Study of Efficacy, Safety, and Tolerability of LNA043 in Patients With Knee Osteoarthritis
NCT ID: NCT04864392
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
582 participants
INTERVENTIONAL
2021-05-31
2025-05-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Safety, Tolerability, Preliminary Efficacy of Intra-articular LNA043 Injections in Patients With Articular Cartilage Lesions and Knee Osteoarthritis.
NCT03275064
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)
NCT04814368
Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants
NCT04564053
First-in-human Single Ascending Dose Study of LNA043 in Patients Scheduled for Total Knee Replacement
NCT02491281
Safety, Tolerability and Preliminary Efficacy of Multiple Intra-articular Injections of LRX712 in Patients With Knee OA
NCT04097379
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LNA043 Dosing Regimen A
LNA043 injection to the knee with dosing regimen A
LNA043 Dosing Regimen A
Injection to the knee
LNA043 Dosing Regimen B
LNA04 injection to the knee with dosing regimen B
LNA043 Dosing Regimen B
Injection to the knee
LNA043 Dosing Regimen C
LNA043 injection to the knee with dosing regimen C
LNA043 Dosing Regimen C
Injection to the knee
LNA043 Dosing Regimen D
LNA043 injection to the knee with dosing regimen D
LNA043 Dosing Regimen D
Injection to the knee
Placebo
Injection to the knee
Placebo
Injection to the knee
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
40 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Elite Clinical Studies
Phoenix, Arizona, United States
Tucson Orthopedic Institute PC
Tucson, Arizona, 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
Artemis Institute Clinical Research
Riverside, California, United States
Northern California Research
Sacramento, California, United States
Arthemis Clinical Research
San Diego, California, United States
Stamford Therapeutics Consortium LLC
Stamford, Connecticut, United States
Sensible Healthcare
Ocoee, Florida, United States
Clinical Research of West Florida Inc
Tampa, Florida, United States
Conquest Research
Winter Park, Florida, United States
Chicago Clinical Research Inst
Chicago, Illinois, United States
Tandem clinical research
Marrero, Louisiana, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
Center For Pharmaceutical Research
Kansas City, Missouri, United States
Drug Trials America
Hartsdale, New York, United States
AMR Knoxville
Knoxville, Tennessee, United States
Metroplex Clinical Research
Dallas, Texas, United States
Pioneer Research Solutions
Sugar Land, Texas, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Annapolis Rheumatology LLC
Fairfax, Virginia, United States
Virginia Ispine Physicians PC
Richmond, Virginia, United States
Novartis Investigative Site
Ciudad Autonoma de Bs As, , Argentina
Novartis Investigative Site
Córdoba, , Argentina
Novartis Investigative Site
San Miguel de Tucumán, , Argentina
Novartis Investigative Site
Broadmeadow, New South Wales, Australia
Novartis Investigative Site
Maroochydore, Queensland, Australia
Novartis Investigative Site
Woodville South, South Australia, Australia
Novartis Investigative Site
Hobart, Tasmania, Australia
Novartis Investigative Site
Malvern East, Victoria, Australia
Novartis Investigative Site
Christchurch, , Australia
Novartis Investigative Site
St Leonards, , Australia
Novartis Investigative Site
Waikanae Beach, , Australia
Novartis Investigative Site
Québec, Quebec, Canada
Novartis Investigative Site
Trois-Rivières, Quebec, Canada
Novartis Investigative Site
Beijing, Beijing Municipality, China
Novartis Investigative Site
Bengbu, , China
Novartis Investigative Site
Brno, Czech Republic, Czechia
Novartis Investigative Site
Pardubice, Czech Republic, Czechia
Novartis Investigative Site
Brno-Zidonice, CZE, Czechia
Novartis Investigative Site
Brno, , Czechia
Novartis Investigative Site
Prague, , Czechia
Novartis Investigative Site
Uherské Hradiště, , Czechia
Novartis Investigative Site
Aarhus N, , Denmark
Novartis Investigative Site
Gandrup, , Denmark
Novartis Investigative Site
Vejle, , Denmark
Novartis Investigative Site
Tallinn, , Estonia
Novartis Investigative Site
Tartu, , Estonia
Novartis Investigative Site
Vadodara, Gujarat, India
Novartis Investigative Site
Belagavi, Karnataka, India
Novartis Investigative Site
Lucknow, Uttar Pradesh, India
Novartis Investigative Site
Pune, , India
Novartis Investigative Site
Shinagawa, Tokyo, Japan
Novartis Investigative Site
Shinjuku Ku, Tokyo, Japan
Novartis Investigative Site
Suginami, Tokyo, Japan
Novartis Investigative Site
Chuoh-ku, , Japan
Novartis Investigative Site
Osaka, , Japan
Novartis Investigative Site
Guadalajara, Jalisco, Mexico
Novartis Investigative Site
Culiacán, Sinaloa, Mexico
Novartis Investigative Site
Ciudad de, , Mexico
Novartis Investigative Site
Kielce, , Poland
Novartis Investigative Site
Krakow, , Poland
Novartis Investigative Site
Poznan, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Santiago de Compostela, A Coruna, Spain
Novartis Investigative Site
Sabadell, Barcelona, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
A Coruña, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Seville, , Spain
Novartis Investigative Site
Changhua, , Taiwan
Novartis Investigative Site
Tainan City, , Taiwan
Novartis Investigative Site
Barnet, , United Kingdom
Novartis Investigative Site
Glasgow, , United Kingdom
Novartis Investigative Site
Norwich, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gerwin N, Scotti C, Halleux C, Fornaro M, Elliott J, Zhang Y, Johnson K, Shi J, Walter S, Li Y, Jacobi C, Laplanche N, Belaud M, Paul J, Glowacki G, Peters T, Wharton KA Jr, Vostiar I, Polus F, Kramer I, Guth S, Seroutou A, Choudhury S, Laurent D, Gimbel J, Goldhahn J, Schieker M, Brachat S, Roubenoff R, Kneissel M. Angiopoietin-like 3-derivative LNA043 for cartilage regeneration in osteoarthritis: a randomized phase 1 trial. Nat Med. 2022 Dec;28(12):2633-2645. doi: 10.1038/s41591-022-02059-9. Epub 2022 Dec 1.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-004897-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-509937-37-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CLNA043A12202
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.