A Multicenter, Randomized, Double-blind, Placebo- and Active-Controlled Phase III Study on the Safety and Efficacy of a Single Intra-articular Administration of JTA-004 in Symptomatic Knee Osteoarthritis
- Conditions
- Symptomatic osteoarthritis of the knee with Kellgren-Lawrence grade II and IIIMedDRA version: 21.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2019-000796-16-GB
- Lead Sponsor
- Bone Therapeutics SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 742
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 < 30 minutes
• Kellgren-Lawrence grade II or III (confirmed by appropriate X-rays taken within 6 months prior to screening Visit)
4. Target knee pain = 200 mm and = 400 mm out of 0-500 mm on the WOMAC ® VA3.1 pain questionnaire (sum of 5 questions) at screening and baseline
5. Insufficient/failed response or intolerance to analgesics and/or non-steroidal anti-inflammatory drugs (NSAIDs) as reported by the subject
6. Willing and able to abstain from initiation of physical therapy and knee braces at the target knee up to the 6-month follow up visit (a subject undergoing physical therapy or using knee braces at a stable frequency for at least 2 weeks prior to screening is allowed to continue at same frequency (frequency increase is not allowed)
7. Capable to understand and comply with study requirements and to provide a written, dated, and signed informed consent prior to any study procedure for participation in the study and transmission of personal pseudo-anonymized data
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 409
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 333
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method