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Osteoarthritis, KneePhase 1NCT04119687

Study to Evaluate the Safety and Tolerability of FX201 in Patients With Osteoarthritis of the Knee

A Phase 1 study testing FX201 in people with Osteoarthritis, Knee, run by Pacira Pharmaceuticals, Inc at 6 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
FX201
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
6 sitesUnited States
Study dates
2 Mar 2020to 28 Nov 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written consent to participate in the study
  • Male or female 30 to 80 years of age, inclusive, on the day of enrollment (Day 1)
  • Body mass index (BMI) ≤ 40 kilograms per meters squared (kg/m2)
  • Clinical diagnosis of OA of the knee on the American College of Rheumatology criteria (Altman, 1986) with radiologic evidence of OA (K-L Grade 2 or 3 for SAD Phase Cohort A and K-L Grade 2, 3 or 4 for SAD Phase Cohorts B and C and the Expansion Phase) at the index joint at the screening visit
  • Moderate pain in the index joint
  • Failed two or more types of conservative therapy for index knee osteoarthritis (e.g., structured exercise programs, topical or oral non-steroidal anti-inflammatory therapies); or failed one prior type of conservative therapy and at least one prior index knee IA treatment (corticosteroid or hyaluronic acid)
  • Sexually active females and males agree to use highly effective methods of contraception

Who cannot join

  • Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
  • History of or current infection in the index knee joint
  • Inability to undergo Magnetic Resonance Imaging (MRI) due to presence of surgical hardware or other foreign body in the index knee
  • Unstable index knee joint (e.g., torn anterior cruciate ligament, etc.) within 12 months of Screening
  • Any IA drug/biologic use within 6 months of Screening or 5 half-lives (whichever is longer) (e.g., IA corticosteroid, IA hyaluronic acid, platelet rich plasma injection, stem cells, prolotherapy and amniotic fluid injection, etc.)
  • Cold or radiofrequency nerve ablation of the index knee within 12 months of Screening
Show all 16Show fewer
  • Arthroscopic or open surgery on the index knee within 12 months of Screening or planned/anticipated surgery on the index knee for the study period
  • Anticipated major surgery during the study period
  • Laboratory values that meet exclusion criteria
  • ECG abnormality at Screening or Baseline judged clinically significant
  • Use of immunomodulators, immunosuppressive, or chemotherapeutic agents within 5 years of Screening
  • Use of any other investigational drug, biologic or device within 3 months of Screening
  • Any systemic or local bacterial or viral infection requiring IV antibiotics or antivirals within 4 weeks of Screening or oral antibiotics or antivirals within 2 weeks of Screening
  • Known allergy or sensitivity to methylprednisolone
  • Any other clinically significant acute or chronic medical conditions (e.g., bleeding disorder) that, in the judgment of the Investigator, would preclude the use of an IA injection or that could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study
  • Note: Other protocol defined inclusion/exclusion criteria apply.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • University Orthopedics Center

    Altoona, Pennsylvania, 16602

  • Metroplex Clinical Research Center

    Dallas, Texas, 75231

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Center for Pharmaceutical Research

    Kansas City, Missouri, 64114

  • Arizona Research Center

    Phoenix, Arizona, 85053

  • Gulfcoast Research Institute, LLC

    Sarasota, Florida, 34232

Other trials in United States

About this study

Official title: An Open-Label, Single Ascending Dose Study to Assess 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 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.

Read the detailed description

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 - SAD Phase: Up to three ascending doses of FX201 (low dose, mid dose and high dose) will be tested in cohorts of 5-8 patients. Each patient will only receive one injection of FX201. A maximum of 24 patients will be enrolled (range 15 to 24).

When a minimum of 4 weeks have elapsed since the last patient of the current cohort has been treated, all safety data will be collected and reviewed by an independent Data Monitoring Committee (DMC). After evaluating cohort safety data, the DMC will evaluate continuing the trial and initiating treatment in the next dosing cohort as well as expanding enrollment in dose level(s).

Part 2 - Expansion Phase: After the DMC has met to review safety data from each Cohort and has recommended expanding dose level(s), enrollment slots for dose levels reviewed by the DMC will be opened. A maximum of 105 patients [up to an additional 35 patients per dose level (up to 20 FX201 alone and up to 15 FX201 with IA methylprednisolone 40 mg/mL pre-treatment)].

Being tested
FX201
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FX201Biological

    FX201, humantakinogene hadenovec, is a novel interleukin-1 receptor antagonist (IL-1Ra) gene therapy for IA administration that is being developed for the treatment of patients with OAK.

Study groups in NCT04119687
Study groupRoleWhat they receive
Low Dose FX201ExperimentalSingle low dose FX201 injection
Receives: Biological: FX201
Mid Dose FX201ExperimentalSingle mid dose FX201 injection
Receives: Biological: FX201
High Dose FX201ExperimentalSingle high dose FX201 injection
Receives: Biological: FX201

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Outcome Measure: Incidence of treatment emergent adverse events after a single intra-articular (IA) injection of FX201 (safety and tolerability)

    Incidence of treatment emergent adverse events after a single intra-articular (IA) injection of FX201

    Measured: Baseline to Week 104

Secondary outcomes (1)

  1. Secondary Outcome Measure: Characterization of the systemic biodistribution of FX201 as seen through the percentage of patients positive for FX201 at Baseline, Day 1, Day 2, Week 1, Week 2, Week 3, and Week 4

    The percentage of patients positive for FX201 at select timepoints

    Measured: Baseline, Day 1, Day 2, Week 1, Week 2, Week 3, Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2019
  2. Study start2 Mar 2020
  3. Primary completion28 Nov 2023
  4. Study completion28 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Part 1 - Open-Label, Single Ascending Dose Phase Part 2 - Open-Label, Expansion Phase to enroll additional patients in DMC-cleared dose levels by sequential assignment against a pre-defined randomized list
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04119687
Sponsor's protocol ID
FX201-2019-001
Status last verified
Sep 2026
First submitted
3 Oct 2019
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Mehta S, He T, Bajpayee AG. Recent advances in targeted drug delivery for treatment of osteoarthritis. Curr Opin Rheumatol. 2021 Jan;33(1):94-109. doi: 10.1097/BOR.0000000000000761.

    PubMed 33229973

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FX201 in people with Osteoarthritis, Knee, run by Pacira Pharmaceuticals, Inc at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome Measure: Incidence of treatment emergent adverse events after a single intra-articular (IA) injection of FX201 (safety and tolerability) (time frame: Baseline to Week 104). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04119687, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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