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

Conditions: Cat Allergy; Mild Asthma

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