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

Last updated: May 15, 2024
Sponsor: Regeneron Pharmaceuticals
Overall Status: Terminated

Phase

3

Condition

Common Cold

Allergy

Nasal Obstruction

Treatment

Matching Placebo

REGN1908-1909

Clinical Study ID

NCT04981717
R1908-1909-ALG-2102
2021-002089-42
  • Ages > 12
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Generally healthy males and females who are 12 years and older at the time ofscreening.

  2. Weight must be ≥40 kg at the time of screening

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

  4. Positive skin prick test (SPT) with cat hair extract (mean wheal diameter atleast 5 mm greater than a negative control) at screening

  5. Positive allergen-specific IgE (sIgE) tests for cat and Fel d 1 (both ≥0.7kUa/L at screening)

  6. Documented or patient reported history of nasal and/or ocular symptoms upon catexposure

  7. Symptomatic despite the use of medications to treat their nasal and/or ocularsymptoms

  8. At least 1 generally healthy cat (that is unlikely to die during the study) livingin the home resulting in regular exposure

  9. A daily total rhinitis/conjunctivitis symptom score (total symptom score [TSS]) ofat least 8 of 18 during at least 8 days of the 15-day baseline assessment period anduse of standard, therapeutic doses of pharmacotherapy for the treatment of allergicrhinoconjunctivitis on at least 8 days of the 15-day baseline assessment period.

Exclusion

Key Exclusion Criteria:

  1. History of significant multiple and/or severe allergies, as assessed by theinvestigator, that would potentially interfere with the assessments during thebaseline and 12-week efficacy assessment periods or confound results, perinvestigator discretion, including significant rhinitis or sinusitis due to dailycontact with other allergens causing symptoms that are expected to coincide with thebaseline period or any of the efficacy assessment periods

  2. Received REGN1908-1909 in a prior REGN1908-1909 clinical trial (receipt of placeboin 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 (ifknown), whichever is longer, prior to screening

  6. Persistent chronic or recurring acute infection requiring treatment withantibiotics, antivirals, or antifungals, or any untreated respiratory infectionswithin 4 weeks prior to screening. Patients may be re-evaluated after resolution ofsymptoms and specified time duration

NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply

Study Design

Total Participants: 446
Treatment Group(s): 2
Primary Treatment: Matching Placebo
Phase: 3
Study Start date:
July 30, 2021
Estimated Completion Date:
April 24, 2023

Connect with a study center

  • UZ Gent

    Gent, Oost-Vlaanderen 9000
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, Vlaams Brabant 3000
    Belgium

