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

NCT ID: NCT04981717

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 446 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-30
• Study Completion Date: 2023-04-24

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

Conditions

Allergic Rhinitis Due to Cat Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

REGN1908-1909

Randomized 1:1

Group Type: EXPERIMENTAL

REGN1908-1909

Intervention Type: DRUG

Subcutaneous (SC) for a total of 5 administrations

Placebo

Randomized 1:1

Group Type: PLACEBO_COMPARATOR

Matching Placebo

Intervention Type: DRUG

SC for a total of 5 administrations

Interventions

REGN1908-1909

Subcutaneous (SC) for a total of 5 administrations

Intervention Type: DRUG

Matching Placebo

SC for a total of 5 administrations

Intervention Type: DRUG

Eligibility Criteria

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.

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Allergy and Asthma Associates of Southern California - CRN - PPDS

Mission Viejo, California, United States

Integrated Research of Inland, Inc

Riverside, California, United States

Peninsula Research Associates - CRN - PPDS

Rolling Hills Estates, California, United States

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

San Diego, California, United States

Asthma and Allergy Associates PC - CRN - PPDS

Colorado Springs, Colorado, United States

Colorado Allergy and Asthma Centers PC - CRN - PPDS

Denver, Colorado, United States

Emory University

Atlanta, Georgia, United States

Velocity Clinical Research, Inc. (Meridan)

Meridian, Idaho, United States

Rush University Medical Center

Chicago, Illinois, United States

Asthma and Allergy Center of Chicago Sc-Oak Park

Oak Park, Illinois, United States

Sneeze Wheeze and Itch Associates LLC

Springfield, Illinois, United States

South Bend Clinic

South Bend, Indiana, United States

Bluegrass Allergy Research

Lexington, Kentucky, United States

Allergy and Asthma Specialists PSC

Owensboro, Kentucky, United States

Charleston Allergy and Asthma

Baltimore, Maryland, United States

Institute For Asthma and Allergy

Chevy Chase, Maryland, United States

Respiratory Medicine Research Institute of Michigan PLC

Ypsilanti, Michigan, United States

Clinical Research Institute, Inc - CRN - PPDS

Plymouth, Minnesota, United States

University of Missouri - Hospital

Columbia, Missouri, United States

Montana Medical Research

Missoula, Montana, United States

Somnos Clinical Research

Lincoln, Nebraska, United States

Nebraska Medical Research Institute, Inc. - CRN - PPDS

Papillion, Nebraska, United States

Riverside Medical Group - Circuit - PPDS

Belleville, New Jersey, United States

Atlantic Research Center LLC

Ocean City, New Jersey, United States

Princeton Center For Clinical Research - CRN - PPDS

Skillman, New Jersey, United States

Allergy Partners of NJ, P.C.

Teaneck, New Jersey, United States

Allergy Consultants PA

Verona, New Jersey, United States

SUNY Downstate Health Science University

Brooklyn, New York, United States

NYU Langone Medical Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Allergy Partners of Western North Carolina

Asheville, North Carolina, United States

Bernstein Clinical Research Center Inc

Cincinnati, Ohio, United States

Optimed Research Ltd - Clinedge - PPDS

Columbus, Ohio, United States

Aventiv Research Inc - Columbus - HyperCore - PPDS

Dublin, Ohio, United States

Allergy Asthma and Clinical Research Center

Oklahoma City, Oklahoma, United States

PDX Allergy, LLC dba Portland Research

Happy Valley, Oregon, United States

Northwest Research Center - CRN - PPDS

Portland, Oregon, United States

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania, United States

Asthma, Nasal Disease and Allergy Research Center of New England

East Providence, Rhode Island, United States

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

Warwick, Rhode Island, United States

Seattle Allergy & Asthma Research Institute

Seattle, Washington, United States

The Medical College of Wisconsin, Inc.

