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    Summary
    EudraCT Number:2009-014735-20
    Sponsor's Protocol Code Number:MI-CP219
    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:2009-10-21
    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 number2009-014735-20
    A.3Full title of the trial
    A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial to investigate the effects of Mavrilimumab, a drug used in clinical research, in subjects with rheumatoid arthritis, which is a disease causing pain and swelling in joints.
    A.3.2Name or abbreviated title of the trial where available
    EARTH
    A.4.1Sponsor's protocol code numberMI-CP219
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01050998
    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 SponsorMedImmune Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportMedImmune Ltd
    B.4.2CountryBulgaria
    B.4.1Name of organisation providing supportMedImmune Ltd
    B.4.2CountryCzech Republic
    B.4.1Name of organisation providing supportMedImmune Ltd
    B.4.2CountryEstonia
    B.4.1Name of organisation providing supportMedImmune Ltd
    B.4.2CountryHungary
    B.4.1Name of organisation providing supportMedImmune Ltd
    B.4.2CountryLatvia
    B.4.1Name of organisation providing supportMedImmune Ltd
    B.4.2CountryLithuania
    B.4.1Name of organisation providing supportMedImmune Ltd
    B.4.2CountryPoland
    B.4.1Name of organisation providing supportMedImmune Ltd
    B.4.2CountryRomania
    B.4.1Name of organisation providing supportMedImmune Ltd
    B.4.2CountryRussian Federation
    B.4.1Name of organisation providing supportMedImmune Ltd
    B.4.2CountryUkraine
    B.4.1Name of organisation providing supportMedImmune Ltd
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune Ltd
    B.5.2Functional name of contact pointMedical Affairs
    B.5.3 Address:
    B.5.3.1Street AddressOne MedImmune Way
    B.5.3.2Town/ cityGaithersburg, Maryland
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrialsenquiries@medimmune.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 namemavrilimumab
    D.3.2Product code CAM-3001
    D.3.4Pharmaceutical form Concentrate 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 INNmavrilimumab
    D.3.9.1CAS number 1085337-57-0
    D.3.9.2Current sponsor codeCAM-3001
    D.3.9.3Other descriptive nameanti-GM-CSF receptor alpha
    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 placeboSolution 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
    Rheumatoid Arthritis
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    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 objectives of this study are to evaluate the safety, tolerability and efficacy of multiple doses of CAM-3001 administered subcutaneously in subjects with at least moderately active RA.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    1) To evaluate clinical outcomes in RA
    2) To explore CAM-3001 dose and the relationship with safety and efficacy
    3) To evaluate the pharmacokinetics (PK) and immunogenicity of CAM-3001
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following criteria:
    1) Male or female
    2) Age 18 through 80 years at the time of screening
    3) Signed and dated informed consent, prior to receipt of any study medication or any study related procedures
    4) A diagnosis of adult onset RA of at least 3 months duration as defined by the 1987 ACR classification criteria (Arnett et al, 1988)
    5) Treatment with methotrexate (7.5 to 25 mg/week) for at least 12 weeks and at stable and tolerated doses for at least 4 weeks prior to Screening.
    6) Positive anti-cyclic citrullinated peptide (CCP) IgG antibodies (> 5 IU/mL) and/ or rheumatoid factor (> 14 IU/mL) at screening
    7) Subjects must receive ≥ 5 mg/week folic acid as a single or divided dose during the study
    8) At least moderately active disease as defined by DAS28 ≥ 3.2 at screening and baseline (Smolen et al, 2003)
    9)a) Females of childbearing potential; unless surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy), has a sterile male partner, is premenarchal or at least 2 years postmenopausal, or practices abstinence; must use 2 effective methods of avoiding pregnancy (including oral, transdermal, or implanted hormonal contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap with spermicide, or use of a condom with spermicide by the sexual partner) for 21 days prior to randomisation and at baseline, and must agree to continue using such precautions until the end of the 12 weeks safety follow-up; cessation of birth control after this point should be discussed with a responsible physician. A negative pregnancy test is required both at screening and prior to dosing.
    b) Males, unless surgically sterile, must use 2 effective methods of birth control with a female partner and must agree to continue using such contraceptive precautions from screening through the end of the 12 weeks safety follow-up
    10) No evidence of medically significant respiratory disease. A local pulmonologist will review subjects’ respiratory system including, chest x-ray, pulmonary function, and diffusing capacity for carbon monoxide (DLCO), which are performed at screening. Subjects must have:
    DLCO ≥ 80% predicted value
    Forced expiration volume in first second (FEV1) by spirometry ≥ 80% predicted value
    No pneumonitis and clinically significant obstructive or restrictive lung disease
    11) Willing and able to comply with the protocol and complete the study period
    E.4Principal exclusion criteria
    Any of the following would exclude the subject from participation in the study:

    1) A rheumatic autoimmune disease other than RA, or significant systemic extra-articular involvement secondary to RA. Subjects with secondary Sjögren’s syndrome or secondary limited cutaneous vasculitis with RA are eligible
    2) A history of, or current, inflammatory joint disease other than RA or other systemic autoimmune disorder
    3) Functional class IV defined by the 1992 ACR Classification of Functional Status in RA
    4) Treatment with any investigational drug therapy within 28 days or 5 half-lives of the drug, whichever is longer, prior to screening
    5) Previous treatment with > 1 biologic therapy for RA that was discontinued for lack of efficacy
    6) Any cell depleting therapies within 12 months prior to screening; or previous treatment with non-depleting biologic therapies within 30 days or 5 half-lives of the biologic agent, whichever is longer, prior to screening
    7) Previous administration of CAM-3001
    8) History of known allergy or reaction to any component of the CAM-3001/investigational product formulation
    9) Treatment with disease modifying anti-rheumatic drugs, other than background methotrexate within 28 days of screening.