    Site Not Available

  • CHU Brugmann

    Brussels, 1020
    Belgium

    Site Not Available

  • Private Practice Dr Jean Benoit Martinot

    Erpent, 5101
    Belgium

    Site Not Available

  • CHR de la Citadelle

    Liege, 4000
    Belgium

    Site Not Available

  • Aggarwal and Associates Ltd

    Brampton, Ontario L6T 0G1
    Canada

    Site Not Available

  • Hamilton Allergy

    Hamilton, Ontario L8S 1G5
    Canada

    Site Not Available

  • Kingston Health Science Centre

    Kingston, Ontario K7L 2V7
    Canada

    Site Not Available

  • Red Maple Trials

    Ottawa, Ontario K1Y 4G2
    Canada

    Site Not Available

  • Stouffville Medical Clinic

    Stouffville, Ontario L4A 1H2
    Canada

    Site Not Available

  • Gordon Sussman Clinical Research Inc

    Toronto, Ontario M4V 1R2
    Canada

    Site Not Available

  • Toronto Allergy Clinic

    Toronto, Ontario M5G 1E2
    Canada

    Site Not Available

  • Joel Liem Medicine Professional Corporation

    Windsor, Ontario N8X 2G1
    Canada

    Site Not Available

  • LMC Manna Research - Quebec - HyperCore - PPDS

    Levis, Quebec G6W 5M6
    Canada

    Site Not Available

  • Centre d'investigation Clinique Mauricie

    Trois-Rivieres, Quebec G8T 7A1
    Canada

    Site Not Available

  • Clinique Spécialisée en Allergie de la Capitale

    Quebec, G1V 4M6
    Canada

    Site Not Available

  • Nouvel Hopital Civil

    Strasbourg, Bas-Rhin 67000
    France

    Site Not Available

  • HNO Praxis am Neckar

    Heidelberg, Baden-Wurttemberg 69120
    Germany

    Site Not Available

  • Klinikum Stuttgart

    Stuttgart, Baden-Wurttemberg 70374
    Germany

    Site Not Available

  • Beldio Research GmbH

    Memmingen, Bayern 87700
    Germany

    Site Not Available

  • Praxis Dr. med. Elke Decot

    Dreieich, Hessen 63303
    Germany

    Site Not Available

  • Praxis Dr. med. Claus Keller

    Frankfurt am Main, Hessen 60389
    Germany

    Site Not Available

  • Praxis Dr. med. Gerhard Schindlbeck

    Viernheim, Hessen 68519
    Germany

    Site Not Available

  • Universitatsklinikum Dusseldorf

    Dusseldorf, Nordrhein-Westfalen 40225
    Germany

    Site Not Available

  • Universitatsklinikum Munster

    Munster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Klinische Forschung Dresden GmbH (KFGN)

    Dresden, Sachsen 01069
    Germany

    Site Not Available

  • Praxis für HNO und Allergologie

    Dresden, Sachsen 01139
    Germany

    Site Not Available

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • BAG Prof. Dr. G. Hoheisel Dr. A. Bonitz

    Leipzig, Sachsen 04275
    Germany

    Site Not Available

  • Salvus-Klinische Studien GmbH

    Leipzig, Sachsen 04207
    Germany

    Site Not Available

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Emovis GmbH

    Berlin, 10629
    Germany

    Site Not Available

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

    Wroclaw, Dolnoslaskie 50-088
    Poland

    Site Not Available

  • ALL-MED - Specjalistyczna Opieka Medyczna - Medyczny Instytut Badawczy

    Wroclaw, Dolnoslaskie 53-201
    Poland

    Site Not Available

  • ETG Lodz - PPDS

    Lodz, Lodzkie 90-302
    Poland

    Site Not Available

  • IP Clinic Sp. z o. o.

    Lodz, Lodzkie 90-752
    Poland

    Site Not Available

  • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

    Lodz, Lodzkie 90-153
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow

    Lodz, Lodzkie 90-153
    Poland

    Site Not Available

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

    Lodz, Lodzkie 90-329
    Poland

    Site Not Available

  • Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna

    Lublin, Lubelskie 20-552
    Poland

    Site Not Available

  • ETG Lublin - PPDS

    Lublin, Lubelskie 20-089
    Poland

    Site Not Available

  • ETG Zamosc - PPDS

    Zamosc, Lubelskie 22-400
    Poland

    Site Not Available

  • Malopolskie Centrum Alergologii

    Krakow, Malopolski 31-624
    Poland

    Site Not Available

  • Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.

    Krakow, Malopolskie 31-011
    Poland

    Site Not Available

  • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o

    Tarnow, Malopolskie 33-100
    Poland

    Site Not Available

  • ETG Warszawa - PPDS

    Piaseczno, Mazowieckie 05-500
    Poland

    Site Not Available

  • Regeneron Study Site

    Siedlce, Mazowieckie 08-110
    Poland

    Site Not Available

  • EMed Centrum Uslug Medycznych

    Rzeszow, Podkarpackie 35-205
    Poland

    Site Not Available

  • Homeo Medicus Szczesiul sp. j.

    Bialystok, Podlaskie 15-687
    Poland

    Site Not Available

  • Clinica Vitae Sp z o o

    Gdansk, Pomorskie 80-382
    Poland

    Site Not Available

  • ETG Kielce

    Kielce, Swietokrzyskie 25-355
    Poland

    Site Not Available

  • Centrum Alergologii Teresa Hofman

    Pila, Wielkopolskie 64-920
    Poland

    Site Not Available

  • Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z.o.o

    Poznan, 61-578
    Poland

    Site Not Available

  • Allergy and Asthma Associates of Southern California - CRN - PPDS

    Mission Viejo, California 92691
    United States

    Site Not Available

  • Integrated Research of Inland, Inc

    Riverside, California 92506
    United States

    Site Not Available

  • Peninsula Research Associates - CRN - PPDS

    Rolling Hills Estates, California 90274
    United States

    Site Not Available

  • Allergy and Asthma Medical Group and Research Center - CRN - PPDS

    San Diego, California 92123
    United States

    Site Not Available

  • Regeneron Study Site

    San Jose, California 95117
    United States

    Site Not Available

  • Asthma and Allergy Associates PC - CRN - PPDS

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Colorado Allergy and Asthma Centers PC - CRN - PPDS

