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    The EU Clinical Trials Register currently displays   41228   clinical trials with a EudraCT protocol, of which   6756   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2019-003168-37
    Sponsor's Protocol Code Number:CAIN457ADE15
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-10-24
    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 ConcernedGermany - PEI
    A.2EudraCT number2019-003168-37
    A.3Full title of the trial
    A randomized, double-blind, multicenter, 24-week study of subcutaneous secukinumab to assess anti-interleukin-17A treatment in plaque psoriasis patients with coexisting non-alcoholic fatty liver disease (pINPOINt)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study in patients with plaque psoriasis with coexisting non-alcoholic fatty liver disease
    A.3.2Name or abbreviated title of the trial where available
    pINPOINt
    A.4.1Sponsor's protocol code numberCAIN457ADE15
    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 GmbH
    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 supportNovartis Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma GmbH
    B.5.2Functional name of contact pointMedizinischer Infoservice
    B.5.3 Address:
    B.5.3.1Street AddressRoonstr. 25
    B.5.3.2Town/ cityNürnberg
    B.5.3.3Post code90419
    B.5.3.4CountryGermany
    B.5.4Telephone number+4991127312100
    B.5.5Fax number+4991127312160
    B.5.6E-mailinfoservice.novartis@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 milligram(s)
    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
    plaque psoriasis with coexisting non-alcoholic fatty liver disease
    E.1.1.1Medical condition in easily understood language
    plaque psoriasis with coexisting non-alcoholic fatty liver disease
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071117
    E.1.2Term Plaque psoriasis
    E.1.2System Organ Class 100000004858
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10029530
    E.1.2Term Non-alcoholic fatty liver
    E.1.2System Organ Class 100000004871
    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 superiority of secukinumab compared to placebo in patients with moderate to severe chronic plaque-type psoriasis and NAFLD with respect to PASI90 response at Week 12.
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of secukinumab compared to placebo on hepatic inflammation in patients with moderate to severe psoriasis and NAFLD with respect to serum ALT levels at Week 12.
    • To evaluate the effect of secukinumab in patients with moderate to severe psoriasis and NAFLD compared to placebo on quality of life with respect to DLQI at Week 12.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study, and must provide written, signed and dated informed consent before any study assessment is performed.
    2. Men and women ≥ 18 years of age at the time of consent.
    3. Moderate to severe plaque-type psoriasis diagnosed for at least 6 months prior to Screening with a PASI of >10 at baseline.
    4. Candidate for systemic therapy, defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by:
    • topical treatment and/or,
    • Phototherapy and/or,
    • Previous systemic therapy.
    5. Diagnosis of NAFLD by either ultrasound at Screening or liver histology within 6 months before Baseline.
    6. Obesity with BMI > 25 kg/m2 at Screening.
    7. Elevation of ALT 1.2 to 3.0 × ULN.
    8. Liver fat ≥ 8% at Screening as determined by the reading of the central MRI vendor of locally produced images. Note: the MRI assessment should only be performed after eligibility has been confirmed for all other Screening assessments.
    E.4Principal exclusion criteria
    1. Forms of psoriasis other than chronic plaque-type psoriasis at Screening.
    2. Drug-induced psoriasis at Screening and baseline.
    3. Ongoing use of prohibited treatments. Respective washout periods detailed in this section have to be adhered to.
    4. History of hypersensitivity to any of the study drug constituents.
    5. Pregnant or nursing (lactating) women.
    6. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during the study or longer if required by locally approved prescribing information.
    7. Previous treatment with biological drug targeting IL-17 or the IL-17 receptor.
    8. Past medical history record of infection with HIV, hepatitis B or hepatitis C prior to screening.
    9. Active systemic infections during the last two weeks (exception: common cold) prior to randomization or any infection that reoccurs on a regular basis.
    10. History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold Plus (QFT) test at screening. Subjects with a positive or indeterminate QFT test may participate in the study if full tuberculosis work up (according to local practice/guidelines) was completed within 12 weeks prior to randomization and establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment according to local guidelines must have been completed prior to screening. During treatment of latent tuberculosis, ALT had to remain below 2x compared to pre-treatment ALT value.
    11. Significant medical problems, including but not limited to:
    • Congestive heart failure [New York Heart Association status of class III or IV].
    • Severely reduced kidney function (eGFR ≤ 29 mL/min/1.73 m2).
    12. Unstable weight (± 5%) over the last 6 months prior to Screening.
    13. Type I diabetes, or uncontrolled Type II diabetes defined as HbAlc ≥ 10% at Screening.
    14. Total white blood cell (WBC) count < 2500/μL, or neutrophils < 1500/μL or hemoglobin < 8.5 g/dL at Screening.
    15. Evidence of hepatic decompensation or severe liver impairment or cirrhosis, as defined by the presence of any of the following abnormalities:
    • Serum albumin < 3.2 mg/dL
    • INR > 1.3
    • Total bilirubin > 1.3 mg/dL
    • AST > 5 × ULN
    • Alkaline phosphatase > 300 IU/L
    • Platelets outside of normal reference range (± 5%)
    • History of esophageal varices, ascites, or hepatic encephalopathy
    • Splenomegaly
    16. History of liver transplantation or planned liver transplant.
    17. History of biliary diversion.
    18. Presence or history of other liver disease (including but not limited to autoimmune hepatitis, hereditary hemochromatosis, alpha 1-antitrypsin deficiency, Wilson’s disease, drug-induced liver disease).
    19. Current, or history of, significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more than 20 g/day in females or more than 30 g/day in males, on average) or a score on the modified AUDIT questionnaire ≥ 8.
    20. History of bariatric surgery or intention to have bariatric surgery during study conduct.

    Other protocol-defined exclusion criteria may apply.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients achieving PASI90 response at Week 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    • Serum ALT level at Week 12.
    • Proportion of patients achieving DLQI 0/1 at Week 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12
    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 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
    The aim of this study is to assess the therapeutic efficacy of secukinumab on the psoriatic skin and to explore the anti-inflammatory (reduction of hepatic inflammation and cell damage), anti-steatotic (reduction of hepatic triglyceride content) and anti-fibrotic (reduction of hepatic fibrosis) effects of secukinumab in patients with psoriasis and coexisting NAFLD.
    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 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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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 months11
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days8
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 90
    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)
    None (subjects who have ended the participation in the Trial will be treated according to the physicians discretion)
    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 Decision2019-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-07-23
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