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

NCT04981717 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: R1908-1909-ALG-21022021-002089-42
• Study Type: interventional
• Target: 446
• Locations: 6 countries
• Sites: 92

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

Keywords

Cat allergy induced allergic rhinitis; Allergic conjunctivitis; Asthma

Outcome Measures

Primary Outcomes (1)

• 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).

  Weeks 48 to 60

Secondary Outcomes (38)

• Daily Total Nasal Symptom Score (TNSS) Averaged Over the Last 12 Weeks of Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

  Weeks 48 to 60

• 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

  Weeks 48 to 60

• 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

  Weeks 48 to 60

• Daily Total Symptom Score (TSS) Averaged Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

  Weeks 48 to 60

• 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

  Weeks 48 to 60

Study Arms (2)

REGN1908-1909

EXPERIMENTAL

Randomized 1:1

Drug: REGN1908-1909

Placebo

PLACEBO COMPARATOR

Randomized 1:1

Drug: Matching Placebo

Interventions

REGN1908-1909 DRUG

Subcutaneous (SC) for a total of 5 administrations

REGN1908-1909

Matching Placebo DRUG

SC for a total of 5 administrations

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (92)

Allergy and Asthma Associates of Southern California - CRN - PPDS

Mission Viejo, California, 92691, United States

Location

Integrated Research of Inland, Inc

Riverside, California, 92506, United States

Location

Peninsula Research Associates - CRN - PPDS

Rolling Hills Estates, California, 90274, United States

Location

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

San Diego, California, 92123, United States

Location

Asthma and Allergy Associates PC - CRN - PPDS

Colorado Springs, Colorado, 80907, United States

Location

Colorado Allergy and Asthma Centers PC - CRN - PPDS

Denver, Colorado, 80230, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Velocity Clinical Research, Inc. (Meridan)

Meridian, Idaho, 83642, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Asthma and Allergy Center of Chicago Sc-Oak Park

Oak Park, Illinois, 60301, United States

Location

Sneeze Wheeze and Itch Associates LLC

Springfield, Illinois, 62702, United States

Location

South Bend Clinic

South Bend, Indiana, 46617, United States

Location

Bluegrass Allergy Research

Lexington, Kentucky, 40509, United States

Location

Allergy and Asthma Specialists PSC

Owensboro, Kentucky, 42301, United States

Location

Charleston Allergy and Asthma

Baltimore, Maryland, 21224, United States

Location

Institute For Asthma and Allergy

Chevy Chase, Maryland, 20815, United States

Location

Respiratory Medicine Research Institute of Michigan PLC

Ypsilanti, Michigan, 48187, United States

Location

Clinical Research Institute, Inc - CRN - PPDS

Plymouth, Minnesota, 55441, United States

Location

University of Missouri - Hospital

Columbia, Missouri, 65212, United States

Location

Montana Medical Research

Missoula, Montana, 59808, United States

Location

Somnos Clinical Research

Lincoln, Nebraska, 68505, United States

Location

Nebraska Medical Research Institute, Inc. - CRN - PPDS

Papillion, Nebraska, 68046, United States

Location

Riverside Medical Group - Circuit - PPDS

Belleville, New Jersey, 07109, United States

Location

Atlantic Research Center LLC

Ocean City, New Jersey, 07712, United States

Location

Princeton Center For Clinical Research - CRN - PPDS

Skillman, New Jersey, 08558, United States

Location

Allergy Partners of NJ, P.C.

Teaneck, New Jersey, 07666, United States

Location

Allergy Consultants PA

Verona, New Jersey, 07044, United States

Location

SUNY Downstate Health Science University

Brooklyn, New York, 11203, United States

Location

NYU Langone Medical Center

New York, New York, 10029, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Allergy Partners of Western North Carolina

Asheville, North Carolina, 28801, United States

Location

Bernstein Clinical Research Center Inc

Cincinnati, Ohio, 45231, United States

Location

Optimed Research Ltd - Clinedge - PPDS

Columbus, Ohio, 43235, United States

Location

Aventiv Research Inc - Columbus - HyperCore - PPDS

Dublin, Ohio, 43016, United States

Location

Allergy Asthma and Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

Location

PDX Allergy, LLC dba Portland Research

Happy Valley, Oregon, 97068, United States

Location

Northwest Research Center - CRN - PPDS

Portland, Oregon, 97202, United States

Location

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania, 15241, United States

Location

Asthma, Nasal Disease and Allergy Research Center of New England

East Providence, Rhode Island, 02914, United States

Location

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

Warwick, Rhode Island, 02886, United States

Location

Seattle Allergy & Asthma Research Institute

Seattle, Washington, 98115, United States

Location

The Medical College of Wisconsin, Inc.

