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    Summary
    EudraCT Number:2018-000605-24
    Sponsor's Protocol Code Number:CSL312_2001
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-06-28
    Trial results View 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 number2018-000605-24
    A.3Full title of the trial
    A multicenter, randomized, placebo-controlled, parallel-arm study to
    investigate the efficacy, pharmacokinetics, and safety of CSL312 in
    subjects with hereditary angioedema
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate CSL312 in subjects with hereditary angioedema
    (HAE)
    A.4.1Sponsor's protocol code numberCSL312_2001
    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 SponsorCSL Behring LLC
    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 supportCSL Behring LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCSL Behring LLC
    B.5.2Functional name of contact pointTrial Registration Coordinator
    B.5.3 Address:
    B.5.3.1Street Address1020 First Avenue
    B.5.3.2Town/ cityKing of Prussia
    B.5.3.3Post codePA 19406
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1610 878 4000
    B.5.6E-mailclinicaltrials@cslbehring.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 nameFactor XIIa antagonist monoclonal antibody
    D.3.2Product code CSL312
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFactor XIIa antagonist monoclonal antibody
    D.3.9.2Current sponsor codeCSL312
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution 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
    Hereditary angioedema
    E.1.1.1Medical condition in easily understood language
    Hereditary angioedema (HAE) is a condition characterized by painful,
    recurring attacks of swelling in parts of the body including the face,
    throat, hands, feet, abdomen.
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10019860
    E.1.2Term Hereditary angioedema
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to evaluate the efficacy of CSL312 in the
    prevention of HAE attacks in subjects with C1-INH HAE.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    1. To further evaluate the efficacy of CSL312 in subjects with C1-INH
    HAE
    2. To evaluate the pharmacokinetics of CSL312 in subjects with C1-INH
    HAE
    3. To evaluate the safety and tolerability of CSL312 in subjects with C1-
    INH HAE
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female
    - Aged ≥ 18 to ≤ 65 years
    - A diagnosis of C1-INH HAE or FXII/PLG HAE;
    - For subjects with C1-INH HAE: ≥ 4 HAE attacks over a consecutive 2-
    month period during the 3 months before Screening, as documented in
    the subject's medical record.
    E.4Principal exclusion criteria
    - History of clinically significant arterial or venous thrombosis, or current
    clinically significant prothrombotic risk
    - History of an uncontrolled, abnormal bleeding event due to a
    coagulopathy, or a current clinically significant coagulopathy or clinically
    significant risks for bleeding events
    - Known incurable malignancies
    E.5 End points
    E.5.1Primary end point(s)
    Time normalized number of HAE attacks
    E.5.1.1Timepoint(s) of evaluation of this end point
    13 weeks
    E.5.2Secondary end point(s)
    1. The number of Responder subjects and HAE attack-free subjects with
    C1-INH HAE during Treatment Period 1
    2. The percentage of Responder subjects and HAE attack-free subjects
    with C1-INH HAE during Treatment Period 1
    3. The number of mild, moderate or severe HAE attacks, as well as mild,
    moderate or severe HAE attacks treated with on-demand HAE
    medication, in subjects with C1-INH HAE during Treatment Period 1
    4. The time-normalized number of mild, moderate or severe HAE attacks,
    as well as mild, moderate or severe HAE attacks treated with on-demand
    HAE medication, in subjects with C1-INH HAE during Treatment Period 1
    5. The percentage of mild, moderate or severe HAE attacks, as well as
    mild, moderate or severe HAE attacks treated with on-demand HAE
    medication, in subjects with C1-INH HAE during Treatment Period 1
    6. Maximum concentration (Cmax) of CSL312 in subjects with C1-INH
    HAE during Treatment Period 1
    7. Area under the concentration-time curve in 1 dosing interval (AUC0-
    tau) of CSL312 in subjects with C1-INH HAE during Treatment Period 1
    8. Time of maximum concentration (Tmax) of CSL312 in subjects with
    C1-INH HAE during Treatment Period 1
    9. Terminal elimination half-life (T1/2) of CSL312 in subjects with C1-
    INH HAE during Treatment Period 1
    10. Total systemic clearance (CLtot) of CSL312 in subjects with C1-INH
    HAE during Treatment Period 1
    11 Volume of distribution during the elimination phase (Vz) of CSL312
    in subjects with C1-INH HAE during Treatment Period 1
    12. The number of subjects with C1-INH HAE with adverse events,
    serious adverse events, adverse events of special interest, injection site
    reactions, inhibitory antibodies to CSL312, clinically significant
    abnormalities in laboratory assessment that are reported as adverse
    events during Treatment Period 1
    13. The percentage of subjects with C1-INH HAE with adverse events,
    serious adverse events, adverse events of special interest, injection site
    reactions, inhibitory antibodies to CSL312, clinically significant abnormalities in laboratory assessment that are reported as adverse events during Treatment Period 1
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 to 13: 13 weeks
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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 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 trial6
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    Australia
    Canada
    Denmark
    Germany
    Israel
    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
    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 months7
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days21
    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: 50
    F.1.3Elderly (>=65 years) No
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 14
    F.4.2.2In the whole clinical trial 50
    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)
    Standard of care
    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 Decision2018-11-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-10-15
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