    Denver, Colorado 80230
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Velocity Clinical Research, Inc. (Meridan)

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Asthma and Allergy Center of Chicago Sc-Oak Park

    Oak Park, Illinois 60301
    United States

    Site Not Available

  • Sneeze Wheeze and Itch Associates LLC

    Springfield, Illinois 62702
    United States

    Site Not Available

  • South Bend Clinic

    South Bend, Indiana 46617
    United States

    Site Not Available

  • Bluegrass Allergy Research

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • Allergy and Asthma Specialists PSC

    Owensboro, Kentucky 42301
    United States

    Site Not Available

  • Charleston Allergy and Asthma

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • Institute For Asthma and Allergy

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Respiratory Medicine Research Institute of Michigan PLC

    Ypsilanti, Michigan 48187
    United States

    Site Not Available

  • Clinical Research Institute, Inc - CRN - PPDS

    Plymouth, Minnesota 55441
    United States

    Site Not Available

  • University of Missouri - Hospital

    Columbia, Missouri 65212
    United States

    Site Not Available

  • Montana Medical Research

    Missoula, Montana 59808
    United States

    Site Not Available

  • Somnos Clinical Research

    Lincoln, Nebraska 68505
    United States

    Site Not Available

  • Nebraska Medical Research Institute, Inc. - CRN - PPDS

    Papillion, Nebraska 68046
    United States

    Site Not Available

  • Riverside Medical Group - Circuit - PPDS

    Belleville, New Jersey 07109
    United States

    Site Not Available

  • Atlantic Research Center LLC

    Ocean City, New Jersey 07712
    United States

    Site Not Available

  • Regeneron Study Site

    Secaucus, New Jersey 07094
    United States

    Site Not Available

  • Princeton Center For Clinical Research - CRN - PPDS

    Skillman, New Jersey 08558
    United States

    Site Not Available

  • Allergy Partners of NJ, P.C.

    Teaneck, New Jersey 07666
    United States

    Site Not Available

  • Allergy Consultants PA

    Verona, New Jersey 07044
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10461
    United States

    Site Not Available

  • SUNY Downstate Health Science University

    Brooklyn, New York 11203
    United States

    Site Not Available

  • NYU Langone Medical Center

    New York, New York 10029
    United States

    Site Not Available

  • Allergy Partners of Western North Carolina

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • Bernstein Clinical Research Center Inc

    Cincinnati, Ohio 45231
    United States

    Site Not Available

  • Optimed Research Ltd - Clinedge - PPDS

    Columbus, Ohio 43235
    United States

    Site Not Available

  • Aventiv Research Inc - Columbus - HyperCore - PPDS

    Dublin, Ohio 43016
    United States

    Site Not Available

  • Allergy Asthma and Clinical Research Center

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • PDX Allergy, LLC dba Portland Research

    Happy Valley, Oregon 97068
    United States

    Site Not Available

  • Northwest Research Center - CRN - PPDS

    Portland, Oregon 97202
    United States

    Site Not Available

  • Allergy and Clinical Immunology Associates

    Pittsburgh, Pennsylvania 15241
    United States

    Site Not Available

  • Asthma, Nasal Disease and Allergy Research Center of New England

    East Providence, Rhode Island 02914
    United States

    Site Not Available

  • Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)

    Warwick, Rhode Island 02886
    United States

    Site Not Available

  • Regeneron Study Site

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Seattle Allergy & Asthma Research Institute

    Seattle, Washington 98115
    United States

    Site Not Available

  • The Medical College of Wisconsin, Inc.

    Greenfield, Wisconsin 53228
    United States

    Site Not Available

  • The Medical College of Wisconsin, Inc.

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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