drugset / Trial / NCT03694158
Investigating Dupilumab's Effect in Asthma by Genotype
Phase 4
Active not recruiting
150 enrolled
Boston Children's Hospital
HealthBeacon Plc · collabMerck Sharp & Dohme LLC · collabNational Institute of Allergy and Infectious Diseases (NIAID) · collabRegeneron Pharmaceuticals · collabSanofi · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The Goal of this study is to investigate if individuals ages 12 years and older, carrying the IL-4RαR576 gene variant, will have a greater response to therapy acting directly on the anti-IL-4R. This will be conducted by examining the effect of a 48 week therapy with dupilumab on the rate of asthma exacerbations.
Timeline
- Start
- 2021-09-08
- Primary completion
- 2027-01
- Completion
- 2027-03
Publications
- Background Lai PS, Massoud AH, Xia M, Petty CR, Cunningham A, Chatila TA, Phipatanakul W. Gene-environment interaction between an IL4R variant and school endotoxin exposure contributes to asthma symptoms in inner-city children. J Allergy Clin Immunol. 2018 Feb;141(2):794-796.e3. doi: 10.1016/j.jaci.2017.08.023. Epub 2017 Sep 21. No abstract available.
- Background Massoud AH, Charbonnier LM, Lopez D, Pellegrini M, Phipatanakul W, Chatila TA. An asthma-associated IL4R variant exacerbates airway inflammation by promoting conversion of regulatory T cells to TH17-like cells. Nat Med. 2016 Sep;22(9):1013-22. doi: 10.1038/nm.4147. Epub 2016 Aug 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dupilumab | Monoclonal antibody | 300 mg | Subcutaneous |