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    Summary
    EudraCT Number:2021-002089-42
    Sponsor's Protocol Code Number:R1908-1909-ALG-2102
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-05
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2021-002089-42
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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.4.1Sponsor's protocol code numberR1908-1909-ALG-2102
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRegeneron Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@regeneron.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameREGN1908
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNREGN1908
    D.3.9.1CAS number 2453195-94-1
    D.3.9.2Current sponsor codeREGN1908
    D.3.9.3Other descriptive nameREGN1908
    D.3.9.4EV Substance CodeSUB130948
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameREGN1909
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNREGN1909
    D.3.9.1CAS number 2453195-99-6
    D.3.9.2Current sponsor codeREGN1909
    D.3.9.3Other descriptive nameREGN1909
    D.3.9.4EV Substance CodeSUB130949
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboLyophilisate for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Allergic Rhino conjunctivitis due to Cat Allergy
    E.1.1.1Medical condition in easily understood language
    Cat-Allergy
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10001708
    E.1.2Term Allergic conditions
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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
    E.2.2Secondary objectives of the trial
    The key secondary objectives are:
    • The key 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 combined symptom and medication score (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 (SPT) with cat allergen
    • To assess the durability of effect in allergic rhinitis and conjunctivitis symptom and medication scores after multiple doses of REGN 1908-1909
    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
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Future Biomedical Research (Optional)
    Patients who agree to participate in the future biomedical research (FBR) sub-study will be required to consent to this optional sub-study before samples are banked for FBR.

    Pharmacogenomic Analysis (Optional)
    Patients who agree to participate in the genomics sub-study will be required to consent to this optional sub-study before collection of the samples.
    E.3Principal inclusion criteria
    1. Generally healthy males and females who are 12 years and older at the time of screening. Note that for those countries where local
    regulations or approvals permit enrollment of adults only, subject recruitment will be restricted to those who are ≥18 years of age.
    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 in the protocol
    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
    6. Willing and able to comply with clinic visits and study-related procedures
    7. Provide informed consent signed by study patient or legally acceptable representative as described in the protocol
    8. Able to understand and complete study-related questionnaires

    Additional protocol-defined inclusion criteria apply
    E.4Principal exclusion criteria
    1. History of significant multiple and/or severe allergies that would potentially interfere with the assessments during the baseline and 12week 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. Forced expiratory volume (FEV)1 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 reevaluated after resolution of symptoms and specified time duration
    7. Any laboratory findings showing evidence of organ dysfunction or any clinically significant deviation from the normal range, as decided by the
    Investigator at the screening visit as defined in the protocol
    8. Any medical illness, which in the judgment of the investigator could preclude participation in the study or in whom treatment with epinephrine or beta-2 agonists or systemic corticosteroids would pose an increased risk (eg, history of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease etc.)
    9. History of life-threatening asthma, defined as an asthma episode that required intubation, and/or was associated with hypercapnia, respiratory arrest, and/or hypoxic seizures
    10. History of intensive care hospitalization for asthma within past 2 years
    11. Positive serum human chorionic gonadotropin pregnancy test at the screening visit or randomization visit for women of childbearing 1. History of significant multiple and/or severe allergies that would potentially interfere with the assessments during the baseline and 12week efficacy assessment periods or confound results, per investigator potential (WOCBP) as described in the protocol

    Additional protocol-defined exclusion criteria apply
    E.5 End points
    E.5.1Primary end point(s)
    Daily combined symptom and medication score (CSMS) averaged over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 48 to 60
    E.5.2Secondary end point(s)
    •1. Daily total nasal symptom score (TNSS), averaged over the last 12
    weeks of treatment period, in patients who receive REGN1908-1909
    versus placebo
    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
    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
    4. Daily total symptom score (TSS), averaged over the last 12 weeks of
    the treatment period, in patients who receive REGN1908-1909 versus
    placebo
    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
    6. Percent change from baseline to the end of treatment in cat SPT mean
    wheal diameter in patients who receive REGN1908-1909 versus placebo
    7. Daily CSMS, averaged over the initial 12 weeks of the treatment
    period, in patients who receive REGN1908-1909 versus placebo
    8. Daily TNSS, averaged over the initial 12 weeks of treatment period, in
    patients who receive REGN1908-1909 versus placebo
    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
    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
    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
    12. Daily TSS score, averaged over the initial 12 weeks of the treatment
    period, in patients who receive REGN1908-1909 versus placebo
    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
    14. Daily total ocular symptom score (TOSS), averaged over the last 12
    weeks of the treatment period, in patients who receive REGN1908-1909
    versus placebo
    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
    16. Percent change in FEV1 in patients with asthma who receive
    REGN1908-1909 versus placebo
    17. Percent change in FEV1 in patients with asthma who receive
    REGN1908-1909 versus placebo
    18. Percent change in cat skin prick test (SPT) mean wheal diameter in
    patients who receive REGN1908-1909 versus placebo
    19. Change in FEV1 in patients with asthma who receive REGN1908-1909
    versus placebo
    20. Change in FEV1 in patients with asthma who receive REGN1908-1909
    versus placebo
    21. Change in RQLQ(S)+12 in patients who receive REGN1908-1909
    versus placebo
    22. Daily medication score (DMS), averaged over the initial 12 weeks of
    the treatment period, in patients who receive REGN1908-1909 versus
    placebo
    23. DMS, averaged over the last 12 weeks of the treatment period, in
    patients who receive REGN1908-1909 versus placebo
    24. 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
    25. Percent change from baseline to end of study in cat SPT mean wheal
    diameter in patients who receive REGN1908-1909 versus placebo
    26. 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
    27. 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
    28. Daily TOSS, averaged over the initial 12 weeks of the treatment
    period, in patients who receive REGN1908-1909 versus placebo
    29. Change in Asthma Control Questionnaire 5 Question Version (ACQ-5)
    in patients with asthma who receive REGN1908-1909 versus placebo
    30. 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
    31. 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
    32. Incidence of treatment-emergent adverse events (TEAEs), adverse
    event of special interest (AESIs), and serious TEAEs throughout the
    study
    33. Total REGN1908 and REGN1909 concentration in serum over the
    study duration
    34. Incidence of treatment-emergent anti-drug antibodies (ADAs) to
    REGN1908 and REGN1909 throughout the study
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-5: Weeks 48 to 60
    6. Week 60
    7-13: Weeks 0 to 12
    14-15: Weeks 48 to 60
    16. Baseline to week 12
    17. Baseline to week 60
    18-19: Baseline to week 12
    20-21: Change from baseline to week 60
    22: Weeks 0 to 12
    23-24: Weeks 48 to 60
    25: Week 72
    26: Weeks 0 to 12
    27: Weeks 48 to 60
    28: Weeks 0 to 12
    29: Baseline to week 60
    30: Weeks 0 to 12
    31: Weeks 48 to 60
    32-34: Weeks 0 to 72
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Canada
    France
    Germany
    Poland
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of study is defined as the date the last patient completes the last study visit or withdraws from the study, or is lost to follow-up (ie, the study patient can no longer be contacted by the investigator).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months23
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months25
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 65
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 65
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    pediatric patients cannot legally consent personally (they are providing assent and the parent provides consent)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state93
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 315
    F.4.2.2In the whole clinical trial 630
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-18
    P. End of Trial
    P.End of Trial StatusOngoing
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