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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   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).

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    Summary
    EudraCT Number:2018-000176-15
    Sponsor's Protocol Code Number:IZN-101
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-07-03
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-000176-15
    A.3Full title of the trial
    A phase 2a proof of concept, randomised, double-blind, placebo-controlled study to evaluate the safety/tolerability and efficacy of 4 subcutaneous injections of namilumab (150 mg) given over 10 weeks in subjects with moderate-to-severely active axial spondyloarthritis including those previously exposed to anti-TNF therapy (NAMASTE study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 2a proof of concept, randomised, double-blind, placebo-controlled study to evaluate the safety/tolerability and efficacy of 4 subcutaneous injections of namilumab (150 mg) given over 10 weeks in subjects with moderate-to-severely active axial spondyloarthritis including those previously exposed to anti-TNF therapy (NAMASTE study)
    A.3.2Name or abbreviated title of the trial where available
    Namilumab in Axial Spondyloarthritis Therapy Study
    A.4.1Sponsor's protocol code numberIZN-101
    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 SponsorIzana Bioscience Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInnovate UK (Government Body)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationN/A
    B.5.2Functional name of contact pointN/A
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityN/A
    B.5.3.3Post codeN/A
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone numberN/AN/AN/A
    B.5.5Fax numberN/AN/AN/A
    B.5.6E-mailinfo@izanabio.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 nameAnti-GM-CSF-Antibody
    D.3.2Product code MT03, IZN-101
    D.3.4Pharmaceutical form 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 INNNamilumab
    D.3.9.1CAS number 1206681-39-1
    D.3.9.2Current sponsor codeMT03, IZN-101
    D.3.9.3Other descriptive nameNAMILUMAB
    D.3.9.4EV Substance CodeSUB129920
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 solution for infusion
    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
    moderate-to-severe axial spondyloarthritis
    E.1.1.1Medical condition in easily understood language
    Axial spondyloarthritis is a rheumatic disease that causes back pain, stiffness, extreme tiredness, breathing , sleep problems and depression.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10071400
    E.1.2Term Axial spondyloarthritis
    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
    To assess the efficacy of namilumab 150 mg subcutaneous (sc), given on weeks 0, 2, 6 and 10 in subjects with axSpA
    E.2.2Secondary objectives of the trial
    To assess the efficacy of namilumab 150 mg sc, given on weeks 0, 2, 6 and 10 on other clinical responses in subjects with axSpA
    To assess the safety and tolerability of namilumab 150 mg sc, given on weeks 0, 2, 6 and 10 in subjects with axial spondyloarthritis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 and ≤ 75 years of age.
    2. Diagnosis of axSpA by an appropriately qualified physician and classified using ASAS criteria ≥ 3 months prior to Baseline; symptoms must have started before age 45.
    3. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 and spinal pain score ≥ 40, at screening and Baseline.
    4. MRI evidence of active axSpA ≤ 6 (ideally ≤ 3) months prior to randomisation using ASAS criteria.
    5. A negative tuberculosis (TB) screening assessment.
    6. A female subject of childbearing potential who is sexually active with a nonsterilised male partner agrees to routinely use adequate contraception from signing of the informed consent throughout the duration of the study until the end of the safety follow up (18 weeks after last dose) (see Appendix 7 of protocol).
    7. A male subject who is non-sterilised and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of the informed consent throughout the duration of the study until the end of the safety follow up (18 weeks after last dose) (see (see Appendix 7 of protocol).
    8. Stable NSAID use for 28 days prior to study entry.
    9. Stable use of MTX (≤ 25 mg/week), sulfasalazine (≤ 3 g/day) and leflunomide (≤ 20 mg/day) for 28 days prior to study entry.
    10. Stable oral corticosteroid dose ≤ 10 mg for 28 days prior to study entry.
    11. Capable of giving signed informed consent as described in Appendix 2, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    In addition, the following inclusion criteria will apply for some subjects:
    12. Inadequately responded to or experienced intolerance to previous treatment with an anti-TNF agent (limited to 50% of the total study population).
    Note: Criteria for inadequate response to or experienced intolerance to previous treatment with an anti-TNF agent are defined as:
    • Signs and symptoms of persistently active disease despite a history of at least one 12 week regimen of one of the following agents:
     Infliximab: 5 mg/kg i.v.
     Etanercept: 50 mg weekly
     Adalimumab: 40 mg fortnightly
     Golimumab: 50 mg monthly
     Certolizumab pegol: 400 mg SC initially and at weeks 2 and 4, followed by 200 mg every 2 weeks or 400 mg every 4 weeks
    OR
    • Recurrence of symptoms during scheduled maintenance dosing following prior clinical benefit (discontinuation despite clinical benefit does not qualify).
    OR
    • History of intolerance of at least one TNF antagonist (including, but not limited to infusion-related reaction, demyelination, congestive heart failure and infection).
    E.4Principal exclusion criteria
    1. A current diagnosis of axSpA with a BASDAI > 4 but no evidence of inflammation on MRI.
    2. Discontinued biologic therapy such as adalimumab, etanercept, infliximab, golimumab and certolizumab pegol < 8 weeks prior to Baseline.
    3. Previous or current use oral corticosteroid and meets one of the following criteria:
    • Is receiving prednisone or prednisone equivalent > 10 mg/day at Baseline;
    • Has discontinued use of corticosteroid within 28 days of Baseline;
    • Has not been on stable doses of corticosteroid for at least 28 days prior to Baseline; or
    • Has been taking both oral budesonide and prednisone (or equivalent) simultaneously.
    4. Received intra-articular or i.v. corticosteroids within 14 days prior to Screening or during the Screening Period.
    5. Received anti-IL-17A or anti IL12/23 therapy.
    6. Received cyclosporine, tacrolimus or mycophenolate mofetil within 28 days prior to Baseline.
    7. Previously received stem cell transplantation.
    8. Infection(s) requiring treatment with i.v. anti-infectives within 28 days prior to the Baseline Visit or oral anti-infectives within 14 days prior to the Baseline Visit.
    9. Screening laboratory and other analyses show any of the following abnormal results:
    • Serum AST or ALT > 1.5 × upper limit of normal (ULN); if bilirubin > ULN, then AST and ALT will be rechecked, and if > 1.5 × ULN, subject will be excluded;
    • Estimated glomerular filtration rate < 40 mL/min/1.73 m2;
    • Total white blood cell (WBC) count < 3,000/μL;
    • Absolute neutrophil count (ANC) < 1,000/μL;
    • Platelet count < 100,000/μL;
    • Absolute lymphocyte count < 750/μL;
    • Haemoglobin < 9 g/dL.
    10. Any active or recurrent viral infection that based on the Investigator's clinical assessment makes the subject an unsuitable candidate for the study, including recurrent/disseminated herpes zoster or known history of human immunodeficiency virus (HIV).
    11. Hepatitis B (hepatitis B virus surface antigen [HBsAg] positive [+] or detected sensitivity on the hepatitis B virus [HBV] DNA polymerase chain reaction [PCR] qualitative test for hepatitis B core antibodies [HBc Ab]/hepatitis B surface antibody [HBsAb] positive subjects) or hepatitis C (hepatitis C virus [HCV] RNA detectable in any subject with anti-hepatitis C virus antibody [HCV Ab]).
    12. Any active or chronic recurring infections or untreated latent TB.
    13. History of moderate-to-severe congestive heart failure (New York Heart Association [NYHA] class III or IV), risk factors for coronary syndrome, hypertension, angina and myocardial infarction, cerebrovascular accident and any other condition within 6 months, which in the opinion of the Investigator, would put the subject at risk by participation in the study.
    14. Receipt of any live vaccine within 2 weeks prior to randomisation, or will require live vaccination during study participation including up to 1 month after the last dose of study drug.
    15. Evidence of current or prior dysplasia or history of malignancy (including of the gastrointestinal tract) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localised carcinoma in situ of the cervix or adenomatous polyp that has been completely resected.
    16. Has had any uncontrolled and/or clinically significant (per Investigator's judgement) illness, hospitalisation, or has had any surgical procedure requiring general anaesthesia within 30 days prior to Screening, or has any planned surgical procedure within 6 months after randomisation.
    17. Known current or previous interstitial lung disease.
    18. Positive pregnancy test at Screening (serum) or Baseline (urine).
    19. Female subjects who are breastfeeding or considering becoming pregnant during the study.
    20. Considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
    21. Received any investigational agent or procedure within 30 days or 5 half-lives prior to Baseline, whichever is longer.
    22. History of clinically significant drug or alcohol (> 40 units per week) use in the last 12 months.
    23. Related to or a dependent of the site staff, or a member of the site staff.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects who achieve an ASAS20 clinical response at week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    E.5.2Secondary end point(s)
    1. Proportion of subjects who achieve ASAS40 and ASAS70 response at week 12
    2. Proportion of subjects who achieve an ASAS20 clinical response at week 6
    3. Proportion of subjects who achieve ASDAS-CRP response at weeks 6 and 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. week 12
    2. week 6
    3. weeks 6 and 12
    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 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) 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 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 concerned8
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The end of the study is defined as the date of the last visit of 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 years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned 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: 42
    F.1.3Elderly (>=65 years) No
    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 state42
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 42
    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 Decision2018-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-02-04
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