Dupilumab As An Adjunct For Subcutaneous Grass Immunotherapy

Status:	Recruiting
Conditions:	Allergy
Therapuetic Areas:	Otolaryngology
Healthy:	No
Age Range:	18 - 55
Updated:	11/11/2018
Start Date:	June 7, 2018
End Date:	May 24, 2019
Contact:	Clinical Trials Administrator
Email:	clinicaltrials@regeneron.com
Phone:	844-734-6643

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

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 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

Key Inclusion Criteria:

1. Male and female subjects aged 18 to 55

2. History of grass pollen-induced seasonal allergic rhinitis

3. Grass pollen allergy confirmed by both:

1. Positive skin prick test (SPT) with Timothy Grass extract (mean wheal diameter at
least ≥5 mm greater than a negative control)

2. Positive serum Timothy Grass-specific IgE (≥0.35KU/L)

Key Exclusion Criteria:

1. Significant rhinitis, sinusitis, outside of the grass pollen season

2. Any contraindications to SCIT (i.e, severe cardiovascular disease, malignancies,
autoimmune disease, use of beta blocker, asthma severe enough to require chronic
medication, acute infection)

3. Use of systemic corticosteroids within 4 weeks of screening visits or any NAC visits

4. Abnormal lung function as judged by the investigator

5. A clinical history of asthma requiring chronic medication such as regular inhaled
corticosteroids for >4 weeks per year

6. History of significant recurrent sinusitis, defined as 3 episodes per year for the
last 2 years, all of which required antibiotic treatment

7. History of chronic sinusitis (with or without nasal polyps)

8. Tobacco smoking (ANY) within the last year

Note: Other protocol defined inclusion/ exclusion criteria apply

We found this trial at

sites

Regeneron Investigational Site

Denver, Colorado 80206

from

Denver, CO