Osteoarthritis (OA) of the Knee study: Enekinragene Inzadenovec
Official title A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee
ClinicalTrials.gov ID: NCT06884865
What this study is testing
What is Enekinragene Inzadenovec (PCRX-201)?
An investigational single knee injection being studied for osteoarthritis of the knee.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if a single knee injection of PCRX-201 is safe and tolerable, and to learn how the body reacts to it and whether it helps with pain and function.
- Who it's for
- Adults aged 45 to 80 who have osteoarthritis of the knee.
- What's involved
- Participants receive one knee injection of PCRX-201 after a steroid pretreatment. They will visit the clinic for the injection and for regular check‑ups and tests to monitor safety and knee pain.
- Time commitment
- The study lasts up to 5 years, with frequent visits in the first year (weekly, bi‑weekly, then monthly) and eight additional visits over the next four years.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 80
You may be able to join if
- people must be willing and able to comply with the study procedures and visit schedule and able to follow verbal and written instructions.
- people must be male or female and 45 to 80 years old, inclusive, at Screening.
- people must exhibit symptoms associated with osteoarthritis of the index knee for ≥12 months before Screening (subject self-reporting is acceptable).
- people must have index knee pain for \>15 days over the last month before Screening (subject self-reporting is acceptable).
- people must have received 2 or more failed 2 or more therapies: Restricted physical activity as per Osteoarthritis Research Society International...
You likely can't join if
- people have any current or prior diagnosis of autoimmune connective tissue disorders, secondary OA conditions, benign synovial tumors...
- people have any active systemic or local infection, including infection of the index knee
- people are unable to undergo MRI with contrast MRI
- people with X-ray or MRI exclusionary events
- people have an unstable index knee joint (eg, torn anterior cruciate ligament) within 12 months of Screening
- people have used any approved or investigational IA drug/biologic in index knee within 6 months of Screening (eg, hyaluronic acid, platelet rich...
See the full eligibility criteria
- people must be willing and able to comply with the study procedures and visit schedule and able to follow verbal and written instructions.
- people must be male or female and 45 to 80 years old, inclusive, at Screening.
- people must exhibit symptoms associated with osteoarthritis of the index knee for ≥12 months before Screening (subject self-reporting is acceptable).
- people must have index knee pain for \>15 days over the last month before Screening (subject self-reporting is acceptable).
- people must have received 2 or more failed 2 or more therapies: Restricted physical activity as per Osteoarthritis Research Society International (OARSI) core level recommendation, ie, "structured land-based exercise"...
- people must have a body mass index (BMI) ≤40 kg/m2 at Screening.
- people 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.
- people must have an index knee Average Daily Knee Pain (NRS) between ≥5.0 and ≤9.0 at Screening and Baseline.
- Sexually active people of child-bearing potential (SOCBP) and their partners must agree to use effective birth control while in the study
- people must have active synovitis in the index knee as determined by ultrasound Doppler (Part A only) For Part B, participants must have active synovitis in the index knee as determined by contrast-enhanced MRI.
- Knee pain
- At least 1 of the following: i. Age \>50 years ii. Morning stiffness \<30 minutes iii. Crepitus on knee motion c. Osteophytes
- people must have K-L Grade 2, 3, or 4 (Part A) or K-L Grade 2 or 3 (Part B) in the index knee based on X-rays performed during Screening and confirmed by trained radiographers at a central facility before enrollment
- people need to show the presence of moderate or severe synovitis based on 11-point synovitis score using contrast-enhanced MRI (Part A).
- people 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...
- people have any active systemic or local infection, including infection of the index knee
- people are unable to undergo MRI with contrast MRI
- people with X-ray or MRI exclusionary events
- people have an unstable index knee joint (eg, torn anterior cruciate ligament) within 12 months of Screening
- people 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)
- people are receiving or have received any gene therapy treatment (eg, IL-1Ra) in the past 3 years
- people have used IA steroids ≤3 months before screening
- For Part B, people with any surgery related tot he index knee. Other protocol-defined criteria apply
The study team makes the final eligibility decision.
Where it is enrolling
- Huntington Beach, California, United States
- Daytona Beach, Florida, United States
- Lincoln, Nebraska, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Huntington Beach, California, United States; Daytona Beach, Florida, United States; Lincoln, Nebraska, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.