Dupixent for Itchiness

Overseen By Jo Ann Katz, BSN

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Akron Children's Hospital

Must not be taking: Dupixent, Steroids

Disqualifiers: Pregnancy, Cancer, Kidney disease, 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: 6

Duration: 12 weeks

46 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking steroids or Dupixent for another condition.

What data supports the effectiveness of the drug Dupixent for itchiness?

Dupixent (dupilumab) is effective for treating moderate-to-severe atopic dermatitis, a condition often associated with itchiness, by blocking certain proteins (IL-4 and IL-13) involved in inflammation. It is also being developed for other conditions like asthma, which suggests its potential in managing type 2 inflammation-related symptoms. ^{1 2 3 4 5}

Is Dupixent (dupilumab) generally safe for humans?

Dupixent (dupilumab) is generally well tolerated, but some patients, especially those treated for atopic dermatitis, have reported eye-related side effects. Other potential side effects include blood eosinophilia (high levels of a type of white blood cell), rosacea-like skin lesions, and weight gain, though their direct link to the drug is not fully understood. ^{1 5 6 7 8}

How is the drug Dupixent unique for treating itchiness?

Dupixent is unique because it is a monoclonal antibody that targets the IL-4 receptor, blocking signals from proteins IL-4 and IL-13, which are involved in allergic reactions. Unlike traditional treatments, it does not suppress the immune system, potentially reducing the risk of severe infections. ^{1 2 4 5 9}

What is the purpose of this trial?

The goal of this study is to test the efficacy of Dupixent in improving post-burn itching symptoms versus the current standard of care.

Eligibility Criteria

This trial is for adults aged 18-60 with post-burn hypertrophic scars that were treated with grafting. Participants should have ongoing itchiness not relieved by standard treatments like antihistamines and neuroleptics, at least four weeks after their last surgery, and must speak English well enough to participate.

Inclusion Criteria

I am 18-60 years old with itchy scars from burns treated with grafting, and treatments haven't helped.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive six injections of Dupixent or placebo over 12 weeks

12 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dupilumab

Trial Overview The study tests Dupixent's effectiveness in relieving persistent itching in burn patients compared to a placebo. It aims to see if Dupixent can improve symptoms better than the usual care involving medications such as antihistamines.

Participant Groups

Group I: ARM 1 - Dupixent Active Control 1 Intervention

Two subcutaneous injection of 300mg Dupixent at visit 1 and every two weeks (+/- 2 days) for a total of 6 administrations. Injections may be administered in the thigh, lower abdomen or upper arm. The initial dose (two 300 mg doses) will be given in two different injection sites. There are not restriction or guidance regarding dose administration related to meals. No dose modifications will occur during study participation.

Group II: ARM 2 - Placebo Placebo Group 1 Intervention

Two subcutaneous injection of the placebo at visit 1 and every two weeks (+/- 2 days) for a total of 6 administrations. Injections may be administered in the thigh, lower abdomen or upper arm. The initial dose (two doses) will be given in two different injection sites. There are not restriction or guidance regarding dose administration related to meals. No dose modifications will occur during study participation.

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?

Akron Children's Hospital

Lead Sponsor

Trials

50

Recruited

5,009,000+

Ohio State University Wexner Medical Center

Collaborator

Trials

3

Recruited

620+

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

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Findings from Research

Dupilumab is a monoclonal antibody that targets the IL-4 receptor, effectively inhibiting the action of IL-4 and IL-13, which are key players in allergic diseases.

It received its first approval in March 2017 for treating moderate-to-severe atopic dermatitis in adults who do not respond well to topical treatments, and is also being developed for asthma, nasal polyps, and eosinophilic esophagitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab: First Global Approval. Shirley, M.[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]

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]

In a study of 818 adults with moderate-to-severe atopic dermatitis treated with dupilumab for at least 16 weeks, 12% of patients successfully spaced their doses or withdrew treatment while still maintaining effectiveness.

Key predictors for successful dose spacing or treatment withdrawal included having non-cutaneous atopic manifestations, a prurigo nodularis phenotype, and being older at the start of treatment, suggesting specific patient profiles can benefit from adjusted treatment regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of clinical predictors for dupilumab dose spacing in adults with atopic dermatitis: a real-world study. Chiricozzi, A., Dal Bello, G., Gori, N., et al.[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 (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 46 adult patients with moderate-to-severe atopic dermatitis treated with dupilumab, 34.8% experienced ocular adverse events (OAEs), primarily mild to moderate dry eye disease and superficial punctate keratitis.

Patients with pre-existing conditions such as dry eye disease, eyelid eczema, or high IgE levels were more likely to develop OAEs, suggesting that these factors should be considered before starting dupilumab treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and risk factors for dupilumab associated ocular adverse events: a real-life prospective study. Touhouche, AT., Cassagne, M., Bérard, E., et al.[2021]

Dupilumab is effective and generally well tolerated for treating moderate to severe atopic dermatitis, but patients may experience ocular surface disease more frequently compared to those on placebo.

Real-world data have identified some previously unreported adverse events, such as blood eosinophilia and rosacea-like skin lesions, indicating the need for further long-term studies to clarify their relationship with dupilumab treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of dupilumab in patients with atopic dermatitis: expert opinion. Francuzik, W., Alexiou, A., Worm, M.[2021]

Patients treated with Dupilumab showed a higher risk of contracting COVID-19, but the infections were generally less severe, suggesting that Dupilumab may have a protective effect against severe disease.

The analysis included data from the WHO global pharmacovigilance database, identifying 109 COVID-19 cases among Dupilumab users, indicating a need for further research to clarify the immunological mechanisms behind these observations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Higher rates of COVID-19 but less severe infections reported for patients on Dupilumab: a Big Data analysis of the World Health Organization VigiBase. Mahroum, N., Damiani, G., Watad, A., et al.[2022]

References

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

Dupilumab: First Global Approval. [2022]

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

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

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

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

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

Identification of clinical predictors for dupilumab dose spacing in adults with atopic dermatitis: a real-world study. [2023]

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

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

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

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

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

Incidence and risk factors for dupilumab associated ocular adverse events: a real-life prospective study. [2021]

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

Safety of dupilumab in patients with atopic dermatitis: expert opinion. [2021]

9. Italy pubmed.ncbi.nlm.nih.gov

Higher rates of COVID-19 but less severe infections reported for patients on Dupilumab: a Big Data analysis of the World Health Organization VigiBase. [2022]