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NCT06865079 · ClinicalTrials.gov registry record · Phase 2
53-Week Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 With Mild to Severe Tibio-Femoral Osteoarthritis of the Knee
A Phase 2 study of Osteoarthritis (OA) of the Knee, sponsored by OrthoTrophix.
- Active
- Registry status
- Phase 2
- Development phase
- 270
- Enrollment target
- 20
- Study locations
NCT06865079: Active Phase 2 study of Osteoarthritis (OA) of the Knee, sponsored by OrthoTrophix.
NCT06865079 is a Phase 2 study of Osteoarthritis (OA) of the Knee that is active but no longer recruiting, run by OrthoTrophix. The registered enrollment target is 270 participants, below the 1,380-participant average among 8 other Osteoarthritis (OA) of the Knee trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06865079, a Phase 2 study of Osteoarthritis (OA) of the Knee, is active but no longer recruiting, sponsored by OrthoTrophix.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 270 participants
- Enrollment target
- 20
- Study locations
Study Summary
53-Week Study Evaluating the Safety and Efficacy of Intra-articular (IA) Injections of TPX-100 vs Placebo in Subjects with Mild to Severe Tibio-Femoral Osteoarthritis of the Knee
Primary Outcome
CTC 5.0, also known as Common Terminology Criteria for Adverse/Serious Adverse Events version 5.0, is an extensively used classification system for assessing drug toxicity. This system categorizes drug toxicity into five levels: Grade 0, Grade 1, Grade 2, Grade 3, and Grade 4.
Conditions Studied
Interventions
- DRUG TPX-100 200mg, Once weekly for 4 weeks
- OTHER PBS
Study Locations (20)
California
- Legent Orthopedic Hospital - Carrolton
- Medvin Clinical Research - Covina
- CORE Orthopaedic Medical Center - Encinitas
- Marvel Clinical Research (Elite Clinical Network) - Huntington Beach
- Medvin Clinical Research Center - Riverside
- Medvin Clinical Research Center - Tujunga
- Medvin Clinical Research Center - Whittier
Florida
- K2 Medical Research - Maitland
- Wellness Research Center - Miami
- Well Pharma Medical Research - Miami
- Las Mercedes Medical Research - Miami
Arizona
- Elite Clinical Network - Scottsdale
- Noble Clinical Research - Tucson
Kansas
- AMR Kansas City - Kansas City
- University of Kansas Medical Center - Kansas City
Georgia
- Drug Studies of America - Marietta
Kentucky
- AMR Lexington - Lexington
Louisiana
- Accurate Clinical Research Inc. - Lake Charles
Minnesota
- Mayo Clinic (Rochester) - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2025-05-09 |
| Est. Completion | 2027-04-15 |
| Phase | Phase 2 |
What the registry record for NCT06865079 still lists
NCT06865079 is an interventional study that assigns participants to a tested intervention. The registered 270 participants enrollment target is mid-sized for trials with a published cap, below the 1,380-participant average among 8 other Osteoarthritis (OA) of the Knee trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Osteoarthritis (OA) of the Knee appearing as the primary indexed condition, and to 2 interventions - of which TPX-100 200mg, Once weekly for 4 weeks is the first listed.
NCT06865079 names 20 study sites across 9 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT06865079 about?
NCT06865079 is a clinical study titled "53-Week Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 With Mild to Severe Tibio-Femoral Osteoarthritis of the Knee". 53-Week Study Evaluating the Safety and Efficacy of Intra-articular (IA) Injections of TPX-100 vs Placebo in Subjects with Mild to Severe Tibio-Femoral Osteoarthritis of the Knee
What is the current status of trial NCT06865079?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 270 participants. The study started on 2025-05-09. Estimated completion is 2027-04-15.
What conditions does trial NCT06865079 study?
This clinical trial studies the following conditions: Osteoarthritis (OA) of the Knee.
What interventions are being tested in trial NCT06865079?
The interventions under investigation include: TPX-100 200mg, Once weekly for 4 weeks (DRUG), PBS (OTHER).
Who is sponsoring clinical trial NCT06865079?
This trial is sponsored by OrthoTrophix, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06865079 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteoarthritis (OA) of the Knee
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 NCT06865079's enrollment target sits among peer trials
270 2nd of 8 the highest of 8 other Osteoarthritis (OA) of the Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis (OA) of the Knee 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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