Greenfield, Wisconsin, 53228, United States

Location

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

Private Practice Dr Jean Benoit Martinot

Erpent, 5101, Belgium

Location

CHR de la Citadelle

Liège, 4000, Belgium

Location

Aggarwal and Associates Ltd

Brampton, Ontario, L6T 0G1, Canada

Location

Hamilton Allergy

Hamilton, Ontario, L8S 1G5, Canada

Location

Kingston Health Science Centre

Kingston, Ontario, K7L 2V7, Canada

Location

Red Maple Trials

Ottawa, Ontario, K1Y 4G2, Canada

Location

Stouffville Medical Clinic

Stouffville, Ontario, L4A 1H2, Canada

Location

Gordon Sussman Clinical Research Inc

Toronto, Ontario, M4V 1R2, Canada

Location

Toronto Allergy Clinic

Toronto, Ontario, M5G 1E2, Canada

Location

Joel Liem Medicine Professional Corporation

Windsor, Ontario, N8X 2G1, Canada

Location

LMC Manna Research - Quebec - HyperCore - PPDS

Lévis, Quebec, G6W 5M6, Canada

Location

Centre d'investigation Clinique Mauricie

Trois-Rivières, Quebec, G8T 7A1, Canada

Location

Clinique Spécialisée en Allergie de la Capitale

Québec, G1V 4M6, Canada

Location

Nouvel Hopital Civil

Strasbourg, Bas-Rhin, 67000, France

Location

HNO Praxis am Neckar

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Klinikum Stuttgart

Stuttgart, Baden-Wurttemberg, 70374, Germany

Location

Beldio Research GmbH

Memmingen, Bavaria, 87700, Germany

Location

Praxis Dr. med. Elke Decot

Dreieich, Hesse, 63303, Germany

Location

Praxis Dr. med. Claus Keller

Frankfurt am Main, Hesse, 60389, Germany

Location

Praxis Dr. med. Gerhard Schindlbeck

Viernheim, Hesse, 68519, Germany

Location

Universitatsklinikum Munster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Klinische Forschung Dresden GmbH (KFGN)

Dresden, Saxony, 01069, Germany

Location

Praxis für HNO und Allergologie

Dresden, Saxony, 01139, Germany

Location

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Saxony, 01307, Germany

Location

Salvus-Klinische Studien GmbH

Leipzig, Saxony, 04207, Germany

Location

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

Leipzig, Saxony, 04275, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Emovis GmbH

Berlin, 10629, Germany

Location

Centrum Alergologii Teresa Hofman

Piła, Greater Poland Voivodeship, 64-920, Poland

Location

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

Krakow, Lesser Poland Voivodeship, 31-011, Poland

Location

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

Tarnów, Lesser Poland Voivodeship, 33-100, Poland

Location

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

Wroclaw, Lower Silesian Voivodeship, 50-088, Poland

Location

ALL-MED - Specjalistyczna Opieka Medyczna - Medyczny Instytut Badawczy

Wroclaw, Lower Silesian Voivodeship, 53-201, Poland

Location

ETG Lublin - PPDS

Lublin, Lublin Voivodeship, 20-089, Poland

Location

Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna

Lublin, Lublin Voivodeship, 20-552, Poland

Location

ETG Zamosc - PPDS

Zamość, Lublin Voivodeship, 22-400, Poland

Location

Malopolskie Centrum Alergologii

Krakow, Malopolski, 31-624, Poland

Location

ETG Warszawa - PPDS

Piaseczno, Masovian Voivodeship, 05-500, Poland

Location

EMed Centrum Uslug Medycznych

Rzeszów, Podkarpackie Voivodeship, 35-205, Poland

Location

Homeo Medicus Szczesiul sp. j.

Bialystok, Podlaskie Voivodeship, 15-687, Poland

Location

Clinica Vitae Sp z o o

Gdansk, Pomeranian Voivodeship, 80-382, Poland

Location

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

Poznan, 61-578, Poland

Location

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

Lodz, Łódź Voivodeship, 90-153, Poland

Location

Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow

Lodz, Łódź Voivodeship, 90-153, Poland

Location

ETG Lodz - PPDS

Lodz, Łódź Voivodeship, 90-302, Poland

Location

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

Lodz, Łódź Voivodeship, 90-329, Poland

Location

IP Clinic Sp. z o. o.

Lodz, Łódź Voivodeship, 90-752, Poland

Location

ETG Kielce

Kielce, Świętokrzyskie Voivodeship, 25-355, Poland

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic; Asthma

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity

Limitations and Caveats

The study met prespecified interim futility criteria for CSMS and TNSS, therefore, an efficacy analysis was not performed for the primary and secondary endpoints as specified in the protocol

Results Point of Contact

• Title: Clinical Trials Administrator
• Organization: Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

8447346643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: July 29, 2021
• Study Start: July 30, 2021
• Primary Completion: January 4, 2023
• Study Completion: April 24, 2023
• Last Updated: June 11, 2024
• Results First Posted: June 11, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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

Locations

US (42); BE (4); FR (1); CA (11); PL (20); DE (14)