Prevention of Asthma Exacerbations Using Dupilumab in Urban Children and Adolescents

• Status: Not yet recruiting
• Trial end date: 2025-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Childhood Asthma in Urban Settings (CAUSE); Regeneron Pharmaceuticals; Rho Federal Systems Division, Inc.
• Treatments: Antibodies, Monoclonal

Criteria

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. Females 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 female partner practicing an approved birth control method for females.

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 are 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.