FX201 for Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called FX201 for individuals with painful knee osteoarthritis (OA). Researchers aim to determine if a single injection of FX201 can reduce pain and improve knee function. The trial will evaluate different doses to identify the most effective and safe option. Individuals with moderate knee pain from OA, who have tried at least two other treatments without success, might be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude those who have used certain treatments like intra-articular (IA) drugs or biologics within 6 months before screening. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that FX201 is likely to be safe for humans?
Research has shown that FX201, a new gene therapy for osteoarthritis, was well tolerated in past studies. In earlier trials, patients experienced only minor side effects. Reports indicate that FX201 was tolerated for over a year, even at different doses. While some mild side effects appeared, they did not pose a major concern. Animal studies also demonstrated its safety. The ongoing research remains in the early stages, so researchers are closely monitoring safety. However, the results are promising for those considering joining this trial.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about FX201 for osteoarthritis because it offers a potentially transformative approach compared to traditional treatments like NSAIDs, corticosteroids, and physical therapy. Unlike these standard options, which mainly address symptoms, FX201 is designed to deliver a single injection that could provide long-lasting relief. FX201 works uniquely by using gene therapy to produce an anti-inflammatory protein directly in the joint, targeting the root cause of pain and inflammation. This innovative mechanism could lead to more sustained improvements with fewer doses, making it a promising option for those suffering from osteoarthritis.
What evidence suggests that FX201 might be an effective treatment for osteoarthritis?
Research shows that FX201, a gene therapy injected directly into the joint, may help reduce pain in people with osteoarthritis (OA). Studies have found that patients treated with FX201 experienced significant pain relief and improved joint function, with benefits lasting at least 52 weeks. Most patients tolerated the treatment well, with no serious side effects. Additionally, animal studies suggest FX201 can reduce joint damage caused by OA. These findings support the potential of FX201 in treating knee osteoarthritis.14567
Who Is on the Research Team?
Cecilia Barese, MD
Principal Investigator
Pacira Pharmaceuticals, Inc
Are You a Good Fit for This Trial?
This trial is for men and women aged 30-80 with painful knee osteoarthritis (K-L Grade 2, 3 or 4), a BMI ≤40 kg/m², who have tried at least two conservative therapies or one therapy plus an injection treatment without success. Participants must be willing to use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- FX201
Trial Overview
The study tests FX201, a new drug given as a single injection in the knee. The first part involves escalating doses in small groups monitored for safety. The second part expands patient numbers at each dose level after safety review.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Single mid dose FX201 injection
Single low dose FX201 injection
Single high dose FX201 injection
Find a Clinic Near You
Who Is Running the Clinical Trial?
Flexion Therapeutics, Inc.
Lead Sponsor
Pacira Pharmaceuticals, Inc
Lead Sponsor
Dr. Jonathan Slonin
Pacira Pharmaceuticals, Inc
Chief Medical Officer since 2020
BSc in Biomedical Engineering and MD from University of Miami, MBA from George Washington University
Frank D. Lee
Pacira Pharmaceuticals, Inc
Chief Executive Officer since 2024
BSc in Chemical Engineering from Vanderbilt University, MBA from Wharton Graduate School of Business
Citations
1.
cgtlive.com
cgtlive.com/view/intraarticular-gene-therapy-well-tolerated-improves-pain-in-knee-osteoarthritisIntraarticular Gene Therapy Well-Tolerated, Improves Pain ...
Updated data from a phase 1 study of PCXR201, formerly known as Flexion's FX201, were presented at the 2023 ASCGT Annual Meeting.
Efficacy and Safety of FX201, a Novel Intra-Articular IL-1Ra ...
Consistent with equine and murine data, efficacy data suggest that HDAd-ratIL-1Ra decreased OA-induced joint damage in ACLT-operated rats, even at a 10-fold ...
3.
investor.pacira.com
investor.pacira.com/news-releases/news-release-details/pacira-biosciences-announces-pcrx-201-granted-regenerativePacira BioSciences Announces PCRX-201 Granted ...
PCRX-201 was well tolerated, with efficacy observed through at least 52 weeks at all doses and cohorts. ... Preliminary 36-week data were ...
Intra-Articular FX201 Gene Therapy Shows Promise for ...
The therapy was generally well-tolerated and offered substantial pain relief in patients.
5.
digitalscholar.lsuhsc.edu
digitalscholar.lsuhsc.edu/cgi/viewcontent.cgi?article=1170&context=sommrdŽs FX201, for theTreatment of Osteoarthritis
We will test the ability for FX201 to reduce inflammatory output and fibrotic output in patient synoviocytes and improve survival of patient chondrocytes. This ...
6.
ctv.veeva.com
ctv.veeva.com/study/study-to-evaluate-the-safety-and-tolerability-of-fx201-in-patients-with-osteoarthritis-of-the-kneeStudy to Evaluate the Safety and Tolerability of FX201 in ...
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 ...
Trial | NCT04119687
Official Title. An Open-Label, Single Ascending Dose Study to Assess the Safety and Tolerability of FX201 in Patients with Osteoarthritis of the Knee · Snapshot.
Other People Viewed
By Subject
By Trial
Related Searches
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.