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)

Part of paid clinical trials in La Mesa, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04814368
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • canakinumab — BIOLOGICAL
    Canakinumab 600 mg single intra-articular injection (into the knee) on Day 1
  • LNA043 — BIOLOGICAL
    LNA043 40 mg intra-articular injection (into the knee) every 4 weeks, on Days 15, 43 and 71
  • Placebo to canakinumab — OTHER
    Placebo to canakinumab single intra-articular injection (into the knee) on Day 1

Study Details

The study was established to show safety and efficacy of canakinumab and LNA043 in patients with knee osteoarthritis (OA).

Key Dates

Start date
Aug 27, 2021
Status verified
Oct 2025
Primary completion
Jun 24, 2024
Completion
Jun 24, 2024

Study Design

Enrollment
23 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Placebo+LNA043
    Placebo to canakinumab on Day 1 followed by LNA043 on Days 15, 43 and 71
  • Placebo Comparator: Placebo
    Placebo to canakinumab on Day 1
  • Experimental: canakinumab + LNA043
    Canakinumab on Day 1 followed by LNA043 on Days 15, 43 and 71
  • Experimental: canakinumab
    Canakinumab on Day 1

Primary Outcome Measure

Change in Cartilage Volume in the Index Region Measured by MRI at Day 197 (Placebo to ACZ885+LNA043 Versus Placebo to ACZ885) [ Time Frame: Baseline, Day 197 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Horizon Clinical ResearchLa MesaCalifornia91942-
Clinical Res Of W FloridaClearwaterFlorida33765-
Precision Clinical Research LLCSunriseFlorida33351-
LV ResearchLas VegasNevada89119-
Lucas ResearchMorehead CityNorth Carolina28557-

Find similar trials in La Mesa, CA

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
Horizon Clinical Research· La Mesa, CAClinical Res Of W Florida· Clearwater, FLPrecision Clinical Research LLC· Sunrise, FLLV Research· Las Vegas, NVLucas Research· Morehead City, NC

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