Greenfield, Wisconsin, United States

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

UZ Leuven

Leuven, Vlaams Brabant, Belgium

Private Practice Dr Jean Benoit Martinot

Erpent, , Belgium

CHR de la Citadelle

Liège, , Belgium

Aggarwal and Associates Ltd

Brampton, Ontario, Canada

Hamilton Allergy

Hamilton, Ontario, Canada

Kingston Health Science Centre

Kingston, Ontario, Canada

Red Maple Trials

Ottawa, Ontario, Canada

Stouffville Medical Clinic

Stouffville, Ontario, Canada

Gordon Sussman Clinical Research Inc

Toronto, Ontario, Canada

Toronto Allergy Clinic

Toronto, Ontario, Canada

Joel Liem Medicine Professional Corporation

Windsor, Ontario, Canada

LMC Manna Research - Quebec - HyperCore - PPDS

Lévis, Quebec, Canada

Centre d'investigation Clinique Mauricie

Trois-Rivières, Quebec, Canada

Clinique Spécialisée en Allergie de la Capitale

Québec, , Canada

Nouvel Hopital Civil

Strasbourg, Bas-Rhin, France

HNO Praxis am Neckar

Heidelberg, Baden-Wurttemberg, Germany

Klinikum Stuttgart

Stuttgart, Baden-Wurttemberg, Germany

Beldio Research GmbH

Memmingen, Bavaria, Germany

Praxis Dr. med. Elke Decot

Dreieich, Hesse, Germany

Praxis Dr. med. Claus Keller

Frankfurt am Main, Hesse, Germany

Praxis Dr. med. Gerhard Schindlbeck

Viernheim, Hesse, Germany

Universitatsklinikum Munster

Münster, North Rhine-Westphalia, Germany

Klinische Forschung Dresden GmbH (KFGN)

Dresden, Saxony, Germany

Praxis für HNO und Allergologie

Dresden, Saxony, Germany

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Saxony, Germany

Salvus-Klinische Studien GmbH

Leipzig, Saxony, Germany

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

Leipzig, Saxony, Germany

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Emovis GmbH

Berlin, , Germany

Centrum Alergologii Teresa Hofman

Piła, Greater Poland Voivodeship, Poland

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

Krakow, Lesser Poland Voivodeship, Poland

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

Tarnów, Lesser Poland Voivodeship, Poland

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

Wroclaw, Lower Silesian Voivodeship, Poland

ALL-MED - Specjalistyczna Opieka Medyczna - Medyczny Instytut Badawczy

Wroclaw, Lower Silesian Voivodeship, Poland

ETG Lublin - PPDS

Lublin, Lublin Voivodeship, Poland

Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna

Lublin, Lublin Voivodeship, Poland

ETG Zamosc - PPDS

Zamość, Lublin Voivodeship, Poland

Malopolskie Centrum Alergologii

Krakow, Malopolski, Poland

ETG Warszawa - PPDS

Piaseczno, Masovian Voivodeship, Poland

EMed Centrum Uslug Medycznych

Rzeszów, Podkarpackie Voivodeship, Poland

Homeo Medicus Szczesiul sp. j.

Bialystok, Podlaskie Voivodeship, Poland

Clinica Vitae Sp z o o

Gdansk, Pomeranian Voivodeship, Poland

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

Poznan, , Poland

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

Lodz, Łódź Voivodeship, Poland

Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow

Lodz, Łódź Voivodeship, Poland

ETG Lodz - PPDS

Lodz, Łódź Voivodeship, Poland

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

Lodz, Łódź Voivodeship, Poland

IP Clinic Sp. z o. o.

Lodz, Łódź Voivodeship, Poland

ETG Kielce

Kielce, Świętokrzyskie Voivodeship, Poland

Countries

United States; Belgium; Canada; France; Germany; Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2021-002089-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R1908-1909-ALG-2102

Identifier Type: -

Identifier Source: org_study_id