Clinical trial NCT03793010: Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Osteoarthritis, Hip
Keywords: Osteoarthritis
Hip
Pain
Intra-articular
Injection
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2019-01-04
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-blind, Placebo-controlled, Parallel-group
Primary purpose: TREATMENT

Brief summary: This is a two-part, multi-center, randomized, double-blind, placebo-controlled, parallel-group study in patients with hip OA. Approximately 70 patients will be enrolled in Part I and approximately 440 patients will be enrolled in Part II of the study. In each part, 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.

Detailed description: This is a two-part, multi-center, randomized, double-blind, placebo-controlled, parallel-group study in patients with hip OA. Approximately 70 patients will be enrolled in Part I and approximately 440 patients will be enrolled in Part II of the study. In each part, 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 participating in Part I of the study will be treated with a single IA injection of either 32 mg FX006 or normal saline and will return for follow up visits at Weeks 12, 16, 20, and 24. The patients will be discontinued at the time of notification by the Investigator.

Patients participating in Part II of the study will be treated with a single IA injection of either 32 mg FX006 or normal saline and will return for follow up visits at Weeks 12, 16, 20, and 24.

Patients participating in Part II of the study that 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 participating in Part II of the study 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.

Eligibility 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

Primary outcomes:
measure: Change in WOMAC A (Pain) Score at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change in WOMAC C (Function) Score at Week 12
timeFrame: Baseline and Week 12
measure: PGIC Score at Week 12
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: El Cajon
country: United States
facility: TriWest Research Associates, LLC
state: California
city: La Mesa
country: United States
facility: BioSolutions Clinical Research Center
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Denver
country: United States
facility: Mountain View Clinical Research, Inc.
state: Colorado
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: DeLand
country: United States
facility: Florida Research Associates, LLC
state: Florida
city: Naples
country: United States
facility: Advanced Research for Health Improvement
state: Florida
city: Naples
country: United States
facility: Medallion Clinical Research Institute, LLC
state: Florida
city: Oviedo
country: United States
facility: Oviedo Medical Research
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research, LLC
state: Florida
city: Winter Park
country: United States
facility: National Pain Research Institute
state: Florida
city: Newnan
country: United States
facility: Better Health Clinical Research, Inc
state: Georgia
city: Boise
country: United States
facility: Injury Care Research, LLC
state: Idaho
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Newton
country: United States
facility: Heartland Research Associates
state: Kansas
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: Raleigh
country: United States
facility: M3 Wake Research, Inc.
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Altoona
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research, LLC
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Danville
country: United States
facility: Spectrum Medical, Inc.
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Pacira Pharmaceuticals, Inc
name: Scott Kelley, MD
role: STUDY_DIRECTOR
References: