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

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

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

Study Overview

• Status: Terminated
• Conditions: Allergic Rhinitis Due to Cat Allergy
• Intervention / Treatment: Drug: REGN1908-1909; Drug: Matching Placebo

• Study Type: Interventional
• Enrollment (Actual): 446
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Erpent, Belgium, 5101
    • Private Practice Dr Jean Benoit Martinot
  • Liege, Belgium, 4000
    • CHR de la Citadelle
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • UZ Gent
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • UZ Leuven
• Canada
  • Quebec, Canada, G1V 4M6
    • Clinique Specialisee en Allergie de la Capitale
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • Aggarwal and associates Ltd
    • Hamilton, Ontario, Canada, L8S 1G5
      • Hamilton Allergy
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston Health Science Centre
    • Ottawa, Ontario, Canada, K1Y 4G2
      • Red Maple Trials
    • Stouffville, Ontario, Canada, L4A 1H2
      • Stouffville Medical Clinic
    • Toronto, Ontario, Canada, M4V 1R2
      • Gordon Sussman Clinical Research Inc
    • Toronto, Ontario, Canada, M5G 1E2
      • Toronto Allergy Clinic
    • Windsor, Ontario, Canada, N8X 2G1
      • Joel Liem Medicine Professional Corporation
  • Quebec
    • Levis, Quebec, Canada, G6W 5M6
      • LMC Manna Research - Quebec - HyperCore - PPDS
    • Trois-Rivieres, Quebec, Canada, G8T 7A1
      • Centre d'investigation Clinique Mauricie
• France
  • Bas-Rhin
    • Strasbourg, Bas-Rhin, France, 67000
      • Nouvel Hopital Civil
• Germany
  • Berlin, Germany, 10629
    • emovis GmbH
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin Berlin
  • Baden-Wurttemberg
    • Heidelberg, Baden-Wurttemberg, Germany, 69120
      • HNO Praxis am Neckar
    • Stuttgart, Baden-Wurttemberg, Germany, 70374
      • Klinikum Stuttgart
  • Bayern
    • Memmingen, Bayern, Germany, 87700
      • Beldio Research Gmbh
  • Hessen
    • Dreieich, Hessen, Germany, 63303
      • Praxis Dr. med. Elke Decot
    • Frankfurt am Main, Hessen, Germany, 60389
      • Praxis Dr. med. Claus Keller
    • Viernheim, Hessen, Germany, 68519
      • Praxis Dr. med. Gerhard Schindlbeck
  • Nordrhein-Westfalen
    • Munster, Nordrhein-Westfalen, Germany, 48149
      • Universitätsklinikum Münster
  • Sachsen
    • Dresden, Sachsen, Germany, 01069
      • Klinische Forschung Dresden GmbH (KFGN)
    • Dresden, Sachsen, Germany, 01139
      • Praxis für HNO und Allergologie
    • Dresden, Sachsen, Germany, 01307
      • Universitätsklinikum Carl Gustav Carus an der TU Dresden
    • Leipzig, Sachsen, Germany, 04207
      • Salvus-Klinische Studien GmbH
    • Leipzig, Sachsen, Germany, 04275
      • BAG Prof. Dr. G. Hoheisel Dr. A. Bonitz
• Poland
  • Poznan, Poland, 61-578
    • Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z.o.o
  • Dolnoslaskie
    • Wroclaw, Dolnoslaskie, Poland, 50-088
      • AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
    • Wroclaw, Dolnoslaskie, Poland, 53-201
      • ALL-MED - Specjalistyczna Opieka Medyczna - Medyczny Instytut Badawczy
  • Lodzkie
    • Lodz, Lodzkie, Poland, 90-153
      • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
    • Lodz, Lodzkie, Poland, 90-153
      • Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow
    • Lodz, Lodzkie, Poland, 90-302
      • ETG Lodz - PPDS
    • Lodz, Lodzkie, Poland, 90-329
      • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
    • Lodz, Lodzkie, Poland, 90-752
      • IP Clinic Sp. z o. o.
  • Lubelskie
    • Lublin, Lubelskie, Poland, 20-552
      • Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
    • Lublin, Lubelskie, Poland, 20-089
      • ETG Lublin - PPDS
    • Zamosc, Lubelskie, Poland, 22-400
      • ETG Zamosc - PPDS
  • Malopolski
    • Krakow, Malopolski, Poland, 31-624
      • Malopolskie Centrum Alergologii
  • Malopolskie
    • Krakow, Malopolskie, Poland, 31-011
      • Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
    • Tarnow, Malopolskie, Poland, 33-100
      • ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z.o.o
  • Mazowieckie
    • Piaseczno, Mazowieckie, Poland, 05-500
      • ETG Warszawa - PPDS
  • Podkarpackie
    • Rzeszow, Podkarpackie, Poland, 35-205
      • EMed Centrum Uslug Medycznych
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-687
      • Homeo Medicus Szczesiul sp. j.
  • Pomorskie
    • Gdansk, Pomorskie, Poland, 80-382
      • Clinica Vitae Sp z o o
  • Swietokrzyskie
    • Kielce, Swietokrzyskie, Poland, 25-355
      • ETG Kielce
  • Wielkopolskie
    • Pila, Wielkopolskie, Poland, 64-920
      • Centrum Alergologii Teresa Hofman
• United States
  • California
    • Mission Viejo, California, United States, 92691
