NCT03558997

Dupilumab As An Adjunct For Subcutaneous Grass Immunotherapy

A Study To Evaluate The Efficacy Of Dupilumab As An Adjunct For Subcutaneous Grass Immunotherapy To Reduce Provoked Allergic Rhinitis Symptoms Using The Nasal Allergen Challenge Model

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Dupilumab	Dupilumab was administered SC in a single-use, pre-filled glass syringe
DRUG	Timothy Grass SCIT	Timothy grass extract was administered SC.
DRUG	Placebo matching dupilumab	Placebo matching dupilumab was prepared in the same formulation without the addition of protein
DRUG	Placebo matching SCIT	Placebo matching SCIT was prepared in the same formulation (SCIT diluent) without the addition of Timothy grass extract

Timeline

• Start date: 2018-06-07
• Primary completion: 2019-05-14
• Completion: 2019-06-13
• First posted: 2018-06-15
• Last updated: 2020-05-28
• Results posted: 2020-05-28

Locations

17 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study