Dupilumab for Eczema

Recruiting at 76 trial locations

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Regeneron Pharmaceuticals

Must be taking: Dupilumab

Must not be taking: Immunosuppressives, Live vaccines

Disqualifiers: Severe illness, Endoparasitic infections, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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: 2

Duration: 260 weeks

880 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you have not used immunosuppressive or immunomodulating drugs within 4 weeks before starting. If you're on such medications, you may need to stop them before joining the trial.

What data supports the effectiveness of the drug Dupilumab for eczema?

Dupilumab has been shown to improve symptoms of moderate-to-severe eczema, such as skin inflammation, itching, and sleep disturbances, in adults who did not respond well to other treatments. It is also generally well tolerated, with most side effects being mild, like injection site reactions and conjunctivitis. ^{1 2 3 4 5}

What is the safety profile of Dupilumab for eczema?

Dupilumab is generally considered safe for treating eczema, with common side effects including injection site reactions, conjunctivitis (eye inflammation), headache, and nasopharyngitis (cold-like symptoms). Some rare side effects have been reported, such as increased sweating and certain eye conditions, but overall, its safety profile is similar to a placebo. ^{2 6 7 8 9}

What makes the drug Dupilumab unique for treating eczema?

Dupilumab is unique because it is the first FDA-approved biological therapy for moderate-to-severe eczema that works by blocking the IL-4 receptor, which helps reduce inflammation caused by the immune system. Unlike traditional topical treatments, it is administered as an injection and is specifically designed for patients whose eczema is not well-controlled with topical therapies. ^{1 2 9 10 11}

What is the purpose of this trial?

The primary objective of the study is to assess the long-term safety of dupilumab in pediatric participants with AD. The secondary objectives of the study are: * To assess the long-term efficacy of dupilumab in pediatric participants with AD * To assess the trough concentrations of functional dupilumab in serum and the immunogenicity in pediatric participants with AD after re-treatment with dupilumab Optional Pre-filled Pen (PFP) Sub-Study in pediatric patients ≥2 to \<12 years of age with AD Co-Primary Objectives are: * To evaluate the pharmacokinetic (PK) of dupilumab PFPs * To evaluate the safety of dupilumab PFPs Secondary Objective is: - To evaluate the immunogenicity of dupilumab PFPs

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

This trial is for children aged ≥6 months to <18 years with Atopic Dermatitis (AD) who have participated in a prior dupilumab study. For the sub-study, only kids ≥2 to <12 years old and weighing between 5kg and 60kg can join. Participants must not have severe illnesses or recent treatments that could interfere with the study.

Inclusion Criteria

You have already taken part in a study for dupilumab in kids with AD and finished all the required visits and tests for that study.

I've been on the same dupilumab dose for the last 12 weeks as in the PFP study.

My weight is between 5 kg and 60 kg.

Exclusion Criteria

I haven't taken any experimental drugs recently, except for dupilumab.

I have or am at high risk for serious worm infections.

You have missed one or more of the last three planned injections in the main study before entering the sub-study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dupilumab with dosing frequency based on body weight, assessing long-term safety and efficacy

260 weeks

Visits every 2 to 4 weeks depending on body weight

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Open-label extension

Participants continue to receive dupilumab to assess long-term safety and efficacy

Long-term

Treatment Details

Interventions

• Dupilumab

Trial Overview The main goal is to check long-term safety of dupilumab in young patients with AD. It also looks at how well it works over time, its levels in blood after repeated use, and if bodies react against it. A sub-study tests a pre-filled pen version for safety, dosage levels in blood, and immune response.

Participant Groups

Group I: Body weight ≥60 kg Experimental Treatment 1 Intervention

Administered every two weeks (Q2W)

Group II: Body weight 5 kg to <15 kg Experimental Treatment 1 Intervention

Administered Q4W

Group III: Body weight 30 kg to <60 kg Experimental Treatment 1 Intervention

Administered Q2W

Group IV: Body weight 15 kg to <30 kg Experimental Treatment 1 Intervention

Administered every 4 weeks (Q4W)

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?

Regeneron Pharmaceuticals

Lead 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

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, an IL-4 receptor antagonist, is the first FDA-approved biological therapy for moderate-to-severe atopic dermatitis (AD) and has shown improved outcomes in patients inadequately controlled by topical treatments.

However, this case report highlights new side effects, specifically hyperhidrosis and bromhidrosis, in two patients after starting dupilumab, suggesting the need for further research on its long-term safety and potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Something to Sweat About: Two Cases of Dupilumab-Induced Hyperhidrosis and Bromhidrosis. Rowane, M., Valencia, R., Schend, J., et al.[2022]

Dupilumab is the first biologic therapy approved for adults with moderate-to-severe atopic dermatitis (AD), showing significant improvements in disease severity, itching, sleep quality, and overall quality of life in phase III trials involving patients inadequately controlled by other treatments.

The treatment was well tolerated with low rates of serious side effects, making dupilumab a promising long-term option for patients with AD, especially since it maintains its benefits over a year of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab: A Review in Moderate-to-Severe Atopic Dermatitis. Frampton, JE., Blair, HA.[2019]

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, a monoclonal antibody approved by the FDA in 2017, effectively treats moderate to severe atopic dermatitis by inhibiting IL-4 and IL-13 signaling, providing an alternative for patients not responding to topical therapies.

While dupilumab is generally effective, it can cause adverse effects such as injection site reactions and conjunctivitis, with rare cases like alopecia areata reported, highlighting the need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab side effect in a patient with atopic dermatitis: a case report study. Albader, SS., Alharbi, AA., Alenezi, RF., et al.[2020]

Dupilumab significantly improved symptoms of atopic dermatitis (AD) in both adults (n=3,817) and children/adolescents (n=618), showing a marked reduction in the Eczema Area Severity Index (EASI) score and pruritus, indicating its efficacy as a treatment option.

The safety profile of dupilumab was comparable to that of a placebo, with no increase in adverse events, suggesting it is a safe option for managing AD-related symptoms and improving patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment With Dupilumab in Patients With Atopic Dermatitis: Systematic Review and Meta-Analysis. Koskeridis, F., Evangelou, E., Ntzani, EE., et al.[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 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, a monoclonal antibody targeting the IL-4 receptor, has shown promising therapeutic outcomes for dermatologic conditions in children and adolescents, although the data is still limited.

Current evidence consists of a small number of clinical trials and case reports, highlighting the need for more extensive long-term studies to better understand the efficacy and safety of dupilumab in the pediatric population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab in pediatric dermatology. Plachouri, KM., Georgiou, S.[2022]

References

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

Dupilumab: First Global Approval. [2022]

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

Something to Sweat About: Two Cases of Dupilumab-Induced Hyperhidrosis and Bromhidrosis. [2022]

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

Dupilumab: A Review in Moderate-to-Severe Atopic Dermatitis. [2019]

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

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

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

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

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

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

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

Dupilumab side effect in a patient with atopic dermatitis: a case report study. [2020]

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

Treatment With Dupilumab in Patients With Atopic Dermatitis: Systematic Review and Meta-Analysis. [2022]

9. England pubmed.ncbi.nlm.nih.gov

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

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

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

11. England pubmed.ncbi.nlm.nih.gov

Dupilumab in pediatric dermatology. [2022]