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NCT04864392 Clinical Trial

Study of Efficacy, Safety, and Tolerability of LNA043 in Patients With Knee Osteoarthritis

Osteoarthritis Clinical Trial

— ONWARDS  

Official title:
A 5-year, Randomized, Double-blind, Placebo-controlled, Multi-center Study Assessing the Efficacy, Safety, and Tolerability of Intra-articular Regimens of LNA043 Versus Placebo in Patients With Symptomatic Knee Osteoarthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04864392
Other study ID # CLNA043A12202
Secondary ID 2020-004897-22
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date May 31, 2021
Est. completion date October 25, 2027

Study information
Verified date April 2024
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will determine the optimal dosing regimen of LNA043 in patients with knee osteoarthritis (OA).

Description:

This study is a 2-period, multicenter, randomized, parallel-group, double-blind, placebo-controlled study consisting of a 2-year Core period, followed by a 3 year extension period. The primary objective of this study is to assess the efficacy of LNA043 compared to placebo at Week 104 as measured by the mean change from baseline in cartilage thickness using qMRI of the target knee

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 581
Est. completion date October 25, 2027
Est. primary completion date October 7, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility 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 - and other criteria as specified by the protocol Exclusion Criteria: - Participants with radiographic knee OA K-L grade = 4 on the non-target knee - Arthroscopy of the target knee within the 6 months prior to Screening - Hemoglobin < 8.5 g/dL (85 g/L) or platelet count < 100,000/µL - and other criteria as specified by the protocol

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• LNA043 Dosing Regimen A
Injection to the knee
• LNA043 Dosing Regimen B
Injection to the knee
• LNA043 Dosing Regimen C
Injection to the knee
• LNA043 Dosing Regimen D
Injection to the knee
• Placebo
Injection to the knee

Locations
Country Name City State
Argentina Novartis Investigative Site Ciudad Autonoma de Bs As
Argentina Novartis Investigative Site Cordoba
Argentina Novartis Investigative Site Tucuman
Australia Novartis Investigative Site Broadmeadow New South Wales
Australia Novartis Investigative Site Christchurch
Australia Novartis Investigative Site Hobart Tasmania
Australia Novartis Investigative Site Malvern East Victoria
Australia Novartis Investigative Site Maroochydore Queensland
Australia Novartis Investigative Site Paraparaumu
Australia Novartis Investigative Site St Leonards New South Wales
Australia Novartis Investigative Site Woodville South Australia
Canada Novartis Investigative Site Quebec
Canada Novartis Investigative Site Trois Rivieres Quebec
China Novartis Investigative Site Beijing Beijing
China Novartis Investigative Site Bengbu
Czechia Novartis Investigative Site Brno Czech Republic
Czechia Novartis Investigative Site Brno
Czechia Novartis Investigative Site Brno-Zidonice CZE
Czechia Novartis Investigative Site Pardubice Czech Republic
Czechia Novartis Investigative Site Praha 2
Czechia Novartis Investigative Site Uherske Hradiste
Denmark Novartis Investigative Site Aarhus N
Denmark Novartis Investigative Site Gandrup
Denmark Novartis Investigative Site Vejle
Estonia Novartis Investigative Site Tallinn
Estonia Novartis Investigative Site Tartu
India Novartis Investigative Site Belagavi
India Novartis Investigative Site Lucknow Uttar Pradesh
India Novartis Investigative Site Pune
India Novartis Investigative Site Vadodara Gujarat
Japan Novartis Investigative Site Chuoh-ku
Japan Novartis Investigative Site Osaka
Japan Novartis Investigative Site Shinagawa Tokyo
Japan Novartis Investigative Site Shinjuku ku Tokyo
Japan Novartis Investigative Site Suginami Tokyo
Mexico Novartis Investigative Site Ciudad De
Mexico Novartis Investigative Site Culiacan Sinaloa
Mexico Novartis Investigative Site Guadalajara Jalisco
Poland Novartis Investigative Site Kielce
Poland Novartis Investigative Site Krakow
Poland Novartis Investigative Site Poznan
Poland Novartis Investigative Site Warszawa
Spain Novartis Investigative Site Barcelona Catalunya
Spain Novartis Investigative Site La Coruna Galicia
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Sabadell Barcelona
Spain Novartis Investigative Site Santiago De Compostela A Coruna
Spain Novartis Investigative Site Sevilla
Taiwan Novartis Investigative Site Changhua
Taiwan Novartis Investigative Site Tainan
United Kingdom Novartis Investigative Site Barnet
United Kingdom Novartis Investigative Site Glasgow
United Kingdom Novartis Investigative Site Norwich
United States Charlottesville Medical Research Main centre Charlottesville Virginia
United States Chicago Clinical Research Inst Chicago Illinois
United States Metroplex Clinical Research Dallas Texas
United States Annapolis Rheumatology LLC Fairfax Virginia
United States Drug Trials America Hartsdale New York
United States Center for Pharmaceutical Research Kansas City Missouri
United States New Orleans Center For Clinical Research-Knoxville Main Center Knoxville Tennessee
United States Sharps Hospital Grossmont La Mesa California
United States Clinical Trials Research . Lincoln California
United States Long Beach Clinical Trials Long Beach California
United States Tandem clinical research Marrero Louisiana
United States Sensible Healthcare Ocoee Florida
United States Elite Clinical Studies . Phoenix Arizona
United States Virginia Ispine Physicians PC Richmond Virginia
United States Artemis Institute Clinical Research Riverside California
United States Northern California Research Sacramento California
United States Arthemis Clinical Research San Diego California
United States Stamford Therap Consortium LLC Stamford Connecticut
United States Pioneer Research Solutions . Sugar Land Texas
United States Clinical Research of West FL Inc. . Tampa Florida
United States Tucson Orthopedic Institute PC . Tucson Arizona
United States Novartis Investigative Site Wheaton Maryland
United States Conquest Research Winter Park Florida

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  China,  Czechia,  Denmark,  Estonia,  India,  Japan,  Mexico,  Poland,  Spain,  Taiwan,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in the cartilage thickness of the medial compartment of the knee as assessed by imaging. To evaluate cartilage thickness changes Week 0 to Week 104
Secondary Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index pain scale. The scale (5 questions) ranges from 0 to 50. Higher score indicates a worse outcome. To evaluate changes from baseline in OA pain Week 0 to Week 104
Secondary Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index function scale. The scale (17 questions) ranges from 0 to 170. Higher scores indicates a worse outcome. To evaluate changes from baseline in physical function Week 0 to Week 104
Secondary Change from baseline in the cartilage thickness of the knee as assessed by imaging. To evaluate changes from baseline the cartilage structure Week 0 to Week 104
Secondary Change from baseline in the Osteoarthritis Research Society International physical performance-based assessment of 40-meter (4×10m) fast-paced walk test To evaluate changes from baseline in physical function Week 0 to Week 104
Secondary Change from baseline in the Osteoarthritis Research Society International physical performance-based assessments 30-second chair stand test To evaluate changes from baseline in physical function Week 0 to Week 104
Secondary Change from baseline in the Osteoarthritis Research Society International physical performance-based assessment of 6-minute walking test To evaluate changes from baseline in physical function Weeek 0 to Week 104
Secondary Proportion of participants demonstrating structural progression To evaluate structural progression Week 0 to Week 104
Secondary Assessing percentage of participants with adverse events and serious adverse events To evaluate safety and tolerability of the various LNA043 regimens Week 0 to Week 104
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