Study of efficacy, safety, and tolerability of LNA043 in patients with knee osteoarthritis
- Conditions
- osteoarthritisMedDRA version: 21.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2020-004897-22-LT
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 550
-Males and females between 40 and 75 years of age
-Body mass index (BMI) < 40 kg/m2
-Diagnosis of primary tibiofemoral knee OA by standard American College of Rheumatology clinical and radiographic criteria
-and other criteria as specified by the protocol
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 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
-Participants with radiographic knee OA K-L grade = 4 on the non-target knee
-Arthroscopy of the target knee within the 6 months prior to Screening
-Hemoglobin < 8.5 g/dL (85 g/L) or platelet count < 100,000/µL
-and other criteria as specified by the protocol
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