Osteoarthritis of the Knee MedDRA version: 21.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859
Conditions
Interventions
Product Name: SB-061
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: None
Current Sponsor code: SB-061
Other descriptive name: SB-061
Concentration unit: mg milligram
Sponsors
Nordic Bioscience Clinical Development A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 185 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 93
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of SB-061 administered via intra-articular injection to reduce pain in subjects with symptomatic osteoarthritis of the knee. ;Secondary Objective: • 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;Primary 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. ;Timepoint(s) of evaluation of this end point: Week 8 of trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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;Timepoint(s) of evaluation of this end point: (8), 24 and 52 weeks | — |
Countries
Denmark, Hong Kong
Contacts
Public ContactRegulatory Affairs Department
Nordic Bioscience CLinical Development
Outcome results
None listed