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Completed

NCT Number: NCT02609126

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rebalance MD, Victoria, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EP-104IAR

Drug

Single, ultrasound-guided injection of EP-104IAR into the knee

Vehicle

Drug

Single, ultrasound-guided injection of vehicle placebo into the knee

Primary outcomes

  1. Peak Plasma Concentration (Cmax) of fluticasone propionate

    Time frame: Up to 42 weeks

  2. Fluticasone propionate concentrations in synovial fluid

    Time frame: Up to 30 weeks

  3. Area under the plasma concentration versus time curve (AUC) of fluticasone propionate

    Time frame: 12 weeks

  4. Incidence of treatment-emergent adverse events

    Time frame: Up to 42 weeks

  5. Change from baseline in clinical laboratory parameters: hematology, chemistry (including cortisol) and urinalysis

    Time frame: Up to 42 weeks

Secondary outcomes

  1. Time to baseline pain in patient-reported Pain Numerical Rating Scale for Index knee

    Time frame: Weekly up to 42 weeks

  2. Change from baseline in patient-reported Pain Numerical Rating Scale for Index knee

    Time frame: Weekly up to 42 weeks

  3. Change from baseline in patient-reported Global Assessment of Arthritis

    Time frame: Up to 42 weeks

  4. Change from baseline in patient-reported Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    Time frame: Up to 42 weeks

  5. Change from baseline in patient-reported Short Form - 36 quality of life scores

    Time frame: Up to 42 weeks

  6. Change from baseline in Physician's Global Assessment of Arthritis

    Time frame: Up to 42 weeks

Sponsors and collaborators

Lead sponsor

Eupraxia Pharmaceuticals Inc.

Industry

Collaborators

  • Syreon Corporation

Registry information

Official study title

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

Acronym: STEPUP

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 20, 2015
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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