Phase
Condition
Common Cold
Allergy
Nasal Obstruction
Treatment
Matching Placebo
REGN1908-1909
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Generally healthy males and females who are 12 years and older at the time ofscreening.
Weight must be ≥40 kg at the time of screening
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:
Positive skin prick test (SPT) with cat hair extract (mean wheal diameter atleast 5 mm greater than a negative control) at screening
Positive allergen-specific IgE (sIgE) tests for cat and Fel d 1 (both ≥0.7kUa/L at screening)
Documented or patient reported history of nasal and/or ocular symptoms upon catexposure
Symptomatic despite the use of medications to treat their nasal and/or ocularsymptoms
At least 1 generally healthy cat (that is unlikely to die during the study) livingin the home resulting in regular exposure
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:
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
Received REGN1908-1909 in a prior REGN1908-1909 clinical trial (receipt of placeboin 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 (ifknown), whichever is longer, prior to screening
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
Connect with a study center
UZ Gent
Gent, Oost-Vlaanderen 9000
BelgiumSite Not Available
UZ Leuven
Leuven, Vlaams Brabant 3000
BelgiumSite Not Available
CHU Brugmann
Brussels, 1020
BelgiumSite Not Available
Private Practice Dr Jean Benoit Martinot
Erpent, 5101
BelgiumSite Not Available
CHR de la Citadelle
Liege, 4000
BelgiumSite Not Available
Aggarwal and Associates Ltd
Brampton, Ontario L6T 0G1
CanadaSite Not Available
Hamilton Allergy
Hamilton, Ontario L8S 1G5
CanadaSite Not Available
Kingston Health Science Centre
Kingston, Ontario K7L 2V7
CanadaSite Not Available
Red Maple Trials
Ottawa, Ontario K1Y 4G2
CanadaSite Not Available
Stouffville Medical Clinic
Stouffville, Ontario L4A 1H2
CanadaSite Not Available
Gordon Sussman Clinical Research Inc
Toronto, Ontario M4V 1R2
CanadaSite Not Available
Toronto Allergy Clinic
Toronto, Ontario M5G 1E2
CanadaSite Not Available
Joel Liem Medicine Professional Corporation
Windsor, Ontario N8X 2G1
CanadaSite Not Available
LMC Manna Research - Quebec - HyperCore - PPDS
Levis, Quebec G6W 5M6
CanadaSite Not Available
Centre d'investigation Clinique Mauricie
Trois-Rivieres, Quebec G8T 7A1
CanadaSite Not Available
Clinique Spécialisée en Allergie de la Capitale
Quebec, G1V 4M6
CanadaSite Not Available
Nouvel Hopital Civil
Strasbourg, Bas-Rhin 67000
FranceSite Not Available
HNO Praxis am Neckar
Heidelberg, Baden-Wurttemberg 69120
GermanySite Not Available
Klinikum Stuttgart
Stuttgart, Baden-Wurttemberg 70374
GermanySite Not Available
Beldio Research GmbH
Memmingen, Bayern 87700
GermanySite Not Available
Praxis Dr. med. Elke Decot
Dreieich, Hessen 63303
GermanySite Not Available
Praxis Dr. med. Claus Keller
Frankfurt am Main, Hessen 60389
GermanySite Not Available
Praxis Dr. med. Gerhard Schindlbeck
Viernheim, Hessen 68519
GermanySite Not Available
Universitatsklinikum Dusseldorf
Dusseldorf, Nordrhein-Westfalen 40225
GermanySite Not Available
Universitatsklinikum Munster
Munster, Nordrhein-Westfalen 48149
GermanySite Not Available
Klinische Forschung Dresden GmbH (KFGN)
Dresden, Sachsen 01069
GermanySite Not Available
Praxis für HNO und Allergologie
Dresden, Sachsen 01139
GermanySite Not Available
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Sachsen 01307
GermanySite Not Available
BAG Prof. Dr. G. Hoheisel Dr. A. Bonitz
Leipzig, Sachsen 04275
GermanySite Not Available
Salvus-Klinische Studien GmbH
Leipzig, Sachsen 04207
GermanySite Not Available
Charité - Universitätsmedizin Berlin
Berlin, 10117
GermanySite Not Available
Emovis GmbH
Berlin, 10629
GermanySite Not Available
AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, Dolnoslaskie 50-088
PolandSite Not Available
ALL-MED - Specjalistyczna Opieka Medyczna - Medyczny Instytut Badawczy
Wroclaw, Dolnoslaskie 53-201
PolandSite Not Available
ETG Lodz - PPDS
Lodz, Lodzkie 90-302
PolandSite Not Available
IP Clinic Sp. z o. o.
Lodz, Lodzkie 90-752
PolandSite Not Available
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, Lodzkie 90-153
PolandSite Not Available
Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow
Lodz, Lodzkie 90-153
PolandSite Not Available
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, Lodzkie 90-329
PolandSite Not Available
Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
Lublin, Lubelskie 20-552
PolandSite Not Available
ETG Lublin - PPDS
Lublin, Lubelskie 20-089
PolandSite Not Available
ETG Zamosc - PPDS
Zamosc, Lubelskie 22-400
PolandSite Not Available
Malopolskie Centrum Alergologii
Krakow, Malopolski 31-624
PolandSite Not Available
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
Krakow, Malopolskie 31-011
PolandSite Not Available
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o
Tarnow, Malopolskie 33-100
PolandSite Not Available
ETG Warszawa - PPDS
Piaseczno, Mazowieckie 05-500
PolandSite Not Available
Regeneron Study Site
Siedlce, Mazowieckie 08-110
PolandSite Not Available
EMed Centrum Uslug Medycznych
Rzeszow, Podkarpackie 35-205
PolandSite Not Available
Homeo Medicus Szczesiul sp. j.
