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A Study to Examine the Efficacy and Safety of Anti-Fel d 1 Antibodies Injections in Cat-allergic Adolescent and Adult Patients With Allergic Rhinitis Who Live With a Cat

Primary Purpose

Allergic Rhinitis Due to Cat Allergy

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
REGN1908-1909
Matching Placebo
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis Due to Cat Allergy focused on measuring Cat allergy induced allergic rhinitis, Allergic conjunctivitis, Asthma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  1. Generally healthy males and females who are 12 years and older at the time of screening.
  2. Weight must be ≥40 kg at the time of screening

  3. Documented or patient reported history (for at least 2 years) of symptomatic cat allergen-triggered allergic rhinitis with or without conjunctivitis and with or without asthma as defined by all of the following criteria:

    1. Positive skin prick test (SPT) with cat hair extract (mean wheal diameter at least 5 mm greater than a negative control) at screening
    2. Positive allergen-specific IgE (sIgE) tests for cat and Fel d 1 (both ≥0.7 kUa/L at screening)
    3. Documented or patient reported history of nasal and/or ocular symptoms upon cat exposure
    4. Symptomatic despite the use of medications to treat their nasal and/or ocular symptoms
  4. At least 1 generally healthy cat (that is unlikely to die during the study) living in the home resulting in regular exposure
  5. A daily total rhinitis/conjunctivitis symptom score (total symptom score [TSS]) of at least 8 of 18 during at least 8 days of the 15-day baseline assessment period and use of standard, therapeutic doses of pharmacotherapy for the treatment of allergic rhinoconjunctivitis on at least 8 days of the 15-day baseline assessment period.

Key Exclusion Criteria:

  1. History of significant multiple and/or severe allergies, as assessed by the investigator, that would potentially interfere with the assessments during the baseline and 12-week efficacy assessment periods or confound results, per investigator discretion, including significant rhinitis or sinusitis due to daily contact with other allergens causing symptoms that are expected to coincide with the baseline period or any of the efficacy assessment periods
  2. Received REGN1908-1909 in a prior REGN1908-1909 clinical trial (receipt of placebo in a previous trial is allowed)
  3. Active lung disease other than asthma
  4. FEV1 less than 70% of predicted at screening or randomization
  5. Treatment with an investigational drug within 2 months or within 5 half-lives (if known), whichever is longer, prior to screening
  6. Persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals, or any untreated respiratory infections within 4 weeks prior to screening. Patients may be re-evaluated after resolution of symptoms and specified time duration

NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply

Sites / Locations

  • Allergy and Asthma Associates of Southern California - CRN - PPDS
  • Integrated Research of Inland, Inc
  • Peninsula Research Associates - CRN - PPDS
  • Allergy and Asthma Medical Group and Research Center - CRN - PPDS
  • Asthma and Allergy Associates PC - CRN - PPDS
  • Colorado Allergy and Asthma Centers PC - CRN - PPDS
  • Emory University
  • Velocity Clinical Research, Inc. (Meridan)
  • Rush University Medical Center
  • Asthma and Allergy Center of Chicago Sc-Oak Park
  • Sneeze Wheeze and Itch Associates LLC
  • South Bend Clinic
  • Bluegrass Allergy Research
  • Allergy and Asthma Specialists PSC
  • Charleston Allergy and Asthma
  • Institute For Asthma and Allergy
  • Respiratory Medicine Research Institute of Michigan PLC
  • Clinical Research Institute, Inc - CRN - PPDS
  • University of Missouri - Hospital
  • Montana Medical Research
  • Somnos Clinical Research
  • Nebraska Medical Research Institute, Inc. - CRN - PPDS
  • Riverside Medical Group - Circuit - PPDS
  • Atlantic Research Center LLC
  • Princeton Center For Clinical Research - CRN - PPDS
  • Allergy Partners of NJ, P.C.
  • Allergy Consultants PA
  • Montefiore Medical Center
  • SUNY Downstate Health Science University
  • NYU Langone Medical Center
  • Allergy Partners of Western North Carolina
  • Bernstein Clinical Research Center Inc
  • Optimed Research Ltd - Clinedge - PPDS
  • Aventiv Research Inc - Columbus - HyperCore - PPDS
  • Allergy Asthma and Clinical Research Center
  • PDX Allergy, LLC dba Portland Research
  • Northwest Research Center - CRN - PPDS
  • Allergy and Clinical Immunology Associates
  • Asthma, Nasal Disease and Allergy Research Center of New England
  • Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)
  • Seattle Allergy & Asthma Research Institute
  • The Medical College of Wisconsin, Inc.
  • UZ Gent
  • UZ Leuven
  • Private Practice Dr Jean Benoit Martinot
  • CHR de la Citadelle
  • Aggarwal and Associates Ltd
  • Hamilton Allergy
  • Kingston Health Science Centre
  • Red Maple Trials
  • Stouffville Medical Clinic
  • Gordon Sussman Clinical Research Inc
  • Toronto Allergy Clinic
  • Joel Liem Medicine Professional Corporation
  • LMC Manna Research - Quebec - HyperCore - PPDS
  • Centre d'investigation Clinique Mauricie
  • Clinique Spécialisée en Allergie de la Capitale
  • Nouvel Hopital Civil
  • HNO Praxis am Neckar
  • Klinikum Stuttgart
  • Beldio Research GmbH
  • Praxis Dr. med. Elke Decot
  • Praxis Dr. med. Claus Keller
  • Praxis Dr. med. Gerhard Schindlbeck
  • Universitatsklinikum Munster
  • Klinische Forschung Dresden GmbH (KFGN)
  • Praxis für HNO und Allergologie
  • Universitätsklinikum Carl Gustav Carus an der TU Dresden
  • Salvus-Klinische Studien GmbH
  • BAG Prof. Dr. G. Hoheisel Dr. A. Bonitz
  • Charité - Universitätsmedizin Berlin
  • Emovis GmbH
  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
  • ALL-MED - Specjalistyczna Opieka Medyczna - Medyczny Instytut Badawczy
  • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
  • Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow
  • ETG Lodz - PPDS
  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
  • IP Clinic Sp. z o. o.
  • ETG Lublin - PPDS
  • Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
  • ETG Zamosc - PPDS
  • Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
  • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o
  • Malopolskie Centrum Alergologii
  • ETG Warszawa - PPDS
  • EMed Centrum Uslug Medycznych
  • Homeo Medicus Szczesiul sp. j.
  • Clinica Vitae Sp z o o
  • ETG Kielce
  • Centrum Alergologii Teresa Hofman
  • Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z.o.o

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

REGN1908-1909

Placebo

Arm Description

Randomized 1:1

Randomized 1:1

Outcomes

Primary Outcome Measures

Daily combined symptom and medication score (CSMS) averaged over last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo.
CSMS is calculated by adding the Daily Medication Score (DMS) and Total Symptom Score (TSS) together, with scores ranging between 0 (none) and 38 (severe).

Secondary Outcome Measures

Daily total nasal symptom score (TNSS) averaged over the last 12 weeks of treatment period in patients who receive REGN1908-1909 versus placebo
Total nasal symptom score (TNSS) is from 0 to 12 and is based on assessment of 4 nasal symptoms graded on a Likert scale ranging from 0 (none) to 3 (severe) for congestion, itching, and rhinorrhea, and from 0 (none) to 3 (5 or more sneezes) for sneezing.
Percent change from pre-treatment baseline in average CSMS over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Percent change from pre-treatment baseline in average TNSS over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Daily total symptom score (TSS) averaged over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
TSS is a combined score of TOSS and TNSS. TNSS and TOSS are scored as in part 1 each for a combined TSS of 0 (none) to 18 (severe)
Percent change from pre-treatment baseline in average TSS over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Percent change from baseline to the end of treatment in cat skin prick test (SPT) mean wheal diameter in patients who receive REGN1908-1909 versus placebo
Daily CSMS averaged over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Daily TNSS averaged over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Percent change from pre-treatment baseline in average CSMS over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Percent change from pre-treatment baseline in average TNSS over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Percent change from pre-treatment baseline in average TSS over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Daily TSS score averaged over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Percent change from pre-treatment baseline in average TOSS, over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Total ocular symptom score is 0 to 6 and is based on itching/redness/gritty feeling and tearing/watering; each of the 2 symptoms is graded 0 (absent), 1 (mild), 2 (moderate), and 3 (severe)
Daily TOSS averaged over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Percent change from pre-treatment baseline in average TOSS over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Percent change in forced expiratory volume (FEV)1 in patients with asthma who receive REGN1908-1909 versus placebo
Percent change in FEV1 in patients with asthma who receive REGN1908-1909 versus placebo
Percent change in cat SPT mean wheal diameter in patients who receive REGN1908-1909 versus placebo
Change in FEV1 in patients with asthma who receive REGN1908-1909 versus placebo
Change in FEV1 in patients with asthma who receive REGN1908-1909 versus placebo
Change in Rhinoconjunctivitis Quality of Life Questionnaire for Ages 12+ (RQLQ(S)+12) in patients who receive REGN1908-1909 versus placebo
The RQLQ has 25 questions in 6 domains (nose symptoms, eye symptoms, practical problems, activity limitation, non-hay fever symptoms and emotional function). Patients recall how they have been during the previous week and respond to each question on a 7-point scale. The overall RQLQ score is the mean of all 25 responses and the individual domain scores are the means of the items in those domains.
Daily medication score (DMS) averaged over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
The Daily Medication Score (DMS) is calculated by adding points for each pre-specified medication. The scale is 0 (minimum) to 20 (maximum)
DMS averaged over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Percent change from pre-treatment baseline in average DMS averaged over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Percent change in cat SPT mean wheal diameter in patients who receive REGN1908-1909 versus placebo
Asthma daily symptom (ADS) score, averaged over the initial 12 weeks of the treatment period using Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD) in patients with asthma who receive REGN1908-1909 versus placebo
The total daily asthma symptom score is a patient-reported outcome concerning the occurrence of asthma symptoms and their effect on a patient's daily activities and sleep. It is composed of two parts: daytime (five items) and nighttime (four items), both scored ordinally. Higher scores indicate more severe symptoms.
ADS score averaged over the last 12 weeks of the treatment period using ADSD and the ANSD in patients with asthma who receive REGN1908-1909 versus placebo
Daily TOSS averaged over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Change from baseline to week 60 in Asthma Control Questionnaire 5 Question Version (ACQ-5) in patients with asthma who receive REGN1908-1909 versus placebo
The ACQ-5 had 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total mean score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), higher scores indicated lower asthma control.
Daily number of nighttime awakenings averaged over the initial 12 weeks of the treatment period in patients with asthma who receive REGN1908-1909 versus placebo
Daily number of nighttime awakenings averaged over the last 12 weeks of the treatment period in patients with asthma who receive REGN1908-1909 versus placebo
Incidence of treatment-emergent adverse events (TEAEs) throughout the study
Incidence of adverse event of special interests (AESIs) throughout the study
Incidence of serious TEAEs throughout the study
Total REGN1908 concentration in serum over the study duration
Total REGN1909 concentration in serum over the study duration
Incidence of treatment-emergent anti-drug antibodies (ADAs) to REGN1908 throughout the study
Incidence of treatment-emergent ADAs to REGN1909 throughout the study

Full Information

First Posted
July 19, 2021
Last Updated
June 25, 2023
Sponsor
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04981717
Brief Title
A Study to Examine the Efficacy and Safety of Anti-Fel d 1 Antibodies Injections in Cat-allergic Adolescent and Adult Patients With Allergic Rhinitis Who Live With a Cat
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study in Cat-Allergic Patients With Allergic Rhinitis Who Live With a Cat to Assess the Efficacy and Safety of Anti-Fel d 1 Antibodies During Natural Cat Exposure in the Home
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Lack of efficacy
Study Start Date
July 30, 2021 (Actual)
Primary Completion Date
January 4, 2023 (Actual)
Study Completion Date
April 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of the study is to determine the efficacy of REGN1908-1909, as compared to placebo, to reduce allergic rhinitis/conjunctivitis symptoms and allergy rescue medication use during natural cat exposure. The Secondary Objectives are: To assess the reduction of allergic symptoms and use of allergy rescue medications after treatment with REGN1908-1909 versus placebo, as measured by the individual components of the CSMS To assess health-related quality of life (HRQoL) as measured by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[S]) To determine the efficacy of REGN1908-1909, as compared to placebo, to inhibit a wheal-and-flare response to a skin prick test with cat allergen To assess the durability of effect in allergic rhinitis and conjunctivitis symptom and medication scores after multiple doses of REGN1908-1909 compared to placebo given every 12 weeks (Q12W) To determine the efficacy following multiple doses of REGN1908-1909 compared to placebo at inhibiting a wheal-and-flare response to a skin prick test with cat allergen To estimate the effect of REGN1908-1909 on lung function, as compared to placebo, in patients with asthma To determine the efficacy of REGN1908-1909 as compared to placebo to reduce asthma symptoms in patients with asthma To assess whether there is a difference in asthma rescue medication use in patients with asthma who are treated with REGN1908-1909 compared to placebo To assess whether there is a difference in nighttime awakenings in patients with asthma treated with REGN1908-1909 compared to placebo To evaluate the short-term and long-term safety and tolerability of REGN1908-1909, including the incidence of hypersensitivity reactions, local injection site reactions, and asthma exacerbations To determine systemic exposure of total (free and antigen-bound) antibodies as measured by concentration of REGN1908 and REGN1909 To assess the immunogenicity of REGN1908 and REGN1909

