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Monoclonal Antibodies

Dupilumab (double-blind period) 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52 through week 116
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Part A: Annualized rate of hospitalization, ER or urgent care visit for asthma exacerbation during the 52week treatment period.
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
+18 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367
12%
Accidental Overdose
2%
Conjunctivitis
2%
Nasopharyngitis
2%
Headache
2%
Dermatitis Atopic
1%
Fall
1%
Multiple Fractures
100%
80%
60%
40%
20%
0%
Study treatment Arm
DB Period: Placebo
OLE Period: Dupilumab/Dupilumab
OLE Period: Placebo/Dupilumab
DB Period: Dupilumab

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dupilumab (double-blind period)Experimental Treatment1 Intervention
Dupilumab subcutaneous injection as per protocol
Group II: PlaceboPlacebo Group1 Intervention
Placebo matching dupilumab subcutaneous injection as per protocol
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~12230

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsIndustry Sponsor
621 Previous Clinical Trials
380,515 Total Patients Enrolled
28 Trials studying Asthma
11,897 Patients Enrolled for Asthma
SanofiLead Sponsor
2,164 Previous Clinical Trials
3,514,890 Total Patients Enrolled
46 Trials studying Asthma
27,248 Patients Enrolled for Asthma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to apply and participate in this ongoing medical trial?

"As per the details on clinicaltrials.gov, this investigation is actively seeking volunteers. The trial was initially listed on 1st March 2024 and its most recent update was made on 2nd February 2024."

Answered by AI

What is the upper limit on the number of individuals participating in this research endeavor?

"This research study aims to enroll 90 eligible participants. Patients meeting the defined criteria can partake in this trial at various locations, such as Investigational Site Number : 0320002 situated in Caba, Buenos Aires or Investigational Site Number : 1240007 located in Hamilton, Ontario."

Answered by AI

Has the FDA officially endorsed Dupilumab during its double-blind phase?

"According to our assessment at Power, the safety rating for Dupilumab during the double-blind phase is a 3. This decision aligns with it being a Phase 3 trial where there are existing data supporting its effectiveness and numerous rounds of data validating its safety profile."

Answered by AI

Am I eligible to enroll in this research trial?

"This trial seeks to enroll 90 young children aged between 2 and 5 years with asthma. Essential eligibility criteria include a physician diagnosis of Atopic dermatitis, age ranging from 2 to under 6 years, the ability of participants/parents/caregivers/legal guardians to comprehend and complete study-related questionnaires, confirmed diagnosis of uncontrolled asthma or recurring severe asthmatic wheeze despite using inhaled corticosteroids (ICS) for at least three months, allergic sensitization towards milk, eggs, or peanuts defined by serum-specific IgE levels exceeding >0.35 kU/L., positive allergic sensitivity toward at"

Answered by AI

Is the clinical trial limited to individuals who have reached adulthood, specifically those over 18 years of age?

"Participants aged between 2 and 5 years old are sought for enrollment in this research study. There are a total of 130 trials available for individuals under 18 years old, and 203 trials cater to those above the age of 65."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)
2024. "Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06191315.
~60 spots leftby Dec 2028
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