LNA043 for Knee Osteoarthritis

(ONWARDS Trial)

Recruiting at 88 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Disqualifiers: Knee OA K-L grade 4, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

581 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests LNA043 to see if it can help people with knee osteoarthritis by improving cartilage thickness in their knees. It targets patients with worn-down knee cartilage, aiming to reduce pain and improve movement.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

You have a diagnosis of primary knee OA by standard American College of Rheumatology clinical and radiographic criteria.

There may be additional requirements for participation that are outlined in the study plan.

You are between 40 and 75 years of age.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Core Treatment

Participants receive intra-articular injections of LNA043 or placebo for 2 years

104 weeks

Regular visits for injections and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may continue treatment in a 3-year extension period

156 weeks

Treatment Details

Interventions

• LNA043

Participant Groups

Group I: LNA043 Dosing Regimen D Experimental Treatment 1 Intervention

LNA043 injection to the knee with dosing regimen D

Group II: LNA043 Dosing Regimen C Experimental Treatment 1 Intervention

LNA043 injection to the knee with dosing regimen C

Group III: LNA043 Dosing Regimen B Experimental Treatment 1 Intervention

LNA04 injection to the knee with dosing regimen B

Group IV: LNA043 Dosing Regimen A Experimental Treatment 1 Intervention

LNA043 injection to the knee with dosing regimen A

Group V: Placebo Placebo Group 1 Intervention

Injection to the knee

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD