Study of efficacy, safety, and tolerability of LNA043 in patients with symptomatic knee osteoarthritis
- Conditions
- Knee osteoarthritis
- Registration Number
- JPRN-jRCT2031210160
- Lead Sponsor
- Yamada Hiroyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
1. Body mass index (BMI) < 40 kg/m2 at Screening Visit 1
2. Diagnosis of primary tibiofemoral knee OA in the target knee by standard American College of Rheumatology (ACR) clinical and radiographic criteria at Screening Visits
3. 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 at Screening Visit 1
4. Symptomatic OA with pain in the target knee for at least 6 months prior to Screening Visit 1
5. Primary source of pain throughout body is due to OA in the target knee: Widespread Pain Index (WPI) score of =<6 and a Symptom Severity score (SS score) of <7 at Screening Visit 2
1. Radiographic knee OA K-L = 4 on the non-target knee at Screening Visit 1
2. WOMAC Pain > 15 (out of 50) in the non-target knee at Screening Visit 2
3. Severe malalignment (>7.5 degree varus or valgus) in the anatomical axis of the target knee, measured using X-ray at Screening Visit 1
4. Arthroscopy of the target knee within the 6 months prior to Screening Visit 1 or planned during the study
5. Previous surgical treatment of the target knee using mosaicplasty, microfracture, meniscectomy >50% or osteotomy; partial or complete joint replacement for either knee; planned knee surgery for either knee during the study
6. Inability to undergo MRI (e.g., claustrophobia, body size, leg not fitting in the coil) or contraindications to MRI (e.g., non MRI-compatible metallic implants, metallic foreign bodies, pacemaker, defibrillator)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in cartilage thickness in the cMTFC at Week 104 assessed by qMRI
- Secondary Outcome Measures
Name Time Method