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

Osteoarthritis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04564053
• Other study ID #: CLNA043A11101
• Status: Completed
• Phase: Phase 1
• Start date: September 23, 2020
• Est. completion date: December 10, 2020

Study information

• Verified date: August 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 10, 2020
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Knee
• Osteoarthritis

Intervention

Drug:
• LNA043
Single intra-articular injection on Day 1
• Placebo
Single intra-articular injection on Day 1

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to Day 22
Secondary	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	0 (pre-dose), 0.25, 2, 4, 8, 12, 24, 36, 48, 72, 168 hours post-dose
Secondary	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	0 (pre-dose), 0.25, 2, 4, 8, 12, 24, 36, 48, 72, 168 hours post-dose
Secondary	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	Day 1 (pre-dose), 4, 8, 15, 22

External Links

•   A Plain Language Trial Summary is available on novctrd.com