Study of Efficacy, Safety, and Tolerability of LNA043 in Patients With Knee Osteoarthritis
A 5-year, Randomized, Double-blind, Placebo-controlled, Multi-center Study Assessing the Efficacy, Safety, and Tolerability of Intra-articular Regimens of LNA043 Versus Placebo in Patients With Symptomatic Knee Osteoarthritis
ClinicalTrials.gov Identifier: NCT04864392
Novartis Reference Number: CLNA043A12202
Last Update: Feb 01, 2022
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
Study Description
The study will determine the optimal dosing regimen of LNA043 in patients with knee osteoarthritis (OA).
Interventions
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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 Locations
Contacts
Have a question?
Call 1-888-669-6682 or email [email protected]