      • Allergy and Asthma Associates of Southern California - CRN - PPDS
    • Riverside, California, United States, 92506
      • Integrated Research of Inland, Inc
    • Rolling Hills Estates, California, United States, 90274
      • Peninsula Research Associates - CRN - PPDS
    • San Diego, California, United States, 92123
      • Allergy and Asthma Medical Group and Research Center - CRN - PPDS
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Asthma and Allergy Associates PC - CRN - PPDS
    • Denver, Colorado, United States, 80230
      • Colorado Allergy and Asthma Centers PC - CRN - PPDS
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Velocity Clinical Research, Inc. (Meridan)
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Oak Park, Illinois, United States, 60301
      • Asthma and Allergy Center of Chicago Sc-Oak Park
    • Springfield, Illinois, United States, 62702
      • Sneeze Wheeze and Itch Associates Llc
  • Indiana
    • South Bend, Indiana, United States, 46617
      • South Bend Clinic
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Bluegrass Allergy Research
    • Owensboro, Kentucky, United States, 42301
      • Allergy and Asthma Specialists PSC
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Charleston Allergy and Asthma
    • Chevy Chase, Maryland, United States, 20815
      • Institute for Asthma and Allergy
  • Michigan
    • Ypsilanti, Michigan, United States, 48187
      • Respiratory Medicine Research Institute of Michigan PLC
  • Minnesota
    • Plymouth, Minnesota, United States, 55441
      • Clinical Research Institute, Inc - CRN - PPDS
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri - Hospital
  • Montana
    • Missoula, Montana, United States, 59808
      • Montana Medical Research
  • Nebraska
    • Lincoln, Nebraska, United States, 68505
      • Somnos Clinical Research
    • Papillion, Nebraska, United States, 68046
      • Nebraska Medical Research Institute, Inc. - CRN - PPDS
  • New Jersey
    • Belleville, New Jersey, United States, 07109
      • Riverside Medical Group - Circuit - PPDS
    • Ocean City, New Jersey, United States, 07712
      • Atlantic Research Center LLC
    • Skillman, New Jersey, United States, 08558
      • Princeton Center For Clinical Research - CRN - PPDS
    • Teaneck, New Jersey, United States, 07666
      • Allergy Partners of NJ, P.C.
    • Verona, New Jersey, United States, 07044
      • Allergy Consultants PA
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate Health Science University
    • New York, New York, United States, 10029
      • NYU Langone Medical Center
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Allergy Partners of Western North Carolina
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • Bernstein Clinical Research Center Inc
    • Columbus, Ohio, United States, 43235
      • Optimed Research Ltd - Clinedge - PPDS
    • Dublin, Ohio, United States, 43016
      • Aventiv Research Inc - Columbus - HyperCore - PPDS
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Allergy Asthma and Clinical Research Center
  • Oregon
    • Happy Valley, Oregon, United States, 97068
      • PDX Allergy, LLC dba Portland Research
    • Portland, Oregon, United States, 97202
      • Northwest Research Center - CRN - PPDS
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15241
      • Allergy and Clinical Immunology Associates
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Asthma, Nasal Disease and Allergy Research Center of New England
    • Warwick, Rhode Island, United States, 02886
      • Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)
  • Washington
    • Seattle, Washington, United States, 98115
      • Seattle Allergy & Asthma Research Institute
  • Wisconsin
    • Greenfield, Wisconsin, United States, 53228
      • The Medical College of Wisconsin, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REGN1908-1909; Randomized 1:1	Drug: REGN1908-1909; Subcutaneous (SC) for a total of 5 administrations
Placebo Comparator: Placebo; Randomized 1:1	Drug: Matching Placebo; SC for a total of 5 administrations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily total nasal symptom score (TNSS) averaged over the last 12 weeks of treatment period in patients who receive REGN1908-1909 versus placebo	Total nasal symptom score (TNSS) is from 0 to 12 and is based on assessment of 4 nasal symptoms graded on a Likert scale ranging from 0 (none) to 3 (severe) for congestion, itching, and rhinorrhea, and from 0 (none) to 3 (5 or more sneezes) for sneezing.	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	TSS is a combined score of TOSS and TNSS. TNSS and TOSS are scored as in part 1 each for a combined TSS of 0 (none) to 18 (severe)	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
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		Week 60
