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

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