Dupilumab for Keloids

Recruiting in Palo Alto (17 mi)

Overseen byEmma Guttman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Icahn School of Medicine at Mount Sinai

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests dupilumab injections in patients with keloid scars, many of whom also have inflammatory conditions. Dupilumab helps reduce inflammation by blocking specific proteins. The study aims to see if this treatment can improve keloid scars and related symptoms.

Eligibility Criteria

Adults with keloid scars that didn't improve after minimal treatments like creams and injections can join this trial. They must be in good health, understand the study, and follow its schedule. Women who can have children need a negative pregnancy test and must use effective birth control. People with HIV, hepatitis B or C, serious diseases, recent cancer (except certain skin/cervical cancers), previous dupilumab treatment, or recent live vaccines cannot participate.

Inclusion Criteria

Subject is able to understand and voluntarily sign an informed consent document prior to participation in any study assessments or procedures

I have at least two keloids not fully treated by creams or injections, and one hasn't had surgery or other deforming treatments.

The female subject's chosen form of contraception must be effective by the time the female subject is randomized into the study (for example, hormonal contraception should be initiated at least 28 days before randomization).

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Exclusion Criteria

I have been treated with dupilumab before.

I have used specific skin creams on my keloid scars within the last week.

I have not received a live vaccine in the last 30 days.

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Treatment Details

Interventions

Dupilumab (Monoclonal Antibodies)

Trial OverviewThe trial is testing Dupilumab against a placebo to treat keloids. Initially, participants are randomly assigned to receive either Dupilumab or placebo weekly for 24 weeks; then all get Dupilumab until week 52. The study aims to see if Dupilumab helps reduce keloid size compared to no active treatment.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DupilumabExperimental Treatment1 Intervention

dupilumab 600mg loading dose at Baseline (given as two 300 mg injections) followed by one 300mg weekly subcutaneous injection through Week 52.

Group II: PlaceboPlacebo Group2 Interventions

matching placebo loading dose at Baseline (given as two injections) followed by one weekly subcutaneous injection through Week 24. Starting at Week 24, dupilumab 600mg loading dose (given as two 300 mg injections) followed by one 300mg weekly subcutaneous injection through Week 52.

Dupilumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Dupixent for: