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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

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ClinicalTrials.gov Identifier: NCT03838731
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Cat Allergy Mild Asthma Drug: REGN1908-1909 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : November 12, 2019
Estimated Study Completion Date : February 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: REGN1908-1909 Drug: REGN1908-1909
Single subcutaneous (SC) dose of REGN1908 and REGN1909

Placebo Comparator: Placebo Drug: Placebo
Single subcutaneous (SC) dose of matching placebo




Primary Outcome Measures :
  1. Time to Early asthmatic response (EAR) upon Controlled Cat Allergen Challenge in an Environmental exposure unit (EEU) [ Time Frame: Day 8 ]

Secondary Outcome Measures :
  1. Time to EAR upon Controlled Cat Allergen Challenge in an EEU [ Time Frame: Days 29, 57, and 85 ]
  2. AUC of the percent change in FEV1 induced by a Controlled Cat Allergen Challenge over the exposure interval from baseline to the Controlled Cat Allergen Challenge Allergen Challenge [ Time Frame: Days 8, 29, 57, and 85 ]
  3. AUC of the percent change in patient-assessed nasal symptoms induced by a Controlled Cat Allergen Challenge over the exposure interval from baseline to the Controlled Cat Allergen Challenge [ Time Frame: Days 8, 29, 57, and 85 ]
  4. AUC of the percent change in patient-assessed ocular symptoms induced by a Controlled Cat Allergen Challenge over the exposure interval from baseline to the Controlled Cat Allergen Challenge [ Time Frame: Days 8, 29, 57, and 85 ]
  5. Change in cat allergen quantity as experienced by patients during exposure [ Time Frame: Days 8, 29, 57, and 85 ]
  6. Percent change in cat allergen quantity as experienced by patients during exposure [ Time Frame: Days 8, 29, 57, and 85 ]
  7. Incidence rates of treatment-emergent adverse events (TEAEs) and serious TEAEs [ Time Frame: Up to 16 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Documented history (for at least 2 years) of symptomatic cat hair-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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838731


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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France
Regeneron Research Site Recruiting
Strasbourg, France, 67000
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03838731     History of Changes
Other Study ID Numbers: R1908-1909-ALG-1703
2018-002477-22 ( EudraCT Number )
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification
Access Criteria: Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan) that support the methods and findings reported in a manuscript. Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification
URL: https://errs.regeneron.com/external

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases