Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)

Description

This is a parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to \<6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze. The study will be conducted in 2 parts. Part A will be a 52-week, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of dupilumab in children aged 2 to \<6 years old with uncontrolled asthma and/or recurrent severe asthmatic wheeze. At the end of Part A, all eligible participants will be offered participation in Part B, an optional open-label extension phase. Study details include: Part A: The study duration of part A will be up to 68 weeks consisting of a 4-week Screening, a 52week treatment period, and a 12-week post-treatment follow-up period. For participants who will chose to participate in Part B, the study duration will be up to 120 weeks (additional 52-week treatment period). Part B: For participants who will choose to participate in Part B, the study duration will be up to 120 weeks (Part A \[4-week Screening and a 52-week treatment period\] plus additional 52-week treatment period and a 12-week post-treatment follow-up period).

Conditions

Wheezing, Asthma

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Study Overview

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Study Details

Study overview

This is a parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to \<6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze. The study will be conducted in 2 parts. Part A will be a 52-week, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of dupilumab in children aged 2 to \<6 years old with uncontrolled asthma and/or recurrent severe asthmatic wheeze. At the end of Part A, all eligible participants will be offered participation in Part B, an optional open-label extension phase. Study details include: Part A: The study duration of part A will be up to 68 weeks consisting of a 4-week Screening, a 52week treatment period, and a 12-week post-treatment follow-up period. For participants who will chose to participate in Part B, the study duration will be up to 120 weeks (additional 52-week treatment period). Part B: For participants who will choose to participate in Part B, the study duration will be up to 120 weeks (Part A \[4-week Screening and a 52-week treatment period\] plus additional 52-week treatment period and a 12-week post-treatment follow-up period).

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Longterm Safety of Dupilumab in Children 2 to <6 Years of Age With Uncontrolled Asthma and/or Recurrent Severe Asthmatic Wheeze

Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)

Condition
Wheezing
Intervention / Treatment

-

Contacts and Locations

Phoenix

Phoenix Children's Hospital- Site Number : 8400001, Phoenix, Arizona, United States, 85016

Newport Beach

Newport Children's Medical Group - Newport Beach- Site Number : 8400023, Newport Beach, California, United States, 92660

Destin

Allervie Health - Destin (AllerVie Clinical Research)- Site Number : 8400016, Destin, Florida, United States, 32541

Chicago

Ann & Robert H. Lurie Children's Hospital of Chicago- Site Number : 8400011, Chicago, Illinois, United States, 60611

Owensboro

Allergy and Asthma Specialist- Site Number : 8400002, Owensboro, Kentucky, United States, 42301

Rochester

Mayo Clinic Hospital Rochester- Site Number : 8400008, Rochester, Minnesota, United States, 55905

Buffalo

UBMD Pediatrics, Oishei Childrens Hospital- Site Number : 8400013, Buffalo, New York, United States, 14203

Hawthorne

Boston Childrens Health Physicians- Site Number : 8400010, Hawthorne, New York, United States, 10532

Chapel Hill

UNC Children's Hospital- Site Number : 8400005, Chapel Hill, North Carolina, United States, 27514

Cincinnati

Cincinnati Children's Hospital Medical Center- Site Number : 8400004, Cincinnati, Ohio, United States, 45229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participant must be 2 to \<6 years of age
  • * Diagnosis of asthma or recurrent severe asthmatic wheeze that is not controlled with chronic ICS for at least 3 months with stable use of at least low dose ICS for ≥1 month prior to Screening Visit 1 with evidence of uncontrolled asthma and/or recurrent severe asthmatic wheeze\*.
  • * At least one additional major criterion from the modified asthma predictive index:
  • 1. Physician diagnosed Atopic Dermatitis,
  • 2. Allergic sensitization to at least 1 aeroallergen (with a positive serum IgE defined as a value ≥0.35 kU/L).
  • 3. Wheezing unrelated to colds,
  • 4. Peripheral blood eosinophilia ≥4%,
  • 5. Allergic sensitization to milk, eggs, or peanuts (defined by serum specific IgE \>0.35 kU/L.
  • * Parent(s)/caregiver(s)/legal guardian(s) willing and able to comply with clinic visits and study-related procedures.
  • * Parent(s)/caregiver(s)/legal guardian(s) able to understand the study requirements.
  • * Participants/parent(s)/caregiver(s)/legal guardian(s), as appropriate, must be able to understand and complete study-related questionnaires
  • * Body weight at screening and randomization \>5 kg and \<30 kg.
  • * Parents or caregivers or legal guardian capable of giving signed informed consent.
  • * Severe asthma with the need for chronic oral/systemic corticosteroid use (\>1 month continuous) at the time of screening enrollment.
  • * History of a systemic hypersensitivity reaction or anaphylaxis to dupilumab or any other biologic therapy, including any excipient.
  • * History of prematurity (\<34 weeks gestation).
  • * Any other chronic lung disease that would impair lung function (eg, cystic fibrosis, bronchopulmonary dysplasia) or chronic lung disease of prematurity or need for oxygen for more than 5 days in the neonatal period.
  • * History of life-threatening asthma (eg, requiring intubation).

Ages Eligible for Study

2 Years to 5 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sanofi,

Study Record Dates

2028-12-21