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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

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ClinicalTrials.gov Identifier: NCT04981717
Recruitment Status : Recruiting
First Posted : July 29, 2021
Last Update Posted : September 27, 2021
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Due to Cat Allergy Drug: REGN1908-1909 Drug: Matching Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 30, 2021
Estimated Primary Completion Date : June 28, 2022
Estimated Study Completion Date : August 17, 2023

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




Primary Outcome Measures :
  1. Daily combined symptom and medication score (CSMS) averaged in patients who receive REGN1908-1909 versus placebo. [ Time Frame: Weeks 0 to 12 ]
    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).


Secondary Outcome Measures :
  1. Daily total nasal symptom score (TNSS) score averaged over the initial 12 weeks of treatment in patients who receive REGN1908-1909 versus placebo [ Time Frame: Weeks 0 to 12 ]
    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.

  2. Daily TNSS averaged over the last 12 weeks of treatment in patients who receive REGN1908-1909 versus placebo [ Time Frame: Weeks 48 to 60 ]
  3. Daily CSMS averaged over the last 12 weeks of treatment in patients who receive REGN1908-1909 versus placebo [ Time Frame: Weeks 48 to 60 ]
  4. Daily total symptom score (TSS) score averaged over the initial 12 weeks of treatment in patients who receive REGN1908-1909 versus placebo [ Time Frame: Weeks 0 to 12 ]
    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)

  5. Daily TSS averaged over the last 12 weeks of treatment in patients who receive REGN1908-1909 versus placebo [ Time Frame: Weeks 48 to 60 ]
  6. Percent change from baseline to the week 12 cat skin prick test (SPT) mean wheal diameter in patients who receive REGN1908-1909 versus placebo [ Time Frame: Baseline to week 12 ]
  7. Percent change from baseline to the end of treatment cat SPT mean wheal diameter in patients who receive REGN1908-1909 versus placebo [ Time Frame: Baseline to week 60 ]
  8. Percent change from baseline to week 12 FEV1 in patients with asthma who receive REGN1908-1909 versus placebo [ Time Frame: Baseline to week 12 ]
  9. Percent change from baseline to week 60 FEV1 in patients with asthma who receive REGN1908-1909 versus placebo [ Time Frame: Baseline to week 60 ]
  10. Daily total ocular symptom score (TOSS) averaged over the initial 12 weeks of treatment in patients who receive REGN1908-1909 versus placebo [ Time Frame: Weeks 0 to 12 ]
    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)

  11. Daily total ocular symptom score (TOSS) averaged over the last 12 weeks of treatment in patients who receive REGN1908-1909 versus placebo [ Time Frame: Weeks 48 to 60 ]
  12. Change from baseline to week 12 FEV1 in patients with asthma who receive REGN1908-1909 versus placebo [ Time Frame: Baseline to week 12 ]
  13. Change from baseline to week 60 FEV1 in patients with asthma who receive REGN1908-1909 versus placebo [ Time Frame: Baseline to week 60 ]
  14. Change from baseline to week 12 Rhinoconjunctivitis Quality of Life Questionnaire for Ages 12+ (RQLQ[S])+12 in patients who receive REGN1908-1909 versus placebo [ Time Frame: Baseline to week 12 ]
    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.

  15. Change from baseline to week 60 RQLQ(S)+12 in patients who receive REGN1908-1909 versus placebo [ Time Frame: Baseline to week 60 ]
  16. Daily medication score (DMS) averaged in patients who receive REGN1908-1909 versus placebo [ Time Frame: Weeks 0 to 12 ]
    The Daily Medication Score (DMS) is calculated by adding points for each pre-specified medication. The scale is 0 (minimum) to 20 (maximum)

  17. DMS averaged in patients who receive REGN1908-1909 versus placebo [ Time Frame: Weeks 48 to 60 ]
  18. Percent change from baseline to week 72 in cat SPT mean wheal diameter in patients who receive REGN1908-1909 versus placebo [ Time Frame: Baseline to week 72 ]
  19. 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 [ Time Frame: Weeks 0 to 12 ]
    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.

  20. Change from baseline to week 12 in Asthma Control Questionnaire 5 Question Version (ACQ-5) in patients with asthma who receive REGN1908-1909 versus placebo [ Time Frame: Baseline to week 12 ]
    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.

  21. 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 [ Time Frame: Baseline to week 60 ]
  22. Daily frequency of asthma rescue medication use, averaged over the initial 12 weeks, in patients with asthma who receive REGN1908-1909 versus placebo [ Time Frame: Weeks 0 to 12 ]
  23. Daily number of nighttime awakenings averaged over the initial 12 weeks in patients with asthma who receive REGN1908-1909 versus placebo [ Time Frame: Weeks 0 to 12 ]
  24. Incidence of treatment-emergent adverse events (TEAEs) throughout the study [ Time Frame: Weeks 0 to 72 ]
  25. Incidence of adverse event of special interests (AESIs) throughout the study [ Time Frame: Weeks 0 to 72 ]
  26. Incidence of serious TEAEs throughout the study [ Time Frame: Weeks 0 to 72 ]
  27. Total REGN1908 concentration in serum over the study duration [ Time Frame: Weeks 0 to 72 ]
  28. Total REGN1909 concentration in serum over the study duration [ Time Frame: Weeks 0 to 72 ]
  29. Incidence of treatment-emergent anti-drug antibodies (ADAs) to REGN1908 throughout the study [ Time Frame: Weeks 0 to 72 ]
  30. Incidence of treatment-emergent ADAs to REGN1909 throughout the study [ Time Frame: Weeks 0 to 72 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 hair and Fel d 1 (≥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 of at least 8/18 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 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04981717


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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United States, Kentucky
Regeneron Study Site Recruiting
Owensboro, Kentucky, United States, 42301
United States, Michigan
Regeneron Study Site Recruiting
Ypsilanti, Michigan, United States, 48187
United States, Montana
Regeneron Study Site Recruiting
Missoula, Montana, United States, 59808
United States, New Jersey
Regeneron Study Site Recruiting
Secaucus, New Jersey, United States, 07094
United States, Oregon
Regeneron Study Site Recruiting
Portland, Oregon, United States, 97202
United States, Pennsylvania
Regeneron Study Site Recruiting
Pittsburgh, Pennsylvania, United States, 15241
United States, Rhode Island
Regeneron Study Site Recruiting
Warwick, Rhode Island, United States, 02886
United States, Wisconsin
Regeneron Study Site Recruiting
Greenfield, Wisconsin, United States, 53228
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04981717    
Other Study ID Numbers: R1908-1909-ALG-2102
2021-002089-42 ( EudraCT Number )
First Posted: July 29, 2021    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
Cat allergy induced allergic rhinitis
Allergic conjunctivitis
Asthma
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Hypersensitivity
Immune System Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate