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: Nov 09, 2022

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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).

Condition 
Osteoarthritis
Phase 
Phase 2
Overall status 
Recruiting
Start date 
May 31, 2021
Completion date 
Oct 25, 2027
Gender 
All
Age(s)
40 Years - 75 Years (Adult, Older Adult)

Interventions

Drug
LNA043 Dosing Regimen A
Injection to the knee
Drug
LNA043 Dosing Regimen B
Injection to the knee
Drug
LNA043 Dosing Regimen C
Injection to the knee
Drug
LNA043 Dosing Regimen D
Injection to the knee
Drug
Placebo
Injection to the knee

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

United States
Novartis Investigative Site
Recruiting
Houston, 77058
Texas
United States
Japan
Novartis Investigative Site
Recruiting
Suginami, 166-0002
Tokyo
Japan

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]