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    Summary
    EudraCT Number:2018-002062-39
    Sponsor's Protocol Code Number:CAIN457M2302
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-12-27
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2018-002062-39
    A.3Full title of the trial
    A randomized, double-blind, multicenter study assessing short (16 weeks) and long-term efficacy (up to 1 year), safety, and tolerability of 2 subcutaneous secukinumab dose regimens in adult patients with moderate to severe hidradenitis suppurativa
    Atsitiktinių imčių, dvigubai koduotas, daugiacentris tyrimas 2-jų sekukinumabo dozės vartojimo po oda režimų veiksmingumui trumpalaikiu (16 savaičių) ir ilgalaikiu (iki 1 metų) laikotarpiu, saugumui ir toleravimui įvertinti, skiriant suaugusiems pacientams, kuriems nustatytas vidutinio sunkumo arba sunkus supūliavęs hidradenitas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to evaluate treatment with a drug called secukinumab in adult patients who are diagnosed with moderate to severe hidradenitis suppurativa (long term skin disease characterized by the occurrence of inflamed and swollen lumps)
    A.3.2Name or abbreviated title of the trial where available
    SUNRISE
    A.4.1Sponsor's protocol code numberCAIN457M2302
    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 SponsorNovartis Pharma AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSIA Novartis Baltics Lithuanian Branch
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressUpės str. 19
    B.5.3.2Town/ cityVilnius
    B.5.3.3Post codeLT-08128
    B.5.3.4CountryLithuania
    B.5.4Telephone number+370 5 269 1650
    B.5.5Fax number+370 5 249 6338
    B.5.6E-mailDRA.Lithuania@novartis.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 Yes
    D.2.1.1.1Trade name Cosentyx
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameSecukinumab
    D.3.2Product code AIN457
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNSecukinumab
    D.3.9.1CAS number 1229022-83-6
    D.3.9.2Current sponsor codeAIN457
    D.3.9.3Other descriptive nameSECUKINUMAB
    D.3.9.4EV Substance CodeSUB33242
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Yes
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    hidradenitis suppurativa
    E.1.1.1Medical condition in easily understood language
    a long term skin disease characterized by the occurrence of inflamed and swollen lumps
    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 LLT
    E.1.2Classification code 10020041
    E.1.2Term Hidradenitis suppurativa
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of secukinumab compared to placebo with respect to HiSCR after 16 weeks of treatment.
    E.2.2Secondary objectives of the trial
    To demonstrate the efficacy of secukinumab compared to placebo after
    16 weeks of treatment with respect to:
    ● percentage change in AN count
    ● proportion of patients with HS flares
    ● proportion of patients with clinical response in HS related skin pain.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    a. Optional skin biopsy sampling sub-study: Objectives: The substudy
    may include, but is not limited to analyses to gain a better
    understanding of the mechanistic aspects of HS. These data may also
    support the identification of pathways/markers that characterize the
    disease or response to treatment with secukinumab. Exploratory biopsy
    research will entail histology and transcriptomics.
    b. Optional DNA sampling: this is standard and used in most studies.
    Objectives: Exploratory DNA research studies are planned as a part of this study with the objectives of identifying genetic factors which may
    (1) predict response to treatment with secukinumab; (2) predict relative
    susceptibility to drug-drug interactions; (3) predict genetic
    predisposition to side effects; or (4) be related to HS or autoimmune
    diseases.
    E.3Principal inclusion criteria
    Patients eligible for inclusion in this study must meet all of the following criteria:
    1. Written informed consent must be obtained before any assessment is performed.
    2. Male and female patients ≥ 18 years of age.
    3. Diagnosis of HS ≥ 1 year prior to baseline.
    4. Patients with moderate to severe HS defined as:
    - A total of at least 5 inflammatory lesions, i.e. abscesses and/or inflammatory nodules
    AND
    - Inflammatory lesions should affect at least 2 distinct anatomic areas
    5. Patients agree to daily use of topical over-the-counter antiseptics on the areas affected by HS lesions while on study treatment
    E.4Principal exclusion criteria
    Patients meeting any of the following criteria are not eligible for inclusion in this study.
