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    Summary
    EudraCT Number:2021-002062-40
    Sponsor's Protocol Code Number:UMCN-AKF-21.04
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-11-22
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-002062-40
    A.3Full title of the trial
    Pharmacokinetic study with a loading dose of clofazimine in adult patients with nontuberculous mycobacterial disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Blood concentrations of clofazimine after a higher starting dose ('loading dose') in adult patients with infections caused by nontuberculous mycobacteria
    A.3.2Name or abbreviated title of the trial where available
    C-LOAD
    A.4.1Sponsor's protocol code numberUMCN-AKF-21.04
    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 SponsorRadboud university medical center
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRadboud university medical center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud university medical center
    B.5.2Functional name of contact pointRob Aarnouste
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein-Zuid 10
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31243617744
    B.5.5Fax number+31243668755
    B.5.6E-mailrob.aarnoutse@radboudumc.nl
    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 Yes
    D.2.1.1.1Trade name Lamprene
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Capsule
    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 INNClofazimine
    D.3.9.1CAS number 2030-63-9
    D.3.9.3Other descriptive nameCLOFAZIMINE
    D.3.9.4EV Substance CodeSUB06694MIG
    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
    Nontuberculous mycobacterial disease
    E.1.1.1Medical condition in easily understood language
    Infection caused by nontuberculous mycobaceria
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overarching aim of this study is to contribute to dose optimization of CFZ in the treatment of NTM diseases.

    The primary objective of this study is to describe the PK of CFZ, after 4 weeks of treatment with a loading dose regimen of 300 mg once daily, in adult patients with NTM disease.
    E.2.2Secondary objectives of the trial
    Secondary objectives are:
    • To compare the PK of CFZ after the loading dose phase in this study, quantified by the highest measured concentrations at approximately 1 and 4 months of treatment, with the same metric measured in a reference study without loading dose (the PERC study; EudraCT number 2015-003786-28).
    • To compare the predicted time to reach steady state concentrations of CFZ with and without a loading dose.
    • To predict PK parameters of CFZ, including AUC0-24, Cmax and C0, based on sparse sampling at approximately 1 and 4 months of treatment in both this study and the reference study.
    • To evaluate the adequacy of the existing population PK model for CFZ derived in TB patients for application in the NTM population.
    • To assess the safety and tolerability of CFZ in this study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - The participant is diagnosed with pulmonary or extrapulmonary NTM disease and is eligible for treatment with CFZ
    - The participant is at least 18 years of age
    - The participant has a body weight (in light clothing and with no shoes) of at least 45 kg
    - The participant is able and willing to provide written, informed consent
    E.4Principal exclusion criteria
    - The participant is in poor general condition where participation in the study cannot be accepted per discretion of the Investigator
    - There is evidence showing the participant has clinically significant metabolic, gastrointestinal, or other abnormalities that could possibly alter the PK of CFZ
    - The participant is diagnosed with cystic fibrosis*
    - The participant has a prolongation of the QTc interval, > 450 milliseconds for males and > 460 milliseconds for females, on the screening ECG
    - The participant has abnormal alanine aminotransferase (ALT) and/or aspartate transferase (AST) levels of > 3 times the upper limit of the laboratory reference range at screening
    - The participant is pregnant or is using inadequate contraceptive measures (if applicable)
    - The participant is breastfeeding
    - The participant has a known or suspected, current drug or alcohol abuse, that is, in the opinion of the Investigator, sufficient to compromise the safety or cooperation of the patient
    - The participant has as history of allergy/hypersensitivity to CFZ
    - The participant has received clofazimine in the past 3 months before inclusion with the exception of short-term use of no more than 7 days in the period of 1 to 3 months before inclusion
    E.5 End points
    E.5.1Primary end point(s)
    The primary study parameters of this study are the PK parameters of CFZ at day 28 of treatment, including AUC0-24, Cmax, and C0, after a loading dose regimen of 300 mg once daily for 4 weeks in adult patients with pulmonary or extrapulmonary NTM disease.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pharmacokinetic (PK) samples (a PK curve) will be collected from patients at Day 28 of the study after the intake of the last dose of 300 mg.
    E.5.2Secondary end point(s)
    Secondary study parameters are:
    • Difference between the highest measured concentrations of CFZ in this study and a reference study (PERC study; EudraCT number 2015-003786-28) after approximately 1 and 4 months of treatment.
    • The predicted time to reach steady state concentrations with and without a loading dose.
    • The predicted PK parameters, including AUC0-24, Cmax and C0, after approximately 1 and 4 months of treatment in both this study and a reference cohort (i.e. PERC study).
    • The performance of the existing population PK model for CFZ derived in TB patients for the NTM population.
    • Safety and tolerability of CFZ in this study, assessed by the occurrence and grading of adverse events.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pharmacokinetic (PK) samples will be collected from patients at Day 28, Day 29 and after 4 months of treatment.
    In addition, adverse events will be evaluated during scheduled visits or Phone calls (visits 1-6 at Day 1, 7, 28, 29, 1 month and 4 months respectively. In addition, a Phone call is scheduled after 3 months).
    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 No
    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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 months6
    E.8.9.1In the Member State concerned days
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    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 state10
    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)
    During the last 3 months of the study, patients already receive the regular treatment that is appropriate for their disease. After the end of the study, the treating physician determines whether or not and for how long the treatment needs to be continued.
    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 Decision2021-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-15
    P. End of Trial
    P.End of Trial StatusOngoing
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