drugset / Trial / NCT04502966
Grass Pollen Immunotherapy Plus Dupilumab for Tolerance Induction
Phase 2
Completed
199 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
ALK-Abelló A/S · collabImmune Tolerance Network (ITN) · collabPPD Development, LP · collabRegeneron Pharmaceuticals · collabRho Federal Systems Division, Inc. · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The primary objective of this study is to assess whether the combination of grass allergen sublingual immunotherapy (SLIT) and dupilumab for 2 years is more effective than double placebo in suppressing the nasal allergen challenge (NAC) response to grass pollen at 1 year after completion of study medication.
Timeline
- Start
- 2020-11-05
- Primary completion
- 2025-02-20
- Completion
- 2025-02-20
Outcome
Met primary endpoint
registry analysis (superiority test); SLIT/Dupilumab vs Double-Placebo; p <0.001; Mean Difference (Final Values) -1.63 (95% CI -2.30 to -0.96) NCT04502966 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dupilumab | Monoclonal antibody | 300 mg | Subcutaneous |
| Subject | Grazax | Other / unclassified | 75000 unknown | Other |