Symptomatic osteoarthritis of the knee with Kellgren-Lawrence grade II and III MedDRA version: 21.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859
Conditions
Sponsors
Bone Therapeutics SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects must satisfy ALL the following criteria to be included in the study: 1. Male/female aged above 40 years 2. Ambulatory (able to walk unassisted, the use of a crutch or a walking stick (only one) is allowed if already used at screening but should be avoided during the study up to the 6-month follow-up visit) 3. Diagnosed with primary knee OA, fulfilling the following American College of Rheumatology (ACR) criteria at the target knee: • Pain present for most days of the preceding month • Morning stiffness =65 years) yes F.1.3.1 Number of subjects for this age range 333
Exclusion criteria
Exclusion criteria: Current symptoms and/or signs related to the disease under study: 1. History of trauma or surgery or arthroscopy at the target knee within 12 months before inclusion 2. Concomitant inflammatory disease or other conditions affecting the joints (e.g., infectious arthritis, rheumatoid arthritis, psoriatic arthritis or spondyloarthropathy, Paget’s disease, hemochromatosis…) 3. Any target knee abnormality that could impact safety or efficacy assessment. 4. Microcrystalline arthropathies: chondrocalcinosis/calcium pyrophosphate dihydrate disease (pseudo-gout) or gout if believed likely to interfere with the study endpoints, in the opinion of the Investigator 5. Clinically significant valgus/varus deformities at the Investigator’s discretion 6. Any musculoskeletal condition (such as symptomatic hip osteoarthritis, amputation, neurologic disorder, chronic back pain with or without radiculopathy, sciatica) that would impede measurement of efficacy at target knee 7. Contralateral knee pain equal to or exceeding the pain in the target knee (on the WOMAC ® VA3.1 pain questionnaire) at screening and/or baseline 8. Knee arthroplasty planned within 12 months after the screening visit Current or previous diagnoses, signs and/or symptoms: 9. Uncontrolled diabetes mellitus (hemoglobin A1c [HbA1c] > 10% or > 86 mmol/mol), end-stage hepatic or renal disease (severe and clinically significant abnormalities according to local laboratory ranges) documented in the subject’s file 10. Any relevant cardiovascular disease (severe coronary insufficiency, conduction disturbances, recent myocardial infarction, cerebrovascular disease) or any clinically significant electrocardiogram (ECG) abnormality as judged by the Investigator 11. Subject with neuropathic pain or chronic pain syndrome including fibromyalgia 12. Current (or within the last 5 years prior to entering the study) history of solid or hematological neoplasia or bone marrow transplantation (except for basal cell carcinoma and completely excised squamous cell carcinoma) 13. Other severe acute or chronic medical or psychiatric conditions or pre-dispositions or laboratory abnormalities, as judged by the Investigator 14. Current or past history of coagulation disorders (according to local laboratory ranges), as judged by the Investigator 15. Hypersensitivity to any components of hyaluronic acid (HA)-based injection products 16. Hypersensitivity to human biological material including blood and blood derived products, potential excipients and residues from manufacturing process, documented clinically or by laboratory tests 17. Hypersensitivity to avian proteins Current or previous treatment: 18. Participation in another clinical trial within 3 months prior to screening (within 1 year prior to screening if disease-modifying OA drug [DMOAD] received and if the Investigator considers it could impact the safety or efficacy assessment) 19. Subject previously treated with JTA-004 within 2 years prior to screening 20. Subject treated with intra-articular viscosupplement or blood-derived product (e.g., platelet-rich plasma) injection in the target knee within 6 months prior to screening 21. Subject treated with intra-articular glucocorticoid injection in the target knee within 4 months prior to screening 22. Started the use of slow acting drugs for OA such as glucosamine, glucosamine sulfate, chondroitin sulfate, diacerein, curcumin, soybean/avocado extracts or related products within 1 months prior to screening 23.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that treatment with JTA-004 leads to a reduction in knee pain intensity with respect to placebo in subjects suffering from symptomatic OA of the knee at Month 3.;Secondary Objective: Key Secondary Objectives To demonstrate that treatment with JTA-004 leads to a reduction in knee pain intensity with respect to placebo at Month 6 To demonstrate that reduction in knee pain intensity with JTA-004 is non inferior to reduction in knee pain intensity with active comparator at Month3 To demonstrate that treatment with JTA-004 leads to an improvement in knee physical function with respect to placebo at Month 3 To demonstrate that treatment with JTA-004 leads to an improvement in Patient Global Assessment with respect to placebo at Month 3 To demonstrate that treatment with JTA-004 leads to an improvement in knee physical function with respect to placebo at Month 6 To demonstrate that treatment with JTA-004 leads to an improvement in subject global health and well-being with respect to placebo at Month 3 To demonstrate that treatment with JTA-004 leads to a higher rate of responders (defined as = 30% pain intensity reduction) with respect to placebo at Month 3;Primary end point(s): The primary endpoint is the difference between JTA-004 and placebo in mean change from baseline in knee pain at Month 3 using the Western Ontario McMaster University (WOMAC®) VA3.1 pain subscale (subscale A).;Timepoint(s) of evaluation of this end point: 3 months after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy endpoints: a) Key secondary endpoints: - Difference between JTA-004 and placebo in mean change from baseline in knee pain at Month 6 using the WOMAC® VA3.1 pain subscale (subscale A) - Difference between JTA-004 and active comparator in mean change from baseline in knee pain at Month 3 using the WOMAC® VA3.1 pain subscale (subscale A) - Difference between JTA-004 and placebo in mean change from baseline in knee physical function at Month 3 using the WOMAC® VA3.1 physical function subscale (subscale C) - Difference between JTA-004 and placebo in mean change from baseline in PGA at Month 3 - Difference between JTA-004 and placebo in mean change from baseline in knee physical function at Month 6 using the WOMAC® VA3.1 physical function subscale (subscale C) - Difference between JTA-004 and placebo in mean change from baseline in subject global health and well-being score at Month 3 using the EQ-5D-5L questionnaire - Difference between JTA-004 and placebo in responder rate (defined as = 30% pain intensity reduction) at Month 3 b) Other secondary endpoints: - Difference between JTA-004 and placebo in mean change from baseline in knee pain at Month 1 using the WOMAC® VA3.1 pain subscale (subscale A) - Difference between JTA-004 and placebo in mean change from baseline in knee stiffness at each follow-up visit using the WOMAC® VA3.1 stiffness subscale (subscale B) - Difference between JTA-004 and placebo in mean change from baseline in knee physical function at Month 1 using the WOMAC® VA3.1 physical function subscale (subscale C) - Difference between JTA-004 and placebo in mean change from baseline in PGA at Month 1 and at Month 6 - Difference between JTA-004 and placebo in mean change from baseline in IGA at each follow-up visit - Difference between JTA-004 and placebo in mean change from baseline in subject global health and well-being score at Month 1 and at Month 6 using the EQ-5D-5L questionnaire - Difference between JTA-00 | — |
Countries
Belgium, Czechia, Czech Republic, Denmark, Hong Kong, Moldova, Republic of, Poland, United Kingdom
Contacts
Public ContactJTA Clinical Trial Team
Bone Therapeutics S.A.
Outcome results
None listed