880 Participants Needed

Dupilumab for Eczema

Recruiting at 76 trial locations
Age: < 18
Sex: Any
Trial Phase: Phase 3
Sponsor: Regeneron Pharmaceuticals
Must be taking: Dupilumab
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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.12345

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.26789

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.1291011

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 dupilumabOptional Pre-filled Pen (PFP) Sub-Study in pediatric patients ≥2 to \<12 years of age with ADCo-Primary Objectives are:* To evaluate the pharmacokinetic (PK) of dupilumab PFPs* To evaluate the safety of dupilumab PFPsSecondary Objective is:- To evaluate the immunogenicity of dupilumab PFPs

Research Team

CT

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.
See 1 more

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.
See 7 more

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
4Treatment groups
Experimental Treatment
Group I: Body weight ≥60 kgExperimental Treatment1 Intervention
Administered every two weeks (Q2W)
Group II: Body weight 5 kg to <15 kgExperimental Treatment1 Intervention
Administered Q4W
Group III: Body weight 30 kg to <60 kgExperimental Treatment1 Intervention
Administered Q2W
Group IV: Body weight 15 kg to <30 kgExperimental Treatment1 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

Find a Clinic Near You

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 profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

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 profile image

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico profile image

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

References

Dupilumab: First Global Approval. [2022]
Something to Sweat About: Two Cases of Dupilumab-Induced Hyperhidrosis and Bromhidrosis. [2022]
Dupilumab: A Review in Moderate-to-Severe Atopic Dermatitis. [2019]
Dupixent, a New Entrant In the Asthma Lists. [2019]
Dupilumab for the treatment of adolescents with atopic dermatitis. [2021]
Safety update: dupilumab and ocular adverse reactions. [2022]
Dupilumab side effect in a patient with atopic dermatitis: a case report study. [2020]
Treatment With Dupilumab in Patients With Atopic Dermatitis: Systematic Review and Meta-Analysis. [2022]
Prevalence of ocular disease during dupilumab treatment for atopic dermatitis: a bicentric retrospective comparative cohort study. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Dupilumab (Dupixent): An Interleukin-4 Receptor Antagonist for Atopic Dermatitis. [2020]
Dupilumab in pediatric dermatology. [2022]
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