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: osteoarthritis; MedDRA version: 21.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2020-003631-21-LV
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Last Update Posted: 8 July 2024

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 during Screening
- High sensitivity C-reactive Protein (hsCRP) =2 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)
- 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 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)
- 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