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Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03793010
Recruitment Status : Active, not recruiting
First Posted : January 4, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Flexion Therapeutics, Inc.

Brief Summary:
This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study in patients with hip OA. Approximately 440 patients will be randomized to one of two treatment groups (1:1) and treated with a single IA injection of either 32 mg FX006 or normal saline.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Hip Drug: FX006 Drug: Normal saline Phase 3

Detailed Description:

This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study in patients with hip OA. Approximately 440 patients will be randomized to one of two treatment groups (1:1) and treated with a single IA injection of either 32 mg FX006 or normal saline.

FX006 or saline placebo will be administered as a single IA injection with a 12-week follow-up period in the double-blind phase.

Patients eligible for the second injection in the open-label phase at Week 12 will receive an open-label injection of FX006 at Week 12 and return for follow-up visits at Weeks 16, 20, and 24. These patients will complete the study at Week 24.

Patients who are not clinically indicated for a second injection at Week 12 will return to the clinic at Weeks 16, 20, and 24 and will receive an open-label injection of FX006 at the first evaluation where the patient has been determined to meet all criteria. Patients will then return for follow-up visits every 4 weeks for 12 weeks post second injection and will complete the study 12 weeks post second injection (e.g., Week 24, 28, 32, or 36 depending on when the patient receives the open-label injection).

Patients who are not eligible for a second injection after evaluation at Weeks 12, 16, 20, and 24 will complete the study at the Week 24 visit and complete the End of Study (EOS) assessments.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Double-blind, Placebo-controlled, Parallel-group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: FX006
FX006 32mg
Drug: FX006
Single Intra-articular injection

Placebo Comparator: Normal Saline
Normal Saline
Drug: Normal saline
Single Intra-articular injection




Primary Outcome Measures :
  1. Change in WOMAC A (pain) score at Week 12 [ Time Frame: Baseline to Week 12 ]
    The change from baseline on the average Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A (pain) score at Week 12. The average WOMAC A score is calculated by taking the average of five subscales with a range from 0 (no pain) to 10 (extreme pain).


Secondary Outcome Measures :
  1. Change in WOMAC C (function) score at Week 12 [ Time Frame: Baseline to Week 12 ]
    Change from Baseline on the WOMAC C (function) score at Week 12. The average WOMAC C score is calculated by taking the average of seventeen subscales with a range from 0 (no difficulty) to 10 (extreme difficulty).

  2. PGIC score at Week 12 [ Time Frame: Baseline at Week 12 ]
    PGIC (Patient Global Impression of Change) at week 12. The PGIC score has a range from 1(very much improved) to 7 (very much worse) and indicates the overall status of the patient since baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
  • Patients 40 to 80 years of age, inclusive, on the day of randomization (Day 1)
  • Body Mass Index (BMI) ≤ 40 kg/m2
  • Symptoms associated with OA of the index hip for ≥ 3 months prior to Screening visit
  • Currently meet the American College of Radiology (ACR) Criteria (clinical and radiological) for OA of the index hip
  • Kellgren-Lawrence (KL) Grade 2 or 3 in the index hip as confirmed by X-ray during Screening visit (centrally read)
  • Qualifying mean score on the WOMAC A and C (0-10 NRS scale)
  • Agree to maintain the similar activity level throughout the study
  • Willingness to abstain from use of restricted medications

Exclusion Criteria:

  • Patients who cannot washout of prohibited medications
  • Diagnosed as secondary OA in the index hip including but not limited to articular fracture, major dysplasia or congenital abnormality, osteochondritis dissecans, acromegaly, ochronosis, hemochromatosis, Wilson's disease, or primary osteochondromatosis, etc.
  • Ipsilateral chronic knee pain
  • Sciatica
  • Atrophic osteoarthritis, femoral head necrosis and/or collapse, or subchondral bone insufficiency fracture in the index hip joint determined via central reading
  • Current or history of infection in the index hip (e.g. osteomyelitis) or current skin infection at injection site
  • Trauma or surgeries (e.g., arthroscopy, knee surgery) of lower limbs within 52 weeks with sequelae, etc.
  • History or current evidence of reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease, systemic lupus erythematosus or other autoimmune diseases
  • Any planned surgeries in the lower limbs during the study period, or any other surgery during the study period that would require use of a restricted medication
  • Presence of surgical hardware or other foreign body in the index hip
  • Planned/anticipated surgery of the index hip or any other surgery that would require use of a restricted medication during the study period
  • IA corticosteroid of any joint within 3 months of Screening visit (investigational or marketed, including FX006)
  • IA treatment of index hip with any of the following agents within 6 months of Screening: any biologic agent or hyaluronic acid (investigational or marketed)
  • IV or IM corticosteroids (investigational or marketed) within 3 months of Screening
  • Oral corticosteroids (investigational or marketed) within 1 month of Screening
  • Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening visit
  • Planned or expected changes to lifestyle with regard to physical activity, physical therapy, acupuncture, transcutaneous electrical nerve stimulation (TENS), or bracing within 1 month prior to Screening and changes throughout the duration of the study
  • Women of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year as documented in medical history) not using a highly effective method or who are pregnant or nursing

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): NCT03793010


  Show 32 Study Locations
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: NCT03793010     History of Changes
Other Study ID Numbers: FX006-2018-015
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Flexion Therapeutics, Inc.:
Osteoarthritis
Hip
Pain
Intra-articular
Injection

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases