A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee
Public ClinicalTrials.gov record NCT06884865. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Two-Part, Randomized, Double-Blind, Active-Controlled Study to Assess the Safety and Tolerability of Enekinragene Inzadenovec (PCRX-201) in Subjects With Painful Osteoarthritis of the Knee
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this clinical trial is to learn if a single knee injection of different doses (Dose A and Dose B) of an investigation product PCRX-201, following steroid pretreatment, is safe and tolerable in male of female patients 45 to 80 years old with osteoarthritis of the knee. It will also learn how the body reacts to the PCRX-201 injection and how effective the treatment is. Researchers will compare Dose A and Dose B of PCRX-201 versus placebo from Week 1 through Week 52 to assess adverse events. Researchers will also explore how PCRX-201 may impact knee pain and joint function over time. Participants will be asked to * Visit the clinic for pretreatment and drug administration * Visit the clinic for checkups and tests: 1. Screening through Week 52: intially weekly, bi-weekly, later monthly 2. Week 53 through Week 260 (Year 5): 8 visits throughout the period
Study identification
- NCT ID
- NCT06884865
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 135 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 45 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 25, 2025
- Primary completion
- Oct 31, 2026
- Completion
- Jun 30, 2032
- Last update posted
- Aug 24, 2026
2025 – 2032
United States locations
- U.S. sites
- 40
- U.S. states
- 18
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Flourish Research - Birmingham | Birmingham | Alabama | 35205 | Not yet recruiting |
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35235 | Withdrawn |
| OrthoArizona | Phoenix | Arizona | 85018 | Not yet recruiting |
| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix | Phoenix | Arizona | 85032 | Not yet recruiting |
| Osteoporosis Medical Center | Beverly Hills | California | 90211 | Active, not recruiting |
| Advanced Clinical Research Center, LLC dba TriWest Research Associates, LLC | Chula Vista | California | 91910 | Not yet recruiting |
| Medvin Clinical Research - Covina | Covina | California | 91722 | Not yet recruiting |
| Beach Physicians Medical Group Inc. | Huntington Beach | California | 92647 | Recruiting |
| Horizon Clinical Research | La Mesa | California | 91942 | Active, not recruiting |
| Source Healthcare | Santa Monica | California | 90403 | Not yet recruiting |
| Alliance Clinical West Hills (Focus Clinical Research) | West Hills | California | 91307 | Withdrawn |
| Medvin Clinical Research - Whittier | Whittier | California | 90602 | Not yet recruiting |
| Arrow Clinical Trials | Daytona Beach | Florida | 32117 | Recruiting |
| Journey Research Inc. | Oldsmar | Florida | 34677-4681 | Active, not recruiting |
| Discovery Health Research Center - Plantation, FL | Plantation | Florida | 33317 | Not yet recruiting |
| Gulfcoast Research Institute | Sarasota | Florida | 34232 | Not yet recruiting |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | Active, not recruiting |
| Conquest Research | Winter Park | Florida | 32789 | Active, not recruiting |
| Pinnacle Trials, Inc. | Atlanta | Georgia | 30329 | Not yet recruiting |
| Rush Medical College - Division of Rheumatology | Chicago | Illinois | 60612 | Not yet recruiting |
| Accurate Clinical Research, Inc. - Lake Charles | Lake Charles | Louisiana | 70605 | Not yet recruiting |
| Best Clinical Trials, LLC | New Orleans | Louisiana | 70115 | Not yet recruiting |
| LifeBridge Health | Baltimore | Maryland | 21215 | Not yet recruiting |
| Michigan Orthopaedic and Spine Surgeons | Rochester Hills | Michigan | 48307 | Not yet recruiting |
| Physicians Research Collaboration | Lincoln | Nebraska | 68516 | Recruiting |
| Excel Clinical Research | Las Vegas | Nevada | 89109 | Active, not recruiting |
| NY Scientific | Brooklyn | New York | 11235-3919 | Not yet recruiting |
| New York University (NYU) Center for Musculoskeletal Care | New York | New York | 10016 | Not yet recruiting |
| West Clinical Research | Morehead City | North Carolina | 28557 | Not yet recruiting |
| M3 Wake Research - Wilmington, NC | Wilmington | North Carolina | 28412 | Not yet recruiting |
| META Medical Research Institute | Dayton | Ohio | 45432 | Not yet recruiting |
| University Orthopedics Center | Altoona | Pennsylvania | 16602-4472 | Not yet recruiting |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | Active, not recruiting |
| Clinical Trials of South Carolina - Charleston | Charleston | South Carolina | 29406 | Active, not recruiting |
| Clinical Trials of South Carolina - Columbia | Columbia | South Carolina | 29206 | Active, not recruiting |
| Campbell Clinic | Collierville | Tennessee | 38017 | Not yet recruiting |
| Zenos Clinical Research | Dallas | Texas | 75230 | Active, not recruiting |
| Helios CR, Inc. | Dallas | Texas | 75231 | Not yet recruiting |
| Accurate Clinical Research, Inc - Houston | Houston | Texas | 77034 | Not yet recruiting |
| Epic Clinical Research | Lewisville | Texas | 75057 | Active, not recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06884865, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 24, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06884865 live on ClinicalTrials.gov.