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    Summary
    EudraCT Number:2022-003170-23
    Sponsor's Protocol Code Number:HCQPET
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-09-30
    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 ConcernedFinland - Fimea
    A.2EudraCT number2022-003170-23
    A.3Full title of the trial
    Prospective, randomized, double-blind, placebo-controlled, single-center comparative trial evaluating oral hydroxychloroquine 200 mg BID for reducing microglial activation in the brain of patients with progressive multiple sclerosis (MS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Hydroxychloroquine in progressive MS
    Hydroksiklorokiinin vaikutus MS-taudin etenemiseen
    A.4.1Sponsor's protocol code numberHCQPET
    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 SponsorVarsinais-Suomen sairaanhoitopiirin kuntayhtymä
    B.1.3.4CountryFinland
    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 supportFunding will be applied from US Department of Defense Multiple Sclerosis Research Program,
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVarsinais-Suomen sairaanhoitopiirin kuntayhtymä
    B.5.2Functional name of contact pointVarsinais-Suomen sairaanhoitopiirin
    B.5.3 Address:
    B.5.3.1Street AddressKiinamyllynkatu 4-8
    B.5.3.2Town/ cityTurku
    B.5.3.3Post code20521
    B.5.3.4CountryFinland
    B.5.6E-maillaura.airas@utu.fi
    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 Oxiklorin
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Corporation
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 nameOxiklorin
    D.3.4Pharmaceutical form 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 INNHydroxychloroquine sulfate
    D.3.9.1CAS number 747-36-4
    D.3.9.4EV Substance CodeSUB02587MIG
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Progressive multiple sclerosis
    E.1.1.1Medical condition in easily understood language
    Progressive MS
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10053395
    E.1.2Term Progressive multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system 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 examine the impact of HCQ treatment on TSPO-PET–measurable microglial activation in supratentorial cerebral white matter (excluding T1 lesions) in a progressive MS patient population, and to evaluate the safety and tolerability of the drug in patients with progressive MS
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of HCQ in the study population for the duration of the study
    To assess the effect of HCQ on following parameters when compared to placebo group
    - disease progression measured with T25FW or 9HPT
    - cognition, measured with neuropsychological evaluation
    - quality of life or fatigue, measured with the RAND-36, MSIS-29, MFIS and FSS questionnaires
    - MRI volumetric measures in the lesional and non-lesional brain regions of interest
    - the number of TSPO-PET-measurable or QSM iron rim+ chronic active lesions
    - the proportion of TSPO-PET-detectable active voxels at the rim of chronic lesions and in the NAWM (change in proportion of active voxels)
    - TSPO-PET signal (distribution volume ratio) at the edges of chronic lesions and in the NAWM
    - sNfL and sGFAP levels in blood
    - neuroaxonal damage as measured by DTI-MRI parameters
    To assess the impact of HCQ treatment on brain synaptic density as measured by UCB-J PET in patients with progressive MS
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Written informed consent obtained
    2.Men and women who are 35-65 years of age at time of consent
    3.With Primary Progressive Multiple Sclerosis, according to current diagnostic criteria (Polman et al., 2005) or non-active Secondary Progressive Multiple Sclerosis (nSPMS, with no relapses in the last 2 years)
    4.Screening Expanded Disability Status Scale (Kurtzke, 1983) (EDSS) score between 3.5 and 7.0 at screening.
    5.Worsening of MS symptoms or enlarging of T1 lesions in brain MRI during the previous 2 years The worsening of MS symptoms can be indicated as an increase in total EDSS, or as an increase in points in Kurzke’s functional system evaluation over the last two years. Enlargement of T1 lesions is determined by visual inspection by the treating neurologist or clinical neuroradiologist.
    6.Patients must, in the investigator’s opinion, exhibit reliability and physiologic capability (e.g., sufficient vision, hearing, etc.) to comply with all protocol procedures, and have attained an educational achievement of minimum 8th grade
    7.Patients must be fluent in the Finnish language
    E.4Principal exclusion criteria
    1.Patients undergoing treatment with other antimalarial drugs, amiodarone, dapsone or digoxin, other drugs associated with a significant risk for QT prolongation, systemic glucocorticoids, or immunorupressing drugs mitoxantrone, cyclophosphamide, natalizumab, alemtuzumab or cladribine
    2.Patients with other neurodegenerative disease or other significant neurological disease than MS (including epilepsy); patients with any generalized seizures within one year of screening are also excluded
    3.Patients with known significant spinal cord lesion burden, where clinical worsening is likely due to spinal cord involvement rather than brain involvement. This is assessed by the treating neurologist.
    4.Patients with major psychiatric illness in the past 3 years prior to screening
    5.Any suicidal behavior in the past 1-year period prior to screening or during the screening period
    6.Suicidal ideation type 5 in the C-SSRS (i.e. active suicidal thought with plan and intent) in the past 6 months prior to screening or during the screening period; patients with suicidal ideation type 4 in the C-SSRS
    7.Positive urine test result for drugs of abuse at the screening or baseline visit, unless explained in a manner acceptable by the investigator by the patient’s medical history and concomitant medications
    8.Patients whose screening ophthalmological examination shows retinopathy
    9.Patients whose screening MRI scan shows gadolinium enhancing lesions
    10.Patients with significant abnormal findings other than MS-related in the screening MRI
    11.Patients with moderate or severe renal insufficiency
    12.Patients with indication of liver disease
    13.Active infection with hepatitis B or C virus
    14.Patients with known active infection with the SARS-CoV-2 virus within the last 35 days prior to the baseline visit
    15.Patients with known porphyria or psoriasis
    16.Patients with known allergy or other intolerability to HCQ, or to gadolinium MRI contrast agent
    17.Patients who are unable or unwilling to undergo gadolinium enhanced MRI scans
    18.Patients with claustrophobia, or a history of moderate-to-severe anxiety disorder or panic attacks
    19.Pregnant or breast-feeding women, and women of child-bearing potential (WOCBP) with heterosexual relationships who are not capable or willing to use highly effective birth control measures
    20.Exposure to experimental radiation in the past 12 months such that radiodosimetry limits would be exceeded by participating in this study
    21.Patients with intolerance to previous PET scans
    22.Participation in another investigational drug trial in the 3 months prior to baseline, or within 4 elimination half-lives of the trial medication, whichever is longer
    23.Patients who are using systemically acting glucocorticoids during the study period; use of topical formulations (ointments, nasal sprays, eye drops etc.) is allowed
    24.Evidence of current or history of any significant autoimmune disease that, in the opinion of the investigator, could interfere with evaluation of the study results or constitute a health hazard for the subject
    25.Evidence of an immune system that is compromised; including, but not limited to, a diagnosis of HIV; or the subject has been splenectomised or has received an organ transplant (corneal transplants excluded)
    26.Diagnosis of cancer (haematological or solid tumour) for which the subject is currently being treated, or for which there is evidence of active disease. Subjects with local prostate cancer or local dermatological tumours, such as basal or squamous cell carcinoma, may be included
    27.Any of the following, according to the judgment of the investigator:
    1.Clinically significant abnormal finding of the physical examination, vital signs (including blood pressure and heart rate), ECG, or laboratory value that would jeopardize the patient’s safety while participating in the trial or capability to participate in the trial, or confound the assessments of the trial
    2.Symptomatic/uncontrolled/unstable or clinically relevant concomitant disease or any other clinical condition that would jeopardize the patient’s safety while participating in the trial or capability to participate in the trial, or confound the assessments of the trial
    3.Significant or unstable physical condition that may require change to concomitant medication or hospitalization that would impact the assessments of the trial
    4.Planned major surgery requiring withdrawal from study medication for more than 2 weeks during the study period
    28.Patients with artificial cardiac pacemaker or other metal implants that might interfere with the MRI procedures; patients with tattoos, history as metal workers or history of metallic foreign objects in the body need to be evaluated by the investigator for MRI-related risks before inclusion in the study
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this study will be change in proportion of active voxels in supratentorial cerebral white matter (excluding T1 lesions) in the end-of-treatment TSPO-PET images vs. baseline TSPO-PET images in patients with progressive MS treated with HCQ vs. placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and 12 months
    E.5.2Secondary end point(s)
    PET-based endpoints
    -To assess the effect of HCQ on the number of TSPO-PET-measurable chronic active lesions when compared to placebo group
    -To assess the effect of HCQ on the proportion of TSPO-PET-detectable active voxels at the rim of chronic lesions when compared to placebo group (change in proportion of active voxels)
    -To assess the effect of HCQ on the proportion of TSPO-PET-detectable active voxels in the NAWM when compared to placebo group (change in proportion of active voxels)
    -To assess the effect of HCQ on TSPO-PET signal (DVR, distribution volume ratio) at the rim of chronic lesions when compared to placebo group
    -To assess the effect of HCQ on TSPO-PET signal (DVR, distribution volume ratio) in the NAWM when compared to placebo group
    -To assess the impact of HCQ treatment on brain synaptic density as measured by 11C-UCB-J PET in patients with progressive MS
    MRI-based endpoints:
    -To assess the effect of HCQ on the number of QSM positive iron rim lesions when compared to placebo group
    -To assess the effect of HCQ on MRI volumetric measures in the brain regions of interest when compared to placebo group
    -To assess the effect of HCQ on T1 and T2 lesion burden using MRI when compared to placebo group
    -To assess the effect of HCQ on neuroaxonal damage as measured by DTI-MRI parameters (FA, MD, AD and RD) when compared to placebo group
    Clinical endpoints:
    -To assess the safety and tolerability of HCQ in the study population for the duration of the study
    -To assess the effect of HCQ on disease progression as measured with the T25FW when compared to placebo group
    -To assess the effect of HCQ on hand dexterity as measured with the 9HPT when compared to placebo group
    -To assess the effect of HCQ on cognition, as measured with neuropsychological evaluation when compared to placebo group
    -To assess the effect of HCQ on health-related quality of life, as measured with the RAND-36 and MSIS-29 questionnaires when compared to placebo group
    -To assess the effect of HCQ on fatigue, as measured with the MFIS and FSS questionnaires when compared to placebo group
    -To assess the effect of HCQ on neuroaxonal damage as measured with sNfL and sGFAP when compared to placebo group
    E.5.2.1Timepoint(s) of evaluation of this end point
    PET-based endpoints: At baseline and at 12 months
    MRI-based endpoints: At screening and at 12 months
    Biomarkers: baseline, 6, 12, 14 months

    Clinical endpoints:
    Safety: screening, baseline, 1, 3, 6, 9, 12, 14 months
    T25FT and 9HPT: baseline, 6, 12 months
    Neuropsychological: baseline and 12 months
    Quality of life: baseline, 1, 6, 12, 14 months
    Fatigue: baseline, 1, 6, 12, 14 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 Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    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 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 trial2
    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 years3
    E.8.9.1In the Member State concerned months
    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: 29
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state30
    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)
    The participants will not be offered a possibility to continue on the study medication after the trial has been completed. Off-label use of any approved medication is legally acceptable in Finland, but this will only be possible under the responsibility of the treating physician. The study team will not assume responsibilities relating to patient care after the trial, but pertinent information will be shared with the patients and entered into their medical records at Turku University Hospital
    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 Decision2022-10-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-20
    P. End of Trial
    P.End of Trial StatusOngoing
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