Study of efficacy, safety, and tolerability of LNA043 in patients with symptomatic 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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210160

Enrollment

Registered

2021-06-23

Start date

2021-07-16

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Knee osteoarthritis

Interventions

Arm 1: LNA043 20 mg Q4w x3 , Cycle every 6 months Arm 2: LNA043 40 mg x1 and placebo Q4w x2, Cycle every 6 months Arm 3: LNA043 40 mg Q4w x3 , Cycle every 12 months Arm 4: LNA043 40 mg Q4w x3 , Cycle

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Body mass index (BMI) lateral Joint Space Narrowing (latJSN) in the target knee at Screening Visit 1 4. Symptomatic OA with pain in the target knee for at least 6 months prior to Screening Visit 1 5. Primary source of pain throughout body is due to OA in the target knee: Widespread Pain Index (WPI) score of =<6 and a Symptom Severity score (SS score) of <7 at Screening Visit 2

Exclusion criteria

Exclusion criteria: 1. Radiographic knee OA K-L = 4 on the non-target knee at Screening Visit 1 2. WOMAC Pain > 15 (out of 50) in the non-target knee at Screening Visit 2 3. Severe malalignment (>7.5 degree varus or valgus) in the anatomical axis of the target knee, measured using X-ray at Screening Visit 1 4. Arthroscopy of the target knee within the 6 months prior to Screening Visit 1 or planned during the study 5. Previous surgical treatment of the target knee using mosaicplasty, microfracture, meniscectomy >50% or osteotomy; partial or complete joint replacement for either knee; planned knee surgery for either knee during the study 6. Inability to undergo MRI (e.g., claustrophobia, body size, leg not fitting in the coil) or contraindications to MRI (e.g., non MRI-compatible metallic implants, metallic foreign bodies, pacemaker, defibrillator)

Design outcomes

Primary

Measure	Time frame
Change from baseline in cartilage thickness in the cMTFC at Week 104 assessed by qMRI	—

Countries

America, Australia, Canada, Denmark, Japan

Contacts

Public ContactHideki Maruyama

Novartis Pharma. K.K.

rinshoshiken.toroku@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026