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

NCT04564053 | Completed Phase 1

• 1 other identifier: CLNA043A11101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis; Knee

Keywords

osteoarthritis; knee; cartilage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Observed maximum serum concentration of LNA043

  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

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

Study Arms (2)

LNA043

EXPERIMENTAL

LNA043

Drug: LNA043; Drug: Placebo

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

LNA043 DRUG

Single intra-articular injection on Day 1

LNA043

Placebo DRUG

Single intra-articular injection on Day 1

LNA043; placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Investigative Site

Shinjuku-ku, Tokyo, 162-0053, Japan

Location

Novartis Investigative Site

Osaka, 532-0003, Japan

Location

Related Links

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

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a non-confirmatory, randomized, participant- and investigator-blinded, placebo-controlled, single ascending dose study.

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 25, 2020
• Study Start: September 23, 2020
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)