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    Summary
    EudraCT Number:2010-022865-81
    Sponsor's Protocol Code Number:ALX-0061-1.1/10
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-12-22
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2010-022865-81
    A.3Full title of the trial
    A phase I/II, multi-center, randomized, double-blind, placebo controlled study, with a single ascending dose part followed by a multiple ascending dose part, evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of intravenous ALX-0061 in patients with rheumatoid arthritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to investigate the safety, efficacy, and absorption, distribution, and elimination of ALX-0061 compared to placebo in patients with rheumatoid arthritis
    A.3.2Name or abbreviated title of the trial where available
    ALX-0061 phase I/II, single ascending dose and multiple ascending dose study in rheumatoid arthritis
    A.4.1Sponsor's protocol code numberALX-0061-1.1/10
    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 SponsorAblynx NV
    B.1.3.4CountryBelgium
    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 supportAblynx NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAblynx NV
    B.5.2Functional name of contact pointClinical Trials Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressTechnologiepark 21
    B.5.3.2Town/ cityZwijnaarde
    B.5.3.3Post code9052
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32 9 262 0000
    B.5.5Fax number+32 9 262 0001
    B.5.6E-mailclinicaltrials@ablynx.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 nameALX-0061
    D.3.2Product code ALX-0061
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameALX-0061 Nanobody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    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 Yes
    D.3.11.13.1Other medicinal product typeIsolated Nanobody (therapeutic protein based on the smallest functional fragments of heavy chain only antibody) comprised of an IL6R-binding and a HSA-binding domain
    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 infusion
    D.8.4Route of administration of the placeboIntravenous 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
    Swelling of the joints
    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 14.1
    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
    1. To investigate the safety and tolerability of single and multiple doses of ALX-0061 given by intravenous injection/infusion to patients with RA
    2. To determine the maximum tolerated dose and/or biologically effective dose of ALX-0061
    E.2.2Secondary objectives of the trial
    1. To determine the efficacy of multiple dosing with ALX-0061 in patients with RA
    2. To investigate the pharmacokinetics of ALX-0061 after single and multiple dosing in patients with RA
    3. To investigate the pharmacodynamics of ALX-0061 after single and multiple dosing in patients with RA
    4. To investigate the immunogenicity of ALX-0061 after single and multiple dosing in patients with RA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For SAD and MAD:
    1. Gender: male and female
    2. Age: 18-80 years, inclusive
    3. Body mass index (BMI): <35.0 kg/m2
    4. Diagnosed with RA according to the 2010 European League Against Rheumatism (EULAR)/ American College of Rheumatology (ACR) criteria for at least 6 months prior to randomization
    5. Treatment with methotrexate (MTX) for at least 12 weeks prior to screening, with at least 4 weeks before screening at a stable dose, that will remain stable throughout the study period. Inadequate response or intolerance to disease modifying antirheumatic drugs (DMARDs) (including MTX, where a patient may remain on treatment with MTX at a lower dose for improved tolerance, but with reduced effectiveness).
    6. For patients (men and women) of reproductive potential, use of an acceptable method of contraception for the duration of the study. Female patients must be willing to use appropriate birth control measures that would prevent pregnancy starting from the time of signing the informed consent until 90 days after the last dose of study drug is administered
    7. Ability and willingness to provide written informed consent and to comply with the protocol’s requirements

    For SAD:
    8. Disease Activity Score using 28 joint counts (DAS28) >= 2.4

    For MAD:
    8. DAS28 >= 3.2
    9. Swollen joint count ≥ 3
    E.4Principal exclusion criteria
    1. A documented history of an autoimmune disease other than RA (other than secondary Sjögren’s syndrome)
    2. Functional class IV by ACR classification
    3. Any new/additional biologic DMARD therapy, cytotoxic drugs and immunosuppressants within four weeks prior to screening, and between screening and Day 1 with the exception of ALX-0061
    4. Suspicion of active tuberculosis verified by quantiferon test and abnormal chest X-ray
    5. Female patients who are pregnant during the study, or are breastfeeding
    6. History of anaphylactic reactions to protein therapeutics
    7. Participation in an investigational drug study within 60 days prior to drug administration except for the patients who participated in the SAD part of this study and who are eligible to participate in the MAD part
    8. Donation of more than 300 mL of blood within 60 days prior to drug administration
    9. Malignancy, or prior malignancy, with a disease free interval of <5 years after diagnosis and intervention except curative treatment for non-melanoma skin cancer or resected carcinoma in situ
    10. Any current or recent (within 4 weeks prior to first dose) signs or symptoms of infection that requires parenteral antibiotic administration, any known active viral infection (hepatitis B virus [HBV], hepatitis C virus [HCV], human immunodeficiency virus [HIV]) that would impair the participation in the study
    11. Major surgery (including joint surgery) within 8 weeks prior to screening and hospitalization for a clinically relevant event within the 4 weeks prior to screening
    12. Any other disease, metabolic dysfunction, physical examination finding, or clinically significant laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk for treatment complications
    13. Administration of a live, attenuated vaccine within 1 month before dosing with ALX-0061, or anticipation that such a live attenuated vaccine will be required during the study or within 60 days after the last dose
    MAD part only:
    14. Contraindication to MRIs or the use of contrast agents for MRI scanning, as determined by the Investigator and/or radiologist at the site’s MRI facility. Patients with potential contraindications to MRIs may include: patients who have a physical limitation related to fitting in the bore of the magnet (i.e. body weight > 115 kilograms); patients who have a history of allergic reaction to contrast agents; patients who have had exposure to a radiological contrast agent within 72 hours prior to the MRI examination; patients with implanted electronic devices (e.g. heart pacemaker), insulin pump, cochlear implants, neural stimulators, intracranial or other internal vascular clips or intraocular metal foreign bodies; patients with severe renal insufficiency (i.e. glomerular filtration rate as estimated by creatinine clearance < 30 mL/min at screening) due to increased risk of Nephrogenic Systemic Fibrosis following administration of gadolinium-based MRI contrast agents. Careful consideration should be given to patients with: metallic endoprosthesis, metal sutures and foreign bodies in other locations than the examined one, and claustrophobia.
    E.5 End points
    E.5.1Primary end point(s)
    As this is a phase I/II trial with only descripitve statistics, formal primary endpoints have not been statistically defined.
    Endpoints that will be assessed include:
    - evaluation of dose limiting toxicities (DLT) of ALX-0061
    - evaluation of treatment-emergent adverse events of ALX-0061
    - evaluation of pharmacokinetic and pharmacodynamic parameters for ALX-0061
    - evaluation of the efficacy of multiple dosing with ALX-0061 in patients with RA
    - evaluation of immunogenicity of ALX-0061
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 or 24 weeks
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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 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 the trial is the last visit of the last subject
    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: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 72
    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)
    See protocol.
    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 Decision2011-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-02
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