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)

Phase 1

Conditions: Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
osteoarthritis

Registration Number: EUCTR2020-003631-21-HU

Lead Sponsor: ovartis Pharma AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 138

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 at Screening 1 and at Day 1
- High sensitivity C-reactive Protein (hsCRP) =2 mg/L
- Radiographic KL grade 2 or 3 knee OA and joint space width (JSW) 2-4 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)
- other protocol-defined inclusion criteria may apply

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 98

Exclusion Criteria

- History of, or planned; knee replacement(partial or total) in either knee; arthroscopy or lavage of the target knee within 6 months prior to screening; any other previous surgical intervention in the target knee, 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 orvalgus)
- Any diagnosis of inflammatory arthritis or connective tissue disease (e.g. rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout, Paget's disease, systemic lupus erythematosus) or other systemic condition that might confound assessment of OA
- lpsilateral hip OA or hip prosthesis recently implanted (within 1 year prior to screening) or hip replacement on either side planned within the study period
- other protocol-defined exclusion criteria may apply

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To assess the efficacy in regenerating articular cartilage tissue<br>- To assess the efficacy in relieving OA pain;Secondary Objective: - To assess the safety and tolerability <br>- To assess the potential immunogenicity <br>- To assess endogenous ANGPTL3, and PK <br>- To assess the efficacy in regenerating articular cartilage; <br>- To assess the efficacy in maintaining or regenerating articular cartilage<br>- To assess the efficacy on synovitis<br>- To assess the efficacy, in relieving OA pain and improving function over time<br><br>;Primary end point(s): - Change in cartilage volume in the index region measured by MRI<br>- Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale;Timepoint(s) of evaluation of this end point: - Baseline to Day 197 <br>- Baseline to Day 85

Secondary Outcome Measures