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)

Novartis

Status and phase: Terminated; Phase 2

Conditions: Knee Osteoarthritis

Treatments: Biological: LNA043; Biological: canakinumab; Other: Placebo to canakinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04814368

CLNA043A12203

Details and patient eligibility

About

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

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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23 participants in 4 patient groups, including a placebo group

Placebo+LNA043

Experimental group

Description:

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

Treatment:

Other: Placebo to canakinumab

Biological: LNA043

Placebo

Placebo Comparator group

Description:

Placebo to canakinumab on Day 1

Treatment:

Other: Placebo to canakinumab

canakinumab + LNA043

Experimental group

Description:

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

Treatment:

Biological: canakinumab

Biological: LNA043

canakinumab

Experimental group

Description:

Canakinumab on Day 1

Treatment:

Biological: canakinumab