Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants
NCT ID: NCT04564053
Last Updated: 2022-08-10
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.
COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2020-09-23
2020-12-10
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 Efficacy, Safety, and Tolerability of LNA043 in Patients With Knee Osteoarthritis
NCT04864392
First-in-human Single Ascending Dose Study of LNA043 in Patients Scheduled for Total Knee Replacement
NCT02491281
Study of Safety, Tolerability, Preliminary Efficacy of Intra-articular LNA043 Injections in Patients With Articular Cartilage Lesions and Knee Osteoarthritis.
NCT03275064
Safety, Tolerability and Pharmacokinetics of SAR113945 in Japanese Patients With Knee Osteoarthritis
NCT01511549
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
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
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LNA043
LNA043
LNA043
Single intra-articular injection on Day 1
Placebo
Single intra-articular injection on Day 1
placebo
Placebo
Single intra-articular injection on Day 1
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LNA043
Single intra-articular injection on Day 1
Placebo
Single intra-articular injection on Day 1
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* A body mass index (BMI) 16.0 kg/m2 or more but less than 35.0 kg/m2 at screening
* Established diagnosis of primary tibio-femoral osteoarthritis of the target knee by standard American College of Rheumatology (ACR) criteria for at least 6 months prior to screening (clinical and radiological criteria).
Exclusion Criteria
* Arthroscopy of the target knee within 6 months prior to Screening or planned during the study
* Use of electrotherapy, acupuncture, and/or chiropractic treatments for osteoarthritis of the knee within 4 weeks prior to screening
* Malalignment \>10° in the target knee (varus/valgus)
20 Years
80 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.
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan
Novartis Investigative Site
Osaka, , Japan
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
A Plain Language Trial Summary is available on novctrd.com
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLNA043A11101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.