Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-001074-29
    Sponsor's Protocol Code Number:CLOU064A2201E1
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-07-24
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2019-001074-29
    A.3Full title of the trial
    An open-label, multicenter, extension study to evaluate the long-term safety and tolerability of LOU064 in eligible subjects with CSU who have participated in CLOU064A2201
    Otvorené, multicentrické predĺženie klinického skúšania na zhodnotenie dlhodobej bezpečnosti a znášanlivosti LOU064 u vhodných pacientov s CSU, ktorí ukončili klinické skúšanie CLOU064A2201
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label extension study to evaluate the long-term safety and tolerability of LOU064 in subjects with CSU
    A.4.1Sponsor's protocol code numberCLOU064A2201E1
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04109313
    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 SponsorNovartis Pharma AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Slovakia s.r.o.
    B.5.2Functional name of contact pointDRA information desk
    B.5.3 Address:
    B.5.3.1Street AddressŽižkova 22/B
    B.5.3.2Town/ cityBratislava
    B.5.3.3Post codeSK-811 02
    B.5.3.4CountrySlovakia
    B.5.4Telephone number+421250706116
    B.5.5Fax number+421250706100
    B.5.6E-maildra.slovakia@novartis.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.3.2Product code LOU064
    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 INNRemibrutinib
    D.3.9.2Current sponsor codeLOU064
    D.3.9.4EV Substance CodeSUB178949
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Chronic Spontaneous Urticaria
    E.1.1.1Medical condition in easily understood language
    Chronic Hives
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10072757
    E.1.2Term Chronic spontaneous urticaria
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue 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 assess the long-term safety and tolerability of LOU064 in patients with CSU who have participated in CLOU064A2201
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of LOU064 when given without H1-antihistamines in patients with CSU who have participated in CLOU064A2201 with respect to change from baseline in UAS7, achieving controlled disease (defined by a UAS7≤6), and achieving complete response (defined by a UAS7=0) at Week 4 of treatment.
    - To evaluate the long-term efficacy of LOU064 in patients with CSU who have participated in CLOU064A2201 with respect to maintaining or achieving controlled disease (defined by a UAS7≤6) over time.
    - To evaluate the long-term efficacy of LOU064 in patients with CSU who have participated in CLOU064A2201 with respect to change from
    baseline in UAS7 over time.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Written informed consent must be obtained before any assessment is performed.
    - Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.
    - Subjects must have completed the Week 12 visit (end of treatment period) or the Week 16 visit (end of the follow-up period) of CLOU064A2201 and will be allocated to the treatment period or the observational period of CLOU064A2201E1 based on the UAS7 score (of the 7 days prior to the respective visit) as follows:
    a) Subjects rolling over at Week 12 of CLOU064A2201 with a UAS7≥16 will be allocated to the Treatment period (note: subjects with UAS7<16 at Week 12 are not eligible to rollover into CLOU064A2201E1 but need to enter the follow-up period of CLOU064A2201).
    b) Subjects rolling over at Week 16 of CLOU064A2201 with a UAS7≥16 will be allocated to the Treatment period.
    c) Subjects rolling over at Week 16 of CLOU064A2201 with a UAS7<16 will be allocated to the Observational period.
    E.4Principal exclusion criteria
    - Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days (for small molecules) prior to enrollment or until the expected pharmacodynamic (PD) effect has returned to baseline (for biologics), whichever is longer; or longer if required by local regulations.
    - History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
    - Subjects having a clearly defined, predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact urticaria
    - Other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, or acquired/drug-induced urticaria
    - Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results, eg atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis
    - History or current diagnosis of ECG abnormalities indicating significant risk of safety for subjects participating in the study
    - Patients/subjects taking medications prohibited by the protocol
    - History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
    - Pregnant or nursing (lactating) women
    - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 7 days after stopping study medication.
    - - Major surgery within 8 weeks prior to enrollment or surgery planned prior to end of the treatment period.
    - History of live attenuated vaccine within 6 weeks prior to enrollment or requirement to receive these vaccinations at any time during study drug treatment
    - Evidence of clinically significant cardiac, neurologic, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders or gastrointestinal disease that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participant participation.
    - Uncontrolled disease states, such as asthma, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids.
    - Hematology parameters at last visit before Day 1 of the Treatment period (either last available value from CLOU064A2201 or most recent value taken during observational period): Hemoglobin: < 10 g/dl; Platelets: < 100 000/mm3; White blood cells: < 3 000/mm3; Neutrophils: < 1 500/mm3;
    - Significant bleeding risk or coagulation disorders
    - History of gastrointestinal bleeding, eg in association with use of Nonsteroidal Anti-Inflammatory Drug (NSAID)
    - Requirement for anti-platelet or anticoagulant medication (for example, warfarin, or clopidogrel or Novel Oral Anti-Coagulant - NOAC) other than acetylsalicylic acid (up to 100 mg/d)
    - History or presence of thrombotic or thromboembolic event, or increased risk for thrombotic or thromboembolic event
    - History or current treatment for hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) at last visit before Day 1 of the Treatment period (either last available value from CLOU064A2201 or most recent value taken during observational period)
    - History of renal disease or creatinine level above 1.5x ULN at last visit before Day 1 of the Treatment period (either last available value from CLOU064A2201 or most recent value taken during observational period)
    - Known or suspected history of an ongoing, chronic or recurrent infectious disease including but not limited to opportunistic infections (eg tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis), HIV, Hepatitis B/C
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints will include but not be limited to: occurrence of treatment emergent (serious and non-serious) adverse events during the extension study
    E.5.1.1Timepoint(s) of evaluation of this end point
    56 weeks (treatment plus follow-up period)
    E.5.2Secondary end point(s)
    1. Change from baseline in UAS7 at Week 4
    2. UAS7≤6 response at Week 4
    3. UAS7=0 response at Week 4
    4. UAS7≤ 6 response over time
    5. Change from baseline in UAS7 over time
    E.5.2.1Timepoint(s) of evaluation of this end point
    at Week 4 and over time
    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 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
    Effect of LOU064 on disease-related quality of life
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    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
    Canada
    Japan
    Russian Federation
    United States
    Belgium
    Denmark
    France
    Germany
    Hungary
    Netherlands
    Poland
    Slovakia
    Spain
    United Kingdom
    Czechia
    Argentina
    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
    Study completion is defined as when the last subject finishes their Study Completion visit, and any repeat assessments associated with this visit have been documented and followed-up appropriately by the investigator, or in the event of an early study termination decision, the date of that decision
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days12
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days12
    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: 230
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 156
    F.4.2.2In the whole clinical trial 250
    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)
    A post-trial access program (which may be another extension study or a managed access program) for subjects who complete this study is under consideration.
    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 Decision2019-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-09-09
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 04 22:58:32 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA