Dupilumab for Keloids

Overseen By Giselle Singer

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Immunosuppressives, JAK inhibitors

Disqualifiers: HIV, Hepatitis B/C, Tuberculosis, others

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 33

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called dupilumab to determine its effectiveness in reducing keloid scars, which are thick, raised scars that persist. Researchers aim to compare the efficacy of dupilumab against a placebo (a substance with no active medicine) in individuals who have not found success with other treatments like creams or steroid injections. Ideal candidates for this trial have at least two keloid scars and other allergic conditions such as asthma or eczema. Participants will receive either dupilumab or a placebo for 24 weeks, followed by dupilumab for an additional 28 weeks. As a Phase 4 trial, this study involves an FDA-approved treatment, allowing researchers to understand how dupilumab benefits a broader patient population.

Will I have to stop taking my current medications?

You may need to stop certain medications before joining the trial. Specifically, you cannot use systemic immunosuppressive medications or oral JAK inhibitors shortly before starting the trial. Topical corticosteroids and similar treatments are not allowed on keloid lesions just before the trial begins.

What is the safety track record for this treatment?

Research shows that dupilumab is generally safe for people. It has been tested in conditions like moderate-to-severe atopic dermatitis, a type of eczema. In these studies, most participants did not experience serious side effects. Common side effects included mild reactions at the injection site, such as redness or swelling.

The FDA has already approved dupilumab for other conditions, indicating it has passed many safety tests. However, each new use, such as for keloids, requires careful study.

In summary, while dupilumab has proven safe for other conditions, researching its safety specifically for keloids remains important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Dupilumab for treating keloids because it works differently from traditional therapies. Most current treatments, like surgery, corticosteroids, or laser therapy, focus on reducing the size or appearance of keloids. However, Dupilumab is a biologic that targets and inhibits specific proteins involved in inflammation, potentially addressing the root cause of keloid formation. This novel approach may offer more effective and lasting results for patients struggling with keloids.

What is the effectiveness track record for dupilumab in treating keloids?

Research has shown that dupilumab is effective for conditions like atopic dermatitis, which involves inflammation similar to that in keloids. In this trial, participants will receive either dupilumab or a placebo. Early results suggest that dupilumab might prevent keloids from regrowing after surgery and radiation. Although responses vary, some patients have experienced significant symptom improvement. This medication blocks specific proteins that cause inflammation, potentially reducing the size and symptoms of keloids. Dupilumab is already approved for other inflammatory conditions, demonstrating its potential effectiveness and safety. ^{3 4 6 7 8}

Who Is on the Research Team?

Emma Guttman, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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).

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment Phase I

Participants are randomized to receive weekly dupilumab or placebo for 24 weeks

24 weeks

Visits at weeks 4, 8, 16, 24

Treatment Phase II

All participants receive weekly dupilumab from week 24 to week 52

28 weeks

Visits at weeks 28, 36, 48, 52

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dupilumab

Trial Overview 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.

How Is the Trial Designed?

Group I: Dupilumab Experimental Treatment 1 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: Placebo Placebo Group 2 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:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Approved in European Union as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Sanofi

Industry Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Published Research Related to This Trial

Dupixent (dupilumab) is set to receive FDA approval for asthma treatment on October 20, expanding its use beyond atopic dermatitis.

Once approved, Dupixent will be part of a group of monoclonal antibodies, including Nucala, Cinqair, and Fasenra, that target type 2 inflammation in severe asthma, highlighting its role in managing this specific asthma phenotype.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupixent, a New Entrant In the Asthma Lists. Reinke, T.[2019]

Dupilumab effectively improves signs, symptoms, and quality of life in adolescents with moderate to severe atopic dermatitis (AD) by targeting key inflammatory pathways, specifically blocking IL-4 and IL-13 receptors.

The safety profile of dupilumab in adolescents is similar to that in adults, with common side effects including injection-site reactions and conjunctivitis, while skin infections were less frequent compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab for the treatment of adolescents with atopic dermatitis. Senner, S., Seegräber, M., Frey, S., et al.[2021]

Dupilumab (Dupixent) has been associated with a risk of ocular adverse reactions, highlighting the importance of monitoring patients for eye-related side effects during treatment.

Prompt management of any ocular issues is essential for patients receiving dupilumab, ensuring their safety and well-being while benefiting from the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety update: dupilumab and ocular adverse reactions. [2022]

Dupilumab is an effective treatment for type 2 inflammatory diseases like atopic dermatitis, asthma, and nasosinusal polyposis, as it inhibits the IL-4 receptor, blocking the action of key cytokines involved in these conditions.

