What side effects are associated with this type of intervention?

Common treatments for keloids include corticosteroid injections, surgical removal, laser therapy, and cryotherapy. Side effects of corticosteroid injections can include skin thinning, discoloration, and the formation of small blood vessels on the skin surface. Surgical removal may lead to recurrence and further keloid formation. Laser therapy can cause temporary redness, swelling, and changes in skin pigmentation. Cryotherapy may result in pain, blistering, and changes in skin texture. For treatments similar to Dupilumab, which targets IL-4 and IL-13 signaling, side effects may include injection site reactions, conjunctivitis, and potential allergic reactions. Further studies are needed to fully understand the long-term safety and efficacy of such treatments for keloids.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically for keloids that function by inhibiting IL-4 and IL-13 signaling, like dupilumab. Traditional treatments for keloids include corticosteroid injections, surgical removal, laser therapy, and cryotherapy. Emerging treatments and ongoing studies, such as the trial involving dupilumab, are exploring the potential of targeting specific immune pathways, but these are not yet FDA-approved for keloid treatment.

What other types of research exist?

Promising alternatives to Dupilumab for keloid treatment in 2024 may include other biologics targeting inflammatory pathways, such as IL-17 inhibitors (e.g., Secukinumab, Ixekizumab) and IL-23 inhibitors (e.g., Guselkumab). These have shown efficacy in treating other inflammatory and fibrotic conditions and may offer potential benefits for keloid patients.

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Monoclonal Antibodies

Dupilumab for Keloids

Phase 4

Waitlist Available

Led By Emma Guttman, MD PhD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

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

Must have

Male or female subjects ≥ 18 years of age at the time of signing the informed consent document

Option 1: Any one of the following highly effective contraceptive methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy.

Must not have

Subject was treated previously with dupilumab.

Subject currently uses or plans to use anti-retroviral therapy at any time during the study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and weeks 4, 16, 24, 48, and 52

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Dupilumab may cause side effects such as allergic reactions at the injection site, eye irritation or inflammation (pink eye), cold sores in your mouth or on your lips, and rarely more serious allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years or older and have signed the consent form.

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I am using a highly effective birth control method.

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This criterion does not apply to me.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with dupilumab before.

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I am using or plan to use anti-retroviral therapy during the study.

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I haven't taken any strong immune system suppressing drugs in the last 4 weeks.

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I am currently pregnant or breastfeeding.

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I have or had HIV, immunodeficiency, hepatitis B or C, or tuberculosis.

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I have not taken JAK inhibitors like tofacitinib or ruxolitinib in the last 12 weeks.

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I have severe asthma or have had life-threatening asthma attacks despite treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and weeks 4, 16, 24, 48, and 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and weeks 4, 16, 24, 48, and 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and weeks 4, 16, 24, 48, and 52 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from baseline in dimensions of keloid lesions at 24 weeks

Secondary study objectives

Change from baseline in dimensions of keloid lesions at weeks 4, 16, 24, 48, and 52 of treatment with dupilumab

Other study objectives

Body Surface Area (BSA) affected with disease

Dermatology Life Quality Index (DLQI)

Eczema Area and Severity Index (EASI) score

+4 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367

Conjunctivitis

Headache

Dermatitis Atopic

Nasopharyngitis

Accidental Overdose

Drug Hypersensitivity

Polyarthritis

100%

80%

60%

40%

20%

Study treatment Arm

DB Period: Placebo

DB Period: Dupilumab

OLE Period: Placebo/Dupilumab

OLE Period: Dupilumab/Dupilumab

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dupilumab

2017

Completed Phase 4

~11960

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Keloid treatments often target inflammatory pathways to reduce excessive scar tissue formation. Dupilumab, for instance, inhibits IL-4 and IL-13 signaling, which are cytokines involved in the inflammatory response and fibrosis. By blocking these pathways, Dupilumab can potentially reduce the abnormal collagen production that characterizes keloids. This is crucial for keloid patients as it addresses the underlying inflammation and fibrosis, potentially leading to less pronounced and more manageable scar tissue.