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    Summary
    EudraCT Number:2021-000542-18
    Sponsor's Protocol Code Number:20200497
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-10-22
    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 ConcernedLatvia - SAM
    A.2EudraCT number2021-000542-18
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind Study Evaluating the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Multiple Switches Between Humira® (adalimumab [US]) and ABP 501 Compared With Continued Use of Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Investigate the Impact of Switching Between ABP 501 and Adalimumab for the Treatment of Subjects with Moderate to Severe Plaque Psoriasis
    A.4.1Sponsor's protocol code number20200497
    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 SponsorAmgen 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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationParexel International (IRL) Limited
    B.5.2Functional name of contact pointProject Leadership
    B.5.3 Address:
    B.5.3.1Street Address70 Sir John Rogerson's Quay
    B.5.3.2Town/ cityDublin
    B.5.3.3Post code2
    B.5.3.4CountryIreland
    B.5.6E-mail260859-Amgen@parexel.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.3.2Product code ABP 501-HCF
    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.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.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 holderAbbVie 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.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to Severe Plaque Psoriasis
    E.1.1.1Medical condition in easily understood language
    Moderate to Severe 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 20.0
    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
    To demonstrate similarity of PK in subjects after multiple switches between adalimumab and ABP 501, compared to subjects receiving continued-use of adalimumab.
    E.2.2Secondary objectives of the trial
    To assess the efficacy, safety, and immunogenicity in subjects after multiple switches between ABP 501 and adalimumab compared with subjects receiving continued-use of adalimumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is male or female and is ≥ 18 and ≤ 75 years of age inclusive, at the time of enrollment.
    2. Subject has moderate to severe Ps (with or without psoriatic arthritis) for at least 6 months and has stable disease for at least 2 months (eg, no morphology changes or significant flares of disease activity in the opinion of the investigator).
    3. Subject has a score of PASI ≥ 12, involvement of ≥ 10% body surface area (BSA) and static Physician’s Global Assessment (sPGA) ≥ 3 at screening and at baseline.
    4. Subject is a candidate for phototherapy or systemic therapy, when other systemic therapies are clinically less appropriate.
    5. Female subject (except if postmenopausal or surgically sterile): a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline.
    6. Subject or legally acceptable representative is capable of giving signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) informed consent.
    7. Subject has no known history of latent or active tuberculosis. Subject must meet any 1 of the following 3 criteria:
    • Subject has a negative test for tuberculosis during screening, defined as either:
    o Negative purified protein derivative (PPD); < 5 mm of induration at 48 hours to 72 hours after test is placed, or
    o Negative QuantiFERON®/T-spot®test.
    • Subject with a positive PPD test and a history of Bacillus Calmette Guerin (BCG) vaccination is allowed with a negative QuantiFERON®/T-spot®test.
    • Subject with a positive PPD test (without a history of BCG vaccination) or subject with a positive or indeterminate QuantiFERON®/T-spot®test is allowed if he/she has all of the following:
    o No symptoms per tuberculosis worksheet provided by the sponsor, Amgen Inc.
    o Documented history of adequate prophylaxis initiation prior to receiving investigational product in accordance with local recommendations.
    o No known exposure to a case of active tuberculosis after most recent prophylaxis.
    o No evidence of active tuberculosis on chest radiograph taken within 3 months prior to the first dose of investigational product and read by a qualified radiologist/specialist.
    E.4Principal exclusion criteria
    Skin Disease Related Conditions
    1. Subject has erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at the time of screening (eg eczema) that would interfere with evaluations of the effect of investigational product of psoriasis.
    Other Medical Conditions
    2. Subject has a planned major surgical intervention during the duration of the study.
    3. Subject has an active infection or history of infections, as follows:
    • Any active infection for which systemic anti-infective therapy was used within 28 days prior to enrollment.
    • A serious infection, defined as requiring hospitalization or IV anti--infective therapy within 8 weeks prior to enrollment.
    • Opportunistic, recurrent or chronic infections, or other active infection that, in the opinion of the investigator, might cause this study to be detrimental to the subject.
    4. Subject has known history of human immunodeficiency virus infection or has positive HIV serology at screening.
    5. Subject has hepatitis B surface antigen, is positive for hepatitis B core antibody or has hepatitis C virus antibody positivity at screening.
    6. Subject has uncontrolled, clinically significant systemic disease including, but not limited to metabolic disturbances including, uncontrolled diabetes mellitus, cardiovascular, renal, liver, pulmonary, gastrointestinal, hematologic, psychiatric disease, or hypertension.
