Pharmacokinetic and Pharmacodynamic Study of FX006 in Patients With Osteoarthritis of the Knee

NCT01487200 | Completed Phase 2 Results

• 1 other identifier: FX006-2011-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study was to evaluate the safety, pharmacokinetics and pharmacodynamics of FX006 in patients with osteoarthritis of the knee.

Conditions

Osteoarthritis of the Knee

Keywords

osteoarthritis; knee; corticosteroid; intra-articular; injection

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in 24-hour Weighted Mean Serum Cortisol

  The primary pharmacodynamic endpoint was change from baseline (pre-dose) to Day 1-2, Day 14-15 (Week 2) and Day 42-43 (Week 6) in 24-hour weighted mean serum cortisol. This is defined as AUC over the 0-24 hour measurement period divided by 24

  Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)

• Characterize the Pharmacokinetic Profile of FX006 and TCA IR

  Concentrations below the limit of quantification of 50 pg/mL were treated as 0.

  Day 1 (1, 2, 4, 6, 8, 12 and 24 hours post dose) and Days 3, 4, 5, 8, 15, 22, 29, 36 and 43

Secondary Outcomes (3)

• Change From Baseline in 24-hour Urinary Free Cortisol Excretion

  Baseline to Days 1-2, Baseline to Days 14-15 (Week 2) and Baseline to Days 42-43 (Week 6)

• Total 24-hour Urinary Free Cortisol Excretion

  Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)

• Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol

  Baseline to Days 2, 3, 4, 5, 8, 14, 15, 22, 29, 36, 42 and 43

Study Arms (4)

FX006 10mg

EXPERIMENTAL

Single 3 mL intra-articular (IA) injection Extended-release formulation

Drug: FX006 10 mg

FX006 40mg

EXPERIMENTAL

Single 3 mL intra-articular (IA) injection Extended-release formulation

Drug: FX006 40 mg

FX006 60 mg

EXPERIMENTAL

Single 3 mL intra-articular (IA) injection Extended-release formulation

Drug: FX006 60 mg

TCA IR (40 mg)

ACTIVE COMPARATOR

Single 1 mL intra-articular (IA) injection Immediate-release formulation

Drug: TCA IR 40

Interventions

FX006 10 mg DRUG

single 3 mL IA injection

FX006 10mg

FX006 40 mg DRUG

single 3 mL IA injection

FX006 40mg

FX006 60 mg DRUG

single 3 mL IA injection

FX006 60 mg

TCA IR 40 DRUG

single 1 mL IA injection

Also known as: Kenalog®-40, Kenacort-A 40, Triamcinolone Acetonide Crystalline Suspension (TAcs)

TCA IR (40 mg)

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
• Male or female \>=35 years of age
• Diagnosis of unilateral or bilateral OA of the knee for at least 6 months prior to Screening with confirmation of OA according to American College of Rheumatology Criteria for Classification of Idiopathic OA of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to Screening or during the Screening period
• Body mass index (BMI) ≤ 40 kg/m2
• Willingness to abstain from use of the protocol-specified restricted medications

You may not qualify if:

• History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
• History of arthritides due to crystals (e.g., gout, pseudogout)
• History of infection in the index joint
• Clinical signs and symptoms of active knee infection or crystal disease of the index knee
• Presence of surgical hardware or other foreign body in the index knee
• Unstable joint (such as a torn anterior cruciate ligament)
• IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
• IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
• Oral, inhaled or intranasal corticosteroids (investigational or marketed) within 1 month of Screening
• Prior arthroscopic or open surgery of the index knee within 12 months of Screening
• Planned/anticipated surgery of the index knee during the study period
• History of or active malignancy, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ within 5 years
• Insulin-dependent diabetes
• History of or active Cushing's syndrome
• Any other clinically significant acute or chronic medical conditions (e.g., uncontrolled diabetes)

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (2)

Unknown Facility

Adelaide, South Australia, 5000, Australia

Location

Unknown Facility

Perth, Western Australia, Australia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

FX006; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Scott Kelley, Chief Medical Officer
• Organization: Flexion Therapeutics

skelley@flexiontherapeutics.com

781-305-7142

Study Officials

• Neil Bodick, MD

  Flexion Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 7, 2011
• Study Start: July 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 24, 2024
• Results First Posted: December 6, 2019

Record last verified: 2024-01

Locations

AU (2)