Daily CSMS averaged over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo		Weeks 0 to 12
Daily TNSS averaged over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo		Weeks 0 to 12
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		Weeks 0 to 12
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		Weeks 0 to 12
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		Weeks 0 to 12
Daily TSS score averaged over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo		Weeks 0 to 12
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	Total ocular symptom score is 0 to 6 and is based on itching/redness/gritty feeling and tearing/watering; each of the 2 symptoms is graded 0 (absent), 1 (mild), 2 (moderate), and 3 (severe)	Weeks 0 to 12
Daily TOSS 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 TOSS over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo		Weeks 48 to 60
Percent change in forced expiratory volume (FEV)1 in patients with asthma who receive REGN1908-1909 versus placebo		Baseline to week 12
Percent change in FEV1 in patients with asthma who receive REGN1908-1909 versus placebo		Baseline to week 60
Percent change in cat SPT mean wheal diameter in patients who receive REGN1908-1909 versus placebo		Baseline to week 12
Change in FEV1 in patients with asthma who receive REGN1908-1909 versus placebo		Baseline to week 12
Change in FEV1 in patients with asthma who receive REGN1908-1909 versus placebo		Baseline to week 60
Change in Rhinoconjunctivitis Quality of Life Questionnaire for Ages 12+ (RQLQ(S)+12) in patients who receive REGN1908-1909 versus placebo	The RQLQ has 25 questions in 6 domains (nose symptoms, eye symptoms, practical problems, activity limitation, non-hay fever symptoms and emotional function). Patients recall how they have been during the previous week and respond to each question on a 7-point scale. The overall RQLQ score is the mean of all 25 responses and the individual domain scores are the means of the items in those domains.	Baseline to week 60
Daily medication score (DMS) averaged over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo	The Daily Medication Score (DMS) is calculated by adding points for each pre-specified medication. The scale is 0 (minimum) to 20 (maximum)	Weeks 0 to 12
DMS 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 DMS averaged over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo		Weeks 48 to 60
Percent change in cat SPT mean wheal diameter in patients who receive REGN1908-1909 versus placebo		Baseline to week 72
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 patients with asthma who receive REGN1908-1909 versus placebo	The total daily asthma symptom score is a patient-reported outcome concerning the occurrence of asthma symptoms and their effect on a patient's daily activities and sleep. It is composed of two parts: daytime (five items) and nighttime (four items), both scored ordinally. Higher scores indicate more severe symptoms.	Weeks 0 to 12
ADS score averaged over the last 12 weeks of the treatment period using ADSD and the ANSD in patients with asthma who receive REGN1908-1909 versus placebo		Weeks 48 to 60
Daily TOSS averaged over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo		Weeks 0 to 12
Change from baseline to week 60 in Asthma Control Questionnaire 5 Question Version (ACQ-5) in patients with asthma who receive REGN1908-1909 versus placebo	The ACQ-5 had 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total mean score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), higher scores indicated lower asthma control.	Baseline to week 60
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		Weeks 0 to 12
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
Incidence of treatment-emergent adverse events (TEAEs) throughout the study		Weeks 0 to 72
Incidence of adverse event of special interests (AESIs) throughout the study		Weeks 0 to 72
Incidence of serious TEAEs throughout the study		Weeks 0 to 72
Total REGN1908 concentration in serum over the study duration		Weeks 0 to 72
Total REGN1909 concentration in serum over the study duration		Weeks 0 to 72
Incidence of treatment-emergent anti-drug antibodies (ADAs) to REGN1908 throughout the study		Weeks 0 to 72
Incidence of treatment-emergent ADAs to REGN1909 throughout the study		Weeks 0 to 72

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2021
• Primary Completion (Actual): January 4, 2023
• Study Completion (Actual): April 24, 2023

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 25, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Asthma; Allergic conjunctivitis; Cat allergy induced allergic rhinitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: R1908-1909-ALG-2102; 2021-002089-42 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
• IPD Sharing 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.
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No