Clinical trial NCT04981717: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Allergic Rhinitis Due to Cat Allergy
Keywords: Cat allergy induced allergic rhinitis
Allergic conjunctivitis
Asthma
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-07-29
Enrollment: 446
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Daily Combined Symptom and Medication Score (CSMS) Averaged Over Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo
timeFrame: Weeks 48 to 60
Secondary outcomes:
measure: Daily Total Nasal Symptom Score (TNSS) Averaged Over the Last 12 Weeks of Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo
timeFrame: Weeks 48 to 60
measure: 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
timeFrame: Weeks 48 to 60
measure: 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
timeFrame: Weeks 48 to 60
measure: Daily Total Symptom Score (TSS) Averaged Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo
timeFrame: Weeks 48 to 60
measure: 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
timeFrame: Weeks 48 to 60
measure: 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
timeFrame: Week 60
measure: Daily CSMS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo
timeFrame: Weeks 0 to 12
measure: Daily TNSS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo
timeFrame: Weeks 0 to 12
measure: 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
timeFrame: Weeks 0 to 12
measure: 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
timeFrame: Weeks 0 to 12
measure: 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
timeFrame: Weeks 0 to 12
measure: Daily TSS Score Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo
timeFrame: Weeks 0 to 12
measure: 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
timeFrame: Weeks 0 to 12
measure: Daily TOSS Averaged Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo
timeFrame: Weeks 48 to 60
measure: 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
timeFrame: Weeks 48 to 60
measure: Percent Change in Forced Expiratory Volume (FEV)1 in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo
timeFrame: Baseline to week 12
measure: Percent Change in FEV1 in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo
timeFrame: Baseline to week 60
measure: Percent Change in Cat SPT Mean Wheal Diameter in Patients Who Receive REGN1908-1909 Versus Placebo
timeFrame: Baseline to week 72
measure: 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
timeFrame: Weeks 0 to 12
measure: Number of Participants With Adverse Event of Special Interests (AESIs) Throughout the Study
timeFrame: Weeks 0 to 72
measure: Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) Throughout the Study
timeFrame: Weeks 0 to 60
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study
timeFrame: Weeks 0 to 72
measure: Total REGN1908 Concentration in Serum Over the Study Duration
timeFrame: Weeks 0 to 60
measure: Total REGN1909 Concentration in Serum Over the Study Duration
timeFrame: Weeks 0 to 60
measure: Incidence of Treatment-emergent Anti-drug Antibodies (ADAs) to REGN1908 Throughout the Study
timeFrame: Weeks 0 to 72
measure: Incidence of Treatment-emergent ADAs to REGN1909 Throughout the Study
timeFrame: Weeks 0 to 72
measure: Percent Change in Cat SPT Mean Wheal Diameter in Patients Who Receive REGN1908-1909 Versus Placebo (up to Week 12)
timeFrame: Baseline to week 12
measure: Percent Change in FEV1 in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo (up to Week 12)
timeFrame: Baseline to week 12
measure: Percent Change in FEV1 in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo (up to Week 60)
timeFrame: Baseline to week 60
measure: Change From Baseline to Week 60 in Rhinoconjunctivitis Quality of Life Questionnaire for Ages 12+ (RQLQ(S)+12) in Participants Who Received REGN1908-1909 Versus Placebo
timeFrame: Baseline to week 60
measure: Daily Medication Score (DMS) Averaged Over the Initial 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo
timeFrame: Weeks 0 to 12
measure: DMS Averaged Over the Last 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo
timeFrame: Weeks 48 to 60
measure: Percent Change From Pre-treatment Baseline in Average DMS Averaged Over the Last 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo
timeFrame: Weeks 48 to 60
measure: 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 Participants With Asthma Who Receive REGN1908-1909 Versus Placebo
timeFrame: Weeks 0 to 12
