Safety Study of a Long-Acting Injectable Steroid to Treat Knee Osteoarthritis (STEPUP)

A Randomized, Double-Blind, Placebo-Controlled, Phase I Trial Evaluating the Pharmacokinetics, Safety and Preliminary Efficacy of EP-104IAR (Long-Acting Fluticasone Propionate) in Patients With Osteoarthritis of the Knee

The main purpose of this study is to understand the pharmacokinetics of EP-104IAR and to determine whether it is safe to use in patients with osteoarthritis (OA) of the knee. The study will also provide some preliminary insights into whether the experimental treatment reduces pain in the knee.

Osteoarthritis is the most common joint disease, affecting over 20 million people in the US alone. Currently, pain treatments that are injected directly into the knee often work for only a short time and may also have side effects within the rest of the body. The experimental treatment is a steroid that is in the same family of drugs as the most common current injectable treatments for knee osteoarthritis. For this study, the drug is coated with a polymer intended to prolong the time it stays inside the knee and lessen potential side effects.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: EP-104IAR; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Victoria, British Columbia, Canada
      • Rebalance MD
  • Ontario
    • London, Ontario, Canada, N6A 3K7
      • Centre for Studies in Family Medicine
    • London, Ontario, Canada, N6A 3K7
      • Fowler Kennedy Sports Medicine Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• OA of Index Knee
• Kellgren Lawrence Grade 2 or 3
• Patient-reported pain (PtPain) of Index Knee ≥4 but ≤9
• PtPain of non-Index Knee <6
• BMI ≦ 40 kg/m2

Exclusion Criteria:

• Intra-articular joint injection in the Index Knee within the past 8 weeks for glucocorticoids and 6 months for hyaluronic acid
• Insulin-dependent diabetes
• Active infection
• Pregnant or breast feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EP-104IAR; 15mg EP-104IAR in 4 mL carrier fluid	Drug: EP-104IAR; Single, ultrasound-guided injection of EP-104IAR into the knee
Placebo Comparator: Vehicle; 4 mL carrier fluid	Drug: Vehicle; Single, ultrasound-guided injection of vehicle placebo into the knee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak Plasma Concentration (Cmax) of fluticasone propionate	Up to 42 weeks
Fluticasone propionate concentrations in synovial fluid	Up to 30 weeks
Area under the plasma concentration versus time curve (AUC) of fluticasone propionate	12 weeks
Incidence of treatment-emergent adverse events	Up to 42 weeks
Change from baseline in clinical laboratory parameters: hematology, chemistry (including cortisol) and urinalysis	Up to 42 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to baseline pain in patient-reported Pain Numerical Rating Scale for Index knee	Weekly up to 42 weeks
Change from baseline in patient-reported Pain Numerical Rating Scale for Index knee	Weekly up to 42 weeks
Change from baseline in patient-reported Global Assessment of Arthritis	Up to 42 weeks
Change from baseline in patient-reported Western Ontario and McMaster Universities Arthritis Index (WOMAC)	Up to 42 weeks
Change from baseline in patient-reported Short Form - 36 quality of life scores	Up to 42 weeks
Change from baseline in Physician's Global Assessment of Arthritis	Up to 42 weeks

Collaborators and Investigators

• Sponsor: Eupraxia Pharmaceuticals Inc.
• Collaborators: Syreon Corporation
• Investigators: Study Director: James Helliwell, MD FRCPC, Eupraxia Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): December 28, 2017
• Study Completion (Actual): December 28, 2017

Study Registration Dates

• First Submitted: November 17, 2015
• First Submitted That Met QC Criteria: November 17, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: osteoarthritis; knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: EP-104IAR-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided