may become unblinded to the obvious physical effects related to receiving Dupixent or placebo (pruritus improves or does not improve). Study staff will not discuss or speculate potential treatment arm allocation with participants based on participants' comments, questions, daily itch diary data, or physical observation. Study staff will encourage participants expressing resentful demoralization to remain in the study through their final visit.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 26, 2024
• Study Start: November 21, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 19, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)