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AzTrials

Allergic Rhinitis Due to Cat AllergyPhase 3NCT04981717

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 Phase 3 study testing REGN1908-1909 in people with Allergic Rhinitis Due to Cat Allergy, run by Regeneron Pharmaceuticals at 92 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Allergic Rhinitis Due to Cat Allergy
What is being tested?
REGN1908-1909
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
446 participants
Where
92 sitesin 6 countries
Study dates
30 Jul 2021to 24 Apr 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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
  • NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply

Trial locations and contacts

92 sites in 6 countries.

92 sites in 6 countries

United States42 sites

  • Allergy Partners of Western North Carolina

    Asheville, North Carolina, 28801

  • Emory University

    Atlanta, Georgia, 30322

  • Charleston Allergy and Asthma

    Baltimore, Maryland, 21224

  • Riverside Medical Group - Circuit - PPDS

    Belleville, New Jersey, 07109

  • SUNY Downstate Health Science University

    Brooklyn, New York, 11203

  • Institute For Asthma and Allergy

    Chevy Chase, Maryland, 20815

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Bernstein Clinical Research Center Inc

    Cincinnati, Ohio, 45231

  • Asthma and Allergy Associates PC - CRN - PPDS

    Colorado Springs, Colorado, 80907

  • University of Missouri - Hospital

    Columbia, Missouri, 65212

  • Optimed Research Ltd - Clinedge - PPDS

    Columbus, Ohio, 43235

  • Colorado Allergy and Asthma Centers PC - CRN - PPDS

    Denver, Colorado, 80230

  • Aventiv Research Inc - Columbus - HyperCore - PPDS

    Dublin, Ohio, 43016

  • Asthma, Nasal Disease and Allergy Research Center of New England

    East Providence, Rhode Island, 02914

  • The Medical College of Wisconsin, Inc.

    Greenfield, Wisconsin, 53228

  • PDX Allergy, LLC dba Portland Research

    Happy Valley, Oregon, 97068

  • Bluegrass Allergy Research

    Lexington, Kentucky, 40509

  • Somnos Clinical Research

    Lincoln, Nebraska, 68505

  • Velocity Clinical Research, Inc. (Meridan)

    Meridian, Idaho, 83642

  • Allergy and Asthma Associates of Southern California - CRN - PPDS

    Mission Viejo, California, 92691

  • Montana Medical Research

    Missoula, Montana, 59808

  • NYU Langone Medical Center

    New York, New York, 10029

  • Asthma and Allergy Center of Chicago Sc-Oak Park

    Oak Park, Illinois, 60301

  • Atlantic Research Center LLC

    Ocean City, New Jersey, 07712

  • Allergy Asthma and Clinical Research Center

    Oklahoma City, Oklahoma, 73120

  • Allergy and Asthma Specialists PSC

    Owensboro, Kentucky, 42301

  • Nebraska Medical Research Institute, Inc. - CRN - PPDS

    Papillion, Nebraska, 68046

  • Allergy and Clinical Immunology Associates

    Pittsburgh, Pennsylvania, 15241

  • Clinical Research Institute, Inc - CRN - PPDS

    Plymouth, Minnesota, 55441

  • Northwest Research Center - CRN - PPDS

    Portland, Oregon, 97202

  • Integrated Research of Inland, Inc

    Riverside, California, 92506

  • Peninsula Research Associates - CRN - PPDS

    Rolling Hills Estates, California, 90274

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

    San Diego, California, 92123

  • Seattle Allergy & Asthma Research Institute

    Seattle, Washington, 98115

  • Princeton Center For Clinical Research - CRN - PPDS

    Skillman, New Jersey, 08558

  • South Bend Clinic

    South Bend, Indiana, 46617

  • Sneeze Wheeze and Itch Associates LLC

    Springfield, Illinois, 62702

  • Allergy Partners of NJ, P.C.

    Teaneck, New Jersey, 07666

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Allergy Consultants PA

    Verona, New Jersey, 07044

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

    Warwick, Rhode Island, 02886

  • Respiratory Medicine Research Institute of Michigan PLC

    Ypsilanti, Michigan, 48187

Other trials in United States

Poland20 sites

  • Homeo Medicus Szczesiul sp. j.

    Bialystok, Podlaskie Voivodeship, 15-687

  • Clinica Vitae Sp z o o

    Gdansk, Pomeranian Voivodeship, 80-382

  • ETG Kielce

    Kielce, Świętokrzyskie Voivodeship, 25-355

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

    Krakow, Lesser Poland Voivodeship, 31-011

  • Malopolskie Centrum Alergologii

    Krakow, Malopolski, 31-624

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

    Lodz, Łódź Voivodeship, 90-153

  • Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow

    Lodz, Łódź Voivodeship, 90-153

  • ETG Lodz - PPDS

    Lodz, Łódź Voivodeship, 90-302

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

    Lodz, Łódź Voivodeship, 90-329

  • IP Clinic Sp. z o. o.

