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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41472   clinical trials with a EudraCT protocol, of which   6816   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2014-000444-14
    Sponsor's Protocol Code Number:CHS-0214-04
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-08-05
    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 - PEI
    A.2EudraCT number2014-000444-14
    A.3Full title of the trial
    A Double-Blind, Randomized, Parallel-Group, Active Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel ® in Subjects With Chronic Plaque Psoriasis (CHS-0214-04) (RaPsOdy)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Coherus Psoriasis Study
    A.4.1Sponsor's protocol code numberCHS-0214-04
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02134210
    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 organisationMedpace UK
    B.5.2Functional name of contact pointBlythe McDougall (director RegSub)
    B.5.3 Address:
    B.5.3.1Street Address26 - 28 Hammersmith Grove
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW6 7HA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00447825587853
    B.5.5Fax number00442083156793
    B.5.6E-mailb.mcdougall@medpace.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCHS-0214
    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 INNEtanercept
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeCHS-0214
    D.3.9.3Other descriptive nameCHS-0214
    D.3.9.4EV Substance CodeSUB166284
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.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 Enbrel
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameEtanercept
    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 INNETANERCEPT
    D.3.9.1CAS number 185243-69-0
    D.3.9.4EV Substance CodeSUB01984MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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] - Skin and Connective Tissue Diseases [C17]
    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 objective of Part 1 of the study is to compare the efficacy and safety of CHS-0214 and European sourced Enbrel (Enbrel EU) 50 mg given twice weekly for 12 weeks.
    The objective of Part 2 of the study is to compare the safety and durability of response of CHS-0214 and Enbrel (EU), 50 mg given once a week from 13 weeks up to 47 weeks of treatment. Subjects who discontinue study drug prior to week 47 will be seen for a follow-up visit 28 days after the last dose of study drug. Subjects who complete 47 weeks of study drug will be seen at week 48 and again for a follow-up visit 28 days after the last dose of study drug is applicable.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female adult ≥ 18 years of age
    2.Chronic PsO diagnosed at least 6 months prior to Screening
    3.Moderate to severe chronic PsO as defined at Screening by:
    •PASI score ≥12
    •Physician’s Static Global Assessment (PSGA) score of ≥3 (based on a scale of 0-5)
    •BSA affected by chronic PsO of ≥10%, and
    •Dermatology Life Quality Index (DLQI) ≥10
    4.Must be considered a candidate for starting biological DMARDs by the investigator. This includes patients who: a) have previously received at least one non-biologic systemic PsO therapy or one treatment/course of phototherapy. b) have a contraindication to non-biologic systemic psoriasis treatments or phototherapy. c) or for whom immediate biologic therapy is considered appropriate regardless of their prior treatment.
    5.Must be naïve to all approved or unapproved systemic biologic therapies (other than insulin or hormones)
    6.Able and willing to give written informed consent prior to performance of any study-related procedures
    7.Women who meet one of the following:
    a) Women of childbearing potential with a negative urine pregnancy test at Screening who agree to use 1 or more approved methods of birth control during the study. Approved methods of birth control are: hormonal contraception, intrauterine device; diaphragm plus spermicide; Abstinence from heterosexual intercourse will be acceptable only if it´s the preferred and usual lifestyle of the subject regardless of study participation, abstinence should be practiced for the duration of the study and until 3 weeks after taking the last dose of study drug.
    b)Women who have been postmenopausal for at least 2 years (with amenorrhea for at least one year) or have had a hysterectomy, bilateral salpingo-oophorectomy, or tubal ligation prior to signing the informed consent form.
    E.4Principal exclusion criteria
    1. Forms of psoriasis other than chronic PsO (eg, pustular erythrodermic, guttate psoriasis);
    2. 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). Subjects who have been on a stable dose for at least 6 months prior to Randomization without exacerbation of psoriasis may be enrolled and do not need to discontinue these medications;
    3. Ongoing use of prohibited psoriasis treatments (eg, systemic corticosteroids, ultraviolet (UV) therapy, systemic therapy for PsO) these treatments should have been discontinued at least 4 weeks prior to Randomization;
    4. Use of class 1-5 topical corticosteroids within 2 weeks prior to randomisation. Note: Use of mild (class 6-7) topical corticosteroids only on face, scalp, axillae, genitalia or groin and mild/bland moisturizers/lubricants may be used at any time during the study except within 24 hours prior to a screening PASI assessment or study visit;
    5.Use of phosphodiesterase type 4 (PDE4) inhibitors (e.g., apremilast [Otezla]) within the 4 weeks prior to Randomization;
    6. Subjects taking non-psoriatic concomitant medications should be on stable doses for at least 30 days prior to Randomization;
    7. Administration of a live vaccine within 4 weks prior to screening
    8. Participation in an Investigational drug or device study within the 30 days prior to Randomization or a period equal to 5 times the half-life of the investigational agent, whichever is longer;
    9. History of alcohol or drug abuse within 2 years prior to Screening;
    10. Diagnosis of rheumatic disease, autoimmune disease, connective tissue disease, or immune deficiency disease (e.g., primary Sjögren’s syndrome, systemic lupus erythematosus, and demyelinating diseases such as multiple sclerosis);
    11. White blood cell count <3500 cells/mm3, lymphocyte count <1000 cells/mm3, platelet count ≤125,000 cells/mm3, serum creatinine ≥2 mg/dL (177 µmol/L), alanine transaminase or aspartate transaminase ≥2 × the upper limit of normal, or hemoglobin ≤8.5 g/dL at Screening;
    12. Presence or history of malignancy, except for successfully treated non metastatic basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix;
    13. Presence of tuberculosis (TB) based on positive blood test (QuantiFERON® TB Gold test) during Screening or subjects with known exposure to a patient with active TB; Note: QuantiFERON-TB Gold test can be repeated one time using a fresh sample in subjects with an indeterminate result or low positively defined as Quantiferon TB Antigens minus Nil value = 0.35 - IU/mL, if the repeat test result is negative the subject may participate in the study. If the repeat test result is indeterminate or positive the subject does not qualify for the study.
