Dupilumab As An Adjunct For Subcutaneous Grass Immunotherapy
Status:
Completed
Trial end date:
2019-06-13
Target enrollment:
Participant gender:
Summary
The primary objective is to assess whether 16 weeks of treatment with dupilumab as an adjunct
to Timothy Grass Subcutaneous Immunotherapy (SCIT) improves upon the efficacy of Timothy
Grass SCIT to reduce provoked allergic rhinitis symptoms, as measured by Total Nasal Symptom
Score (TNSS) after nasal allergen challenge (NAC) with Timothy Grass extract at week 17.
The secondary objectives of the study are:
- To assess whether 16 weeks of treatment with dupilumab as compared to placebo reduces
provoked allergic rhinitis symptoms, as measured by TNSS after nasal allergen challenge
(NAC) with Timothy Grass extract
- To assess whether 16 weeks of treatment with dupilumab as compared to dupilumab + SCIT
reduces provoked allergic rhinitis symptoms, as measured by TNSS after nasal allergen
challenge (NAC) with Timothy Grass extract
- To assess changes in serum Timothy-grass-specific immunoglobulin G4 (IgG4), serum
Timothy grass-specific immunoglobulin E (IgE), and ratio of serum Timothy Grass-specific
IgG4 to IgE over 16 weeks of treatment with dupilumab + SCIT as compared to SCIT
monotherapy
- To evaluate the safety and tolerability of 16 weeks of treatment with dupilumab as an
adjunct to Timothy Grass SCIT