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Study of efficacy, safety, and tolerability of LNA043 in patients with symptomatic knee osteoarthritis
EU CTIS ID: 2023-509937-37-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United States
- Argentina
- India
- New Zealand
- Mexico
- United Kingdom
- China
- Canada
- Taiwan
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United States; Argentina; India; New Zealand; Mexico and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.