Study of Efficacy, Safety, and Tolerability of LNA043 in Patients With Knee Osteoarthritis (ONWARDS)

Novartis

Status and phase: Active, not recruiting; Phase 2

Conditions: Osteoarthritis

Treatments: Drug: LNA043 Dosing Regimen A; Drug: Placebo; Drug: LNA043 Dosing Regimen D; Drug: LNA043 Dosing Regimen C; Drug: LNA043 Dosing Regimen B

Study type: Interventional

Funder types: Industry

Identifiers

NCT04864392

2023-509937-37-00 (Registry Identifier)

CLNA043A12202

2020-004897-22 (EudraCT Number)

Details and patient eligibility

About

The study will determine the optimal dosing regimen of LNA043 in patients with knee osteoarthritis (OA).

Full 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 objective of this study is to assess the efficacy of LNA043 compared to placebo at Week 104 as measured by the mean change from baseline in cartilage thickness using qMRI of the target knee

Enrollment: 585 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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585 participants in 5 patient groups, including a placebo group

LNA043 Dosing Regimen A

Experimental group

Description:

LNA043 injection to the knee with dosing regimen A

Treatment:

Drug: LNA043 Dosing Regimen A

LNA043 Dosing Regimen B

Experimental group

Description:

LNA04 injection to the knee with dosing regimen B

Treatment:

Drug: LNA043 Dosing Regimen B

LNA043 Dosing Regimen C

Experimental group

Description:

LNA043 injection to the knee with dosing regimen C

Treatment:

Drug: LNA043 Dosing Regimen C

LNA043 Dosing Regimen D

Experimental group

Description:

LNA043 injection to the knee with dosing regimen D

Treatment:

Drug: LNA043 Dosing Regimen D

Placebo

Placebo Comparator group

Description:

Injection to the knee

Treatment:

Drug: Placebo