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)

Study Purpose

The study will establish safety and efficacy of canakinumab and LNA043 in patients with knee osteoarthritis (OA).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Moderate to severe OA pain (corresponding to NRS Pain ≥5 to ≤9) in the target knee for the majority of days in the last 3 months prior to Screening.
  • - KOOS pain subscale <60 for the target knee during Screening.
  • - High sensitivity C-reactive Protein (hsCRP) ≥2 mg/L.
  • - Radiographic KL grade 2 to 4 knee OA and joint space width (JSW) 2.0-4.0 mm (men) or 1.5-3.5 mm (women) in the medial tibiofemoral compartment (TFC) in the target knee.
  • - Contrast-enhanced MRI (CE-MRI) diagnosed moderate or severe knee synovitis based on an established synovititis scoring system (moderate score 9-12 or severe score ≥13)

    Exclusion Criteria:

    - History of, or planned; knee replacement (partial or total) in either knee; arthroscopy or lavage in either knee within 6 months prior to screening; any other previous surgical intervention in the target knee, or for the contralateral knee within 12 months prior to Screening, including mosaicplasty, microfracture, meniscectomy >50% or osteotomy.
  • - Moderate to severe pain in the contralateral knee for the majority of days in the last 3 months prior to screening.
- Malalignment >7.5° in the target knee (either varus or valgus) - Any diagnosis of systemic inflammatory arthritis or connective tissue disease, including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout, Paget's disease, systemic lupus erythematosus) or other systemic condition that might confound assessment of OA (e.g. fibromyalgia) - Ipsilateral hip OA or hip prosthesis recently implanted (within 1 year prior to screening) or hip replacement on either side planned within the study period

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04814368
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Novartis Pharmaceuticals
Principal Investigator Affiliation Novartis Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China, Czechia, Germany, Hungary, Russian Federation, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Knee Osteoarthritis
Arms & Interventions

Arms

Experimental: LNA043

Placebo to canakinumab + LNA043

Placebo Comparator: Placebo

Placebo to canakinumab

Experimental: canakinumab + LNA043

canakinumab + LNA043

Experimental: canakinumab

canakinumab

Interventions

Biological: - canakinumab

intra-articular injection (into the knee)

Biological: - LNA043

intra-articular injection (into the knee)

Other: - Placebo to canakinumab

intra-articular injection (into the knee)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Novartis Investigative Site, Clearwater, Florida

Status

Recruiting

Address

Novartis Investigative Site

Clearwater, Florida, 33765

Novartis Investigative Site, Sunrise, Florida

Status

Recruiting

Address

Novartis Investigative Site

Sunrise, Florida, 33351

Novartis Investigative Site, Las Vegas, Nevada

Status

Recruiting

Address

Novartis Investigative Site

Las Vegas, Nevada, 89119

Novartis Investigative Site, Morehead City, North Carolina

Status

Recruiting

Address

Novartis Investigative Site

Morehead City, North Carolina, 28557

International Sites

Novartis Investigative Site, Beijing, Beijing, China

Status

Recruiting

Address

Novartis Investigative Site

Beijing, Beijing, 100044

Novartis Investigative Site, Guangzhou, Guangdong, China

Status

Recruiting

Address

Novartis Investigative Site

Guangzhou, Guangdong, 510515

Novartis Investigative Site, Zhuzhou, Hunan, China

Status

Recruiting

Address

Novartis Investigative Site

Zhuzhou, Hunan,

Novartis Investigative Site, Hohhot, Inner Mongolia, China

Status

Recruiting

Address

Novartis Investigative Site

Hohhot, Inner Mongolia, 010017

Novartis Investigative Site, Beijing, China

Status

Recruiting

Address

Novartis Investigative Site

Beijing, , 100044

Novartis Investigative Site, Pardubice, Czech Republic, Czechia

Status

Recruiting

Address

Novartis Investigative Site

Pardubice, Czech Republic, 530 02

Novartis Investigative Site, Praha, Czech Republic, Czechia

Status

Recruiting

Address

Novartis Investigative Site

Praha, Czech Republic, 19000

Novartis Investigative Site, Kolin, Czechia

Status

Recruiting

Address

Novartis Investigative Site

Kolin, , 280 02

Novartis Investigative Site, Uherske Hradiste, Czechia

Status

Recruiting

Address

Novartis Investigative Site

Uherske Hradiste, , 686 01

Novartis Investigative Site, Herne, Germany

Status

Recruiting

Address

Novartis Investigative Site

Herne, , 44649

Novartis Investigative Site, Szekesfehervar, Fejer, Hungary

Status

Recruiting

Address

Novartis Investigative Site

Szekesfehervar, Fejer, 8000

Novartis Investigative Site, St Petersburg, Russian Federation

Status

Withdrawn

Address

Novartis Investigative Site

St Petersburg, , 190068