measure: ADS Score Averaged Over the Last 12 Weeks of the Treatment Period Using ADSD and the ANSD in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo (Weeks 48 to 60)
timeFrame: Weeks 48 to 60
measure: Daily TOSS Averaged Over the Initial 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo
timeFrame: Weeks 0 to 12
measure: Change From Baseline to Week 60 in Asthma Control Questionnaire 5 Question Version (ACQ-5) in Participant With Asthma Who Receive REGN1908-1909 Versus Placebo
timeFrame: Baseline to week 60
measure: 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 (Weeks 48 to 60)
timeFrame: Weeks 48 to 60
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: Allergy and Asthma Associates of Southern California - CRN - PPDS
state: California
city: Riverside
country: United States
facility: Integrated Research of Inland, Inc
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates - CRN - PPDS
state: California
city: San Diego
country: United States
facility: Allergy and Asthma Medical Group and Research Center - CRN - PPDS
state: California
city: Colorado Springs
country: United States
facility: Asthma and Allergy Associates PC - CRN - PPDS
state: Colorado
city: Denver
country: United States
facility: Colorado Allergy and Asthma Centers PC - CRN - PPDS
state: Colorado
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Meridian
country: United States
facility: Velocity Clinical Research, Inc. (Meridan)
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Oak Park
country: United States
facility: Asthma and Allergy Center of Chicago Sc-Oak Park
state: Illinois
city: Springfield
country: United States
facility: Sneeze Wheeze and Itch Associates LLC
state: Illinois
city: South Bend
country: United States
facility: South Bend Clinic
state: Indiana
city: Lexington
country: United States
facility: Bluegrass Allergy Research
state: Kentucky
city: Owensboro
country: United States
facility: Allergy and Asthma Specialists PSC
state: Kentucky
city: Baltimore
country: United States
facility: Charleston Allergy and Asthma
state: Maryland
city: Chevy Chase
country: United States
facility: Institute For Asthma and Allergy
state: Maryland
city: Ypsilanti
country: United States
facility: Respiratory Medicine Research Institute of Michigan PLC
state: Michigan
city: Plymouth
country: United States
facility: Clinical Research Institute, Inc - CRN - PPDS
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri - Hospital
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research
state: Montana
city: Lincoln
country: United States
facility: Somnos Clinical Research
state: Nebraska
city: Papillion
country: United States
facility: Nebraska Medical Research Institute, Inc. - CRN - PPDS
state: Nebraska
city: Belleville
country: United States
facility: Riverside Medical Group - Circuit - PPDS
state: New Jersey
city: Ocean City
country: United States
facility: Atlantic Research Center LLC
state: New Jersey
city: Skillman
country: United States
facility: Princeton Center For Clinical Research - CRN - PPDS
state: New Jersey
city: Teaneck
country: United States
facility: Allergy Partners of NJ, P.C.
state: New Jersey
city: Verona
country: United States
facility: Allergy Consultants PA
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Health Science University
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Asheville
country: United States
facility: Allergy Partners of Western North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center Inc
state: Ohio
city: Columbus
country: United States
facility: Optimed Research Ltd - Clinedge - PPDS
state: Ohio
city: Dublin
country: United States
facility: Aventiv Research Inc - Columbus - HyperCore - PPDS
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy Asthma and Clinical Research Center
state: Oklahoma
city: Happy Valley
country: United States
facility: PDX Allergy, LLC dba Portland Research
state: Oregon
city: Portland
country: United States
facility: Northwest Research Center - CRN - PPDS
state: Oregon
city: Pittsburgh
country: United States
facility: Allergy and Clinical Immunology Associates
state: Pennsylvania
city: East Providence
country: United States
facility: Asthma, Nasal Disease and Allergy Research Center of New England
state: Rhode Island
city: Warwick
country: United States
facility: Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)
state: Rhode Island
city: Seattle
country: United States
facility: Seattle Allergy & Asthma Research Institute
state: Washington
city: Greenfield
country: United States
facility: The Medical College of Wisconsin, Inc.
