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
Condition: Cat Allergy; Mild Asthma
MeSH terms: Asthma
Intervention: REGN1908-1909; Placebo
Intervention description: Single subcutaneous (SC) dose of REGN1908 and REGN1909; Single subcutaneous (SC) dose of matching placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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 prevention of a Controlled Cat Allergen Challenge-induced early asthmatic
      response (EAR) assessed by measures of lung function (FEV1) compared to placebo-treated
      patients.

      Secondary Efficacy Objectives:

        -  To evaluate the prophylactic efficacy of REGN1908-1909 administered as a single dose on
           day 1 in cat-allergic asthmatic patients not living with a cat, in the prevention of a
           Controlled Cat Allergen Challenge-induced: Allergic rhinitis and Ocular symptoms

        -  To evaluate the prophylactic efficacy of REGN1908-1909 administered as a single dose on
           day 1 in cat-allergic asthmatic patients not living with a cat to increase the exposure
           to cat allergen, measured as a product of minute ventilation and time, required to
           induce EAR in a Controlled Cat Allergen Challenge as compared to placebo patients

      Secondary Safety Objective:

        -  To evaluate the safety and tolerability of REGN1908-1909 vs. placebo in patients with
           cat allergen-triggered asthma
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  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 Criteria:

          -  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