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis Due to Cat Allergy
Keywords
Cat allergy induced allergic rhinitis, Allergic conjunctivitis, Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
446 (Actual)

8. Arms, Groups, and Interventions

Arm Title
REGN1908-1909
Arm Type
Experimental
Arm Description
Randomized 1:1
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Randomized 1:1
Intervention Type
Drug
Intervention Name(s)
REGN1908-1909
Intervention Description
Subcutaneous (SC) for a total of 5 administrations
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
SC for a total of 5 administrations
Primary Outcome Measure Information:
Title
Daily combined symptom and medication score (CSMS) averaged over last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo.
Description
CSMS is calculated by adding the Daily Medication Score (DMS) and Total Symptom Score (TSS) together, with scores ranging between 0 (none) and 38 (severe).
Time Frame
Weeks 48 to 60
Secondary Outcome Measure Information:
Title
Daily total nasal symptom score (TNSS) averaged over the last 12 weeks of treatment period in patients who receive REGN1908-1909 versus placebo
Description
Total nasal symptom score (TNSS) is from 0 to 12 and is based on assessment of 4 nasal symptoms graded on a Likert scale ranging from 0 (none) to 3 (severe) for congestion, itching, and rhinorrhea, and from 0 (none) to 3 (5 or more sneezes) for sneezing.
Time Frame
Weeks 48 to 60
Title
Percent change from pre-treatment baseline in average CSMS over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Time Frame
Weeks 48 to 60
Title
Percent change from pre-treatment baseline in average TNSS over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Time Frame
Weeks 48 to 60
Title
Daily total symptom score (TSS) averaged over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Description
TSS is a combined score of TOSS and TNSS. TNSS and TOSS are scored as in part 1 each for a combined TSS of 0 (none) to 18 (severe)
Time Frame
Weeks 48 to 60
Title
Percent change from pre-treatment baseline in average TSS over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Time Frame
Weeks 48 to 60
Title
Percent change from baseline to the end of treatment in cat skin prick test (SPT) mean wheal diameter in patients who receive REGN1908-1909 versus placebo
Time Frame
Week 60
Title
Daily CSMS averaged over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Time Frame
Weeks 0 to 12
Title
Daily TNSS averaged over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Time Frame
Weeks 0 to 12
Title
Percent change from pre-treatment baseline in average CSMS over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Time Frame
Weeks 0 to 12
Title
Percent change from pre-treatment baseline in average TNSS over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Time Frame
Weeks 0 to 12
Title
Percent change from pre-treatment baseline in average TSS over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Time Frame
Weeks 0 to 12
Title
Daily TSS score averaged over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Time Frame
Weeks 0 to 12
Title
Percent change from pre-treatment baseline in average TOSS, over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Description
Total ocular symptom score is 0 to 6 and is based on itching/redness/gritty feeling and tearing/watering; each of the 2 symptoms is graded 0 (absent), 1 (mild), 2 (moderate), and 3 (severe)
Time Frame
Weeks 0 to 12
Title
Daily TOSS averaged over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Time Frame
Weeks 48 to 60
Title
Percent change from pre-treatment baseline in average TOSS over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Time Frame
Weeks 48 to 60
Title
Percent change in forced expiratory volume (FEV)1 in patients with asthma who receive REGN1908-1909 versus placebo
Time Frame
Baseline to week 12
Title
Percent change in FEV1 in patients with asthma who receive REGN1908-1909 versus placebo
Time Frame