    1. Total fistulae count ≥ 20 at baseline.
    2. Any other active skin disease or condition that may interfere with assessment of HS.
    3. Active ongoing inflammatory diseases other than HS that require treatment with prohibited medications.
    4. Underlying conditions (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal such as inflammatory bowel disease) which in the opinion of the investigator significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.
    5. Current severe progressive or uncontrolled diseases which renders the patient unsuitable for the trial or puts the patient at increased risk, including any medical or psychiatric condition which, in the Investigator’s opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
    6. Use or planned use of prohibited treatment. Washout periods detailed in the protocol have to be adhered to.
    7. For patients enrolling in the non-antibiotic strata: use of systemic antibiotics for the treatment of HS within 28 days before baseline. For patients enrolling in the antibiotic strata: patients enter the study under concomitant treatment with systemic antibiotics (as per protocol) on a stable dose (defined as a dose or dose regimen that has not changed in the previous 28 days before baseline and is considered unlikely to change at least for the first 16 weeks during the study).
    8. History of hypersensitivity to any of the study drug constituents.
    9. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 A/F or the IL-17 receptor.
    10. History of chronic or recurrent systemic infections or active systemic infections during the last two weeks (exception: common cold) prior to randomization.
    11. Evidence of tuberculosis infection as defined by a positive QuantiFERON® TB-Gold test (QFT) at screening. Patients with a positive or indeterminate QFT test may participate in the study if a full tuberculosis work-up (according to local practice/guidelines) completed within 12 weeks prior to randomization, establishes conclusively that the patient has no evidence of active or latent tuberculosis. Subjects positive for
    latent TB per work-up may be randomized to the trial if sufficient treatment has been initiated according to local routine clinical practice and was completed at least four weeks before randomization.
    12. Medical history record of infection with human immunodeficiency virus (HIV), hepatitis B or C prior to randomization, except for hepatitis C successfully treated and cured.
    13. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for skin Bowen’s disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
    14. History or evidence of ongoing alcohol or drug abuse, which in the opinion of the investigator will prevent the patient from adhering to the protocol and completing the study.
    15. Pregnant or lactating women.
    16. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g. in European Union (EU) 20 weeks).
    E.5 End points
    E.5.1Primary end point(s)
    Achievement of HiSCR at Week 16. HiSCR is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and/or in the number of draining fistulae.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    E.5.2Secondary end point(s)
    ●Percentage change from baseline in AN count at Week 16.
    ● Flaring up to Week 16. Flare is defined as at least a 25%
    increase in AN count with a minimum increase of 2 AN
    relative to baseline.
    ● Achievement of NRS30 at Week 16, among subjects with
    baseline NRS ≥ 3. NRS30 is defined as at least a 30%
    reduction and at least 2 unit reduction from baseline in Patient's Global
    Assessment of
    Skin Pain - at worst
    E.5.2.1Timepoint(s) of evaluation of this end point
    at/ up to Week 16
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 trial4
    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 EEA59
    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
    Argentina
    Canada
    Colombia
    Guatemala
    India
    Israel
    Lebanon
    Malaysia
    Philippines
    Russian Federation
    Singapore
    South Africa
    Turkey
    United States
    Viet Nam
    Belgium
    Croatia
    Czechia
    Denmark
    France
    Germany
    Greece
    Hungary
    Italy
    Lithuania
    Poland
    Slovakia
    United Kingdom
    Bulgaria
    Netherlands
    Spain
    Switzerland
    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 years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 512
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 29
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    In alignment with ICH/GCP principles, subjects incapable of giving informed consent personally, but who have a witness/ legal guardian to consent on their behalf (if permitted by the local laws), can be considered eligible to participate in the study
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 287
    F.4.2.2In the whole clinical trial 541
    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 completing the core study may be eligible to continue into a planned extension study to collect further safety and efficacy data on secukinumab and provide continuous access to treatment. Investigators must provide follow-up medical care for all subjects who are prematurely withdrawn from the core study or do not continue in
    the extension, or must refer them for appropriate ongoing care. This care may include use of long term antibiotics, surgical intervention and/or use of biologics.
    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 Decision2019-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-19
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