Clinical trial NCT04864392: Study of Efficacy, Safety, and Tolerability of LNA043 in Patients With Knee Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: LNA043
knee
arthritis
OA
knees
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-04-28
Enrollment: 583
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the cartilage thickness of the medial compartment of the knee as assessed by imaging.
timeFrame: Week 0 to Week 104
Secondary outcomes:
measure: 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.
timeFrame: Week 0 to Week 104
measure: 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.
timeFrame: Week 0 to Week 104
measure: Change from baseline in the cartilage thickness of the knee as assessed by imaging.
timeFrame: Week 0 to Week 104
measure: Change from baseline in the Osteoarthritis Research Society International physical performance-based assessment of 40-meter (4×10m) fast-paced walk test
timeFrame: Week 0 to Week 104
measure: Change from baseline in the Osteoarthritis Research Society International physical performance-based assessments 30-second chair stand test
timeFrame: Week 0 to Week 104
measure: Change from baseline in the Osteoarthritis Research Society International physical performance-based assessment of 6-minute walking test
timeFrame: Weeek 0 to Week 104
measure: Proportion of participants demonstrating structural progression
timeFrame: Week 0 to Week 104
measure: Assessing percentage of participants with adverse events and serious adverse events
timeFrame: Week 0 to Week 104
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Elite Clinical Studies
state: Arizona
city: Tucson
country: United States
facility: Tucson Orthopedic Institute PC
state: Arizona
city: La Mesa
country: United States
facility: Sharps Hospital Grossmont
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials
state: California
city: Riverside
country: United States
facility: Artemis Institute Clinical Research
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: San Diego
country: United States
facility: Arthemis Clinical Research
state: California
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium LLC
state: Connecticut
city: Ocoee
country: United States
facility: Sensible Healthcare
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida Inc
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Chicago
country: United States
facility: Chicago Clinical Research Inst
state: Illinois
city: Marrero
country: United States
facility: Tandem clinical research
state: Louisiana
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Kansas City
country: United States
facility: Center For Pharmaceutical Research
state: Missouri
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: Knoxville
country: United States
facility: AMR Knoxville
state: Tennessee
city: Dallas
country: United States
facility: Metroplex Clinical Research
state: Texas
city: Sugar Land
country: United States
facility: Pioneer Research Solutions
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Fairfax
country: United States
facility: Annapolis Rheumatology LLC
state: Virginia
city: Richmond
country: United States
facility: Virginia Ispine Physicians PC
state: Virginia
city: Ciudad Autonoma de Bs As
country: Argentina
facility: Novartis Investigative Site
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Tucuman
country: Argentina
facility: Novartis Investigative Site
city: Broadmeadow
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Maroochydore
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Woodville South
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Hobart
country: Australia
facility: Novartis Investigative Site
state: Tasmania
city: Malvern East
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Christchurch
country: Australia
facility: Novartis Investigative Site
city: St Leonards
country: Australia
facility: Novartis Investigative Site
city: Waikanae Beach
country: Australia
facility: Novartis Investigative Site
city: Trois Rivieres
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Bengbu
country: China
facility: Novartis Investigative Site
city: Brno
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Pardubice
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Brno-Zidonice
country: Czechia
facility: Novartis Investigative Site
state: CZE
city: Brno
country: Czechia
facility: Novartis Investigative Site
city: Praha 2
country: Czechia
facility: Novartis Investigative Site
city: Uherske Hradiste
country: Czechia
facility: Novartis Investigative Site
city: Aarhus N
country: Denmark
facility: Novartis Investigative Site
city: Gandrup
country: Denmark
facility: Novartis Investigative Site
city: Vejle
country: Denmark
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tartu
country: Estonia
facility: Novartis Investigative Site
city: Vadodara
country: India
facility: Novartis Investigative Site
state: Gujarat
city: Lucknow
country: India
facility: Novartis Investigative Site
state: Uttar Pradesh
city: Belgavi
country: India
facility: Novartis Investigative Site
city: Pune
country: India
facility: Novartis Investigative Site
city: Shinagawa
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Suginami
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chuoh-ku
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Guadalajara
country: Mexico
facility: Novartis Investigative Site
state: Jalisco
city: Culiacan
country: Mexico
facility: Novartis Investigative Site
state: Sinaloa
city: Ciudad De
country: Mexico
facility: Novartis Investigative Site
city: Kielce
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Santiago De Compostela
country: Spain
facility: Novartis Investigative Site
state: A Coruna
city: Sabadell
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: La Coruna
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Sevilla
country: Spain
facility: Novartis Investigative Site
city: Changhua
country: Taiwan
facility: Novartis Investigative Site
city: Tainan
country: Taiwan
facility: Novartis Investigative Site
city: Barnet
country: United Kingdom
facility: Novartis Investigative Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: Norwich
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: