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    Summary
    EudraCT Number:2020-001992-34
    Sponsor's Protocol Code Number:EVM-22656
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-08-12
    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 ConcernedGermany - BfArM
    A.2EudraCT number2020-001992-34
    A.3Full title of the trial
    Clinical Trial Exit Interview Study in Cutaneous T-cell Lymphoma (CTCL) to Capture Meaningful Treatment Benefit from a Patient’s Perspective
    Befragungsstudie nach Behandlungsabschluss bei kutanem T-Zell-Lymphom (CTCL) zur Erfassung bedeutsamer Behandlungsnutzen aus Patientensicht
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Interview study after treatment for skin cancer with Galderma gel CD11301 to capture information about treatment benefit as perceived by patient
    Befragungsstudie nach der Behandlung von Hautkrebs mit Galderma Gel CD11301, um Informationen über den Nutzen der Behandlung aus Patientensicht zu erfassen.
    A.4.1Sponsor's protocol code numberEVM-22656
    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 SponsorGALDERMA Research & Development LLC
    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 supportGALDERMA Research & Development LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEvidera
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street Address27-35 rue Victor Hugo Immeuble Optima
    B.5.3.2Town/ cityIvry Sur Seine
    B.5.3.3Post code94200
    B.5.3.4CountryFrance
    B.5.6E-mailCarla.dias-barbosa@evidera.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 / 16 / 1653
    D.3 Description of the IMP
    D.3.1Product nameResiquimod
    D.3.2Product code CD11301
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRESIQUIMOD
    D.3.9.1CAS number 144875-48-9
    D.3.9.2Current sponsor codeCD11301
    D.3.9.4EV Substance CodeSUB120343
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.03 to 0.06
    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
    E.1.1.1Medical condition in easily understood language
    Immune Cancer
    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 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
    Characterize patients’ experienced treatment benefit of CD11301 gel
    a.Provide a patient-focused assessment of disease burden.
    b.Capture patients’ experience of the study treatment (what are the perceived benefits and risks of treatment, changes in patients’ daily life since baseline, unexpected treatment effects, patients’ treatment expectations, satisfaction and comparison to previous treatments).
    c.Explore patients’ perceptions of meaningful change from baseline (i.e., what constitutes a meaningful treatment effect, which aspects are most relevant and most meaningful to patients).
    E.2.2Secondary objectives of the trial
    Explore patients’ experience with clinical trial participation and obtain patients’ insights into the operational aspects of the clinical trial (e.g., burden of visits, study procedures, etc.) to inform the design of future Phase 3 clinical trials with a view to increase their patient centricity.
    The telephone interview findings will also support the development of a comprehensive disease model to support a fit-for-purpose measurement strategy to assess meaningful treatment benefit of CD11301 gel in future clinical trials in CTCL.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Had participated or is currently participating in Galderma’s Phase 2 clinical trial of the CD11301 gel and has completed cycle 2 (week 24)
    or Patient has exited the study trial early due to patient request or clinician judgement
    2. Able to remember experience with taking clinical trial treatment
    3.Willing and able to participate in a 60-90 minute telephone interview
    4.Able to understand, read, and speak native English (US) or German (Germany) sufficiently to participate in the interview
    5. Willing and able to provide oral and written informed consent
    6. Willing and consenting to be audio-recorded during the discussion.
    E.4Principal exclusion criteria
    1. Hearing difficulty, visual impairment, acute psychopathology, or insufficient knowledge of English (US) or German (Germany) that, in the opinion of the investigator/interviewer, could interfere with patient ability to provide oral consent and written consent and complete an interview.
    2. Not able to remember experience with taking clinical trial treatment in the opinion of the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    subject-reported concepts regarding disease burden and meaningful treatment benefit
    E.5.1.1Timepoint(s) of evaluation of this end point
    after interview which takes place after patient has completed treatment
    E.5.2Secondary end point(s)
    not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    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 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 Yes
    E.6.13.1Other scope of the trial description
    This qualitative research study will explore patients’ perspectives about disease burden and meaningful treatment benefit among a subset of patients with early stage CTCL who participate in the Phase 2 clinical trial of the CD11301 gel in the US and Germany.
    The telephone interview findings will also support the development of a comprehensive disease model to support a fit-for-purpose measurement strategy to assess meaningful treatment benefit of CD11301 gel in future clinical trials in CTCL.
    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 No
    E.8.1.3Single blind Information not present in EudraCT
    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.8.3 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 No
    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
    United States
    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 years0
    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 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 30
    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)
    Patients will continue to receive their regular medical treatment
    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 Decision2020-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-04-16
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