Prevention of Asthma Exacerbations Using Dupilumab in Urban Children and Adolescents (PANDA) (CAUSE-01)

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a multi-center, double-blind, placebo-controlled, randomized trial of dupilumab adjunctive therapy for prevention of asthma exacerbations in urban children and adolescents with T2-high exacerbation-prone asthma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: f
View:

• Participant and/or parent guardian must be able to understand and provide informed consent and age-appropriate assent

• Are male and female aged 6-17 years at Visit 0

• Participant has a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the Protocol CAUSE01 Manual of Operations (MOP). Participants who do not live in the pre-selected census tracts but live within the Office of Management and Budget (OMB) defined Metropolitan Statistical Area and have publicly funded health insurance will qualify for inclusion.

• Participant has a diagnosis of asthma made \> 1 year prior to recruitment. Participants who received an asthma diagnosis by a clinician ≤1 year prior to recruitment must report that their respiratory symptoms were present for more than 1 year prior to recruitment.

• Participant has had at least two asthma exacerbations in the prior year (defined as a requirement for systemic corticosteroids and/or hospitalization).

• At Visit 0 (screening), participant must have the following requirement for asthma controller medication:

‣ Participants aged 6 to 11 years: treatments with at least fluticasone 250 mcg dry powder inhaler (DPI) one puff twice daily or its equivalent.

⁃ Participants aged 12 years and older, treatment with at least fluticasone 250 mcg plus long-acting beta agonist (LABA) DPI one puff twice daily or its equivalent.

• Have peripheral blood eosinophils ≥150 cells/mcl and/or FeNO ≥ 20ppb obtained at Visit 0 or via another CAUSE protocol within 6 months.

• Are able to perform acceptable and repeatable spirometry per American Thoracic Society (ATS) criteria prior to randomization.

• Have documentation of current medical insurance with prescription coverage at Visit 0.

Locations
United States
Colorado
Children's Hospital Colorado: Allergy Program
RECRUITING
Aurora
Washington, D.c.
Children's National Medical Center: Children's Research Institute
RECRUITING
Washington D.c.
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology
RECRUITING
Chicago
Massachusetts
Boston Children's Hospital: Department of Immunology
ACTIVE_NOT_RECRUITING
Boston
Missouri
Washington University at St. Louis
RECRUITING
St Louis
New York
Columbia University Medical Center: Division of Pediatric Pulmonology
RECRUITING
New York
Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Institute
RECRUITING
New York
Ohio
Cincinnati Children's Hospital Medical Center: Asthma Center
RECRUITING
Cincinnati
Time Frame
Start Date: 2022-05-04
Estimated Completion Date: 2025-12-15
Participants
Target number of participants: 240
Treatments
Experimental: Dupilumab
Participants between 12-17 years of age will receive an initial dose of 600 mg (two 300 mg injections) followed by 300 mg given every other week (Q2W).~Participants between 6-11 years of age will not complete a loading dose and will receive injections based on their body weight:~Those weighing 15 kg to less than 30 kg will receive 300 mg every four weeks (Q4W). Participants in this weight category who were randomized before July 1, 2024, were assigned to a 100mg Q2W and will not be transitioned to the Q4W dosing schedule.~Those with a body weight of 30 kg or more will receive 200 mg Q2W.
Placebo_comparator: Placebo
Participants between 12-17 years of age will receive an initial dose of placebo (two injections) followed by a placebo injection given every other week (Q2W).~Participants between 6-11 years of age will not receive an initial loading dose of placebo and will receive injections Q2W or Q4W based on their body weight and date of randomization.:~The injection volume of placebo will be matched to the corresponding dupilumab dose based on participant body weight.
Related Therapeutic Areas
Sponsors
Collaborators: Regeneron Pharmaceuticals, Rho Federal Systems Division, Inc., Childhood Asthma in Urban Settings (CAUSE)
Leads: National Institute of Allergy and Infectious Diseases (NIAID)

This content was sourced from clinicaltrials.gov