Bialystok, Podlaskie 15-687
PolandSite Not Available
Clinica Vitae Sp z o o
Gdansk, Pomorskie 80-382
PolandSite Not Available
ETG Kielce
Kielce, Swietokrzyskie 25-355
PolandSite Not Available
Centrum Alergologii Teresa Hofman
Pila, Wielkopolskie 64-920
PolandSite Not Available
Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z.o.o
Poznan, 61-578
PolandSite Not Available
Allergy and Asthma Associates of Southern California - CRN - PPDS
Mission Viejo, California 92691
United StatesSite Not Available
Integrated Research of Inland, Inc
Riverside, California 92506
United StatesSite Not Available
Peninsula Research Associates - CRN - PPDS
Rolling Hills Estates, California 90274
United StatesSite Not Available
Allergy and Asthma Medical Group and Research Center - CRN - PPDS
San Diego, California 92123
United StatesSite Not Available
Regeneron Study Site
San Jose, California 95117
United StatesSite Not Available
Asthma and Allergy Associates PC - CRN - PPDS
Colorado Springs, Colorado 80907
United StatesSite Not Available
Colorado Allergy and Asthma Centers PC - CRN - PPDS
Denver, Colorado 80230
United StatesSite Not Available
Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Velocity Clinical Research, Inc. (Meridan)
Meridian, Idaho 83642
United StatesSite Not Available
Rush University Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
Asthma and Allergy Center of Chicago Sc-Oak Park
Oak Park, Illinois 60301
United StatesSite Not Available
Sneeze Wheeze and Itch Associates LLC
Springfield, Illinois 62702
United StatesSite Not Available
South Bend Clinic
South Bend, Indiana 46617
United StatesSite Not Available
Bluegrass Allergy Research
Lexington, Kentucky 40509
United StatesSite Not Available
Allergy and Asthma Specialists PSC
Owensboro, Kentucky 42301
United StatesSite Not Available
Charleston Allergy and Asthma
Baltimore, Maryland 21224
United StatesSite Not Available
Institute For Asthma and Allergy
Chevy Chase, Maryland 20815
United StatesSite Not Available
Respiratory Medicine Research Institute of Michigan PLC
Ypsilanti, Michigan 48187
United StatesSite Not Available
Clinical Research Institute, Inc - CRN - PPDS
Plymouth, Minnesota 55441
United StatesSite Not Available
University of Missouri - Hospital
Columbia, Missouri 65212
United StatesSite Not Available
Montana Medical Research
Missoula, Montana 59808
United StatesSite Not Available
Somnos Clinical Research
Lincoln, Nebraska 68505
United StatesSite Not Available
Nebraska Medical Research Institute, Inc. - CRN - PPDS
Papillion, Nebraska 68046
United StatesSite Not Available
Riverside Medical Group - Circuit - PPDS
Belleville, New Jersey 07109
United StatesSite Not Available
Atlantic Research Center LLC
Ocean City, New Jersey 07712
United StatesSite Not Available
Regeneron Study Site
Secaucus, New Jersey 07094
United StatesSite Not Available
Princeton Center For Clinical Research - CRN - PPDS
Skillman, New Jersey 08558
United StatesSite Not Available
Allergy Partners of NJ, P.C.
Teaneck, New Jersey 07666
United StatesSite Not Available
Allergy Consultants PA
Verona, New Jersey 07044
United StatesSite Not Available
Montefiore Medical Center
Bronx, New York 10461
United StatesSite Not Available
SUNY Downstate Health Science University
Brooklyn, New York 11203
United StatesSite Not Available
NYU Langone Medical Center
New York, New York 10029
United StatesSite Not Available
Allergy Partners of Western North Carolina
Asheville, North Carolina 28801
United StatesSite Not Available
Bernstein Clinical Research Center Inc
Cincinnati, Ohio 45231
United StatesSite Not Available
Optimed Research Ltd - Clinedge - PPDS
Columbus, Ohio 43235
United StatesSite Not Available
Aventiv Research Inc - Columbus - HyperCore - PPDS
Dublin, Ohio 43016
United StatesSite Not Available
Allergy Asthma and Clinical Research Center
Oklahoma City, Oklahoma 73120
United StatesSite Not Available
PDX Allergy, LLC dba Portland Research
Happy Valley, Oregon 97068
United StatesSite Not Available
Northwest Research Center - CRN - PPDS
Portland, Oregon 97202
United StatesSite Not Available
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania 15241
United StatesSite Not Available
Asthma, Nasal Disease and Allergy Research Center of New England
East Providence, Rhode Island 02914
United StatesSite Not Available
Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)
Warwick, Rhode Island 02886
United StatesSite Not Available
Regeneron Study Site
Charleston, South Carolina 29414
United StatesSite Not Available
Seattle Allergy & Asthma Research Institute
Seattle, Washington 98115
United StatesSite Not Available
The Medical College of Wisconsin, Inc.
Greenfield, Wisconsin 53228
United StatesSite Not Available
The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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