Baseline to week 60
Title
Percent change in cat SPT mean wheal diameter in patients who receive REGN1908-1909 versus placebo
Time Frame
Baseline to week 12
Title
Change in FEV1 in patients with asthma who receive REGN1908-1909 versus placebo
Time Frame
Baseline to week 12
Title
Change in FEV1 in patients with asthma who receive REGN1908-1909 versus placebo
Time Frame
Baseline to week 60
Title
Change in Rhinoconjunctivitis Quality of Life Questionnaire for Ages 12+ (RQLQ(S)+12) in patients who receive REGN1908-1909 versus placebo
Description
The RQLQ has 25 questions in 6 domains (nose symptoms, eye symptoms, practical problems, activity limitation, non-hay fever symptoms and emotional function). Patients recall how they have been during the previous week and respond to each question on a 7-point scale. The overall RQLQ score is the mean of all 25 responses and the individual domain scores are the means of the items in those domains.
Time Frame
Baseline to week 60
Title
Daily medication score (DMS) averaged over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Description
The Daily Medication Score (DMS) is calculated by adding points for each pre-specified medication. The scale is 0 (minimum) to 20 (maximum)
Time Frame
Weeks 0 to 12
Title
DMS averaged over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Time Frame
Weeks 48 to 60
Title
Percent change from pre-treatment baseline in average DMS averaged over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Time Frame
Weeks 48 to 60
Title
Percent change in cat SPT mean wheal diameter in patients who receive REGN1908-1909 versus placebo
Time Frame
Baseline to week 72
Title
Asthma daily symptom (ADS) score, averaged over the initial 12 weeks of the treatment period using Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD) in patients with asthma who receive REGN1908-1909 versus placebo
Description
The total daily asthma symptom score is a patient-reported outcome concerning the occurrence of asthma symptoms and their effect on a patient's daily activities and sleep. It is composed of two parts: daytime (five items) and nighttime (four items), both scored ordinally. Higher scores indicate more severe symptoms.
Time Frame
Weeks 0 to 12
Title
ADS score averaged over the last 12 weeks of the treatment period using ADSD and the ANSD in patients with asthma who receive REGN1908-1909 versus placebo
Time Frame
Weeks 48 to 60
Title
Daily TOSS averaged over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
Time Frame
Weeks 0 to 12
Title
Change from baseline to week 60 in Asthma Control Questionnaire 5 Question Version (ACQ-5) in patients with asthma who receive REGN1908-1909 versus placebo
Description
The ACQ-5 had 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total mean score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), higher scores indicated lower asthma control.
Time Frame
Baseline to week 60
Title
Daily number of nighttime awakenings averaged over the initial 12 weeks of the treatment period in patients with asthma who receive REGN1908-1909 versus placebo
Time Frame
Weeks 0 to 12
Title
Daily number of nighttime awakenings averaged over the last 12 weeks of the treatment period in patients with asthma who receive REGN1908-1909 versus placebo
Time Frame
Weeks 48 to 60
Title
Incidence of treatment-emergent adverse events (TEAEs) throughout the study
Time Frame
Weeks 0 to 72
Title
Incidence of adverse event of special interests (AESIs) throughout the study
Time Frame
Weeks 0 to 72
Title
Incidence of serious TEAEs throughout the study
Time Frame
Weeks 0 to 72
Title
Total REGN1908 concentration in serum over the study duration
Time Frame
Weeks 0 to 72
Title
Total REGN1909 concentration in serum over the study duration
Time Frame
Weeks 0 to 72
Title
Incidence of treatment-emergent anti-drug antibodies (ADAs) to REGN1908 throughout the study
Time Frame
Weeks 0 to 72
Title
Incidence of treatment-emergent ADAs to REGN1909 throughout the study
Time Frame
Weeks 0 to 72

