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    Summary
    EudraCT Number:2014-001096-31
    Sponsor's Protocol Code Number:M14-171
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-02-05
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-001096-31
    A.3Full title of the trial
    A Phase 2a, multicenter, randomized, double-blind, placebo-controlled study comparing the safety and efficacy of ABT-981 to placebo in subjects with erosive hand osteoarthritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2a Study Evaluating the Safety and Efficacy of ABT-981 in Patients with Erosive Hand Osteoarthritis
    A.4.1Sponsor's protocol code numberM14-171
    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 AddressAbbott house, Vanwall Business Park, Vanwall
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628773355
    B.5.5Fax number+441628644330
    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-981
    D.3.2Product code ABT-981
    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-981
    D.3.9.4EV Substance CodeSUB127307
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution for injection
    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
    Adult male and female patients with erosive hand osteoarthritis
    E.1.1.1Medical condition in easily understood language
    Erosive hand osteoarthritis
    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 17.1
    E.1.2Level LLT
    E.1.2Classification code 10019115
    E.1.2Term Hand osteoarthritis
    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
    The primary objective is to evaluate the effect of ABT-981 on pain using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN NR3.1) pain subdomain score, in subjects with erosive hand OA at Week 16.
    E.2.2Secondary objectives of the trial
    ● Evaluate the safety and tolerability of ABT-981 in subjects with erosive hand OA throughout the study.
    ● Evaluate the effect of ABT-981 on AUSCAN NR3.1 total and individual subdomain (pain, physical function and stiffness) scores of erosive hand OA throughout the study.
    ● Evaluate the effect of ABT-981 on Subject Assessment of Hand Pain Intensity via an 11-point Numeric Rating Scale (NRS-11) throughout the study.
    ● Evaluate the effect of ABT-981 on Patient Global Assessment (PGA) of Hand Arthritis Status using a NRS-11 throughout the study.
    ● Evaluate the PK and ADA levels of ABT-981.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PK substudy
    E.3Principal inclusion criteria
    1. Male or female between the ages of 35 to 80 years (inclusive)
    2. Must fulfill 1990 American College of Rheumatology (ACR) hand OA criteria, defined as hand pain, aching, or stiffness and three or four of the following features:
    •hard tissue enlargement of two or more of the following 10 selected joints: the second and third distal interphalangeal (DIP) joint of both hands, the second and third proximal interphalangeal (PIP) joints of both hands, the first carpometacarpal (CMC) joints of both hands,
    •hard tissue enlargement of two or more DIP joints,
    •fewer than three swollen metacarpophalangeal (MCP) joints, and
    •deformity of at least one of the 10 selected joints.
    3. Must have radiographic evidence of erosive hand OA with evidence of an "E" (erosive) or "E/R" (erosive with remodeling) joint as defined by Verbruggen and colleagues in at least one of the hand interphalangeal joints based on hand x-rays obtained during the Screening Period or within 3 months of the Screening Visit
    4. Have one or more clinical signs and symptoms of active inflammation in at least three hand joints, with active inflammation defined as localized tenderness and/or soft tissue swelling at Screening and Day 1 Visit.
    5. Subject Assessment of Hand Pain Intensity in at least one hand is ≥ 6 (11-point Numeric Rating Scale [NRS-11]) at Screening and Day 1 Visit.
    6. Patient Global Assessment of Arthritis Status is ≥ 6 (NRS-11) at Screening and Day 1 Visit.
    E.4Principal exclusion criteria
    1. Previous exposure to any anti-IL-1 treatment including (and not limited to) anakinra, canakinumab and rilonacept OR one or more of the following:
    •Oral, intramuscular (IM), intravenous (IV), epidural or intra-articular corticosteroids within 1 month prior to Screening,
    •Intra-articular hyaluronic acid injection into hand joint(s) within 6 months prior to Screening,
    •Any investigational drug product of chemical or biologic nature within 1 month or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug,
    •Any immunosuppressive biologic therapy including (and not limited to), etanercept, adalimumab, infliximab, golimumab, certolizumab, abatacept, tocilizumab, natalizumab, efalizumab, ustekinumab, belimumab or rituximab within 1 month or 5 half-lives (whichever is longer) prior to the first dose of study drug,
    •Current use of immunosuppressive oral medications including (and not limited to) Tofacitinib, hydroxychloroquine, azathioprine, methotrexate, leflunomide, mycophenolate, sulfasalazine, gold, cyclophosphamide, penicillamine and/or tacrolimus, or tetracycline based agents within 3 months or 5 half-lives (whichever is longer) prior to the first dose of study drug,
    •Colchicine within 1 month prior to the first dose of study drug,
    •Vaccination with a live viral agent (including live attenuated influenza vaccine via nasal spray) ≤ 30 day prior to Screening Visit through 10 weeks (5 × the half-life of ABT-981) after the last dose of study drug.
    2. Absolute neutrophil count (ANC) < 2,000/mm3 at Screening.
    3. Diagnosis of one or more of the following:
    •Fibromyalgia,
    •Inflammatory arthritis such as rheumatoid arthritis, peripheral seronegative spondyloarthropathy,
    •Psoriatic arthritis, evidence of psoriasis,
    •Microcrystalline (including gout and pseudo gout) arthritis affecting the hands,
    •Any OA of the hands due to an infectious origin or acute traumatic episode,
    •Secondary OA due to (but not limited to) hemochromatosis, alkaptonuria, Wilson's disease, acromegaly and/or hyperparathyroidism,
    •OA linked to cartilage and bone dysplasia,
    •Other chronic painful syndromes that could interfere with assessment of pain at the hand(s).
    4. Any uncontrolled medical illness or an unstable treatment or therapy.
    5. Clinically significant cardiac disease (including MI, coronary stenting or CVA) within last 12 months of Study Day 1 or clinically significant findings at Screening ECG including QT interval corrected for heart rate by Fridericia's formula (QTcF) > 470 msec in females or > 450 msec in males or PR interval > 220 msec.
    6. Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) within the past 5 years other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
    7. History of persistent chronic or active infection(s) requiring hospitalization or treatment with antimicrobials/antibiotics within 1 month prior to the first dose of study drug.
    8. Any reason that prohibits a subject to undergo an MRI (e.g., pacemaker, certain types of metal implants, etc.).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variables will be the changes from Baseline to Week 16 in AUSCAN NR3.1 pain subdomain score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints including change in total AUSCAN score and individual subdomain (pain, physical function and stiffness) scores from Baseline, change of patient index hand resting pain from Baseline using NRS-11, and change of Patient Global Assessment of Arthritis from Baseline using NRS-11 will be analyzed similarly at Week 16.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 16
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Belgium
    Denmark
    France
    Netherlands
    Switzerland
    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
    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 months6
    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 months6
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 120
    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)
    Return to standard of care
    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 Decision2015-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-18
    P. End of Trial
    P.End of Trial StatusCompleted
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