    14. History of positive test results for fungal or other infections (e.g., histoplasmosis, coccidiomycosis) required by regional guidelines within 3 months prior to Randomization (Week 0/Day 0);
    15. Abnormal chest X-ray within 6M prior randomization demonstrating active lung disease processes ( eg evidence of TB or another active disease process) if a chest X-ray has not been obtained withing the past 6M one should be obtained during the screening process;
    16. Major systemic infections, including human immunodeficiency virus (HIV);
    17. Unresolved Hepatitis B or Hepatitis C infection (defined as positive hepatitis B surface antigen [HBsAg], hepatitis B core antibody [HBcAb], or hepatitis C virus [HCV]);
    18. Class III or IC congestive heart failure (as defined by the New York Heart Association) (NY Heart Association) (New York Heart Association, 1994)
    19. Presence of any significant comorbid medical condition(s), including, but not limited to:
    a) Uncontrolled diabetes mellitus (Hemoglobin A1C [HgbA1c]  8% within the 3 months prior to Screening or history of diabetic ketoacidosis or hypoglycemic reactions requiring hospitalization within the 12 months prior to Screening),
    b) Uncontrolled hypertension (systolic blood pressure >160 mmHg and diastolic blood pressure >100 mmHg) (Mancia, 2013) within the 3 months prior to Screening,
    c) Severe kidney disease requiring hemodialysis or peritoneal dialysis,
    d) Advanced liver disease, such as liver cirrhosis,
    e) Severe congestive heart failure or history of ejection fraction 30%,
    f) Severe lung disease requiring home oxygen,
    g) Active unstable angina requiring daily treatment with nitrates or other medications;
    20. Presence of any other major medical or psychiatric illness that in the opinion of the Investigator would put the subject at increased risk or affect the ability to participate in the study;
    21. Known or suspected sensitivity or allergic reactions to latex or latex containing products; or
    22. Women who are pregnant or nursing.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy endpoints:
    In order to meet the regulatory requirements of different regions the study will have 2 different primary efficacy endpoints:
    1. Mean percent change in PASI from baseline (first dose of study drug) at week 12. This will be the primary endpoint supporting a marketing authorisation application (MAA) in the European Union (EU)
    2. Proportion of subjects achieving a PASI-75 from Baseline at Week 12. This Endpoint is intended to support a biologics licensing application (BLA) in the US.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints include:
    •Mean percent change in PASI from Baseline at Weeks 4, 8, 24, 36, and 48;
    •The proportion of subjects who achieve PASI-75 from Baseline at Weeks 4, 8, 24, 36, and 48;
    •The proportion number of subjects who achieve a 50% improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% improvement in Psoriasis Area and Severity Index (PASI-90) response rates from Baseline at Weeks 4, 8, 12, 24, 36, and 48;
    •Change in PSGA of disease activity at Baseline to Weeks 4, 8, 12, 24, 36, and 48, and at the Follow-up Visit;
    •The proportion of subjects with a change in PSGA = 0-1, demonstrating clear or almost clear skin at Weeks 4, 8, 12, 24, 36, and 48
    •Change in Subject’s Global Assessment (SGA) of Psoriasis from Baseline to Weeks 4, 8, 12, 24, 36, and 48;
    •Number of subjects with PSGA indicative of clear or almost clear (score 0-1) at Weeks, 4, 8, 12, 24, 36, and 48;
    •Change in DLQI from Baseline to Weeks 12, 24, and 48;
    •Change in EuroQol 5-Dimension Health Status Questionnaire from Baseline to Weeks 12, 24, and 48;
    •Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) from Baseline to Weeks 12, 24, and 48 for subjects with concurrent PsA only; and
    •Change in highly sensitive C-reactive protein (hs CRP mg/L) from Baseline to Weeks 12, 24, and 48 for subjects with PsA only.
    Safety endpoints: Safety will be assessed by evaluating the incidence of and reasons for subject discontinuations, treatment emergent adverse events, ISRs, changes in safety laboratory parameters, vital signs, physical examinations, and electrocardiogram findings. In addition, subjects will be monitored for TB with regular QuantiFERON-TB Gold test (every 6 months or more frequently for regions with a high incidence of TB, or to evaluate signs and symptoms that might be due to TB).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. week 4-8-24-36-48
    2. week 4-8-24-36-48
    3. week 4-8-12-24-36-48
    4. week 4-8-12-24-36-48
    5. week 4-8-12-24-36-48
    6. week 4-8-12-24-36-48
    7. week 4-8-12-24-36-48
    8. Weeks 12, 24, and 48
    9. Weeks 12, 24, and 48
    10. Weeks 12, 24, and 48
    11. Weeks 12, 24, and 48
    12. Continuous
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Australia
    Canada
    Chile
    Germany
    Israel
    Poland
    Russian Federation
    South Africa
    United Kingdom
    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 years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 324
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 150
    F.4.2.2In the whole clinical trial 424
    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)
    The sponsor expect to conduct an open label safety extension study for subjects who complete part 2 of the study
    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 Decision2015-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-27
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