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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
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    The EU Clinical Trials Register currently displays   40995   clinical trials with a EudraCT protocol, of which   6701   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Summary
    EudraCT Number:2020-001644-25
    Sponsor's Protocol Code Number:ACE-ID-201/D822FC00001
    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:2020-04-11
    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 number2020-001644-25
    A.3Full title of the trial
    A Phase 2 Randomized Study of the Efficacy and Safety of Acalabrutinib with Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized with COVID-19
    Étude de phase 2 randomisée évaluant l’efficacité et la tolérance de l’acalabrutinib associé aux Meilleurs Soins de Support (Best Supportive Care - BSC) vs Meilleurs Soins de Support chez des patients hospitalisés infectés par le COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Randomized Study of the Efficacy and Safety of Acalabrutinib with Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized with COVID-19
    A.3.2Name or abbreviated title of the trial where available
    CALAVI
    A.4.1Sponsor's protocol code numberACE-ID-201/D822FC00001
    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 SponsorAcerta Pharma B.V.
    B.1.3.4CountryNetherlands
    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 supportAcerta Pharma B.V.
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcerta Pharma B.V.
    B.5.2Functional name of contact pointClinical Trial Call Center
    B.5.3 Address:
    B.5.3.1Street Address121 Oyster Point Blvd
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1888 2929613
    B.5.6E-mailacertamc@dlss.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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/196/15
    D.3 Description of the IMP
    D.3.1Product nameacalabrutinib
    D.3.2Product code ACP-196
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNACALABRUTINIB
    D.3.9.1CAS number 1420477-60-6
    D.3.9.2Current sponsor codeACP-196
    D.3.9.4EV Substance CodeSUB182073
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects with life-threatening COVID-19 symptoms
    E.1.1.1Medical condition in easily understood language
    Subjects with life-threatening COVID-19 symptoms
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overall objective of the study is to evaluate the efficacy of adding acalabrutinib to BSC for the treatment of COVID-19
    E.2.2Secondary objectives of the trial
    To assess pharmacokinetics of acalabrutinib and its active metabolite in subjects with COVID-19 when administered with BSC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For Part 1 (Randomized cohort):
    1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent or have a legal representative provide consent and authorization to use protected health information (in accordance with national and local patient privacy regulations)
    2. Men and women ≥18 years of age at the time of signing the informed consent form
    3. Confirmed COVID-19 infection confirmed per World Health Organization (WHO) criteria (including positive nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other bodily fluid] within 3 weeks of study entry) with suspected pneumonia requiring hospitalization and oxygen saturation <94% on room air or requires 2-5 L/min of oxygen with at least one of the follow laboratory values:
    (a) Ferritin > 300 ng/mL for men and > 150 ng/mL for women
    (b) C-reactive protein (CRP) ≥ 10 mg/L
    (c) D-dimer > 1 mg/L
    (d) Absolute lymphocyte count < 1000 cells/µL
    4. Able to swallow capsules or receive delivery of emptied capsule via a nasogastric (NG) or an enteral feeding tube
    5. Willing to follow contraception guidelines

    For Part 2 Intensive Care Unit (ICU Cohort):
    1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent or have a legal representative provide consent and authorization to use protected health information (in accordance with national and local patient privacy regulations)
    2. Men and women ≥18 years of age at the time of signing the informed consent form
    3. Confirmed COVID-19 infection requiring ICU admission and requiring ≥ 6 L/min of oxygen or PaO2/FiO2 ≤300 mm Hg)
    4. Able to swallow capsules or receive delivery of emptied capsule via a nasogastric (NG) or an enteral feeding tube
    5. Willing to follow contraception guidelines
    E.4Principal exclusion criteria
    For Part 1 and Part 2 (All Subjects):
    1. Pregnant or breast feeding
    2. Are not committed to aggressive management. For example, the subject’s family or primary physician are unwilling to place the subject on mechanical ventilation or an advanced directive to withhold life support, with the exception of cardiopulmonary resuscitation, is present.
    3. Suspected, uncontrolled active bacterial, fungal, viral, or other infection (besides COVID 19)
    4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 x upper limit of normal (ULN) detected within 24 hours at screening (per local lab)
    5. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, congestive heart failure (New York Heart Association [NYHA] Grade 3 or 4), or require home oxygen for a chronic lung disorder. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.
    6. Use of active systemic or inhaled corticosteroids. Subjects who stop active systemic or inhaled corticosteroids before the first dose of acalabrutinib will not be excluded.
    7. Concomitant use of JAK, PI3K, or Btk (other than acalabrutinib) inhibitors with acalabrutinib. Subjects who stop JAK or PI3K inhibitors before the first dose of acalabrutinib will not be excluded. Use of other Btk inhibitors must be stopped 30 days before the first dose of acalabrutinib.
    For Part 1:
    1. In ICU or on invasive mechanical ventilation or ECMO machine before randomization.
    2. Known medical resuscitation within 14 days of randomization

    For Part 2:
    1. Randomization to Part 1
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is treatment failure rate, where treatment failure is defined as use of assisted ventilation or death. For the purpose of this study assisted ventilation is defined as noninvasive ventilation (eg, continuous positive airway pressure [CPAP] ventilation), invasive mechanical ventilation, or ECMO machine
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately 30 days
    E.5.2Secondary end point(s)
    • Number of days alive free of assisted ventilation from randomization/enrollment to 30 days after randomization/enrollment
    • Number of days with assisted ventilator use from randomization/enrollment to 30 days after randomization/enrollment
    • Number of days hospitalized from randomization/enrollment to 30 days after randomization/enrollment
    • Number of days in ICU from randomization/enrollment to 30 days after randomization/enrollment
    • Number of days alive outside of hospital from randomization/enrollment to 30 days after randomization/enrollment
    • Number of days alive outside of hospital from randomization/enrollment to 90 days after randomization/enrollment
    • Type, frequency, severity, and relationship to study treatment of any treatment-emergent adverse events (TEAEs) or abnormalities of laboratory tests, serious adverse events (SAEs), or adverse events (AEs) leading to discontinuation of study treatment.
    • Standard and appropriate pharmacokinetic parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    approximately 30 days and for survival status approximately 90 days
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Best supportive care
    E.8.2.4Number of treatment arms in the trial3
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    France
    Italy
    Spain
    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 years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 128
    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 Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 428
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Teckro Limited
    G.4.3.4Network Country Ireland
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-05
    P. End of Trial
    P.End of Trial StatusCompleted
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