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    Summary
    EudraCT Number:2018-000727-13
    Sponsor's Protocol Code Number:MRG106-11-201
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-11-13
    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 ConcernedAustria - BASG
    A.2EudraCT number2018-000727-13
    A.3Full title of the trial
    SOLAR: A Phase 2, Randomized, Open-label, Parallel-group, Active Comparator, Multi-center Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) in Subjects with Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects with Mycosis Fungoides
    A.3.2Name or abbreviated title of the trial where available
    SOLAR
    A.4.1Sponsor's protocol code numberMRG106-11-201
    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 SponsormiRagen Therapeutics, Inc.
    B.1.3.4CountryUnited States
    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 supportmiRagen Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationmiRagen Therapeutics, Inc.
    B.5.2Functional name of contact pointSOLAR Clinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address6200 Lookout Road
    B.5.3.2Town/ cityBoulder
    B.5.3.3Post codeCO 80301
    B.5.3.4CountryUnited States
    B.5.6E-mailSOLAR@miragen.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 numberEU/3/17/1872
    D.3 Description of the IMP
    D.3.1Product namecobomarsen
    D.3.2Product code MRG-106
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOBOMARSEN
    D.3.9.1CAS number 1848257-52-2
    D.3.9.2Current sponsor codeMRG-106
    D.3.9.4EV Substance CodeSUB192820
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number141
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Zolinza
    D.2.1.1.2Name of the Marketing Authorisation holderMerck and Co., Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 namevorinostat
    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 INNvorinostat
    D.3.9.1CAS number 149647-78-9
    D.3.9.3Other descriptive nameVORINOSTAT
    D.3.9.4EV Substance CodeSUB23356
    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
    Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype
    E.1.1.1Medical condition in easily understood language
    A cancer of the lymphatic system that affects the skin
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10028483
    E.1.2Term Mycosis fungoides
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the trial is to evaluate the efficacy of cobomarsen in subjects with MF.
    E.2.2Secondary objectives of the trial
    • Investigate the safety and tolerability of cobomarsen in subjects with MF.
    • Characterize the population pharmacokinetics (PK) of cobomarsen in subjects with MF.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Must provide written informed consent (signed and dated) and any authorizations required by law and be able to comply with all study requirements.
    • Males or females, ≥ 18 years of age at the time of informed consent.
    • Biopsy-proven CTCL, MF subtype.
    • Clinical stage IB, II or III, with staging based on Screening assessments.
    • Minimum mSWAT score of 10 at Screening.
    • Receipt of at least one prior therapy for CTCL (per the National Comprehensive Cancer Network [NCCN] guidelines for generalized skin involvement; e.g., topical, phototherapy, Total Skin Electron Beam Therapy [TSEBT] or systemic therapy).
    • Subjects of childbearing potential must agree to use highly effective methods of contraception as defined in the protocol.
    E.4Principal exclusion criteria
    • Previous enrollment in a cobomarsen study.
    • Prior therapy with vorinostat or other HDAC inhibitors, or contraindication to an HDAC inhibitor.
    • Sézary syndrome or mycosis fungoides with B2 involvement.
    • Current evidence of large cell transformation (LCT), defined as > 25% of the lymphocytes at least 4 × the size of normal lymphocytes. Current evidence refers to LCT diagnosis from biopsy performed within 4 months prior to randomization. Subjects with a history of LCT but with a negative current biopsy (within 4 months) are eligible, provided there is no clinical indication for chemotherapy.
    • Evidence of enlarged peripheral or central lymph node(s) > 1.5 cm in the long diameter or > 1.0 cm in the short diameter, by radiographical imaging at Screening. A subject with one or more enlarged lymph node(s) may be allowed, provided that a representative lymph node has been confirmed (via biopsy or positron emission tomography [PET] scan) to be N0-N2 or SUV ≤ 5 within the 3 months prior to Day 1, and there has not been an appearance of new abnormal lymph nodes since the biopsy or PET scan. Subjects with uncharacterized enlarged lymph nodes (i.e. not confirmed by biopsy or PET scan) will not be allowed.
    • Any palpable peripheral node, regardless of size, that on physical examination is firm, irregular, clustered, or fixed, unless histologically confirmed to be non-malignant.
    • Evidence of visceral involvement related to MF at Screening.
    • Receipt of any the following treatments:
    - Macrolide or tetracycline antibiotics within 28 days prior to Screening;
    - More than 3 short courses (≤7 days) of prednisone equivalent > 10 mg per day within 8 weeks prior to Screening; however, a stable regimen of systemic prednisone equivalent to ≤ 10 mg per day (or steroid equivalent) is permitted;
    - Total skin electron beam therapy or radiotherapy within 4 weeks prior to Screening;
    - Investigational small molecule drug within 5 half-lives prior to Screening;
    - Investigational biologic drug within 5 half-lives prior to Screening;
    - Phototherapy within 4 weeks prior to Screening;
    - Antibody-directed or immunoglobulin-based immune therapy or other monoclonal antibody therapies within 8 weeks prior to Screening;
    - Previous chronic (more than 20 days total) high potency topical corticosteroid use within 4 weeks of Screening. Stable doses of low to medium potency topical corticosteroids are allowed;
    - Previous chronic (more than 20 days total) use of topical MF treatments (not listed in the bullets above) within 4 weeks prior to Screening;
    - Previous systemic MF treatments (not listed in the bullets above) within 4 weeks prior to Screening;
    - Previous treatment with an oligonucleotide.
    - Patients on chronic prophylactic (for prevention, more than 20 days per month) nonsteroidal antipruritic medications within 4 weeks of screening are excluded. Patients on symptomatic (for current symptoms) stable nonsteroidal antipruritic medications (dose and frequency remain the same for at least 1 month prior to screening) for symptomatic pruritus are allowed.
    • Clinically significant liver disease within 1 year prior to Screening.
    • Positivity for human immunodeficiency virus (HIV), Hepatitis B surface antigen, or Hepatitis C at the time of Screening,
    • Clinically significant anemia, neutropenia or thrombocytopenia at Screening.
    • Previous or concurrent malignancy with the following exceptions:
    - Adequately treated basal cell or squamous cell carcinoma of the skin (adequate wound healing is required prior to study entry),
    - In situ carcinoma of the cervix, treated curatively and without evidence of recurrence for at least 3 years prior to the study,
    - Or other solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry.
    • History of long QT syndrome and/or a history of persistent hypokalemia.
    • Lactating or pregnant.
    • Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure, as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment.
    • History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
    • Clinically significant abnormalities which, in the opinion of the Investigator, would make subject unsuitable for inclusion in the study.
    • History of intolerance, or adverse or allergic reactions to oligonucleotide products and/or phosphate buffer solutions.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Evaluation:
    Proportion of subjects achieving an objective response (complete response [CR] or partial response [PR]) of at least 4 months duration (ORR4) using composite global response criteria, including radiological imaging, flow cytometry, and the Modified Severity Weighted Assessment Tool (mSWAT) scoring.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Global response criteria collected 4 weeks after 4 months of sustained response (PR or CR) in the skin, and every 12 weeks thereafter.
    E.5.2Secondary end point(s)
    Efficacy measures
    • Key Secondary Endpoint: Progression-free survival (PFS).
    • Change from baseline and longitudinally during the study in Pruritus Numerical Rating Scale (NRS).
    • Change from baseline and longitudinally during the study in Skindex-29 total score.
    • Change from baseline and longitudinally during the study in Skindex-29 Subdomains (Symptoms, Emotion and Functionality).
    • Difference in drug tolerability by Patient Impression of Treatment Side Effects.
    • Change from baseline and longitudinally during the study in Pain NRS.
    • Difference in drug tolerability by Patient Impression of Treatment Side Effects
    • Duration of composite global response for responding subjects.
    • Complete response rate (CRR).
    • Time to progression (TTP).
    • Time to maximal effect in mSWAT.
    • Proportion of subjects achieving ≥ 50% improvement in mSWAT of at least 4-months duration.
    • Proportion of subjects achieving ≥ 50% improvement in mSWAT of at least 28-days duration.
    • Percent of subjects achieving ≥ 50% improvement in mSWAT from baseline at 28 days and at 4 months.
    • Time to ≥ 50% improvement in mSWAT.
    • Duration of response in skin (no progression after achieving ≥ 50% improvement in mSWAT).
    • Change in pruritus medication utilization from baseline and incidence of pruritus medication utilization.
    • Overall survival.
    • Time to next treatment.

    Safety and Tolerability Evaluations:
    • Incidence and severity of clinically significant adverse events (AEs) (including grade 3 and 4 AEs, treatment-related AEs, serious adverse events [SAEs], and AEs requiring discontinuation), physical examination findings, changes in electrocardiograms (ECGs), changes in laboratory parameters and changes in vital signs.

    Pharmacokinetic Evaluation:
    • Population PK parameters.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Progression free survival, time to progression, overall survival, complete response rate: assessed throughout study
    Daily pruritus and pain score, patient impression of treatment side effects: from Day 1 until follow up visit
    Skindex-29, mSWAT: every 4 weeks to week 81, every 8 weeks thereafter
    Safety and tolerability: assessed throughout study
    PK: Days 1, 2, 3, 5, 8, 15, 29, every 4 weeks through week 81 and every 8 weeks thereafter.
    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 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) Yes
    E.8.2.2Placebo No
    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 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 EEA40
    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
    Australia
    Austria
    Belgium
    Canada
    France
    Germany
    Italy
    Netherlands
    Spain
    United Kingdom
    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 years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    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 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: 63
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 63
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 102
    F.4.2.2In the whole clinical trial 126
    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)
    Subjects that have disease progression on the vorinostat arm can be assessed for eligibility for a cobomarsen open-label extension study.
    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 Decision2019-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-12-01
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