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

Osteoarthritis, Knee Clinical Trial

— STEPUP  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02609126
• Other study ID #: EP-104IAR-101
• Status: Completed
• Phase: Phase 1
• Start date: April 2016
• Est. completion date: December 28, 2017

Study information

• Verified date: August 2021
• Source: Eupraxia Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 28, 2017
• Est. primary completion date: December 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• EP-104IAR
Single, ultrasound-guided injection of EP-104IAR into the knee
• Vehicle
Single, ultrasound-guided injection of vehicle placebo into the knee

Locations

Country	Name	City	State
Canada	Centre for Studies in Family Medicine	London	Ontario
Canada	Fowler Kennedy Sports Medicine Clinic	London	Ontario
Canada	Rebalance MD	Victoria	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Eupraxia Pharmaceuticals Inc.	Syreon Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax) of fluticasone propionate		Up to 42 weeks
Primary	Fluticasone propionate concentrations in synovial fluid		Up to 30 weeks
Primary	Area under the plasma concentration versus time curve (AUC) of fluticasone propionate		12 weeks
Primary	Incidence of treatment-emergent adverse events		Up to 42 weeks
Primary	Change from baseline in clinical laboratory parameters: hematology, chemistry (including cortisol) and urinalysis		Up to 42 weeks
Secondary	Time to baseline pain in patient-reported Pain Numerical Rating Scale for Index knee		Weekly up to 42 weeks
Secondary	Change from baseline in patient-reported Pain Numerical Rating Scale for Index knee		Weekly up to 42 weeks
Secondary	Change from baseline in patient-reported Global Assessment of Arthritis		Up to 42 weeks
Secondary	Change from baseline in patient-reported Western Ontario and McMaster Universities Arthritis Index (WOMAC)		Up to 42 weeks
Secondary	Change from baseline in patient-reported Short Form - 36 quality of life scores		Up to 42 weeks
Secondary	Change from baseline in Physician's Global Assessment of Arthritis		Up to 42 weeks