state: Wisconsin
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams Brabant
city: Erpent
country: Belgium
facility: Private Practice Dr Jean Benoit Martinot
city: Liege
country: Belgium
facility: CHR de la Citadelle
city: Brampton
country: Canada
facility: Aggarwal and Associates Ltd
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Allergy
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Science Centre
state: Ontario
city: Ottawa
country: Canada
facility: Red Maple Trials
state: Ontario
city: Stouffville
country: Canada
facility: Stouffville Medical Clinic
state: Ontario
city: Toronto
country: Canada
facility: Gordon Sussman Clinical Research Inc
state: Ontario
city: Toronto
country: Canada
facility: Toronto Allergy Clinic
state: Ontario
city: Windsor
country: Canada
facility: Joel Liem Medicine Professional Corporation
state: Ontario
city: Levis
country: Canada
facility: LMC Manna Research - Quebec - HyperCore - PPDS
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Centre d'investigation Clinique Mauricie
state: Quebec
city: Quebec
country: Canada
facility: Clinique Spécialisée en Allergie de la Capitale
city: Strasbourg
country: France
facility: Nouvel Hopital Civil
state: Bas-Rhin
city: Heidelberg
country: Germany
facility: HNO Praxis am Neckar
state: Baden-Wurttemberg
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart
state: Baden-Wurttemberg
city: Memmingen
country: Germany
facility: Beldio Research GmbH
state: Bayern
city: Dreieich
country: Germany
facility: Praxis Dr. med. Elke Decot
state: Hessen
city: Frankfurt am Main
country: Germany
facility: Praxis Dr. med. Claus Keller
state: Hessen
city: Viernheim
country: Germany
facility: Praxis Dr. med. Gerhard Schindlbeck
state: Hessen
city: Munster
country: Germany
facility: Universitatsklinikum Munster
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH (KFGN)
state: Sachsen
city: Dresden
country: Germany
facility: Praxis für HNO und Allergologie
state: Sachsen
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden
state: Sachsen
city: Leipzig
country: Germany
facility: Salvus-Klinische Studien GmbH
state: Sachsen
city: Leipzig
country: Germany
facility: BAG Prof. Dr. G. Hoheisel Dr. A. Bonitz
state: Sachsen
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Emovis GmbH
city: Wroclaw
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
state: Dolnoslaskie
city: Wroclaw
country: Poland
facility: ALL-MED - Specjalistyczna Opieka Medyczna - Medyczny Instytut Badawczy
state: Dolnoslaskie
city: Lodz
country: Poland
facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
state: Lodzkie
city: Lodz
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow
state: Lodzkie
city: Lodz
country: Poland
facility: ETG Lodz - PPDS
state: Lodzkie
city: Lodz
country: Poland
facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
state: Lodzkie
city: Lodz
country: Poland
facility: IP Clinic Sp. z o. o.
state: Lodzkie
city: Lublin
country: Poland
facility: ETG Lublin - PPDS
state: Lubelskie
city: Lublin
country: Poland
facility: Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
state: Lubelskie
city: Zamosc
country: Poland
facility: ETG Zamosc - PPDS
state: Lubelskie
city: Krakow
country: Poland
facility: Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
state: Malopolskie
city: Tarnow
country: Poland
facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o
state: Malopolskie
city: Krakow
country: Poland
facility: Malopolskie Centrum Alergologii
state: Malopolski
city: Piaseczno
country: Poland
facility: ETG Warszawa - PPDS
state: Mazowieckie
city: Rzeszow
country: Poland
facility: EMed Centrum Uslug Medycznych
state: Podkarpackie
city: Bialystok
country: Poland
facility: Homeo Medicus Szczesiul sp. j.
state: Podlaskie
city: Gdansk
country: Poland
facility: Clinica Vitae Sp z o o
state: Pomorskie
city: Kielce
country: Poland
facility: ETG Kielce
state: Swietokrzyskie
city: Pila
country: Poland
facility: Centrum Alergologii Teresa Hofman
state: Wielkopolskie
city: Poznan
country: Poland
facility: Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z.o.o
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: