Phase 2 N=56 Randomized Quadruple-blind Treatment

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

Cat Allergy · Mild Asthma

Bottom Line

View on ClinicalTrials.gov: NCT03838731 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2021

Primary outcome: Primary: Time to Early Asthmatic Response (EAR) Upon Controlled Cat Allergen Challenge in an Environmental Exposure Unit (EEU) on Day 8 — 51; NA Minutes — p== 0.0083

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: REGN1908-1909 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Regeneron Pharmaceuticals
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Early Asthmatic Response (EAR) Upon Controlled Cat Allergen Challenge in an Environmental Exposure Unit (EEU) on Day 8	51; NA	= 0.0083 sig
SECONDARY Time to EAR Upon Controlled Cat Allergen Challenge in an EEU on Days 29, 57, and 85	41; NA; 56; 232; 41; NA	< 0.0001 sig
SECONDARY 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	1.59; 15.15; 0.46; 16.67; 1.77; 14.07	<0.001 sig
SECONDARY 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	0.01; 0.38; -0.03; 0.43; 0.00; 0.34	< 0.001 sig
SECONDARY 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	-0.71; -0.49; -0.70; -1.39; -0.93; -0.83	= 0.675
SECONDARY 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	-0.37; -0.23; -0.43; -0.43; -0.40; -0.34	= 0.572
SECONDARY Mean Change From Baseline in Cat Allergen Quantity as Experienced by Participants During Exposure on Days 8, 29, 57, and 85	19.55; 59.05; 14.14; 68.21; 21.94; 55.38	= 0.003 sig
SECONDARY Percent Change in Cat Allergen Quantity as Experienced by Participants During Exposure on Days 8, 29, 57, and 85	119.86; 325.29; 93.62; 338.22; 118.08; 301.11	= 0.049 sig
SECONDARY Number of Non-Serious and Serious Treatment-Emergent Adverse Events (TEAEs) Through End of Study	66; 76; 0; 0	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03838731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.