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 (ONWARDS) - ONWARDS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004897-22-AT

Enrollment

550

Registered

2021-04-26

Start date

2021-10-18

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteoarthritis MedDRA version: 21.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859

Interventions

Product Code: LNA043 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Not available Current Sponsor code: LNA043 Concentration unit: mg milligram(s) Concentration type: equa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Males and females between 40 and 75 years of age -Body mass index (BMI) =65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate knee structure changes;Secondary Objective: - To evaluate changes from baseline in OA pain - To evaluate changes from baseline in physical function - To evaluate changes from baseline the cartilage structure - To evaluate changes from baseline in physical function - To evaluate structural progression - To evaluate safety and tolerability of the various LNA043 regimens ;Primary end point(s): Change from baseline in the knee structure;Timepoint(s) of evaluation of this end point: Week 0 to Week 104	—

Measure

Time frame

Main Objective: To evaluate knee structure changes;Secondary Objective: - To evaluate changes from baseline in OA pain - To evaluate changes from baseline in physical function - To evaluate changes from baseline the cartilage structure - To evaluate changes from baseline in physical function - To evaluate structural progression - To evaluate safety and tolerability of the various LNA043 regimens ;Primary end point(s): Change from baseline in the knee structure;Timepoint(s) of evaluation of this end point: Week 0 to Week 104

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Secondary

Measure	Time frame
Secondary end point(s): -Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain -Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function - Change from baseline in cartilage structure - Change from baseline in physical function - Proportion of participants demonstrating structural progression - Assessing adverse events and serious adverse events;Timepoint(s) of evaluation of this end point: - Week 0 to Week 104 - Week 0 to Week 104 - Week 0 to Week 104 - Week 0 to Week 104 - Week 0 to Week 104 - Week 0 to Week 104	—

Measure

Time frame

Secondary end point(s): -Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain -Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function - Change from baseline in cartilage structure - Change from baseline in physical function - Proportion of participants demonstrating structural progression - Assessing adverse events and serious adverse events;Timepoint(s) of evaluation of this end point: - Week 0 to Week 104 - Week 0 to Week 104 - Week 0 to Week 104 - Week 0 to Week 104 - Week 0 to Week 104 - Week 0 to Week 104

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Countries

Argentina, Australia, Austria, Canada, China, Czechia, Czech Republic, Denmark, Estonia, Germany, Hungary, India, Japan, Lithuania, Mexico, Poland, Spain, Taiwan, United Kingdom, United States

Contacts

Public ContactDrug Regulatory Affairs

Novartis Pharma GmbH

austria.dra@novartis.com+43 1 86657 0

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026