RECRUITING

A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee

Conditions

Osteoarthritis (OA) of the Knee gene therapy Knee Pain Arthritis Osteoarthritis of the Knee

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2025-02-26

Study Completion:2032-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06884865

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Subjects must be willing and able to comply with the study procedures and visit schedule and able to follow verbal and written instructions. * Subjects must be male or female and 45 to 80 years old, inclusive, at Screening. * Subjects must exhibit symptoms associated with osteoarthritis of the index knee for ≥12 months before Screening (subject self-reporting is acceptable). * Subjects must have index knee pain for \>15 days over the last month before Screening (subject self-reporting is acceptable). * Subjects must have failed 2 or more therapies: Restricted physical activity as per Osteoarthritis Research Society International (OARSI) core level recommendation, ie, "structured land-based exercise" (this may include physical therapy), and failure of an additional type of conservative therapy for OA of the index knee, eg, nonselective NSAIDs or COX-2 inhibitors, in the past 12 months. * Subjects must have a body mass index (BMI) ≤40 kg/m2 at Screening. * Subjects must have an index knee examination indicating the index knee and the intended injection site area are free of any signs of local or joint infection at Baseline. * Subjects must have an index knee Average Daily Knee Pain (NRS) between ≥5.0 and ≤9.0 at Screening and Baseline. * Sexually active subjects of child-bearing potential (SOCBP) and their partners must agree to use effective birth control while in the study * Subjects must have active synovitis in the index knee as determined by ultrasound Doppler. * Subjects must exhibit American College of Rheumatology Criteria (clinical and radiological) for osteoarthritis as follows: 1. Knee pain 2. At least 1 of the following: * Subjects must have K-L Grade 2, 3, or 4 in the index knee based on X-rays performed during Screening and confirmed by trained radiographers at a central facility before enrollment * Subjects need to show the presence of moderate or severe synovitis based on 11-point synovitis score using contrast-enhanced MRI	* Subjects have any current or prior diagnosis of autoimmune connective tissue disorders, secondary OA conditions, benign synovial tumors, gout/pseudogout, reactive arthritis, RA, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease. * Subjects have any active systemic or local infection, including infection of the index knee * Subjects are unable to undergo MRI with contrast MRI * Subjects with X-ray or MRI exclusionary events * Subjects have an unstable index knee joint (eg, torn anterior cruciate ligament) within 12 months of Screening * Subjects have used any approved or investigational IA drug/biologic in index knee within 6 months of Screening (eg, hyaluronic acid, platelet rich plasma, stem cells, prolotherapy, and amniotic fluid injection) * Subjects are receiving or have received any gene therapy treatment (eg, IL-1Ra) in the past 3 years * Subjects have used IA steroids ≤3 months before screening

Inclusion Criteria

Exclusion Criteria

* Subjects must be willing and able to comply with the study procedures and visit schedule and able to follow verbal and written instructions.
* Subjects must be male or female and 45 to 80 years old, inclusive, at Screening.
* Subjects must exhibit symptoms associated with osteoarthritis of the index knee for ≥12 months before Screening (subject self-reporting is acceptable).
* Subjects must have index knee pain for \>15 days over the last month before Screening (subject self-reporting is acceptable).
* Subjects must have failed 2 or more therapies: Restricted physical activity as per Osteoarthritis Research Society International (OARSI) core level recommendation, ie, "structured land-based exercise" (this may include physical therapy), and failure of an additional type of conservative therapy for OA of the index knee, eg, nonselective NSAIDs or COX-2 inhibitors, in the past 12 months.
* Subjects must have a body mass index (BMI) ≤40 kg/m2 at Screening.
* Subjects must have an index knee examination indicating the index knee and the intended injection site area are free of any signs of local or joint infection at Baseline.
* Subjects must have an index knee Average Daily Knee Pain (NRS) between ≥5.0 and ≤9.0 at Screening and Baseline.
* Sexually active subjects of child-bearing potential (SOCBP) and their partners must agree to use effective birth control while in the study
* Subjects must have active synovitis in the index knee as determined by ultrasound Doppler.
* Subjects must exhibit American College of Rheumatology Criteria (clinical and radiological) for osteoarthritis as follows:
1. Knee pain
2. At least 1 of the following:
* Subjects must have K-L Grade 2, 3, or 4 in the index knee based on X-rays performed during Screening and confirmed by trained radiographers at a central facility before enrollment
* Subjects need to show the presence of moderate or severe synovitis based on 11-point synovitis score using contrast-enhanced MRI

* Subjects have any current or prior diagnosis of autoimmune connective tissue disorders, secondary OA conditions, benign synovial tumors, gout/pseudogout, reactive arthritis, RA, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease.
* Subjects have any active systemic or local infection, including infection of the index knee
* Subjects are unable to undergo MRI with contrast MRI
* Subjects with X-ray or MRI exclusionary events
* Subjects have an unstable index knee joint (eg, torn anterior cruciate ligament) within 12 months of Screening
* Subjects have used any approved or investigational IA drug/biologic in index knee within 6 months of Screening (eg, hyaluronic acid, platelet rich plasma, stem cells, prolotherapy, and amniotic fluid injection)
* Subjects are receiving or have received any gene therapy treatment (eg, IL-1Ra) in the past 3 years
* Subjects have used IA steroids ≤3 months before screening

Contacts and Locations

Principal Investigator

Nino Joy, MD

STUDY_DIRECTOR

Pacira Pharmaceuticals, Inc

Study Locations (Sites)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235

United States

Osteoporosis Medical Center

Beverly Hills, California, 90211

United States

Beach Physicians Medical Group Inc.

Huntington Beach, California, 92647

United States

Horizon Clinical Research

La Mesa, California, 91942

United States

Alliance Clinical West Hills (Focus Clinical Research)

West Hills, California, 91307

United States

Arrow Clinical Trials

Daytona Beach, Florida, 32117

United States

Journey Research Inc.

Oldsmar, Florida, 34677-4681

United States

Palm Beach Research Center

West Palm Beach, Florida, 33409

United States

Conquest Research

Winter Park, Florida, 32789

United States

Physicians Research Collaboration

Lincoln, Nebraska, 68516

United States

Excel Clinical Research

Las Vegas, Nevada, 89109

United States

NY Scientific

Brooklyn, New York, 11235-3919

United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635

United States

Clinical Trials of South Carolina - Charleston

Charleston, South Carolina, 29406

United States

Clinical Trials of South Carolina - Columbia

Columbia, South Carolina, 29206

United States

Zenos Clinical Research

Dallas, Texas, 75230

United States

Epic Clinical Research

Lewisville, Texas, 75057

United States

Collaborators and Investigators

Sponsor: Pacira Pharmaceuticals, Inc

Nino Joy, MD, STUDY_DIRECTOR, Pacira Pharmaceuticals, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-26

Study Completion Date2032-03

Study Record Updates

Study Start Date2025-02-26

Study Completion Date2032-03

Terms related to this study

Keywords Provided by Researchers

gene therapy
Knee Pain Arthritis
Osteoarthritis of the Knee

Additional Relevant MeSH Terms

Osteoarthritis (OA) of the Knee