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NCT02491281 · ClinicalTrials.gov registry record · Phase 1
First-in-human Single Ascending Dose Study of LNA043 in Patients Scheduled for Total Knee Replacement
A Phase 1 study of Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT02491281: Completed Phase 1 study of Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery, sponsored by Novartis Pharmaceuticals.
NCT02491281 is a Phase 1 study of Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02491281, a Phase 1 study of Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed to evaluate the safety and tolerability of ascending single doses of LNA043 given intra-articularly into the human knee joint prior to its removal at total knee replacement surgery. In addition, this will help to establish the presence of LNA043 within the articular cartilage, assess pharmacokinetics and immunogenicity, and will allow exploration of biomarkers of hyaline cartilage repair.
Primary Outcome
Safety and tolerability of LNA043 after one intra-articular injection into the knee of osteoarthritis patients scheduled for total knee replacement
Conditions Studied
Interventions
- DRUG Placebo
- DRUG LNA043
Study Locations (1)
Arizona
- Novartis Investigative Site - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2015-11-16 |
| Est. Completion | 2018-03-06 |
| Phase | Phase 1 |
What the finished NCT02491281 record still lists
NCT02491281 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 1 condition, with Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02491281 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT02491281 about?
NCT02491281 is a clinical study titled "First-in-human Single Ascending Dose Study of LNA043 in Patients Scheduled for Total Knee Replacement". This study is designed to evaluate the safety and tolerability of ascending single doses of LNA043 given intra-articularly into the human knee joint prior to its removal at total knee replacement surgery. In addition, this will help to establish the presence of LNA043 within the articular cartilage,...
What is the current status of trial NCT02491281?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2015-11-16. Estimated completion is 2018-03-06.
What conditions does trial NCT02491281 study?
This clinical trial studies the following conditions: Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery.
What interventions are being tested in trial NCT02491281?
The interventions under investigation include: Placebo (DRUG), LNA043 (DRUG).
Who is sponsoring clinical trial NCT02491281?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02491281 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02491281's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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