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    Summary
    EudraCT Number:2014-005527-27
    Sponsor's Protocol Code Number:M14-198
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-04-28
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2014-005527-27
    A.3Full title of the trial
    A Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Active Psoriatic Arthritis Subjects Who Have Completed a Preceding Study M14-197 Phase 2 Randomized Controlled Trial (RCT)
    Multicentrická, otevřená, prodloužená studie fáze 2 přípravku ABT-122 u pacientů s aktivní psoriatickou artritidou, kteří dokončili předchozí studii M14-197 fáze 2 randomizovaného klinického hodnocení (RKH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Active Psoriatic Arthritis Subjects Who Have Completed a Preceding Study M14-197 Phase 2 Randomized Controlled Trial (RCT)
    A.4.1Sponsor's protocol code numberM14-198
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    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 supportAbbvie Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628561090
    B.5.5Fax number+441628461153
    B.5.6E-maileu-clinical-trials@abbvie.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 nameABT-122
    D.3.2Product code ABT-122
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    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 INNna
    D.3.9.3Other descriptive nameABT-122
    D.3.9.4EV Substance CodeSUB79540
    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
    Psoriatic Arthritis
    E.1.1.1Medical condition in easily understood language
    Psoriatic Arthritis
    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 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the long term efficacy, and safety and tolerability of ABT-122 in psoriatic arthritis (PsA) subjects on background methotrexate (MTX) who have completed Study M14-197 Phase 2 RCT.
    E.2.2Secondary objectives of the trial
    -To explore the effect of continued dosing on anti-drug antibody (ADA) profiles for ABT-122.
    -To explore the longer term effects of ABT-122 on function, quality of life and fatigue.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects who have completed preceding Study M14-197 (ABT-122) RCT study and have not developed any discontinuation criteria, defined in Section 5.4.1 of Study M14-197.
    2. If female, subject must meet one of the following criteria:
    ● Postmenopausal (defined as no menses for at least 1 year, with no alternate cause for amenorrhea).
    ● Surgically sterile (bilateral oophorectomy or hysterectomy).
    ● If subject does not meet one of the above two categories, subject must use one of the following methods of birth control, from the time of the first dose of study drug until 150 days after the last dose of study drug:
    - Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation started at least 2 months prior to the first dose of study drug: oral, intravaginal or transdermal
    - Progestogen-only hormonal contraception associated with inhibition of ovulation started at least two months prior to randomization: oral, injectable, or implantable
    - Intrauterine device (IUD)
    - Intrauterine hormone-releasing system (IUS)
    - Bilateral tubal occlusion / ligation
    - Be with a vasectomized partner (procedure at least 6 months earlier, the vasectomized partner should be your sole partner)
    - Sexual abstinence (refraining from heterosexual intercourse during the entire study period)
    3. If male, subject must be surgically sterile (have had a vasectomy more than 6 months prior to Screening) or must be practicing at least 1 of the following methods of birth control from the time of the first dose of study drug until 150 days after the last dose of study drug:
    ● Subject using condom and female partner(s) using an intrauterine device (IUD);
    ● Subject using condom and female partner(s) using hormonal contraceptives (oral, vaginal, parenteral or transdermal);
    ● Total abstinence from sexual intercourse as the preferred lifestyle of the subject; periodic abstinence is not acceptable;
    ● Subject must also agree to not donate sperm starting on the first day of study drug administration until 150 days after the laast dose of study drug.
    4. Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any study-specific procedures.
    5. Subject is judged to be in good health as determined by the Investigator based on the results of medical history, physical examination and laboratory profile performed.
    E.4Principal exclusion criteria
    1. Pregnant or breastfeeding or plans to become pregnant during study participation.
    2. Ongoing infections at Day 1 (Week 0) that have NOT been successfully treated within 14 days.
    3. Anticipated requirement or receipt of any live vaccine during study participation including up to 120 days after the last dose of study drug.
    4. Current enrollment in another investigational study; with the exception of Study M14-197, which is required.
    5. Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to continue to receive ABT-122.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of Study M14-198 is to assess the long term efficacy, and the safety and tolerability of ABT-122 in PsA subjects on background methotrexate (MTX) who have completed Study M14-197 Phase2 RCT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    ● To explore the effect of continued dosing on anti-drug antibody (ADA) profiles for ABT-122.
    ● To explore the longer term effects of ABT-122 on function, quality of life and fatigue.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24
    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 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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 EEA70
    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
    Bulgaria
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Latvia
    New Zealand
    Poland
    Romania
    Spain
    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
    LSLV
    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 months2
    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 months2
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 195
    F.4.2.2In the whole clinical trial 220
    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)
    Subjects who complete Study M14-198 or prematurely discontinue from the study will be treated in accordance with the investigator's best clinical judgment. At the subject's last visit, the investigator will discuss the appropriate subsequent treatment with the subject.
    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 Decision2015-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-08-02
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