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

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ClinicalTrials.gov Identifier: NCT04119687
Recruitment Status : Not yet recruiting
First Posted : October 8, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Flexion Therapeutics, Inc.

Brief Summary:
The 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 or 3. 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Biological: FX201 Phase 1

Detailed Description:

The 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 or 3. A maximum of 24 patients will be enrolled (range 15 to 24).

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.

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). Only after the current dose level has been judged to be safe by the DMC will dose escalation to the next dosing cohort occur.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Open-Label, Single Ascending Dose
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Single Ascending Dose Study to Assess the Safety and Tolerability of FX201 in Patients With Osteoarthritis of the Knee
Estimated Study Start Date : December 31, 2019
Estimated Primary Completion Date : August 3, 2021
Estimated Study Completion Date : August 3, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Low Dose FX201
Single low dose FX201 injection
Biological: FX201
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.

Experimental: Mid Dose FX201
Single mid dose FX201 injection
Biological: FX201
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.

Experimental: High Dose FX201
Single high dose FX201 injection
Biological: FX201
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.




Primary Outcome Measures :
  1. 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 52 ]
    Incidence of treatment emergent adverse events after a single intra-articular (IA) injection of FX201


Secondary Outcome Measures :
  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 [ Time Frame: Baseline, Day 1, Day 2, Week 1, Week 2, Week 3, Week 4 ]
    The percentage of patients positive for FX201 at select timepoints



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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) at the index joint at the screening visit
  • Moderate pain in the index joint
  • Failed at least one documented conservative therapy (e.g., structured exercise program, topical anti-inflammatory therapy or oral anti-inflammatory therapy)
  • Sexually active females and males agree to use highly effective methods of contraception

Exclusion Criteria:

  • 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
  • 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
  • Any ECG abnormality 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
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119687


Contacts
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Contact: Diane Orino (781)-305-7526 dorino@flexiontherapeutics.com
Contact: Margaret Szerszunowicz (781)-305-7515 mszerszunowicz@flexiontherapeutics.com

Sponsors and Collaborators
Flexion Therapeutics, Inc.
Investigators
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Study Director: Scott Kelley, MD Flexion Therapeutics, Inc.

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Responsible Party: Flexion Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04119687     History of Changes
Other Study ID Numbers: FX201-2019-001
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases