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    Summary
    EudraCT Number:2019-004515-31
    Sponsor's Protocol Code Number:TP-1879
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-12-02
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2019-004515-31
    A.3Full title of the trial
    A Phase 2b Trial of SB-061 for the Treatment of Symptomatic Osteoarthritis of the Knee
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SB-061 for the Treatment of Symptomatic Osteoarthritis of the Knee
    A.4.1Sponsor's protocol code numberTP-1879
    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 SponsorNordic Bioscience Clinical Development A/S
    B.1.3.4CountryDenmark
    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 supportNordic Bioscience Clinical Development A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNordic Bioscience CLinical Development
    B.5.2Functional name of contact pointRegulatory Affairs Department
    B.5.3 Address:
    B.5.3.1Street AddressHerlev Hovedgade 82
    B.5.3.2Town/ cityHerlev
    B.5.3.3Post code2730
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4573707908
    B.5.6E-mailregulatory@nordicbioscience.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 nameSB-061
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNone
    D.3.9.2Current sponsor codeSB-061
    D.3.9.3Other descriptive nameSB-061
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 placeboIntraarticular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Osteoarthritis of the Knee
    E.1.1.1Medical condition in easily understood language
    Osteoarthritis of the Knee
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10023476
    E.1.2Term Knee 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
    To evaluate the efficacy of SB-061 administered via intra-articular injection to reduce pain in subjects with symptomatic osteoarthritis of the knee.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of SB-061 administered via intra-articular injection to improve physical function, in the study population
    • To evaluate the safety of SB-061 administered via intra-articular injection in the study population
    • To assess durability of effect of three doses of SB-061 administered via intra-articular injection to reduce pain in the study population
    • To evaluate the use of rescue medication during the 52 week study period
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is able to read and understand the language and content of the study material, understand the requirements for follow-up visits, and is willing to provide information at the scheduled evaluations, and appropriate written informed consent has been obtained.
    2. Males and females age ≥ 40 years to ≤ 85 years.
    3. Body mass index ≤ 45 kg/m2 .
    4. Knee pain score of at least 20 out of 50 in response to the WOMAC A pain questionnaire (5 questions) at both the screening and the baseline visits.
    5. Femorotibial osteoarthritis of the target knee, according to the American College of Rheumatology (ACR) clinical and radiographic criteria.
    6. Radiological OA grade 2 or 3, of either medial and/or lateral compartment of the target knee of the Kellgren-Lawrence method(Kellgren and Lawrence 1957) by X-ray obtained during screening, or on a recent (within 6 months) X-ray image, which fulfills the specifications for central reading.
    E.4Principal exclusion criteria
    1. Previous treatment with SB-061.
    2. Known hypersensitivity to or previous hypersensitivity reactions to protein-based medication, or any impediment to intra-articular injections.
    3. Intra-articular delivery of corticosteroids or hyaluronic acid in the target knee within 3 months of screening.
    4. High dose (equivalent to >10mg of prednisone/day) systemic corticosteroid treatment of longer (>14 days) duration during the past 6 months prior to screening.
    5. Regular treatment with any Chondroitin Sulfate-containing product within the past 7 days prior to Baseline.
    6. Previous procedures affecting joint homeostasis including total meniscectomy or septic arthritis or any other serious condition leading to secondary OA of the target knee.
    7. Major surgery or arthroscopy of the target knee within the previous year prior to screening.
    8. Known rapid progressive disease in the target knee defined as joint space narrowing >1.2 mm/year.
    9. Planned surgery in the target knee within the next 3 months.
    10. Chronic concomitant treatment with an oral or parenteral anti-coagulant including heparin or warfarin or derivatives thereof.
    11. Use of an investigational drug, device, or biologic within 6 months prior to screening.
    12. Presence of concomitant inflammatory disease affecting either knee, such as rheumatoid arthritis, psoriasis, gout, or active infection, including bacterial skin-lesions affecting the leg of the target knee.
    13. Severely uncontrolled diabetes mellitus, diabetic neuropathy, infections, complications, or any end-stage organ disease, in the opinion of the investigator.
    14. Current immunosuppressive therapy.
    15. Any contraindication to MRI according to MRI guidelines, including the inability to undergo a knee MRI exam because of inability to fit in the scanner or knee coil.
    16. Current malignancy or treatment for malignancy within the past five years, with the exception of non-melanoma skin cancer, or carcinoma in situ events.
    17. For women of childbearing potential:
    (a) Pregnancy (i.e. positive pregnancy test at Screening) or breastfeeding
    (b) Failure to agree to practice a highly effective method of contraception (see Section 4.4), from enrollment up to at least 3 months after the study end.
    18. For sexually active men with a female partner of childbearing potential: failure to agree to use condom (see Section 4.5) from enrollment up to at least 3 months after the study end.
    19. Any other abnormal laboratory results or significant medical conditions that the Investigator believes should preclude the subject’s participation in the trial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change from baseline in reported pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index pain sub-score (WOMAC A 11-point NRS 3.1, 5 questions) in the target knee as evaluated at week 8 of the trial.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8 of trial
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    • Change from baseline in reported pain in the target knee as measured by the WOMAC A, 5 questions at 24 and 52 weeks of the trial
    • Change from baseline in reported pain as measured by the WOMAC weight-bearing pain sub-score, questions 1,2, and 5, in the target knee at 8, 24, and 52 weeks after the first IMP injection
    • Change from baseline in reported pain as measured by the WOMAC non-weight-bearing pain sub-score questions 3 and 4, in the target knee at 8, 24, and 52 weeks after the first IMP injection
    • Proportion of subjects meeting the criteria for OMERACT-OARSI Responder at 8, 24, and 52 weeks after the first IMP injection
    • Change from baseline in the subject reported intermittent and constant pain in the target knee as measured by the ICOAP at 8, 24, and 52 weeks after the first IMP injection
    • Change from baseline in gait speed as measured using the 20 meter walk test at 8, 24, and 52 weeks after the first IMP injection
    • Change from baseline of the total WOMAC score (24 questions) at 8, 24, and 52 weeks after the first IMP injection
    • Change from baseline in function as measured by the WOMAC function sub-score (WOMAC C, 17 questions) at 8, 24, and 52 weeks after the first IMP injection
    • Time to first use of rescue medication
    • Average weekly dose of rescue medication used
    • Total use of rescue medication
    • Change from baseline in the Patient Global Assessment (PGA) score at 8, 24, and 52 weeks after the first IMP injection
    • Change from baseline in the EQ-5D scores at 8, 24, and 52 weeks after the first IMP injection
    E.5.2.1Timepoint(s) of evaluation of this end point
    (8), 24 and 52 weeks
    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 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 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 concerned1
    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 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
    Hong Kong
    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
    LVLS
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 185
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 93
    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 state225
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 225
    F.4.2.2In the whole clinical trial 278
    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)
    Standard of care
    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 Decision2020-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-10-07
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