Prevention of Asthma Exacerbations Using Dupilumab in Urban Children and Adolescents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-04

Study Completion Date

2027-03-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety Study of Dupilumab in Patients With Persistent Asthma

NCT03782532

Asthma

COMPLETED PHASE3

Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma

NCT02573233

Asthma

COMPLETED PHASE2

Study of REGN3500 and Dupilumab in Patients With Asthma

NCT03112577

Asthma, Allergic

COMPLETED PHASE1

Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma

NCT02054130

Asthma

COMPLETED PHASE2

Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma

NCT05097287

Asthma

RECRUITING PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Protocol CAUSE-01 PANDA is a multicenter, double-blind, placebo-controlled, randomized trial of dupilumab adjunctive therapy for the reduction of asthma exacerbations in urban children and adolescents 6 to 17 years with T2-high exacerbation-prone asthma. Approximately 240 participants will be randomized 2:1 to one of two study arms: 1) guidelines-based asthma treatment + dupilumab, or 2) guidelines-based asthma treatment + placebo. Study treatment will continue for 1 year with an additional 3 months of follow-up following completion of study treatment.

An initial Screening Visit will be followed by a 4-week run-in period. After the run-in, participants who continue to meet eligibility criteria will be randomized to one of the 2 treatment arms and receive their first injection. Over the next 2 weeks, participants will return to the clinic for 3 early treatment response visits. Participants will receive injections of dupilumab, or placebo administered subcutaneously every two weeks (Q2W), or every four weeks (Q4W), over 12 months. Each participant will have Evaluation and Management (E\&M) visits every 3 months where their asthma and rhinitis will be assessed and adjustments made to their medications based on asthma guidelines.

Participants will be asked to monitor and self-report cold symptoms throughout the treatment period. Participants will be asked to complete up to three paired cold visits. At the time of a cold, participants will be asked to come into the clinic for collection of blood and nasal secretions for associated mechanistic studies. Approximately three days after the clinic visit, participants will complete symptom assessments and will be asked to collect nasal samples at home

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Dupilumab

Intervention Type DRUG

Dupilumab is a recombinant DNA-derived humanized IgG4ĸ monoclonal antibody that selectively binds to anti IL-4R monoclonal antibody (mAb).

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The composition of the placebo for dupilumab is the same as the active study drug without the dupilumab.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dupilumab

Dupilumab is a recombinant DNA-derived humanized IgG4ĸ monoclonal antibody that selectively binds to anti IL-4R monoclonal antibody (mAb).

Intervention Type DRUG

Placebo

The composition of the placebo for dupilumab is the same as the active study drug without the dupilumab.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dupixent IL4Ra mAb Placebo for Dupilumab

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Participant and/or parent guardian must be able to understand and provide informed consent and age-appropriate assent
2. Are male and female aged 6-17 years at Visit 0
3. 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.
4. 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.
5. Participant has had at least two asthma exacerbations in the prior year (defined as a requirement for systemic corticosteroids and/or hospitalization).
6. At Visit 0 (screening), participant must have the following requirement for asthma controller medication:

1. Participants aged 6 to 11 years: treatments with at least fluticasone 250 mcg dry powder inhaler (DPI) one puff twice daily or its equivalent.
2. 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.
7. Have peripheral blood eosinophils ≥150 cells/mcl and/or FeNO ≥ 20ppb obtained at Visit 0 or via another CAUSE protocol within 6 months.
8. Are able to perform acceptable and repeatable spirometry per American Thoracic Society (ATS) criteria prior to randomization.
9. Have documentation of current medical insurance with prescription coverage at Visit 0.

Exclusion Criteria

1. Parent or guardian is not able or willing to give written informed consent or comply with study protocol.
2. Have concurrent medical problems that would require systemic corticosteroids or other immunomodulators during the study.
3. Are currently receiving immunotherapy.
4. Are currently receiving treatment with a biologic therapy or have received a biologic therapy within 3 months prior to randomization.
5. Are currently requiring greater than fluticasone 500 mcg bid plus long-acting beta agonist (LABA) one puff twice daily or its equivalent plus Long-acting muscarinic antagonists (LAMA) and/or individuals using oral corticosteroids daily or every other day for more than 14 days at the time of Visit 0.
6. Are currently pregnant or lactating, or plan to become pregnant during the time of study participation. Participants of child-bearing potential (post-menarche) must be abstinent or use a medically acceptable birth control method throughout the study (i.e., oral subcutaneous, mechanical, or surgical contraception). Males who are sexually active must agree to use an acceptable method of birth control (i.e., barrier methods with vaginal spermicide) or have a partner practicing an approved birth control method.
7. Have a known, pre-existing clinically important lung condition other than asthma.
8. Have a current malignancy or previous history of cancer in remission for less than 12 months prior to randomization.
9. Is a current smoker or is currently using any electronic cigarette or vaping device (e.g. e-cigarette, e- cig, mod, vape pen, JUUL, e-cigar, e-hookah, e-pipe, vape pods).
10. Have a known immunodeficiency disease.
11. Have a known, active pre-existing parasitic infection or are undergoing treatment for a parasitic infection. Once the participant has been successfully treated, the participant may be reevaluated.
12. Use of investigational drugs within 4 weeks of randomization
13. Have past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
14. Will not allow the study clinician, an asthma specialist, to manage their disease for the duration of the study or who is not willing to change their asthma medications to follow the Protocol CAUSE- 01 PANDA.
15. Have a known history of allergic reaction to dupilumab.
16. Have had a life-threatening asthma exacerbation in the last 2 years requiring intubation, mechanical ventilation or resulting in a hypoxic seizure.
17. Have received a live (attenuated) vaccine within 4 weeks of Visit 0.
18. Have an eosinophil count of ≥1500 cells/mcl at Visit 0.

Potential participants may be reassessed as outlined in the Protocol CAUSE-01 MOP.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No