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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
| Ohio State University | OTHER |
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The goal of this study is to test the efficacy of Dupixent in improving post-burn itching symptoms versus the current standard of care.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | injection every two weeks while on study |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ANJAY KHANDELWAL, MD | Contact | 330-543-4649 | akhandelwal@akronchildrens.org | |
| Jessica Kracker, BSN | Contact | 330-543-0846 | jkracker@akronchildrens.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akron Children's Hospital | Recruiting | Akron | Ohio | 44308 | United States |
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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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.
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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.
| Placebo |
| Other |
injection every two weeks while on study |
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| D013568 | Pathological Conditions, Signs and Symptoms |