Dupixent for Itchiness

Phase 2

Recruiting

Research Sponsored by Akron Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

• 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.

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

This trial aims to see if Dupixent is better at reducing post-burn itching compared to the usual treatment.

Who is the study for?

This trial is for adults aged 18-60 with post-burn hypertrophic scars that were treated with grafting. Participants should have ongoing itchiness not relieved by standard treatments like antihistamines and neuroleptics, at least four weeks after their last surgery, and must speak English well enough to participate.

What is being tested?

The study tests Dupixent's effectiveness in relieving persistent itching in burn patients compared to a placebo. It aims to see if Dupixent can improve symptoms better than the usual care involving medications such as antihistamines.

What are the potential side effects?

Dupixent may cause local reactions at the injection site or general itchiness. The exact side effects will be monitored throughout the trial but are expected based on previous knowledge of the drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Itch Severity Scale (ISS) Scores

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ARM 1 - DupixentActive Control1 Intervention

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.

Group II: ARM 2 - PlaceboPlacebo Group1 Intervention

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.

0 / 1Eligibility criteria met