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    Summary
    EudraCT Number:2015-000632-15
    Sponsor's Protocol Code Number:CHS-1420-02
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-07
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2015-000632-15
    A.3Full title of the trial
    A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-1420 Versus Humira® in Subjects With Chronic Plaque Psoriasis (PsOsim)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare the efficacy and safety of CHS-1420 against Humira®
    A.4.1Sponsor's protocol code numberCHS-1420-02
    A.5.4Other Identifiers
    Name:IND NumberNumber:119540
    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 SponsorCoherus BioSciences, Inc.
    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 supportCoherus BioSciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCoherus BioSciences, Inc.
    B.5.2Functional name of contact pointJennifer Hodge
    B.5.3 Address:
    B.5.3.1Street Address333 Twin Dolphin Drive - Suite 600
    B.5.3.2Town/ cityRedwood City
    B.5.3.3Post codeCA 94065
    B.5.3.4CountryUnited States
    B.5.4Telephone number001650649-3530
    B.5.5Fax number0016866491-7350
    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 nameadalimumab (CHS-1420)
    D.3.2Product code CHS-1420
    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 INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.2Current sponsor codeCHS-1420
    D.3.9.3Other descriptive nameCHS-1420
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    D.3.11.13.1Other medicinal product typeBiosimilar
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holder AbbVie Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 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 INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.2Current sponsor codeHumira
    D.3.9.3Other descriptive nameHumira
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Chronic Plaque Psoriasis
    E.1.1.1Medical condition in easily understood language
    Chronic Plaque Psoriasis
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10071117
    E.1.2Term Plaque psoriasis
    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
    The primary objective of this study is to compare the efficacy (measured by the Psoriasis Area and Severity Index [PASI]) and safety of CHS-1420 and Humira at 12 weeks in subjects with moderate to severe chronic PsO.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare the safety of and response to CHS-1420 and Humira over 24 weeks as well as efficacy/safety of switching from Humira to CHS-1420.
    To assess long term safety and efficacy of CHS-1420 during the open label extension over a further 24 weeks (Treatment Period 3)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female adult at least 18 years of age;
    2. Diagnosis of chronic plaque-type psoriasis at least 6 months prior to Screening;
    3. Moderate to severe chronic plaque type psoriasis as defined at Screening by:
    1. PASI score of greater than or equal to 12,
    2. Physician’s Static Global Assessment (PSGA) score greater than or equal to 3 (based on a scale of 0 to 5), and
    3. Body surface area affected by chronic plaque-type psoriasis of greater than or equal to 10%;
    4. Considered a candidate by the Investigator to start anti-TNF therapy for PsO;
    E.4Principal exclusion criteria
    1. Forms of psoriasis other than chronic PsO (e.g., pustular erythrodermic, guttate psoriasis);
    2. Previous receipt of anti-TNF therapies (and biosimilars to anti-TNF-therapies) for any indication at any time, including infliximab, (Remicade) etanercept (Enbrel), adalimumab (Humira), golimumab (Simponi), certolizumab pegol (Cimzia), pentoxifyllene (Trental);
    3. Initiation of a drug that is known to cause or exacerbate psoriasis (including, but not limited to, beta-blockers, lithium, and anti-malarials), within the 6 months prior to Randomization (Week 0/Day 0); those who have been on a stable dose for at least 6 months prior to Randomization (Week 0/Day 0) without exacerbation of psoriasis may be enrolled and do not need to discontinue these medications;
    4. Receipt of an investigational drug or investigational device study within the 28 days prior to Randomization (Week 0/Day 0) or a period equal to 5 times the half-life of the investigational agent (whichever is longer);
    5. History of alcohol or drug abuse within 2 years prior to Screening;
    6. Diagnosis of rheumatic disease, autoimmune disease, connective tissue disease, or immune deficiency disease (e.g., primary Sjögren’s syndrome, systemic lupus erythematosus, demyelinating diseases such as multiple sclerosis); Note: Psoriatic arthritis is allowed.
    E.5 End points
    E.5.1Primary end point(s)
    75% improvement in Psoriasis Area and Severity Index (PASI-75)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 12 relative to baseline, where baseline will be the last assessment prior to beginning study drug (scheduled for Week 0/day 0).
    E.5.2Secondary end point(s)
    1. PASI-75
    2. Percentage changes in PASI
    3. 50% improvement in Psoriasis Area and Severity Index (PASI-50)
    4. 90% improvement in Psoriasis Area and Severity Index (PASI-90)
    5. Changes in PSGA of disease activity on a scale from 0 to 5
    6. Change in PSGA = 0 to 1, demonstrating clear or almost clear skin
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. at Weeks 2, 4, 6, 8, 10, 16, 20, and 24, 32, 40 and 48;
    2. from Baseline at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24, 32, 40 and 48;
    3. at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24, 32, 40 and 48;
    4. at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24, 32, 40 and 48;
    5. from Baseline to Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40 and 48; and, as applicable, the Follow-up or ET visit;
    6. at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40 and 48 and, as applicable, the Follow-up or ET visit;
    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 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 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 Yes
    E.8.1.7.1Other trial design description
    Double blind plus an open label extention (treatment period 3)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA102
    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
    Armenia
    Belarus
    Bulgaria
    Canada
    Chile
    Croatia
    Estonia
    Georgia
    Hungary
    Israel
    Italy
    Latvia
    Lebanon
    Macedonia, the former Yugoslav Republic of
    Mexico
    Moldova, Republic of
    Poland
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Ukraine
    United Kingdom
    United States
    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 years2
    E.8.9.1In the Member State concerned months0
    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 months7
    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: 375
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 125
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 500
    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"
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-03-16
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