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

Pruritis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06226610
• Other study ID #: 2024-002
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: Akron Children's Hospital
• Contact: ANJAY KHANDELWAL, MD
• Phone: 330-543-4649
• Email: akhandelwal[@]akronchildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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, they 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: December 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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:

1. Currently taking Dupixent for any other diagnosis

2. known allergy to Dupixent

3. pregnant and or lactating mothers

4. anyone treated for pruritus using laser therapy

5. currently receiving adequate relief for pruritis under standard of care medical management by antihistamine or neuroleptic medications

6. Currently taking steroids

7. persons with developmental delays or otherwise unable to complete measures

8. prisoners or anyone otherwise unable to give their own consent or who is not their own guardian

9. 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.

10. 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

11. 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.

12. We similarly exclude anyone treated for pruritis by laser therapy as their perceived benefit could confound our results.

Related Conditions & MeSH terms

• Pruritis
• Pruritus

Intervention

Drug:
• Dupilumab
injection every two weeks while on study

Other:
• Placebo
injection every two weeks while on study

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Akron Children's Hospital	Ohio State University, Regeneron Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ITCH SEVERITY SCALE SCORES	participants' Itch Severity Scale (ISS) scores will decrease more than 2.0 points after 12 weeks following initiating use of Dupixent	12 WEEKS