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

Novartis Pharmaceuticals12 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Osteoarthritis Knee

Interventions

LNA043DRUG

Single intra-articular injection on Day 1

PlaceboDRUG

Single intra-articular injection on Day 1

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (2)

Novartis Investigative Site

Shinjuku-ku, Tokyo, Japan

Novartis Investigative Site

Osaka, Japan

Outcomes

Primary Outcomes

Number of participants with adverse events

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

Time frame: Up to Day 22

Secondary Outcomes

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

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

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

Observed maximum serum concentration of LNA043

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

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

Number of participants with anti-LNA043 antibodies in serum

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

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

Data from ClinicalTrials.gov

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