Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04119687 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety and Tolerability of FX201 in Patients with Osteoarthritis of the Knee
A Phase 1 study of Osteoarthritis, Knee, sponsored by Pacira Pharmaceuticals.
- Active
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 6
- Study locations
NCT04119687: Active Phase 1 study of Osteoarthritis, Knee, sponsored by Pacira Pharmaceuticals.
NCT04119687 is a Phase 1 study of Osteoarthritis, Knee that is active but no longer recruiting, run by Pacira Pharmaceuticals. The registered enrollment target is 72 participants, below the 497-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (86% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04119687, a Phase 1 study of Osteoarthritis, Knee, is active but no longer recruiting, sponsored by Pacira Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 6
- Study locations
Study Summary
This two-part study will be conducted in male and female patients, 30 - 80 years of age with painful OA of the index knee with Kellgren-Lawrence (K-L) Grade 2, 3 or 4. Part 1 - Single Ascending Dose (SAD) Phase: Up to three ascending doses of FX201 will be tested in cohorts of 5-8 patients. Each patient will only receive one injection of FX201. An independent Data Monitoring Committee (DMC) will review safety and guide the conduct of the study. Part 2 - Expansion Phase: Up to an additional 35 patients will be enrolled at each dose level reviewed by the DMC. Each patient will only receive one injection of FX201.
Primary Outcome
Incidence of treatment emergent adverse events after a single intra-articular (IA) injection of FX201
Conditions Studied
Interventions
- BIOLOGICAL FX201
Study Locations (6)
Pennsylvania
- University Orthopedics Center - Altoona
- Altoona Center for Clinical Research - Duncansville
Arizona
- Arizona Research Center - Phoenix
Florida
- Gulfcoast Research Institute, LLC - Sarasota
Missouri
- Center for Pharmaceutical Research - Kansas City
Texas
- Metroplex Clinical Research Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2020-03-02 |
| Est. Completion | 2026-11-28 |
| Phase | Phase 1 |
What the registry record for NCT04119687 still lists
NCT04119687 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 497-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 1 intervention - of which FX201 is the first listed.
NCT04119687 lists 6 locations in 5 states (Pennsylvania, Arizona, Florida).
Frequently Asked Questions
What is clinical trial NCT04119687 about?
NCT04119687 is a clinical study titled "Study to Evaluate the Safety and Tolerability of FX201 in Patients with Osteoarthritis of the Knee". This two-part study will be conducted in male and female patients, 30 - 80 years of age with painful OA of the index knee with Kellgren-Lawrence (K-L) Grade 2, 3 or 4. Part 1 - Single Ascending Dose (SAD) Phase: Up to three ascending doses of FX201 will be tested in cohorts of 5-8 patients. Each pa...
What is the current status of trial NCT04119687?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2020-03-02. Estimated completion is 2026-11-28.
What conditions does trial NCT04119687 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee.
What interventions are being tested in trial NCT04119687?
The interventions under investigation include: FX201 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04119687?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04119687 being conducted?
This trial has 6 study locations across Arizona, Florida, Missouri, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteoarthritis, 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 NCT04119687's enrollment target sits among peer trials
72 78th of 112 higher than 34 of 112 other Osteoarthritis, Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis, 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
-
A Hip Flexion Feedback System for Exercise Monitoring in Individuals With Osteoarthritis and Obesity
RECRUITING · Phase 1
-
CBD for Knee Osteoarthritis
RECRUITING · Phase 1
-
Oral Steroid Taper After Total Knee Arthroplasty
RECRUITING · Phase 1
-
The Role of Vitamin K on Knee Osteoarthritis Outcomes
RECRUITING · Phase 1
-
Safety and Pharmacodynamics of GNSC-001 Intra-articular Injection for Knee Osteoarthritis
ACTIVE NOT RECRUITING · Phase 1
-
Prospective Evaluation of PRP and BMC Treatment to Accelerate Healing After ACL Reconstruction
ACTIVE NOT RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02359253 · 72 participants · NA
Robot Aided Rehabilitation - Intervention
- NCT02962661 · 72 participants · Phase 1
Donor Bone Marrow Derived Mesenchymal Stem Cells in Controlling Heart Failure in Patients With Cardiomyopathy Caused by Anthracyclines
- NCT03113643 · 72 participants · Phase 1
SL-401 in Combination With Azacitidine or Azacitidine/Venetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- NCT03187535 · 72 participants · NA
Effect of TEAS on PONV After Spinal Surgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI