Dupilumab for Eczema

(PELISTAD-EX2 Trial)

Not currently recruiting at 7 trial locations

Overseen By Trial Transparency email recommended (Toll free number for US & Canada)

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Sanofi

Must be taking: Dupixent

Must not be taking: Systemic corticosteroids, JAK inhibitors

Disqualifiers: Severe illness, Skin conditions, 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: 2

Duration: 104 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called dupilumab (also known as Dupixent) to evaluate its effects on children with moderate-to-severe eczema, particularly regarding skin barrier function. Researchers aim to determine if it improves the skin's long-term ability to retain moisture. Children aged 6 to 15 who have had eczema for at least a year and exhibit visible skin issues may qualify for this study. Participants will use the treatment for about two years. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand its benefits for a broader patient population.

Will I have to stop taking my current medications?

Yes, you will need to stop certain medications before joining the trial. Systemic treatments for eczema and some topical treatments must be stopped 4 weeks and 1 week before the trial starts, respectively. However, face and neck can be treated with topical steroids during the washout period if approved by the Investigator.

What is the safety track record for this treatment?

Research shows that dupilumab is generally safe for both children and adults with atopic dermatitis (AD). A study on children aged 6-11 found no major safety issues, with most side effects being mild to moderate, such as eye irritation or minor skin reactions. In adults, long-term research involving over 2,600 participants confirmed that dupilumab remains safe, with no new safety concerns over time. This indicates that even with prolonged use, the treatment continues to be safe. The FDA has already approved dupilumab for treating AD, further supporting its safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Dupilumab is unique because it works by targeting and inhibiting specific proteins involved in the inflammatory response associated with eczema. Unlike traditional treatments like topical corticosteroids or calcineurin inhibitors, which mainly focus on soothing the skin or suppressing the immune system broadly, dupilumab specifically blocks interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling pathways. This targeted approach can lead to more effective control of symptoms with potentially fewer side effects. Researchers are excited about dupilumab because it represents a more precise method of treating eczema, offering hope for better long-term management of the condition.

What is the effectiveness track record for Dupilumab in treating eczema?

Research shows that dupilumab, the treatment under study in this trial, effectively treats atopic dermatitis, commonly known as eczema. Long-term studies have found that patients experience lasting relief from their symptoms and express high satisfaction with the treatment. Data from up to five years of use confirm these benefits, making it a dependable option for many. The treatment has successfully improved the quality of life and overall well-being of people with eczema. Dupilumab targets specific parts of the immune system that cause skin inflammation. This targeted approach helps reduce the symptoms and severity of eczema over time. ^{3 6 7 8 9}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

This trial is for children aged 6 to under 15 with moderate-to-severe atopic dermatitis (eczema). They must meet specific criteria including having had the condition for at least a year and, if new participants, have certain severity in skin lesions. Participants need to be able to avoid topical medications on target areas during the study unless absolutely needed.

Inclusion Criteria

My disease type matches the study's requirements.

The participant should have an unblemished skin area situated 4 cm away from the edge of the affected region

My eczema is moderate to severe, depending on where I live.

Exclusion Criteria

I haven't taken specific immune system medications or undergone phototherapy in the last 4 weeks.

Hypersensitivity to the active substance or to any of the excipients of dupilumab.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive open-label dupilumab treatment for 104 weeks

104 weeks

Regular visits according to local prescribing label

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (telephone)

What Are the Treatments Tested in This Trial?

Interventions

• Dupilumab

Trial Overview The trial tests Dupilumab's long-term effects on skin barrier function in pediatric patients with eczema over a period of two years. It measures how well the skin retains moisture before and after a procedure that stresses the skin. All participants will receive Dupilumab according to local guidelines.

How Is the Trial Designed?

Group I: Pediatric AD participants Experimental Treatment 1 Intervention

Participants will receive dupilumab IMP according to the approved prescribing label in the country/region where the study is conducted.

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?

Sanofi

Lead 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

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 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]

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]

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 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 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]

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, 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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38653344/

Up to 5-year results from the daily practice BioDay registry Dupilumab has demonstrated sustained effectiveness across various PROMs, underscoring the treatment benefits from patients' perspectives.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10442302/

Long-Term Effectiveness of Dupilumab in Patients with Atopic ... In this prospective, longitudinal, real-world study, patients reported maintenance of disease control and treatment satisfaction after 30–36 ...

3. dupixenthcp.com dupixenthcp.com/atopicdermatitis/efficacy-safety/adult-real-world-results

Adult Real-World Data | DUPIXENT® (dupilumab) Long-term effectiveness of dupilumab in patients with atopic dermatitis: results up to 3 years from the RELIEVE-AD study. Dermatol Ther (Heidelb). 2023;13(9): ...

4. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2822203

Long-Term Effectiveness and Reasons for Discontinuation ... Descriptive Clinical Effectiveness Outcomes Among 1286 Patients With Atopic Dermatitis During 5 Years of Dupilumab Treatment. View Large ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0190962224006418

Dupilumab provides sustained effectiveness on patient- ... Dupilumab treatment has demonstrated sustained improvements in patient-reported measures of severity, symptoms, quality of life, overall well-being, and work ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02407756

NCT02407756 | A Study to Determine the Safety and ... The primary objective of the study is to characterize the safety and pharmacokinetics (PK) of dupilumab in pediatric patients with moderate-to-severe atopic ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34462864/

Laboratory Safety of Dupilumab in Patients Aged 6-11 ... The aim of this study was to assess laboratory outcomes in children aged 6-11 years with severe AD in a randomized, placebo-controlled, phase III trial of ...

8. newsroom.regeneron.com newsroom.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-data-revolutionizing-atopic-dermatitis-rad

Dupixent® (dupilumab) Data at Revolutionizing Atopic ... Dupixent achieved 75% or greater improvement in overall disease severity, the primary endpoint, in more than three-quarters of treated patients.

9. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2820911

Dupilumab in Adults With Moderate to Severe Atopic ... In this open-label extension study of 2677 adults with moderate to severe atopic dermatitis, dupilumab was well tolerated with no new safety incidents and ...