A Safety and Efficacy Study of Anti-inflammatory (Canakinumab) and Cartilage Stimulating (LNA043) Drugs Injected Into the Knee Joint of Participants With Knee Osteoarthritis (OA)
Megadott ok: Sponsor Decision
A legfontosabb adatok
- Hol
- Clearwater, La Mesa, Las Vegas, Morehead City és Sunrise (Egyesült Államok)Mind a 5 helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- Clinical Res Of W FloridaClearwater, Egyesült ÁllamokNo longer taking part
- Horizon Clinical ResearchLa Mesa, Egyesült ÁllamokNo longer taking part
- LV ResearchLas Vegas, Egyesült ÁllamokNo longer taking part
- Lucas ResearchMorehead City, Egyesült ÁllamokNo longer taking part
- Precision Clinical Research, LLCSunrise, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Novartis Pharmaceuticals
- Azonosító
- NCT04814368
- A regiszteradat frissítve
- 2025. október 24.
- Eredeti leírás
The study was established to show safety and efficacy of canakinumab and LNA043 in patients with knee osteoarthritis (OA).A teljes eredeti leírásKevesebb
A Randomized, Four-arm, Canakinumab Placebo-controlled, Participant, Investigator and Sponsor-blinded Study Investigating the Safety, Tolerability and Efficacy of Intra-articular Canakinumab Followed by Intra-articular LNA043 in Patients With Knee Osteoarthritis
The study was established to show safety and efficacy of canakinumab and LNA043 in patients with knee osteoarthritis (OA).
Bevonási feltételek: 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 <60 for the target knee during Screening; High sensitivity C-reactive Protein (hsCRP) ≥1.8 mg/L; Radiographic KL grade 2 to 4 knee OA and joint space width (JSW) 2.0-4.0 mm (men) or 1.5-3.5 mm (women) in the medial tibiofemoral compartment (TFC) in the target knee; Contrast-enhanced MRI (CE-MRI) diagnosed moderate or severe knee synovitis based on an established synovititis scoring system (moderate score 9-12 or severe score ≥13).
Kizáró feltételek: 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; Ipsilateral hip OA or hip prosthesis recently implanted (within 1 year prior to screening) or hip replacement on either side planned within the study period; 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); Malalignment >7.5° in the target knee (either varus or valgus).