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NCT Number: NCT04564053

Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants

The objective of this study was to determine the safety, tolerability and pharmacokinetics after single ascending dose of LNA043 in Japanese participants with osteoarthritis of the knee.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Knee Musculoskeletal Diseases Rheumatic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Shinjuku-ku, Tokyo, Japan

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About this study

This was a non-confirmatory, randomized, participant- and investigator-blinded, placebo-controlled, single ascending dose study to investigate the safety, tolerability and PK of LNA043 in Japanese participants with osteoarthritis of the knee. This study consisted of 2 cohorts with a total of 12 participants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female Japanese participants aged 20 to 80 years at screening
  • 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

  • Partial or complete joint replacement in the target knee. Planned knee surgery for either knee during the study.
  • 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)

Treatment and study plan

LNA043

Drug

Single intra-articular injection on Day 1

Placebo

Drug

Single intra-articular injection on Day 1

Primary outcomes

  1. Number of participants with adverse events

    Time frame: Up to Day 22

    To assess the safety and tolerability of single intra-articular injection of LNA043 in Japanese participants with osteoarthritis of the knee

Secondary outcomes

  1. Area under the serum concentration-time curve of LNA043 from zero to the last measurable concentration

    Time frame: 0 (pre-dose), 0.25, 2, 4, 8, 12, 24, 36, 48, 72, 168 hours post-dose

    To assess systemic PK of LNA043 following single intra-articular injection of LNA043 in Japanese participants with osteoarthritis of the knee

  2. Observed maximum serum concentration of LNA043

    Time frame: 0 (pre-dose), 0.25, 2, 4, 8, 12, 24, 36, 48, 72, 168 hours post-dose

    To assess systemic PK of LNA043 following single intra-articular injection of LNA043 in Japanese participants with osteoarthritis of the knee

  3. Number of participants with anti-LNA043 antibodies in serum

    Time frame: Day 1 (pre-dose), 4, 8, 15, 22

    To assess systemic immunogenicity of LNA043 (anti-LNA043 antibodies) following single intra-articular injection of LNA043 in Japanese participants with osteoarthritis of the knee

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Participant and Investigator Blinded, Placebo Controlled, Single Ascending Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Participants Wit Osteoarthritis of the Knee

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 25, 2020
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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