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
• 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
• 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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

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