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)

Last updated: August 9, 2024
Sponsor: Novartis Pharmaceuticals
Overall Status: Terminated

Phase

2

Condition

Knee Injuries

Osteoarthritis

Treatment

Placebo to canakinumab

LNA043

canakinumab

Clinical Study ID

NCT04814368
CLNA043A12203
  • Ages 40-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Moderate to severe OA pain (corresponding to NRS Pain ≥5 to ≤9) in the target kneefor 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) ≥1.8 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 onan established synovititis scoring system (moderate score 9-12 or severe score ≥13)

Exclusion

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 otherprevious surgical intervention in the target knee, or for the contralateral kneewithin 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 thelast 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, ankylosingspondylitis, gout, Paget's disease, systemic lupus erythematosus) or other systemiccondition that might confound assessment of OA (e.g. fibromyalgia)

  • Ipsilateral hip OA or hip prosthesis recently implanted (within 1 year prior toscreening) or hip replacement on either side planned within the study period

Study Design

Total Participants: 23
Treatment Group(s): 3
Primary Treatment: Placebo to canakinumab
Phase: 2
Study Start date:
August 27, 2021
Estimated Completion Date:
June 24, 2024

Connect with a study center

  • Novartis Investigative Site

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • Novartis Investigative Site

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Novartis Investigative Site

    Zhuzhou, Hunan 412000
    China

    Site Not Available

  • Novartis Investigative Site

    Hohhot, Inner Mongolia 010017
    China

    Site Not Available

  • Novartis Investigative Site

    Beijing, 100044
    China

    Site Not Available

  • Novartis Investigative Site

    Brno, Czech Republic 66250
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Pardubice, Czech Republic 530 02
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Praha, Czech Republic 19000
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Kolin, 280 02
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Uherske Hradiste, 686 01
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Tallinn, 10128
    Estonia

    Site Not Available

  • Novartis Investigative Site

    Tartu, 50406
    Estonia

    Site Not Available

  • Novartis Investigative Site

    Bad Doberan, 18209
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin, 10117
    Germany

    Site Not Available

  • Novartis Investigative Site

    Giessen, 35392
    Germany

    Site Not Available

  • Novartis Investigative Site

    Herne, 44649
    Germany

    Site Not Available

  • Novartis Investigative Site

    Muenster, 48149
    Germany

    Site Not Available

  • Novartis Investigative Site

    Kecskemet, Bacs Kiskun 6044
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Szekesfehervar, Fejer 8000
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Budapest, 1036
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Gyor, 9024
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Zalaegerszeg, 8900
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Riga, 1005
    Latvia

    Site Not Available

  • Novartis Investigative Site

    Vilnius, LTU LT-08406
    Lithuania

    Site Not Available

  • Novartis Investigative Site

    Kaunas, 44320
    Lithuania

    Site Not Available

  • Novartis Investigative Site

    Gliwice, 44100
    Poland

    Site Not Available

  • Novartis Investigative Site

    Krakow, 31-501
    Poland

    Site Not Available

  • Novartis Investigative Site

    Warszawa, 02-677
    Poland

    Site Not Available

  • Novartis Investigative Site

    St Petersburg, 190068
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Lausanne, 1011
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    St Gallen, CH 9007
    Switzerland

    Site Not Available

  • Horizon Clinical Research

    La Mesa, California 91942
    United States

    Site Not Available

  • Novartis Investigative Site

    La Mesa, California 91942
    United States

    Site Not Available

  • Clinical Res Of W Florida

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Clinical Res. of W Florida

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Clinical Research of West Florida

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Novartis Investigative Site

    Clearwater, Florida 33765
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Sunrise, Florida 33351
    United States

    Active - Recruiting

  • Precision Clinical Research LLC

    Sunrise, Florida 33351
    United States

    Site Not Available

  • Novartis Investigative Site

    Kansas City, Kansas 66160-7330
    United States

    Site Not Available

  • LV Research

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • Novartis Investigative Site

    Las Vegas, Nevada 89119
    United States

    Active - Recruiting

  • Lucas Research .

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Novartis Investigative Site

    Morehead City, North Carolina 28557
    United States

    Active - Recruiting

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