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

Phase 1

Completed

• Conditions: Osteoarthritis; Knee
• Interventions: Drug: LNA043; Drug: Placebo

• Registration Number: NCT04564053
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2020-09-23
• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-25
• Primary Completion: 2020-12-10
• Study Completion: 2020-12-10
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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).

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LNA043	Placebo	LNA043
LNA043	LNA043	LNA043
placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	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 Outcome Measures

Name	Time	Method
Area under the serum concentration-time curve of LNA043 from zero to the last measurable concentration	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
Observed maximum serum concentration of LNA043	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
Number of participants with anti-LNA043 antibodies in serum	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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Osaka, Japan