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

44 Participants Needed

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.

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 data supports the effectiveness of the drug Dupilumab for treating keloids?

Dupilumab has been shown to be effective in reducing type 2 inflammation in conditions like atopic dermatitis and asthma by blocking specific proteins involved in inflammation. This suggests it might help with keloids, which also involve inflammation, although direct evidence for keloids is not available. ^{1 2 3 4 5}

Is dupilumab generally safe for humans?

Dupilumab is generally considered safe, but it can cause some side effects like eye problems and skin reactions such as facial redness and psoriasis-like symptoms. ^{5 6 7 8 9}

How does the drug Dupilumab differ from other treatments for keloids?

Dupilumab is unique because it targets specific proteins involved in inflammation, which may help reduce the formation of keloids (raised scars). Unlike traditional treatments that focus on surgical removal or steroid injections, Dupilumab works by modulating the immune response, offering a novel approach to managing this condition. ^{10 11 12 13 14}

Research Team

Emma Guttman, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

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).

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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 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]

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, 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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Dupilumab (Dupixent): An Interleukin-4 Receptor Antagonist for Atopic Dermatitis. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Dupilumab for the treatment of adolescents with atopic dermatitis. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Facial erythema after the treatment of dupilumab in SLE patient. [2022]

6. England pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Prevalence of ocular disease during dupilumab treatment for atopic dermatitis: a bicentric retrospective comparative cohort study. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Dupilumab-Associated Psoriasis and Psoriasiform Manifestations: A Scoping Review. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

A review of dupilumab in the treatment of atopic diseases. [2020]

10. Germany pubmed.ncbi.nlm.nih.gov

Oral anticoagulation with edoxaban. [2019]

11. Germany pubmed.ncbi.nlm.nih.gov

Oral anticoagulation with edoxaban. Focus on current phase III clinical development. [2016]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Effect of famotidine on the pharmacokinetics of apixaban, an oral direct factor Xa inhibitor. [2021]

13. Germany pubmed.ncbi.nlm.nih.gov

Factor Xa inhibitors--new anticoagulants for secondary haemostasis. [2015]

14. Spain pubmed.ncbi.nlm.nih.gov

Edoxaban for the prevention of thromboembolic events after surgery. [2017]