    7. Subject has known malignancy within the previous 5 years.
    8. Subject has active neurological disease, such as multiple sclerosis, -Guillain-Barre syndrome, optic neuritis, transverse myelitis, or history of neurologic symptoms suggestive of central nervous system demyelinating disease.
    9. Subject has moderate to severe heart failure, history of significant cardiac arrhythmia and/or cardiac hospitalization within 3 months prior to enrollment.
    10. Subject has known hypersensitivity to the investigational products or to any of the excipients.
    11. Subject has any concurrent medical condition, including hypersensitivity to any biologic medication, that, in the opinion of the investigator, could cause this study to be detrimental to the subject.
    Laboratory Abnormalities
    12. Subject has laboratory abnormalities at screening, including any of the following:
    • Hemoglobin < 9 g/dL
    • Platelet count < 100,000/mm3
    • White blood cell count < 3,000 cells/mm3
    • Aspartate aminotransferase and/or alanine aminotransferase ≥ 2.0 × the upper limit of normal
    • Creatinine clearance < 50 mL/min
    • Any other laboratory abnormality which, in the opinion of the investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results
    Washouts and Non-permitted Drugs
    13. Subject has previously received adalimumab or a biosimilar of adalimumab.
    14. Subject has received biologic treatment for psoriasis within the previous month or 5 drug half-lives (whichever is longer) prior to enrollment.
    15. Subject has received any investigational agents within the previous month or 5 half-lives (whichever is longer) prior to enrollment.
    16. Subject has received nonbiologic systemic psoriasis therapy within 4 weeks prior to enrollment.
    17. Subject has received ultraviolet A phototherapy (with or without psoralen) or excimer laser within 4 weeks prior to enrollment, or UV B phototherapy within 2 weeks prior to enrollment.
    18. Subject has received topical psoriasis treatment within 2 weeks prior to enrollment.
    19. Subject has received live viral or live bacterial vaccination within 4 weeks prior to enrollment or intends to receive live viral or live bacterial vaccine at any time during the study.
    20. Subject has received or plans to receive other investigational procedures or device within 4 weeks prior to enrollment or during the course of the study.
    21. Subject has prior use of two or more biologics for treatment of psoriasis.
    General
    22. Female of childbearing potential who is sexually active with male partner and is unwilling to use an effective method of birth control. Female of childbearing potential must also agree not to donate eggs for at least 5 months after receiving the last dose of the investigational product.
    23. Subject has evidence of active substance abuse within 24 weeks prior to screening that may impact subject’s ability to participate in the study.
    24. Female subject who is pregnant or breastfeeding or planning to become pregnant while participating in the study and for at least 5 months after the last dose of investigational product.
    25. Subject is not likely to comply with all required study procedures, or not available for protocol-required study visits or procedures, to the best of the subject and investigator knowledge.
    26. Subject has any physical or psychiatric disorder that, in the opinion of the investigator, may compromise the ability of the subject to give informed consent and/or to comply with all the required study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetic parameters:
    • AUCtau between week 28 and week 30
    • Cmax between week 28 and week 30.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • between week 28 and week 30
    • between week 28 and week 30
    E.5.2Secondary end point(s)
    Pharmacokinetic related Endpoints:
    • tmax between week 28 and week 30.
    • Ctrough between week 14 and week 28.
    Efficacy related Endpoints:
    • PASI percent improvement from baseline (day 1) to week 30.
    • PASI 75 response at week 30.
    • PASI 90 response at week 30.
    • PASI 100 response at week 30.
    Safety related Endpoints:
    • Treatment-emergent adverse events and serious adverse events, post randomization.
    • Events of interest, post randomization.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pharmacokinetic related Endpoints:
    • between week 28 and week 30.
    • between week 14 and week 28.
    Efficacy related Endpoints:
    • from baseline (day 1) to week 30.
    • at week 30.
    • at week 30.
    • at week 30.
    Safety related Endpoints:
    • post randomization.
    • post randomization.
    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 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
    Immunogenicity, interchangeability
    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 EEA50
    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
    Canada
    United States
    Estonia
    Latvia
    Poland
    Germany
    Hungary
    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
    The end of study is defined as the date of the last visit of the last subject in the study or last scheduled procedure shown in the Schedule of Assessments for the last subject in the study globally.
    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 months5
    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 months8
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 114
    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 state34
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 199
    F.4.2.2In the whole clinical trial 414
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-12-19
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