Dupilumab for Keloids

Overseen By Hye Jin Chung, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Immunosuppressants

Disqualifiers: Infectious disease, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: 1

Duration: 22 weeks

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking any other immunosuppressant systemic medication at least 28 days before starting the study. Additionally, you must not have received any treatment for keloids within 28 days prior to the baseline visit.

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

Dupilumab has been shown to be effective in treating conditions like atopic dermatitis and asthma by reducing type 2 inflammation, which involves the same inflammatory pathways that might be relevant in keloids. Its ability to block specific proteins involved in inflammation suggests it could potentially help with keloids, 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 some people have experienced eye-related side effects and skin reactions like facial redness and psoriasis after using it. ^{3 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 removing or flattening keloids, Dupilumab works by addressing the underlying inflammatory process. ^{10 11 12 13 14}

What is the purpose of this trial?

This trial investigates whether dupilumab, an anti-inflammatory medication, can help patients with keloids. Keloids are excessive scar tissue growths that current treatments often fail to address effectively. By blocking proteins that cause inflammation, dupilumab may reduce keloid size and improve symptoms.

Research Team

Martina Porter, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

This trial is for men and women aged 18-65 with keloids, who can understand the study requirements and consent to participate. They must have at least one large keloid or multiple smaller ones but cannot be pregnant, breastfeeding, or planning pregnancy during the study. Participants should not be on immunosuppressants, have chronic infections including HIV/Hepatitis B/C, or a history of hypersensitivity to dupilumab.

Inclusion Criteria

I can understand and follow the study's requirements and have signed the consent form.

I have a keloid larger than 2 cm or at least two keloids each bigger than 0.4 cm.

Exclusion Criteria

I am not taking any immunosuppressant drugs or haven't taken any in the last 28 days.

Previous hypersensitivity reaction to dupilumab

I do not have HIV, hepatitis B, or hepatitis C.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 600mg of Dupilumab at baseline and 300mg every 2 weeks for 22 weeks

22 weeks

1 visit (in-person) at baseline, followed by bi-weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Dupilumab

Trial Overview The trial is testing the effectiveness and safety of a medication called Dupilumab in treating keloids—overgrown scars that rise above the skin surface. The study will involve participants receiving Dupilumab under controlled conditions to see how well it works and what side effects may occur.

Participant Groups

Group I: Dupilumab Subcutaneous Injection Experimental Treatment 1 Intervention

600 mg at initial visit and 300mg every 2 weeks until week 22 Each subject will receive 600mg of Dupilumab at baseline visit and 300mg of Dupilumab as a subcutaneous injection every 2 weeks for a total of 9 doses over 22 weeks.

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?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

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

Findings from Research

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]

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, 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 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 (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. England pubmed.ncbi.nlm.nih.gov

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

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

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

3. England pubmed.ncbi.nlm.nih.gov

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

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

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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

8. England pubmed.ncbi.nlm.nih.gov

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

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

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

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