    Lodz, Łódź Voivodeship, 90-752

  • ETG Lublin - PPDS

    Lublin, Lublin Voivodeship, 20-089

  • Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna

    Lublin, Lublin Voivodeship, 20-552

  • ETG Warszawa - PPDS

    Piaseczno, Masovian Voivodeship, 05-500

  • Centrum Alergologii Teresa Hofman

    Piła, Greater Poland Voivodeship, 64-920

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

    Poznan, 61-578

  • EMed Centrum Uslug Medycznych

    Rzeszów, Podkarpackie Voivodeship, 35-205

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

    Tarnów, Lesser Poland Voivodeship, 33-100

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

    Wroclaw, Lower Silesian Voivodeship, 50-088

  • ALL-MED - Specjalistyczna Opieka Medyczna - Medyczny Instytut Badawczy

    Wroclaw, Lower Silesian Voivodeship, 53-201

  • ETG Zamosc - PPDS

    Zamość, Lublin Voivodeship, 22-400

Other trials in Poland

Germany14 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

  • Emovis GmbH

    Berlin, 10629

  • Praxis Dr. med. Elke Decot

    Dreieich, Hesse, 63303

  • Klinische Forschung Dresden GmbH (KFGN)

    Dresden, Saxony, 01069

  • Praxis für HNO und Allergologie

    Dresden, Saxony, 01139

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, Saxony, 01307

  • Praxis Dr. med. Claus Keller

    Frankfurt am Main, Hesse, 60389

  • HNO Praxis am Neckar

    Heidelberg, Baden-Wurttemberg, 69120

  • Salvus-Klinische Studien GmbH

    Leipzig, Saxony, 04207

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

    Leipzig, Saxony, 04275

  • Beldio Research GmbH

    Memmingen, Bavaria, 87700

  • Universitatsklinikum Munster

    Münster, North Rhine-Westphalia, 48149

  • Klinikum Stuttgart

    Stuttgart, Baden-Wurttemberg, 70374

  • Praxis Dr. med. Gerhard Schindlbeck

    Viernheim, Hesse, 68519

Other trials in Germany

Canada11 sites

  • Aggarwal and Associates Ltd

    Brampton, Ontario, L6T 0G1

  • Hamilton Allergy

    Hamilton, Ontario, L8S 1G5

  • Kingston Health Science Centre

    Kingston, Ontario, K7L 2V7

  • LMC Manna Research - Quebec - HyperCore - PPDS

    Lévis, Quebec, G6W 5M6

  • Red Maple Trials

    Ottawa, Ontario, K1Y 4G2

  • Clinique Spécialisée en Allergie de la Capitale

    Québec, G1V 4M6

  • Stouffville Medical Clinic

    Stouffville, Ontario, L4A 1H2

  • Gordon Sussman Clinical Research Inc

    Toronto, Ontario, M4V 1R2

  • Toronto Allergy Clinic

    Toronto, Ontario, M5G 1E2

  • Centre d'investigation Clinique Mauricie

    Trois-Rivières, Quebec, G8T 7A1

  • Joel Liem Medicine Professional Corporation

    Windsor, Ontario, N8X 2G1

Other trials in Canada

Belgium4 sites

  • Private Practice Dr Jean Benoit Martinot

    Erpent, 5101

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000

  • UZ Leuven

    Leuven, Vlaams Brabant, 3000

  • CHR de la Citadelle

    Liège, 4000

Other trials in Belgium

France1 site

  • Nouvel Hopital Civil

    Strasbourg, Bas-Rhin, 67000

Other trials in France

About this study

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

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
Being tested
REGN1908-1909, Matching Placebo
Keywords
Cat allergy induced allergic rhinitis, Allergic conjunctivitis, Asthma
Medical subject headings
Conjunctivitis, Allergic, Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REGN1908-1909Drug

    Subcutaneous (SC) for a total of 5 administrations

  • Matching PlaceboDrug

    SC for a total of 5 administrations

Study groups in NCT04981717
Study groupRoleWhat they receive
REGN1908-1909ExperimentalRandomized 1:1
Receives: Drug: REGN1908-1909
PlaceboPlacebo comparatorRandomized 1:1
Receives: Drug: Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Weeks 48 to 60

Secondary outcomes (38)

  1. 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.

    Measured: Weeks 48 to 60

  2. 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

    Measured: Weeks 48 to 60

  3. 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

    Measured: Weeks 48 to 60

  4. 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)

    Measured: Weeks 48 to 60

  5. 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

    Measured: Weeks 48 to 60

  6. 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

    Measured: Week 60

  7. Daily CSMS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

    The combined symptom and medication score (CSMS) is defined as the daily combined allergic rhinitis and conjunctivitis total symptom score (TSS: calculated as the sum of total nasal symptom score [TNSS] and total ocular symptom score [TOSS]) plus daily medication score (DMS). Scores ranging between 0 (none) and 38 (severe).

    Measured: Weeks 0 to 12

  8. Daily TNSS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

    The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing.

    Measured: Weeks 0 to 12

  9. 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

    The combined symptom and medication score (CSMS) is defined as the daily combined allergic rhinitis and conjunctivitis total symptom score (TSS: calculated as the sum of total nasal symptom score [TNSS] and total ocular symptom score [TOSS]) plus daily medication score (DMS).

