To study efficacy, safety and tolerability of intra-artecular regimens of LNA043 versus placebo in adult patients with symptomatic knee osteoarthritis
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2021/10/037098
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Body mass index (BMI) < 40 kg/m2
Diagnosis of primary tibiofemoral knee OA by standard American College of Rheumatology clinical and radiographic criteria
Radiographic disease K-L grade 2 or 3 knee OA with a predominantly medial TFC involvement defined as medial Joint Space Narrowing (medJSN) 1-2 and medJSN > lateral Joint Space Narrowing (latJSN) in the target knee
Participants with double baseline WOMAC Pain of 20-45 (out of 50) for the target knee after discontinuation of analgesics, anti-inflammatories and or low potency opioids within 48 hours or an equivalent of 5Ã?â??T1/2 wash out period (whichever is longer)
Symptomatic OA with pain in the target knee for at least 6 months
Primary source of pain throughout body is due to OA in the target knee: Widespread Pain Index score of �6 and a Symptom Severity score of <7
Participants with radiographic knee OA K-L grade 4 on the non-target knee
Participants with WOMAC Pain > 15 (out of 50) in the non-target knee
Severe malalignment ( >7.5�° varus or valgus) in the anatomical axis of the target knee
Clinical signs of moderate-severe inflammation (i.e., redness, warmth, effusion) of the target knee or requiring aspiration in the target knee within 12 weeks prior to Screening
Arthroscopy of the target knee within the 6 months prior to Screening
Previous surgical treatment of the target knee using mosaicplasty, microfracture, meniscectomy >50% or osteotomy, partial or complete joint replacement or planned knee surgery for either knee during the study
Unstable target knee joint (including, but not limited to, posttraumatic or congenital laxity) or insufficiently reconstructed ligaments based on medical history and/or physical examination by the Investigator
Other pathologies affecting the knee, including subchondral insufficiency fractures, bone fracture (acute or subacute in less than 6 months prior to screening) or bone bruise, osteonecrosis, malignant bone marrow infiltration, solid tumors, and/or patellofemoral dysplasia based on clinical assessment, X-ray or MRI
Symptomatic hip OA on either hip or hip prosthesis recently implanted (within 1 year) or foreseen within the study period (either hip)
1Other pain conditions that could confound assessments of the pain associated with knee OA
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Structural changes from baseline in the central medial tibiofemoral compartment (cMTFC) of LNA043 compared with placebo in the target kneeTimepoint: At Week 104
- Secondary Outcome Measures
Name Time Method Changes from baseline in OA pain in the target knee of LNA043 compared with placebo <br/ ><br>Timepoint: At Week 104;Changes from baseline in performance-based physical function assessment of LNA043 compared with placeboTimepoint: At Week 104;Changes from baseline in physical function of LNA043 compared with placebo <br/ ><br>Timepoint: At week 104;Evaluate safety and tolerability of the various LNA043 regimensTimepoint: At week 104;Structural changes from baseline in the total, medial and lateral tibiofemoral compartments (TFCs) in the target knee of LNA043 compared with placeboTimepoint: At week 104