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Monoclonal Antibodies

Dupilumab for Asthma

Phase 3

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Physician diagnosed Atopic Dermatitis

Body weight at screening and randomization >5 kg and <30 kg

Must not have

History of life-threatening asthma

Severe asthma with the need for chronic oral/systemic corticosteroid use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52 through week 116

Awards & highlights

Pivotal Trial

Summary

This trial is a Phase 3 study that aims to evaluate the effectiveness and safety of dupilumab treatment in children aged 2 to under 6 years with uncontrolled asthma or recurrent severe ast

Who is the study for?

This trial is for children aged 2 to less than 6 with uncontrolled asthma or severe asthmatic wheeze, diagnosed with Atopic Dermatitis. They must have been on inhaled corticosteroids for at least a month and show allergic reactions to certain foods or airborne allergens. Parents need to understand study requirements and help their kids follow the protocol.

What is being tested?

The study tests Dupilumab's effectiveness and safety against a placebo over a year (Part A), followed by an optional second year (Part B). It's double-blind, meaning neither participants nor researchers know who gets the real drug during Part A.

What are the potential side effects?

While not specified here, Dupilumab may commonly cause injection site reactions, eye inflammation or irritation, cold sores in your mouth or throat. Serious side effects can include allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My doctor diagnosed me with Atopic Dermatitis.

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My weight is between 5 kg and 30 kg.

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My guardian can sign the consent form for me.

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I have asthma that hasn't improved with at least 3 months of inhaler use.

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My child is between 2 and 6 years old and has asthma not controlled by inhaled steroids for 3 months.

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I am between 2 and 6 years old.

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I experience wheezing that isn't caused by colds.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had severe asthma attacks that were life-threatening.

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I have severe asthma and need to take steroids regularly.

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I was born prematurely.

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I have a chronic lung condition that affects my breathing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52 through week 116

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52 through week 116

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 through week 116 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A: Annualized rate of severe asthma exacerbations during the 52-week treatment period

Part B: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and AEs leading to permanent treatment discontinuation

Secondary study objectives

Part A: Annualized rate of moderate asthma exacerbations during the 52-week treatment period

Part A: Caregiver Global Impression of Change in their child's asthma control (CGI-change in asthma control) at Week 52

Part A: Change from baseline to Week 52 in Caregiver Global Impression of their child's asthma control (CGI-asthma control)

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