Status:
COMPLETED
Study in Cat-Allergic Patients With Asthma to Evaluate the Efficacy of a Single Dose of REGN1908-1909 to Reduce Bronchoconstriction Upon Cat Allergen Challenge
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Cat Allergy
Mild Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The primary objective is to evaluate the prophylactic efficacy of REGN1908-1909 (anti-Fel d 1) administered as a single dose on day 1 in cat-allergic asthmatic patients not living with a cat in the pr...
Eligibility Criteria
Inclusion
- Key
- Documented or patient reported history (for at least 2 years) of symptomatic cat allergen-triggered asthma with rhinitis with or without conjunctivitis
- No cat exposure at home for the past year and must continue having no exposure at home during the study; cat exposure outside of the home shall be avoided for at least one week prior to any Cat Allergen Challenge and during the defined follow-up period
- Less than 10 pack-years of smoking history
- Key
Exclusion
- Positive human immunodeficiency virus (HIV) test
- Positive hepatitis test (HBsAg and hepatitis C antibody)
- History of significant multiple and/or severe allergies (including latex gloves) or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food
- Participation in a prior REGN1908-1909 clinical trial
- History of severe anaphylactic or severe asthmatic reactions to cat exposure
- Active lung disease other than asthma
- Treatment with an investigational drug within 2 months or within 5 half-lives (if known), whichever is longer, prior to screening
- Persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals, or any untreated respiratory infections within 4 weeks prior to screening
- History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, and/or hypoxic seizures
- Treatment of asthma requiring systemic (oral or parenteral) corticosteroid treatment more than twice within 12 months or once within 3 months prior to screening or has been hospitalized or has attended the ER/Urgent Care facility for asthma more than twice in prior 12 months before screening.
- History of hypersensitivity to corticosteroids or antihistamines, or drug treatment excipient
- Note: Other protocol defined Inclusion/Exclusion Criteria Apply
Key Trial Info
Start Date :
February 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2020
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03838731
Start Date
February 12 2019
End Date
April 6 2020
Last Update
July 1 2021
Active Locations (1)
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1
Regeneron Research Site
Strasbourg, France, 67000