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    Summary
    EudraCT Number:2019-003971-20
    Sponsor's Protocol Code Number:ROS031019
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-12-09
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2019-003971-20
    A.3Full title of the trial
    An open label study to evaluate the efficacy and tolerability of erenumab in the management of persistent redness and flushing in rosacea
    Et åbent eksplorativt studie med henblik på at vurdere effekt og tolerabilitet af erenumab i behandling af persisterende rødme og flushing i rosacea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open label study to evaluate the efficacy and tolerability of erenumab in the management of persistent redness and flushing in rosacea
    A.3.2Name or abbreviated title of the trial where available
    STOP ROS Study
    A.4.1Sponsor's protocol code numberROS031019
    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 SponsorRigshospitalet Glostrup
    B.1.3.4CountryDenmark
    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 supportNovartis
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportRigshospitalet Glostrup
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDanish Headache Center
    B.5.2Functional name of contact pointNita Wienholtz
    B.5.3 Address:
    B.5.3.1Street AddressValdemar Hansens Vej 5
    B.5.3.2Town/ cityGlostrup
    B.5.3.3Post codeDK-2600
    B.5.3.4CountryDenmark
    B.5.4Telephone number004538634612
    B.5.6E-mailnita.wienholtz@regionh.dk
    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 Aimovig (Erenumab)
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNERENUMAB
    D.3.9.1CAS number 1582205-90
    D.3.9.3Other descriptive nameAimovig
    D.3.9.4EV Substance CodeSUB183612
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Rosacea
    E.1.1.1Medical condition in easily understood language
    Rosacea
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10039218
    E.1.2Term Rosacea
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Mean change in number of days with moderate, severe or extreme flushing (defined as a score of 4-10 on the Flushing Assessment Tool part II[1]) from Baseline to week 12.
    E.2.2Secondary objectives of the trial
    1.Mean change in Clinician’s Erythema Assessment
    2.Mean change in Dermatology Life Quality Index
    3.Proportion of patients with at least 50% reduction in number of days with moderate, severe or extreme flushing
    4.Mean change in number of days with moderate, severe or extreme flushing
    5.Mean change in Hospital Anxiety and Depression Scale
    6.Proportion of patients with Investigator’s Global Assessment ‘0’ or ‘1’ with an at least 2-point reduction
    7.Mean change in Inflammatory Lesion Count
    8.Proportion of patients with at least 50% reduction in number of days with Patient’s Self-Assessment (PSA) >2
    9.Mean change PSA
    10.Mean change in Quick Inventory Depressive Symptomatology
    11.Mean change in Rosacea Area and Severity Index
    12.Mean change in Rosacea Clinical Scorecard
    13.Mean change in Rosacea-specific Quality-of-Life index
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Erythematotelangiectatic rosacea with a minimum of 15 days in the run-in period of either:
    oPSA > 2 for a minimum 15 days, and/or
    oModerate, severe or extreme flushing for a minimum of 15 days measured by the Flushing Assessment Tool (PSA)
    •Men and women aged 18 – 65 years
    •Minimum 12 months of rosacea prior to trial
    •If patient has concurrent migraine, a daily headache diary must be filled out
    E.4Principal exclusion criteria
    •Systemic treatment for rosacea ended less than five half-lives or 28 days ago, whichever is longest
    •Topical treatment for rosacea ended less than five half-lives or 28 days ago, whichever is longest
    •Cardiovascular disease of any kind, including cerebrovascular disease
    •Hypertension on the experimental day (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
    •Hypotension on the experimental day (systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg)
    •Ongoing psychiatric disease of any kind – unless it has been effectively treated with a stable treatment for at least 2 months.
    •Anamnestic or clinical symptoms of any kind that are deemed relevant for study participation by the physician who examines the patient
    •Pregnant or breastfeeding women, or women expecting to conceive during the study
    •Women of childbearing potential who are unwilling to use an acceptable method of effective contraception during treatment through 16 weeks after the last dose of erenumab. Acceptable methods of effective birth control include not having intercourse (true abstinence, when this is in line with the preferred and usual lifestyle of the subject), hormonal birth control methods (pills, shots/injections, implants, or patches), intrauterine devices, surgical contraceptive methods (vasectomy with medical assessment of the surgical success of this procedure or bilateral tubal ligation), or two barrier methods (each partner must use one barrier method) with spermicide - males must use a condom with spermicide; females must choose either a diaphragm with spermicide, OR cervical cap with spermicide, OR contraceptive sponge with spermicide. Female subjects not of childbearing potential are defined as any female who: is post-menopausal by history, defined as:
    Age ≥ 55 years with cessation of menses for 12 or more months, OR
    Age < 55 years but no spontaneous menses for at least 2 years, OR
    Age < 55 years and spontaneous menses within the past 1 year, but currently amenorrhoeic (e.g. spontaneous or secondary to hysterectomy), AND with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels > 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved OR Underwent bilateral oophorectomy OR Underwent hysterectomy OR Underwent bilateral salpingectomy
    •Known sensitivity to any component of erenumab
    •Previously randomized into an erenumab study
    •Member of investigational site staff or relative of the investigator
    •Unlikely to be able to complete all protocol required study visits or procedures,
    and/or to comply with all required study procedures to the best of the subject’s and investigator’s knowledge
    E.5 End points
    E.5.1Primary end point(s)
    Mean change in number of days with moderate, severe or extreme flushing (defined as a score of 4-10 on the Flushing Assessment Tool part II)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    1.Mean change in Clinician’s Erythema Assessment (CEA) from baseline to week 4, 8 and 12.
    2.Mean change in Dermatology Life Quality Index (DLQI) from baseline to week 4, 8 and 12.
    3.Proportion of patients with at least 50% reduction in number of days with moderate, severe or extreme flushing (defined as a score of 4-10 on the Flushing Assessment Tool part II) from baseline to week 4, 8 and 12.
    4.Mean change in number of days with moderate, severe or extreme flushing (defined as a score of 4-10 on the Flushing Assessment Tool part II) from baseline to week 4 and 8.
    5.Mean change in Hospital Anxiety and Depression Scale (HADS) from baseline to week 4, 8 and 12.
    6.Proportion of patients with Investigator’s Global Assessment (IGA) ‘0’ or ‘1’ with an at least 2-point reduction from baseline to week 4, 8 and 12.
    7.Mean change in Inflammatory Lesion Count (ILC) from baseline to week 4, 8 and 12.
    8.Proportion of patients with at least 50% reduction in number of days with Patient’s Self-Assessment (PSA) >2 from baseline to week 4, 8 and 12.
    9.Mean change Patient’s Self-Assessment (PSA) from baseline to week 4, 8 and 12.
    10.Mean change in Quick Inventory Depressive Symptomatology (QIDS) from baseline to week 4, 8 and 12.
    11.Mean change in Rosacea Area and Severity Index (RASI) from baseline to week 4, 8 and 12.
    12.Mean change in Rosacea Clinical Scorecard (RCS) from baseline to week 4, 8 and 12.
    13.Mean change in Rosacea-specific Quality-of-Life index (RosaQoL) from baseline to week 4, 8 and 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    4, 8 and 12 weeks
    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 Yes
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 months0
    E.8.9.1In the Member State concerned 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) No
    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 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.4.2 For a multinational trial
    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)
    Patient can have specialist advise on treatment after ended participation, but otherwise no special treatment or 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 Decision2020-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-05-11
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