Grass Pollen Immunotherapy Plus Dupilumab for Tolerance Induction
Phase 2
Completed
NCT04502966
| Condition | Allergic Rhinoconjunctivitis, Grass Pollen Allergy |
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| Phase | Phase 2 |
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| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
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| Status | Completed |
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| Enrollment | 199 participants |
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| Interventions | Dupixent®, Grazax®, Dupixent® Placebo, Grazax® Placebo |
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| Start date | Nov 5, 2020 |
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| Completion date | Feb 20, 2025 |
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| Results posted | Apr 27, 2026 |
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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.
TNSS Area Under Curve (AUC) Post Nasal Allergen Challenge (NAC) Over the First Hour After the Challenge (0-1 Hour (hr) at Year 3
0 to 1 hour of the NAC at Year 3 (One Year After Completion of Treatment) · hr*TNSS
| SLIT/Dupilumab | 2.85 hr*TNSS |
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| SLIT/Dupilumab Placebo | 3.61 hr*TNSS |
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| Double-Placebo | 4.48 hr*TNSS |
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| p-value | <0.001 |
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| Mean Difference (Final Values) | -1.63 (95% CI -2.30–-0.96) |
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Open in BENITIONS
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