Clinical trial NCT03838731: 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
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cat Allergy
Mild Asthma
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-02-12
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Time to Early Asthmatic Response (EAR) Upon Controlled Cat Allergen Challenge in an Environmental Exposure Unit (EEU) on Day 8
timeFrame: Day 8
Secondary outcomes:
measure: Time to EAR Upon Controlled Cat Allergen Challenge in an EEU on Days 29, 57, and 85
timeFrame: Days 29, 57 and 85
measure: Percent Change in Normalized Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1) Induced by a Controlled Cat Allergen Challenge Over Exposure Interval From Baseline to Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
timeFrame: Days 8, 29, 57, and 85
measure: Change in Normalized Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1) Induced by a Controlled Cat Allergen Challenge Over Exposure Interval From Baseline to Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
timeFrame: Days 8, 29, 57, and 85
measure: Change From Baseline in the Normalized AUC of Patient-Assessed Nasal Symptoms Induced by a Controlled Cat Allergen Challenge Over the Exposure Interval to the Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
timeFrame: Days 8, 29, 57 and 85
measure: Change From Baseline in the Normalized AUC in Patient-Assessed Ocular Symptoms Induced by a Controlled Cat Allergen Challenge Over the Exposure Interval to the Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
timeFrame: Days 8, 29, 57 and 85
measure: Mean Change From Baseline in Cat Allergen Quantity as Experienced by Participants During Exposure on Days 8, 29, 57, and 85
timeFrame: Days 8, 29, 57 and 85
measure: Percent Change in Cat Allergen Quantity as Experienced by Participants During Exposure on Days 8, 29, 57, and 85
timeFrame: Days 8, 29, 57 and 85
measure: Number of Non-Serious and Serious Treatment-Emergent Adverse Events (TEAEs) Through End of Study
timeFrame: Baseline to 16 weeks
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Regeneron Research Site
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
citation: de Blay FJ, Gherasim A, Domis N, Meier P, Shawki F, Wang CQ, Orengo JM, DeVeaux M, Ramesh D, Jalbert JJ, Kamal MA, Abdallah H, Dingman R, Perlee L, Weinreich DM, Herman G, Yancopoulos GD, O'Brien MP. REGN1908/1909 prevented cat allergen-induced early asthmatic responses in an environmental exposure unit. J Allergy Clin Immunol. 2022 Dec;150(6):1437-1446. doi: 10.1016/j.jaci.2022.06.025. Epub 2022 Aug 4.