Status:
TERMINATED
Study of Efficacy, Safety, and Tolerability of LNA043 in Patients With Knee Osteoarthritis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Osteoarthritis
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
Brief Summary
The study will determine the optimal dosing regimen of LNA043 in patients with knee osteoarthritis (OA).
Detailed Description
This study is a 2-period, multicenter, randomized, parallel-group, double-blind, placebo-controlled study consisting of a 2-year Core period, followed by a 3 year extension period. The primary objecti...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2025
Estimated Enrollment :
582 Patients enrolled
Trial Details
Trial ID
NCT04864392
Start Date
May 31 2021
End Date
May 29 2025
Last Update
July 24 2025
Active Locations (76)
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1
Elite Clinical Studies
Phoenix, Arizona, United States, 85018
2
Tucson Orthopedic Institute PC
Tucson, Arizona, United States, 85712
3
Sharps Hospital Grossmont
La Mesa, California, United States, 91942
4
Clinical Trials Research
Lincoln, California, United States, 95648