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Generally healthy males and females who are 12 years and older at the time of screening. Weight must be ≥40 kg at the time of screening Documented or patient reported history (for at least 2 years) of symptomatic cat allergen-triggered allergic rhinitis with or without conjunctivitis and with or without asthma as defined by all of the following criteria: Positive skin prick test (SPT) with cat hair extract (mean wheal diameter at least 5 mm greater than a negative control) at screening Positive allergen-specific IgE (sIgE) tests for cat and Fel d 1 (both ≥0.7 kUa/L at screening) Documented or patient reported history of nasal and/or ocular symptoms upon cat exposure Symptomatic despite the use of medications to treat their nasal and/or ocular symptoms At least 1 generally healthy cat (that is unlikely to die during the study) living in the home resulting in regular exposure A daily total rhinitis/conjunctivitis symptom score (total symptom score [TSS]) of at least 8 of 18 during at least 8 days of the 15-day baseline assessment period and use of standard, therapeutic doses of pharmacotherapy for the treatment of allergic rhinoconjunctivitis on at least 8 days of the 15-day baseline assessment period. Key Exclusion Criteria: History of significant multiple and/or severe allergies, as assessed by the investigator, that would potentially interfere with the assessments during the baseline and 12-week efficacy assessment periods or confound results, per investigator discretion, including significant rhinitis or sinusitis due to daily contact with other allergens causing symptoms that are expected to coincide with the baseline period or any of the efficacy assessment periods Received REGN1908-1909 in a prior REGN1908-1909 clinical trial (receipt of placebo in a previous trial is allowed) Active lung disease other than asthma FEV1 less than 70% of predicted at screening or randomization 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. Patients may be re-evaluated after resolution of symptoms and specified time duration NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Allergy and Asthma Associates of Southern California - CRN - PPDS
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Integrated Research of Inland, Inc
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Peninsula Research Associates - CRN - PPDS
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Allergy and Asthma Medical Group and Research Center - CRN - PPDS
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Asthma and Allergy Associates PC - CRN - PPDS
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Colorado Allergy and Asthma Centers PC - CRN - PPDS
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Velocity Clinical Research, Inc. (Meridan)
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Asthma and Allergy Center of Chicago Sc-Oak Park
City
Oak Park
State/Province
Illinois
ZIP/Postal Code
60301
Country
United States
Facility Name
Sneeze Wheeze and Itch Associates LLC
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Bluegrass Allergy Research
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Allergy and Asthma Specialists PSC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Charleston Allergy and Asthma
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Institute For Asthma and Allergy
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Respiratory Medicine Research Institute of Michigan PLC
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48187
Country
United States
Facility Name
Clinical Research Institute, Inc - CRN - PPDS
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
University of Missouri - Hospital
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Montana Medical Research
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Somnos Clinical Research
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68505
Country
United States
Facility Name
Nebraska Medical Research Institute, Inc. - CRN - PPDS
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
Riverside Medical Group - Circuit - PPDS
City
Belleville
State/Province
New Jersey
ZIP/Postal Code
07109
Country
United States
Facility Name
Atlantic Research Center LLC
City
Ocean City
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
Princeton Center For Clinical Research - CRN - PPDS
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Facility Name
Allergy Partners of NJ, P.C.
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Allergy Consultants PA
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
SUNY Downstate Health Science University
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Allergy Partners of Western North Carolina
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Bernstein Clinical Research Center Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Optimed Research Ltd - Clinedge - PPDS
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Aventiv Research Inc - Columbus - HyperCore - PPDS
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
Allergy Asthma and Clinical Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
PDX Allergy, LLC dba Portland Research
City
Happy Valley
State/Province
Oregon
ZIP/Postal Code
97068
Country
United States
Facility Name
Northwest Research Center - CRN - PPDS
City
Portland
State/Province
Oregon
ZIP/Postal Code
97202
Country
United States
Facility Name
Allergy and Clinical Immunology Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Asthma, Nasal Disease and Allergy Research Center of New England