    Measured: Weeks 0 to 12

  10. 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

    The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing.

    Measured: Weeks 0 to 12

  11. 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

    Total symptom score (TSS: calculated as the sum of TNSS and total ocular symptom score [TOSS]) plus daily medication score (DMS).

    Measured: Weeks 0 to 12

  12. Daily TSS Score Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

    Total symptom score (TSS: calculated as the sum of TNSS and total ocular symptom score [TOSS]) plus daily medication score (DMS).

    Measured: Weeks 0 to 12

  13. 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)

    Measured: Weeks 0 to 12

  14. Daily TOSS Averaged Over the Last 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)

    Measured: Weeks 48 to 60

  15. 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

    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)

    Measured: Weeks 48 to 60

  16. Percent Change in Forced Expiratory Volume (FEV)1 in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo

    In-clinic spirometry on all patients to determine FEV1 (forced expiratory volume in 1 second) in liters (L).

    Measured: Baseline to week 12

  17. Percent Change in FEV1 in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo

    In-clinic spirometry on all patients to determine FEV1 (forced expiratory volume in 1 second) in liters (L).

    Measured: Baseline to week 60

  18. Percent Change in Cat SPT Mean Wheal Diameter in Patients Who Receive REGN1908-1909 Versus Placebo

    The full analysis set (FAS) includes all randomized participants; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.

    Measured: Baseline to week 72

  19. 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

    Measured: Weeks 0 to 12

  20. Number of Participants With Adverse Event of Special Interests (AESIs) Throughout the Study

    Measured: Weeks 0 to 72

  21. Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) Throughout the Study

    Measured: Weeks 0 to 60

  22. Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study

    Measured: Weeks 0 to 72

  23. Total REGN1908 Concentration in Serum Over the Study Duration

    Measured: Weeks 0 to 60

  24. Total REGN1909 Concentration in Serum Over the Study Duration

    Measured: Weeks 0 to 60

  25. Incidence of Treatment-emergent Anti-drug Antibodies (ADAs) to REGN1908 Throughout the Study

    Measured: Weeks 0 to 72

  26. Incidence of Treatment-emergent ADAs to REGN1909 Throughout the Study

    Measured: Weeks 0 to 72

  27. Percent Change in Cat SPT Mean Wheal Diameter in Patients Who Receive REGN1908-1909 Versus Placebo (up to Week 12)

    Measured: Baseline to week 12

  28. Percent Change in FEV1 in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo (up to Week 12)

    Measured: Baseline to week 12

  29. Percent Change in FEV1 in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo (up to Week 60)

    Measured: Baseline to week 60

  30. 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

    The RQLQ had 25 questions in 6 domains (nose symptoms, eye symptoms, practical problems, activity limitation, non-hay fever symptoms and emotional function). Participants recalled how they have been during the previous week and responded to each question on a 7-point scale. The overall RQLQ score was the mean of all 25 responses and the individual domain scores were the means of the items in those domains. The RQLQ(S) responses are based on a 7-point Likert scale with responses ranging from 0 (not troubled) to 6 (extremely troubled).

    Measured: Baseline to week 60

  31. Daily Medication Score (DMS) Averaged Over the Initial 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo

    The Daily Medication Score (DMS) was calculated by adding points for each pre-specified medication. Participants will be asked to record their daily rescue medication use using an e-diary, including which medications and the amount of these prespecified medications. The scale is 0 (minimum) to 20 (maximum)

    Measured: Weeks 0 to 12

  32. DMS Averaged Over the Last 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo

    Measured: Weeks 48 to 60

  33. 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

    Measured: Weeks 48 to 60

  34. 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

    The total daily asthma symptom score is a participant-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. The ADSD score will be based on 6 patient-reported symptoms (difficulty breathing, wheezing, shortness of breath, chest tightness, chest pain, and cough at their worst using an 11-point numeric rating scale (NRS) ranging from 0 ('None') to 10 ('As bad as you can imagine').

    Measured: Weeks 0 to 12

  35. 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)

    Measured: Weeks 48 to 60

  36. Daily TOSS Averaged Over the Initial 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo

    The TOSS ranges from 0 to 6 and is based on 2 eye symptoms: itching/redness/gritty feeling and tearing/watering. Each of the 2 symptoms is graded on a Likert scale ranging from 0 (none) to 3 (severe).

    Measured: Weeks 0 to 12

  37. 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

    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.

    Measured: Baseline to week 60

  38. 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)

    Measured: Weeks 48 to 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2021
  2. Study start30 Jul 2021
  3. Primary completion4 Jan 2023
  4. Study completion24 Apr 2023

Why it stopped: Lack of efficacy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
446 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04981717
Sponsor's protocol ID
R1908-1909-ALG-2102
Other IDs
2021-002089-42
Status last verified
May 2024
First submitted
19 Jul 2021
Last updated
11 Jun 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing REGN1908-1909 in people with Allergic Rhinitis Due to Cat Allergy, run by Regeneron Pharmaceuticals at 92 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States, Poland, Germany, Canada, Belgium and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Weeks 48 to 60). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04981717.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.

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