Dupilumab As An Adjunct For Subcutaneous Grass Immunotherapy

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