The drug has a favorable safety profile, with few and reversible side effects, making it a promising option for patients who do not respond well to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dupilumab: beyond atopic dermatitis, off-label use in dermatology]. Russo, G., Laffitte, E.[2023]

In a study of 100 patients with atopic dermatitis, 36% of those treated with dupilumab developed ocular diseases, significantly higher than the 10% in the reference group.

Severe allergic conjunctivitis and blepharitis were notably more common in the dupilumab group, with 30% and 22% of patients affected, respectively, indicating a need for careful monitoring and potential ophthalmologist consultation before starting treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of ocular disease during dupilumab treatment for atopic dermatitis: a bicentric retrospective comparative cohort study. Barbé, J., Poreaux, C., Remen, T., et al.[2021]

Dupilumab is an effective treatment for atopic dermatitis, showing significant improvements in skin symptoms and overall disease control in clinical trials.

The medication works by inhibiting specific pathways in the immune system, which helps reduce inflammation and alleviate the symptoms of atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab (Dupixent): An Interleukin-4 Receptor Antagonist for Atopic Dermatitis. D'Ippolito, D., Pisano, M.[2020]

Dupilumab is a monoclonal antibody that blocks IL-4 and IL-13 signaling, which are key drivers of atopic diseases, and it was first approved by the FDA in March 2017 for treating moderate-to-severe atopic dermatitis in adults who do not respond to topical treatments.

In October 2018, dupilumab was also approved as an add-on therapy for moderate-to-severe asthma in patients aged 12 and older, particularly those with eosinophilic asthma or those dependent on oral corticosteroids, highlighting its efficacy in managing multiple atopic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of dupilumab in the treatment of atopic diseases. Thibodeaux, Q., Smith, MP., Ly, K., et al.[2020]

Dupilumab, a treatment for atopic dermatitis, effectively improved skin lesions in a patient but also caused unexpected facial erythema and desquamation, highlighting potential adverse effects.

The case suggests that while dupilumab is beneficial for atopic dermatitis, it may trigger or exacerbate conditions like systemic lupus erythematosus (SLE), indicating the need for careful monitoring of patients during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facial erythema after the treatment of dupilumab in SLE patient. Jang, DH., Lee, JI., Bae, JY., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39177869

Systematic review of dupilumab safety and efficacy for ... Results indicate variable responses to treatment, including significant improvements, no clinical change, and worsening of keloid symptoms.

2. trial.medpath.com trial.medpath.com/clinical-trial/144e69879733b94c/nct05128383-dupilumab-efficacy-safety-keloids

Study to Assess Efficacy and Safety of Dupilumab ... - MedPath The Investigators hypothesize that dupilumab can decrease the size and symptoms of keloids and improve patient's quality of life. An open-label proof of concept ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10285468/

Effects of dupilumab on keloid stabilization and prevention In this case report, we discuss 2 cases of severe, chronic keloids where dupilumab was used to stabilize keloid regrowth after surgery and radiation.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02277769

NCT02277769 | Study of Dupilumab (REGN668/ ... Study of Dupilumab (REGN668/​SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis (SOLO 2). ClinicalTrials.gov ID ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01639040

NCT01639040 | Study to Assess the Safety of Dupilumab ... The purpose of this study was to assess the safety of Dupilumab administered concomitantly with topical corticosteroids (TCS) in patients with moderate-to- ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40993471/

The Safety Data of Dupilumab for the Treatment ... This study reviews the safety of the drug dupilumab, which is used to treat infants, children, adolescents, and adults who have moderate-to- ...

7. file.medchemexpress.com file.medchemexpress.com/batch_PDF/HY-P9926/Dupilumab-SDS-MedChemExpress.pdf

Safety Data Sheet Use full personal protective equipment. Avoid breathing vapors, mist, dust or gas. Ensure adequate ventilation. Evacuate personnel to safe areas ...

8. abmole.com abmole.com/literature/dupilumab-msds.html?srsltid=AfmBOorkDHCfPAK6MLiw4e814lduXW-rxbwO6LH72glgJrVFnjJE8BA9

Material Safety Data Sheet of Dupilumab Material Safety Data Sheet of Dupilumab contains identification of substance and details of the supplier of the safety data sheet.