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Seattle Allergy & Asthma Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States
Facility Name
The Medical College of Wisconsin, Inc.
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53228
Country
United States
Facility Name
UZ Gent
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Private Practice Dr Jean Benoit Martinot
City
Erpent
ZIP/Postal Code
5101
Country
Belgium
Facility Name
CHR de la Citadelle
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Aggarwal and Associates Ltd
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Facility Name
Hamilton Allergy
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1G5
Country
Canada
Facility Name
Kingston Health Science Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Red Maple Trials
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4G2
Country
Canada
Facility Name
Stouffville Medical Clinic
City
Stouffville
State/Province
Ontario
ZIP/Postal Code
L4A 1H2
Country
Canada
Facility Name
Gordon Sussman Clinical Research Inc
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4V 1R2
Country
Canada
Facility Name
Toronto Allergy Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1E2
Country
Canada
Facility Name
Joel Liem Medicine Professional Corporation
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 2G1
Country
Canada
Facility Name
LMC Manna Research - Quebec - HyperCore - PPDS
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6W 5M6
Country
Canada
Facility Name
Centre d'investigation Clinique Mauricie
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
Clinique Spécialisée en Allergie de la Capitale
City
Quebec
ZIP/Postal Code
G1V 4M6
Country
Canada
Facility Name
Nouvel Hopital Civil
City
Strasbourg
State/Province
Bas-Rhin
ZIP/Postal Code
67000
Country
France
Facility Name
HNO Praxis am Neckar
City
Heidelberg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Klinikum Stuttgart
City
Stuttgart
State/Province
Baden-Wurttemberg
ZIP/Postal Code
70374
Country
Germany
Facility Name
Beldio Research GmbH
City
Memmingen
State/Province
Bayern
ZIP/Postal Code
87700
Country
Germany
Facility Name
Praxis Dr. med. Elke Decot
City
Dreieich
State/Province
Hessen
ZIP/Postal Code
63303
Country
Germany
Facility Name
Praxis Dr. med. Claus Keller
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60389
Country
Germany
Facility Name
Praxis Dr. med. Gerhard Schindlbeck
City
Viernheim
State/Province
Hessen
ZIP/Postal Code
68519
Country
Germany
Facility Name
Universitatsklinikum Munster
City
Munster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Klinische Forschung Dresden GmbH (KFGN)
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01069
Country
Germany
Facility Name
Praxis für HNO und Allergologie
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01139
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus an der TU Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Salvus-Klinische Studien GmbH
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04207
Country
Germany
Facility Name
BAG Prof. Dr. G. Hoheisel Dr. A. Bonitz
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04275
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Emovis GmbH
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-088
Country
Poland
Facility Name
ALL-MED - Specjalistyczna Opieka Medyczna - Medyczny Instytut Badawczy
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
53-201
Country
Poland
Facility Name
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-153
Country
Poland
Facility Name
ETG Lodz - PPDS
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-329
Country
Poland
Facility Name
IP Clinic Sp. z o. o.
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-752
Country
Poland
Facility Name
ETG Lublin - PPDS
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-089
Country
Poland
Facility Name
Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-552
Country
Poland
Facility Name
ETG Zamosc - PPDS
City
Zamosc
State/Province
Lubelskie
ZIP/Postal Code
22-400
Country
Poland
Facility Name
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-011
Country
Poland
Facility Name
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o
City
Tarnow
State/Province
Malopolskie
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Malopolskie Centrum Alergologii
City
Krakow
State/Province
Malopolski
ZIP/Postal Code
31-624
Country
Poland
Facility Name
ETG Warszawa - PPDS
City
Piaseczno
State/Province
Mazowieckie
ZIP/Postal Code
05-500
Country
Poland
Facility Name
EMed Centrum Uslug Medycznych
City
Rzeszow
State/Province
Podkarpackie
ZIP/Postal Code
35-205
Country
Poland
Facility Name
Homeo Medicus Szczesiul sp. j.
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-687
Country
Poland
Facility Name
Clinica Vitae Sp z o o
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-382
Country
Poland
Facility Name
ETG Kielce
City
Kielce
State/Province
Swietokrzyskie
ZIP/Postal Code
25-355
Country
Poland
Facility Name
Centrum Alergologii Teresa Hofman
City
Pila
State/Province
Wielkopolskie
ZIP/Postal Code
64-920
Country
Poland
Facility Name
Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z.o.o
City
Poznan
ZIP/Postal Code
61-578
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD Sharing Time Frame
When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
IPD Sharing Access Criteria
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD Sharing URL
https://vivli.org/

Learn more about this trial

A Study to Examine the Efficacy and Safety of Anti-Fel d 1 Antibodies Injections in Cat-allergic Adolescent and Adult Patients With Allergic Rhinitis Who Live With a Cat

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