Study of efficacy, safety, and tolerability of LNA043 in patients with symptomatic knee osteoarthritis

Phase 1

Recruiting

Conditions: Osteoarthritis
MedDRA version: 21.1Level: LLTClassification code: 10023476Term: Knee osteoarthritis Class: 10028395
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: CTIS2023-509937-37-00

Lead Sponsor: ovartis Pharma AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 581

Inclusion Criteria

Males and females between 40 and 75 years of age, 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 predominantly medical TFC involvement defined as medial Joint Space Narrowing (medJSN) 1-2 and medJSN> lateral Joint Space Narrowing (latJSN) in the target knee, Participants with WOMAC pain of 20-45 (out of 50) for the target knee at both (double baseline) assessments during screening period after discontinuation of analgesics, anti-inflammatories and low potency opioids within 48 hours an equivalent of 5xT ½ 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

Exclusion Criteria

Participants with radiographic knee OA K-L grade = 4 on the non-target knee, Other pain conditions that could confound assessments of the pain associated with knee OA, as judged by the Investigator, Participants with WOMAC Pain >15 (out of 50)v 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 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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate knee structural changes from baseline in the central medial tibiofemoral compartment (cMTFC) of LNA043 compared with placebo in the target knee at Week 104.;Secondary Objective: To evaluate changes from baseline in OA pain in the target knee of LNA043 compared with placebo at Week 104, To evaluate changes from baseline in physical function of LNA043 compared with placebo at Week 104, To evaluate structural changes from baseline in the total, medial and lateral tibiofemoral compartment (TFCs) in the target knee of LNA043 compared with placebo at Week 104, To evaluate changes from baseline in performance- based physical function assessment of LNA043 compared with placebo at Week 104, To evaluate structural progression in the target knee of LNA043 compared with placebo using imaging techniques, To evaluate safety and tolerability of the various LNA043 regimens;Primary end point(s): Change from baseline in the knee structure

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain;Secondary end point(s):Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function;Secondary end point(s):Change from baseline in cartilage structure;Secondary end point(s):Change from baseline in physical function;Secondary end point(s):Proportion of participants demonstrating structural progression;Secondary end point(s):Assessing adverse events and serious adverse events

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