    10) Treatment with alkylating agents 12 weeks prior to screening
    11) If receiving treatment with non steroidal anti-inflammatory drugs these must be on a stable dose for ≥ 28 days prior to baseline and remain stable for the duration of the treatment phase of the study.
    12) Intramuscular, IV or intra-articular corticosteroids within 28 days of screening
    13) Treatment with > 10 mg/day dose prednisone (or equivalent) within 28 days of screening. Concomitant treatment with oral steroids ≤ 10 mg/day prednisone or equivalent is permitted providing that the dose is stable for ≥ 28 days prior to screening and remains stable for the duration of the treatment phase of the study.
    14) Female subjects who are pregnant, intend to become pregnant, or are breast-feeding
    15) Subjects who in the opinion of the investigator have evidence of active tuberculosis (TB), either treated or untreated, or latent TB without completion of an appropriate course of treatment or appropriate ongoing prophylactic treatment.
    16) Current symptoms and signs of clinically significant chronic or recurrent infection and any significant chronic or recurrent infection, or any episode of infection requiring hospitalisation or treatment with IV antibiotics within 12 weeks before screening. Subjects with any opportunistic infection within 6 months before screening will be excluded from the study
    17) Subjects at a high risk of infection
    18) History of hereditary or acquired immune deficiency disorder
    19) Receipt of live vaccine within the 28 days before screening or during the study
    20) Any history of cancer except basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured
    21) Any surgical procedure, including bone or joint surgery/synovectomy within 12 weeks prior to screening or any planned surgery within 3 months after randomisation
    22) Any neurological, psychiatric, vascular, or systemic disorder could also affect the evaluation of efficacy assessments; in particular, joint pain and swelling
    23) Significant respiratory or pulmonary disease including symptomatic lung fibrosis, pneumonitis, uncontrolled asthma, dyspnoea, malignancy and history of chronic respiratory tract infections
    24) Congestive heart failure NYHA classification III or IV
    25) History of methotrexate or any drug induced lung fibrosis or pneumonitis
    26) History of deep space/tissue infection within 12 months prior to screening.
    27) Evidence of any disease or history of any disease, any finding upon physical examination, or any clinically significant laboratory or radiographic abnormality that, in the opinion of the investigator, designated health care provider, or medical monitor, may compromise the safety of the subject in the study or confound the analysis of the data
    28) At Screening blood tests; any of the following:
    Aspartate transaminase (AST) > 2.5 x upper limit of the normal range (ULN)
    Alanine transaminase (ALT) > 2.5 x ULN
    Haemoglobin (Hb) < 8.0 mg/dL
    Neutrophils < 1,500/mm3
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint
    The effect of CAM-3001 on the response rate in terms of improvement in DAS28 c-reactive protein (CRP) score on the day of last dose of study drug (Study Day 85) will be evaluated. According to the European League Against Rheumatism (EULAR) response criteria an improvement from baseline in DAS28(CRP) of more than 1.2 would be considered a good response in subjects experiencing low disease activity (baseline DAS28 < 3.2) and a moderate response in subjects experiencing medium to high disease activity (baseline DAS28(CRP) ≥ 3.2). A responder will be defined as a subject experiencing a decrease of more than 1.2 from their baseline DAS28(CRP) score, on the day of last dose of study drug (Study Day 85 per protocol).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 85
    E.5.2Secondary end point(s)
    The secondary endpoints of this study include disease activity, the onset of response, duration of response after withdrawal of treatment, need for additional medications during the study and the PK and immunogenicity of multiple SC doses of CAM-3001.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The onset of response, duration of response after withdrawal of study treatment and need for additional medications during the study (Yes/No) will be summarised and tabulated together with descriptive statistics and listed by treatment arms. The time-to-events endpoints; the onset of response, duration of response after withdrawal of treatment will be analysed using non-parametric log-rank method and also Cox proportional hazard models (modelling baseline covariates as appropriate).
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 No
    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 trial4
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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
    Bulgaria
    Czech Republic
    Estonia
    Hungary
    Japan
    Latvia
    Lithuania
    Poland
    Romania
    Russian Federation
    Ukraine
    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
    Study completion is defined as the date of the last protocol-specified visit/assessment for the last subject in the study.
    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 years2
    E.8.9.2In all countries concerned by the trial months0
    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: 234
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 216
    F.4.2.2In the whole clinical trial 264
    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)
    Treatment with CAM-3001 will not be provided to patients who complete MI-CP219, because of the current limited understanding of the risk/benefit profile of CAM-3001 beyond the defined treatment period & because an effficacious dose has not yet been identified. The study design includes 3-month safety follow up to assess the potential for longer-term safety signals & should provide the dosing & risk/benefit information to allow extended CAM-3001 use in patients in future studies.
    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 Decision2009-12-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-07-27
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