osteoarthritis MedDRA version: 21.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859
Conditions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 98
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess the efficacy in regenerating articular cartilage tissue - To assess the efficacy in relieving OA pain;Secondary Objective: - To assess the safety and tolerability - To assess the potential immunogenicity - To assess endogenous ANGPTL3, and PK - To assess the efficacy in regenerating articular cartilage; - To assess the efficacy in maintaining or regenerating articular cartilage - To assess the efficacy on synovitis - To assess the efficacy, in relieving OA pain and improving function over time ;Primary end point(s): - Change in cartilage volume in the index region measured by MRI - Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale;Timepoint(s) of evaluation of this end point: - Baseline to Day 197 - Baseline to Day 85 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Anti-LNA043 antibodies in serum - ANGPTL3 serum concentrations - ANGPTL3 synovial fluid concentrations - LNA043 PK profile in serum (Cmax) - LNA043 PK profile in serum (Tmax) - LNA043 PK profile in serum (AUC) - Change in cartilage volume of the index region measured by MRI - Change in cartilage thickness of the index region measured by MRI - Change in synovitis level measured from Ktrans by Dynamic Contrast Enhanced MRI (DCE-MRI) - Change in numeric rating scale (NRS) Pain over time - Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale over time - Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in daily living (ADL) subscale over time;Timepoint(s) of evaluation of this end point: - Day 15, 43, 85, 197 and 365 - Day 1, 15, 43, 85, 197 and 365 - Day 1, 15, 43 and 71 - Day 1 and 43 - Day 1 and 43 - Day 1 and 43 - Baseline to Day 197 and 365 - Baseline to Day 197 and 365 - Baseline to Day 85 - Baseline to Day 15, 29, 43, 57, 71, 85, 197 and 365 - Baseline to Day 15, 29, 43, 57, 71, 85, 197 and 365 - Baseline to Day 15, 29, 43, 57, 71, 85, 197 and 365 | — |
Countries
China, Czechia, Czech Republic, Estonia, Germany, Hungary, Latvia, Lithuania, Poland, Russian Federation, Switzerland, United States
Contacts
Public ContactInformacní služba – klin. hodnocení
Novartis s.r.o.
Outcome results
None listed