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    Summary
    EudraCT Number:2022-002838-13
    Sponsor's Protocol Code Number:CLOU064A2305
    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:2022-12-06
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2022-002838-13
    A.3Full title of the trial
    A multicenter, open-label Phase 3 study: ambulatory blood pressure monitoring in adult patients with chronic spontaneous urticaria inadequately controlled by H1-antihistamines treated with remibrutinib up to 12 weeks
    Otvorené multicentrické klinické skúšanie fázy 3: ambulantné monitorovanie krvného tlaku u dospelých pacientov s chronickou spontánnou urtikáriou nedostatočne zvládnutou H1-antihistaminikami, ktorí sú až 12 týždňov liečení remibrutinibom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate if remibrutinib has an effect on blood pressure in patients with chronic spontaneous urticaria (CSU)
    Štúdia skúmajúca účinok remibrutinibu na tlak krvi u pacientov s chronickou spontánnou urtikáriou
    A.4.1Sponsor's protocol code numberCLOU064A2305
    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+421 2 50706116
    B.5.5Fax number+421 2 50706100
    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.3.1Product nameRemibrutinib
    D.3.2Product code LOU064
    D.3.4Pharmaceutical form Film-coated tablet
    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 CodeSUB204118
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 rule out an increase of >3mmHg in 24-hour average SBP at steady state (Week 4) compared to baseline, measured by ambulatory blood pressure monitoring (ABPM).
    E.2.2Secondary objectives of the trial
    - To evaluate changes in 24-hour average SBP at steady state (Week 4) compared to baseline
    - To evaluate changes in 24-hour average DBP at steady state (Week 4) compared to baseline
    - To evaluate changes in daytime and nighttime average SBP at 4 weeks
    - To evaluate changes in daytime and nighttime average DBP at 4 weeks
    - To evaluate the safety and tolerability of remibrutinib
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    DNA sampling / Pharmacogenetics:
    The study includes an optional genetic research component.
    The purpose of genetic research may be to better understand the safety and efficacy of remibrutinib, or to learn more about human diseases, or to help develop ways to detect, monitor and treat diseases.
    As technology changes over time, the most appropriate technology will be used at the time the exploratory genetic research is performed. This may include the study of the entire genome.
    The use of DNA to search for biomarkers of disease and drug action is exploratory.
    E.3Principal inclusion criteria
    - Signed informed consent must be obtained prior to participation in the study.
    - Male and female adult participants ≥18 years of age at the time of screening.
    - CSU duration for ≥ 6 months prior to screening (defined as the onset of CSU determined by the investigator based on all available supporting documentation).
    - Diagnosis of CSU inadequately controlled by second generation H1-AH at the time of baseline (Day 1) defined as:
    -- The presence of itch and hives for ≥6 consecutive weeks prior to screening despite the use of second generation H1-AH during this time period.
    -- UAS7 score (range 0-42) ≥16, ISS7 score (range 0-21) ≥ 6 and HSS7 score (range 0-21) ≥ 6 during the 7 days prior to baseline (Day 1).
    - Documentation of hives within three months before baseline (either at screening and/or at baseline (Day 1); or documented in the participants` medical history).
    - Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol.
    - Participants must not have had more than two missing UPDD entry (either morning or evening) in the 7 days prior to baseline (Day 1).
    E.4Principal exclusion criteria
    - Use of other investigational drugs within 5 half-lives or within 30 days (for small molecules) prior to Screening or until the expected pharmacodynamic (PD) effect has returned to baseline (for biologics), whichever is longer; or longer if required by local regulations.
    - Previous use of remibrutinib or other BTK inhibitors.
    - History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes.
    - Participants 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 contacturticaria.
    - Ongoing or past history of hypertension and/or SBP ≥140 or ≤90 and/or DBP ≥90 or ≤60 mmHg at screening.
    - Participants unable to tolerate 24-hour ambulatory blood pressure measurement prior to baseline.
    - Participants with an arm circumference greater than 50cm.
    - Other diseases with symptoms of urticaria or angioedema, including but not limited to urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary angioedema, or drug-induced urticaria.
    - Any other skin disease associated with chronic itching that might influence, in the investigator’s opinion, the study evaluations and results, e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis.
    - Participants taking/requiring medications prohibited by the protocol
    - Known history or evidence of ongoing alcohol or drug abuse within the last 6 months before baseline (Day 1).
    - Participants working night shifts.
    - 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.
    - Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, New York Heart Association (NYHA) Class III/IV left ventricular failure, arrhythmia and ongoing hypertension within 12 months prior to Visit 1), neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.
    Significant bleeding risk or coagulation disorders.
    - History of gastrointestinal bleeding.
    - Requirement for antiplatelet medication. The use of acetylsalicylic acid (up to 100mg/day) or clopidogrel (up to 75mg/day) is allowed after the completion of Week 4 visit.
    - Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants (NOAC)).
    - History or current 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) or International Normalized Ratio (INR) of more than 1.5 at screening.

    Other protocol-defined exclusion criteria may apply.
    E.5 End points
    E.5.1Primary end point(s)
    The change in the ABPM-measured 24-hour weighted
    average SBP at Week 4 compared to baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Week 4
    E.5.2Secondary end point(s)
    1. The change in the ABPM-measured 24-hour weighted average SBP at Week 4 compared to baseline
    2. the change in the measured ABPM 24-hour weighted average DBP at Week 4 compared to baseline
    3. the change in the measured ABPM daytime and nighttime weighted average SBP at Week 4
    4. the change in the measured ABPM daytime and nighttime weighted average DBP at Week 4
    5. Occurrence of treatment emergent adverse events and serious adverse events (SAEs) during the study, evaluation of laboratory and vital signs data
    E.5.2.1Timepoint(s) of evaluation of this end point
    At Week 4
    Endpoint #5: End of study
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 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 EEA23
    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
    Argentina
    Singapore
    Canada
    Korea, Republic of
    Turkey
    United States
    France
    Germany
    Slovakia
    Spain
    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 months4
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 123
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 69
    F.4.2.2In the whole clinical trial 136
    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)
    Participants who complete participation in the 12-week treatment period of this trial may be eligible to receive remibrutinib as part of an open-label extension study if they meet the eligibility criteria defined in the extension study protocol. The open-label extension will require endorsement in participating countries and sites as per local laws and regulations.
    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 Decision2023-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
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