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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called dupilumab to determine its effectiveness for keloids, which are raised scars that can be itchy or painful. The goal is to assess how well dupilumab works and its safety for individuals with keloids. Participants will receive dupilumab injections over a 22-week period. Suitable candidates for this trial are adults with at least one keloid measuring two centimeters or multiple smaller keloids. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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.

Is there any evidence suggesting that dupilumab is likely to be safe for humans?

Research has shown that dupilumab is usually safe for use. A large study found that children taking dupilumab experienced fewer side effects compared to other treatments. Common side effects reported in various studies include reactions at the injection site, eye irritation, and sore throat. When used for treating keloids, some individuals see improvements, others see no change, and a few may notice worsening symptoms. Overall, dupilumab is considered safe, but individual responses can vary. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for keloids?

Unlike typical treatments for keloids, which often include corticosteroids, laser therapy, or surgical removal, Dupilumab offers a unique approach. Dupilumab is an antibody that targets and inhibits the signaling of interleukin-4 and interleukin-13, which are proteins involved in inflammatory processes. This targeted mechanism may help reduce the excessive scar tissue formation seen in keloids, potentially leading to better and more sustained outcomes. Researchers are excited about Dupilumab because it represents a novel pathway for managing keloids, with the potential for fewer side effects compared to traditional therapies.

What evidence suggests that dupilumab might be an effective treatment for keloids?

Research suggests that dupilumab, administered as a subcutaneous injection in this trial, might help with keloids. Some studies have shown it can reduce symptoms like itching and pain, making keloids more manageable with other treatments. However, results vary: some individuals experience significant improvements, while others may notice little change or even feel worse. Although limited past data exists on dupilumab's effectiveness specifically for keloids, these early findings offer promise for some patients. ^{3 6 7 8 9}

Who Is on the Research Team?

Martina Porter, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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, 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 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 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 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 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 (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]

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

Effects of dupilumab on keloid stabilization and prevention These cases demonstrate improvement in symptoms of keloids (itch, pain) and allowed our first patient's keloids to be more amenable to intralesional ...

3. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/dupilumab-regeneron-pharmaceuticals-keloids-likelihood-of-approval/

Dupilumab by Regeneron Pharmaceuticals for Keloids According to GlobalData, Phase II drugs for Keloids does not have sufficient historical data to build an indication benchmark PTSR for Phase II.

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

NCT02277769 | Study of Dupilumab (REGN668/ ... In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04988022

NCT04988022 | Dupilumab in the Treatment of Keloids This study is a prospective, randomized, double blind, placebo-controlled clinical trial. The study will include a total of 44 subjects with clinically ...

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

The Safety Data of Dupilumab for the Treatment ... This study is the largest safety analysis of dupilumab to date. We found that children 6 months to 11 years receiving dupilumab had fewer side ...

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

Study to Assess Efficacy and Safety of Dupilumab ... - MedPath The study investigates the efficacy and safety of dupilumab in the treatment of keloids.

8. 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- ...

9. dupixenthcp.com dupixenthcp.com/copd/efficacy-safety/safety-data

COPD Clinical Trials Safety Data Avoid use of live vaccines during treatment with DUPIXENT. ADVERSE REACTIONS: Most common adverse reactions are: Atopic Dermatitis (incidence ≥1%): injection ...