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    Summary
    EudraCT Number:2018-002477-22
    Sponsor's Protocol Code Number:R1908-1909-ALG-1703
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-09-27
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-002477-22
    A.3Full title of the trial
    A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY IN CAT-ALLERGIC PATIENTS WITH ASTHMA TO EVALUATE THE EFFICACY OF A SINGLE DOSE OF REGN1908-1909 TO REDUCE BRONCHOCONSTRICTION UPON CAT ALLERGEN CHALLENGE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A STUDY IN CAT-ALLERGIC PATIENTS WITH ASTHMA TO EVALUATE THE EFFICACY OF REGN1908-1909
    A.4.1Sponsor's protocol code numberR1908-1909-ALG-1703
    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 codeNY 10591
    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.3.2Product code REGN1908
    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.3.9.2Current sponsor codeREGN1908
    D.3.9.3Other descriptive nameHUMAN IGG4 MONOCLONAL ANTIBODY
    D.3.9.4EV Substance CodeSUB33114
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    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.3.2Product code REGN1909
    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.3.9.2Current sponsor codeREGN1909
    D.3.9.3Other descriptive nameHUMAN IGG4 MONOCLONAL ANTIBODY
    D.3.9.4EV Substance CodeSUB33114
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    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
    Cat-allergic asthma and Bronchoconstriction Upon Cat Allergen Challenge
    E.1.1.1Medical condition in easily understood language
    Cat-allergic asthma
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001705
    E.1.2Term Allergic asthma
    E.1.2System Organ Class 100000004855
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10006464
    E.1.2Term Bronchoconstriction
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the prophylactic efficacy of REGN1908-1909 (anti-Felis silvestris catus (domestic cat) allergen 1 (Fel d 1)) administered as a single dose on day 1 in cat-allergic asthmatic patients not living with a cat in the prevention of a Controlled Cat Allergen Challenge induced Early Asthmatic Response (EAR) assessed by measures of lung function (Forced expiratory volume in one second: FEV1) compared to placebo-treated patients on day 8.
    E.2.2Secondary objectives of the trial
    - To evaluate the prophylactic efficacy of REGN1908-1909, compared to placebo, administered as a single dose on day 1 in cat-allergic asthmatic patients not living with a cat in the prevention of a controlled cat allergen challenge-induced:
    *early asthmatic response (EAR), assessed by measures of lung function (FEV1), on days 29, 57, and 85
    *allergic rhinitis symptoms, assessed by total nasal symptom score, on days 8, 29, 57, and 85
    *ocular symptoms, assessed by total ocular symptom score, on days 8, 29, 57, and 85
    - To evaluate the prophylactic efficacy of REGN1908-1909 administered as a single dose on day 1 in cat-allergic asthmatic patients not living with a cat to increase the exposure to cat allergen required to induce EAR in a controlled cat allergen challenge as compared to placebo patients
    - To evaluate the safety and tolerability of REGN1908-1909 vs placebo in patients with cat allergen-triggered asthma
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Generally healthy men and women between the ages of 18 and 65 inclusive at the time of screening.
    2. Documented history (for at least 2 years) of symptomatic cat hair-triggered asthma with rhinitis with or without conjunctivitis as defined by all of the following criteria:
    a. Positive skin prick test (SPT) with cat hair extract (mean wheal diameter at least 5 mm greater than a negative control) at screening
    b. Positive allergen-specific IgE (sIgE) tests for cat hair and Fel d 1 (> 0.35 kAU/l at screening)
    c. History of asthma GINA 1
    d. Screening FEV1 ≥ 70% predicted after withholding long-acting β2-agonists for > 36 hours and short-acting β2-agonists for > 6 hours
    e. Screening asthma control test (ACT) ≥ 20 at all screening visits
    f. Demonstrated ≥ 20% fall in FEV1 within 2 hours during Cat Allergen Challenge in EEU and ability to withstand exposure for at least 10 minutes during screening
    3. Willing and able to comply with clinic visits and study-related procedures
    4. Provide informed consent signed by study patient or legally acceptable representative
    5. Patients covered by health social identification number
    6. Able to understand and complete study related questionnaires
    7. No cat exposure at home for the past year and must continue having no exposure at home during the study; cat exposure outside of the home shall be avoided for at least one week prior to any Cat Allergen Challenge and during the defined follow-up period.
    8. Less than 10 pack-years of smoking history
    E.4Principal exclusion criteria
    1. Patients who experience a ≥ 10% fall in FEV1 at 3 consecutive spirometry measurements during the placebo challenge
    2. History of significant multiple and/or severe allergies (including latex gloves) or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food
    3. History of severe anaphylactic or severe asthmatic reactions to cat exposure
    4. Active lung disease other than asthma
    5. Persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals, or any untreated respiratory infections within 4 weeks prior to screening
    6. Use of systemic corticosteroids within 8 weeks prior to screening visit 1
    7. Use of anti-IgE or other biological therapy within 6 months prior to screening visit 1
    8. History of SIT with cat allergen or vaccines against cat allergy within 5 years of screening visit 1
    9. SIT with any allergen within 6 months prior to screening visit 1
    10. Significant rhinitis (causing TNSS>2), or sinusitis, due to daily contact with other allergens causing symptoms that are expected to coincide with the baseline or the final cat allergen exposure unit assessments as assessed by the investigator, before each exposure
    11. Patients who anticipate major changes in allergen exposure in their home or work environments that are expected to coincide with the baseline or the final cat allergen exposure assessments as assessed by the investigator
    12. 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
    13. Treatment of asthma requiring systemic (oral or parenteral) corticosteroid treatment more than twice within 12 months or once within 3 months prior to screening or has been hospitalized or has attended the ER/Urgent Care facility for asthma more than twice in prior 12 months before screening.
    14. Pregnant or breastfeeding women
    E.5 End points
    E.5.1Primary end point(s)
    Time to Early Asthmatic Response (EAR) upon Controlled Cat Allergen Challenge in an Environmental Exposure Unit (EEU)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 8
    E.5.2Secondary end point(s)
    1 - Time to EAR upon Controlled Cat Allergen Challenge in an EEU on days 29, 57, and 85
    2 - AUC of the percent change (%/h) in FEV1 induced by a Controlled Cat Allergen Challenge over the exposure interval (%/h) from baseline to the Controlled Cat Allergen Challenge on days 8, 29, 57, and 85
    3 - AUC of the percent change (%/h) in patient-assessed nasal symptoms induced by a Controlled Cat Allergen Challenge over the exposure interval (%/h) from baseline to the Controlled Cat Allergen Challenge on days 8, 29, 57, and 85
    4 - AUC of the percent change (%/h) in patient-assessed ocular symptoms induced by a Controlled Cat Allergen Challenge over the exposure interval (%/h) from baseline to the Controlled Cat Allergen Challenge on days 8, 29, 57, and 85
    5 - Change and percent change in cat allergen quantity as experienced by patients during exposure (measured by 40 ng/m3 x minute ventilation x time) on days 8, 29, 57, and 85
    6 - Incidence rates of treatment-emergent adverse events (TEAEs) and serious TEAEs through end of study
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 29, 57, and 85 for timepoint 1.
    Days 8, 29, 57, and 85 for timepoints 2 to 5.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Genomic analysis (DNA and RNA)
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.7.1Other trial design description
    Proof of Concept study
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 57
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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)
    No, this is not applicable in this study with a single dose treatment.
    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 Decision2018-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-04-06
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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