A Safety and Efficacy Study of Anti-inflammatory (Canakinumab) and Cartilage Stimulating (LNA043) Drugs Injected Into the Knee Joint of Participants With Knee Osteoarthritis (OA)

NCT ID: NCT04814368

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-27
• Study Completion Date: 2024-06-24

Brief Summary

The study was established to show safety and efficacy of canakinumab and LNA043 in patients with knee osteoarthritis (OA).

Detailed Description

This was a non-confirmatory, randomized, four arm, placebo-controlled, participant-, investigator and sponsor-blinded study in participants with symptomatic knee OA with synovial inflammation.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo+LNA043

Placebo to canakinumab on Day 1 followed by LNA043 on Days 15, 43 and 71

Group Type: EXPERIMENTAL

LNA043

Intervention Type: BIOLOGICAL

LNA043 40 mg intra-articular injection (into the knee) every 4 weeks, on Days 15, 43 and 71

Placebo to canakinumab

Intervention Type: OTHER

Placebo to canakinumab single intra-articular injection (into the knee) on Day 1

Placebo

Placebo to canakinumab on Day 1

Group Type: PLACEBO_COMPARATOR

Placebo to canakinumab

Intervention Type: OTHER

Placebo to canakinumab single intra-articular injection (into the knee) on Day 1

canakinumab + LNA043

Canakinumab on Day 1 followed by LNA043 on Days 15, 43 and 71

Group Type: EXPERIMENTAL

canakinumab

Intervention Type: BIOLOGICAL

Canakinumab 600 mg single intra-articular injection (into the knee) on Day 1

LNA043

Intervention Type: BIOLOGICAL

LNA043 40 mg intra-articular injection (into the knee) every 4 weeks, on Days 15, 43 and 71

canakinumab

Canakinumab on Day 1

Group Type: EXPERIMENTAL

canakinumab

Intervention Type: BIOLOGICAL

Canakinumab 600 mg single intra-articular injection (into the knee) on Day 1

Interventions

canakinumab

Canakinumab 600 mg single intra-articular injection (into the knee) on Day 1

Intervention Type: BIOLOGICAL

LNA043

LNA043 40 mg intra-articular injection (into the knee) every 4 weeks, on Days 15, 43 and 71

Intervention Type: BIOLOGICAL

Placebo to canakinumab

Placebo to canakinumab single intra-articular injection (into the knee) on Day 1

Intervention Type: OTHER

Other Intervention Names

ACZ885

Eligibility Criteria

Inclusion Criteria

• Moderate to severe OA pain (corresponding to NRS Pain ≥5 to ≤9) in the target knee for the majority of days in the last 3 months prior to Screening
• KOOS pain subscale <60 for the target knee during Screening
• High sensitivity C-reactive Protein (hsCRP) ≥1.8 mg/L
• Radiographic KL grade 2 to 4 knee OA and joint space width (JSW) 2.0-4.0 mm (men) or 1.5-3.5 mm (women) in the medial tibiofemoral compartment (TFC) in the target knee
• Contrast-enhanced MRI (CE-MRI) diagnosed moderate or severe knee synovitis based on an established synovititis scoring system (moderate score 9-12 or severe score ≥13)

Exclusion Criteria

• History of, or planned; knee replacement (partial or total) in either knee; arthroscopy or lavage in either knee within 6 months prior to screening; any other previous surgical intervention in the target knee, or for the contralateral knee within 12 months prior to Screening, including mosaicplasty, microfracture, meniscectomy >50% or osteotomy
• Moderate to severe pain in the contralateral knee for the majority of days in the last 3 months prior to screening
• Malalignment >7.5° in the target knee (either varus or valgus)
• Any diagnosis of systemic inflammatory arthritis or connective tissue disease, including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout, Paget's disease, systemic lupus erythematosus) or other systemic condition that might confound assessment of OA (e.g. fibromyalgia)
• Ipsilateral hip OA or hip prosthesis recently implanted (within 1 year prior to screening) or hip replacement on either side planned within the study period

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Horizon Clinical Research

La Mesa, California, United States

Clinical Res Of W Florida

Clearwater, Florida, United States

Precision Clinical Research LLC

Sunrise, Florida, United States

LV Research

Las Vegas, Nevada, United States

Lucas Research

Morehead City, North Carolina, United States

Novartis Investigative Site

Prague, Czech Republic, Czechia

Novartis Investigative Site

Tartu, , Estonia

Novartis Investigative Site

Kecskemét, Bács-Kiskun county, Hungary

Novartis Investigative Site

Budapest, , Hungary

Novartis Investigative Site

Riga, , Latvia

Novartis Investigative Site

Warsaw, , Poland

Countries

United States; Czechia; Estonia; Hungary; Latvia; Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=2679

A Plain Language Trial Summary is available on www.novctrd.com

Other Identifiers

CLNA043A12203

Identifier Type: -

Identifier Source: org_study_id