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    Summary
    EudraCT Number:2016-000807-99
    Sponsor's Protocol Code Number:4SC-201-6-2015
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-09-19
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-000807-99
    A.3Full title of the trial
    A multicentre, double blind, randomised, placebo controlled, Phase II trial to evaluate Resminostat for maintenance treatment of patients with advanced stage (Stage IIB-IVB) mycosis fungoides (MF) or Sézary Syndrome (SS) that have achieved disease control with systemic therapy – the RESMAIN Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this research study is to determine if the new drug resminostat will be able to delay or prevent worsening of disease in patients with advanced stage mycosis fungoides or Sézary Syndrome that have achieved disease control with previous systemic therapy, recently
    A.3.2Name or abbreviated title of the trial where available
    RESMAIN Study
    A.4.1Sponsor's protocol code number4SC-201-6-2015
    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 Sponsor4SC AG
    B.1.3.4CountryGermany
    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 support4SC AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationICON Clinical Research
    B.5.2Functional name of contact pointJulia Lion
    B.5.3 Address:
    B.5.3.1Street AddressHeinrich-Hertz-Str. 26
    B.5.3.2Town/ cityLangen
    B.5.3.3Post code60322
    B.5.3.4CountryGermany
    B.5.4Telephone number496187123 1436
    B.5.6E-mailJulia.lion@iconplc.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 nameResminostat
    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 INNResminostat
    D.3.9.1CAS number 864814-88-0
    D.3.9.2Current sponsor code4SC-201
    D.3.9.3Other descriptive nameBYK 408740
    D.3.9.4EV Substance CodeSUB120712
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboFilm-coated tablet
    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
    Advanced stage (Stage IIB-IVB) mycosis fungoides (MF) or Sézary Syndrome (SS) that have achieved disease control with systemic therapy
    E.1.1.1Medical condition in easily understood language
    Specific type of lymphoma affecting the skin (Mycosis fungoides or Sézary Syndrome) which has treated recently with systemic therapy, responded to this treatment and has been stabilized
    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 10028508
    E.1.2Term Mycosis fungoides/Sezary syndrome
    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 is to determine if maintenance treatment with resminostat increases progression free survival (PFS) compared to placebo in patients with advanced stage (Stage IIB-IVB) MF or SS that have achieved disease control (complete response [CR], partial response [PR] or stable disease [SD]) with previous systemic therapy.
    E.2.2Secondary objectives of the trial
    Key Secondary Objective
    •To determine if maintenance treatment with resminostat increases time to symptom (pruritus) worsening (TTSW) compared to placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients with histologically confirmed MF (Stage IIB-IVB) or SS in an ongoing CR, PR or SD after at least one prior systemic therapy according to local standards (including but not limited to α-interferon, bexarotene, extracorporeal photopheresis, chemotherapy) or total skin electron beam irradiation, chemotherapy)
    othe most recent systemic therapy must have been completed as planned or stopped due to unacceptable toxicity extracorporeal photopheresis, chemotherapy) or 2- 12 weeks prior to randomisation, i.e. patients should not be withdrawn from a treatment from which they derive benefit
    2.Male or female ≥ 18 years
    3.Written informed consent obtained prior to any trial specific procedure
    4.Eastern Cooperative Oncology Group (ECOG) status score 0-2
    5.Adequate haematological, hepatic and renal function, as demonstrated by:
    a)haemoglobin ≥ 9.0 g/dl (International System [SI] of Units: 5.6 mmol/L)
    b)absolute neutrophil count ≥ 1,000/mm3
    c)platelets ≥ 75 × 109/L
    d)alanine aminotransferase and aspartate amino-transferase ≤ 2 times upper limit of normal
    e)total bilirubin ≤ 2 mg/dL (SI units: 34.2 µmol/L) (unless known Gilbert syndrome)
    f)serum creatinine ≤ 1.5 mg/dL (SI units: 132 µmol/L)
    g)prothrombin time International Normalised Ratio ≤ 2.3
    6.Women of childbearing potential (not post-menopausal for 1 year and not surgically sterile) and males with partners of childbearing potential must be sexually abstinent (i.e. refraining from heterosexual intercourse) or must use a highly effective contraception (at least one of the following: combined (oral, intravaginal or transdermal) or progestegen-only (oral, injectable or implantable) hormonal contraceptives, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomy of the partner from the time of screening to 30 days (female patients) or 3 months (male patients) after the last dose of trial treatment
    7.Adequate recovery from precedent non-haematological toxicities, excluding alopecia, to ≤ National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 1
    8.Able to comply with all the requirements of the protocol
    E.4Principal exclusion criteria
    1.Patients with PD
    2.Known central nervous system involvement
    3.History and current cardiovascular complications, including unstable angina pectoris, uncontrolled hypertension, congestive heart failure (New York Heart Association [NYHA] Class III or IV) related to primary cardiac disease, a condition requiring anti arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to randomisation
    4.Baseline corrected QT (QTc) interval > 500 milliseconds [NOTE: QTcF is relevant]
    5.History of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
    6.Use of concomitant medications that are known to prolong the QT/QTc interval
    7.Concurrent use of any other specific anti tumour therapy including psoralen photo chemotherapy (PUVA), chemotherapy, immunotherapy, hormonal therapy, radiation therapy, or experimental medications
    8.Previous or concurrent cancer that is distinct in primary site or histology from CTCL, except curatively treated squamous-cell carninoma of the skin stage 0-1 and curatively treated melanoma stage 0-1A with a low risk of recurrence/metastasis as per assessment of the investigator, cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumours (Ta, Tis and T1); any cancer curatively treated > 3 years prior to randomisation will be allowed
    9.Current evidence of any uncontrolled clinically significant internal, psychiatric or neurologic disease
    10.Altered mental status precluding understanding of the informed consent process and/or completion of the necessary trial procedures
    11.Pregnant or breast feeding women
    12.History of allergic reactions attributed to compounds of similar chemical or biological composition to the trial drugs
    13.Active alcohol and/or drug abuse
    14.Any other acute or chronic condition that, in the investigator’s opinion, would limit the patient’s ability to complete or participate in this trial
    15. Patients with tumoral stage MF, presenting at baseline only with tumours (thereof at least one tumour ≥ 1 cm in diameter), without current involvement of the skin by patches or plaques in conjunction with a mSWAT > 0 and < 20 [Only applicable for Belgium]
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS) is defined as the time from date of randomisation to first date that criteria for PD have been met according to the global response score or death due to any cause in the absence of documented PD.
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS (progression free survival) is defined as the time from date of
    randomisation to first date that criteria for progressive disease (PD)
    have been met according to the global response score or death due to
    any cause in the absence of documented PD.
    E.5.2Secondary end point(s)
    Key Secondary Endpoint
    •TTSW (pruritus)

    Secondary Endpoints
    •TTP
    •TTNT
    •PFS2
    •PFS3
    •ORR (CR, PR)
    •DOR
    •OS
    •HrQoL
    oVAS (itching)
    oFACT-G
    oSkindex-29
    •PK analysis (peripheral blood)
    E.5.2.1Timepoint(s) of evaluation of this end point
    TTSW (pruritus), the key secondary endpoint, is defined as the time from date of randomisation to first date that criteria for symptom (pruritus) worsening have been met.
    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 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    open label phase to follow the blinded phase, see protocol for details
    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 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 EEA42
    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
    Japan
    Austria
    France
    Poland
    Netherlands
    Spain
    Switzerland
    Germany
    Greece
    Italy
    Belgium
    United Kingdom
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 141
    F.4.2.2In the whole clinical trial 201
    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)
    Standard of Care
    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 Decision2016-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-18
    P. End of Trial
    P.End of Trial StatusOngoing
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