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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 September 2021
• Main ID: NCT02609126
• Date of registration: 17/11/2015
• Prospective Registration: Yes
• Primary sponsor: Eupraxia Pharmaceuticals Inc.
• Public title: Safety Study of a Long-Acting Injectable Steroid to Treat Knee Osteoarthritis STEPUP
• Scientific 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
• Date of first enrolment: April 2016
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02609126
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Canada

Contacts

• Name: James Helliwell, MD FRCPC
• Affiliation: Eupraxia Pharmaceuticals

Key inclusion & exclusion criteria

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



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Osteoarthritis, Knee

Intervention(s)

Drug: Vehicle

Drug: EP-104IAR

Primary Outcome(s)

Fluticasone propionate concentrations in synovial fluid [Time Frame: Up to 30 weeks]

Area under the plasma concentration versus time curve (AUC) of fluticasone propionate [Time Frame: 12 weeks]

Change from baseline in clinical laboratory parameters: hematology, chemistry (including cortisol) and urinalysis [Time Frame: Up to 42 weeks]

Peak Plasma Concentration (Cmax) of fluticasone propionate [Time Frame: Up to 42 weeks]

Incidence of treatment-emergent adverse events [Time Frame: Up to 42 weeks]

Secondary Outcome(s)

Change from baseline in patient-reported Western Ontario and McMaster Universities Arthritis Index (WOMAC) [Time Frame: Up to 42 weeks]

Change from baseline in patient-reported Global Assessment of Arthritis [Time Frame: Up to 42 weeks]

Time to baseline pain in patient-reported Pain Numerical Rating Scale for Index knee [Time Frame: Weekly up to 42 weeks]

Change from baseline in patient-reported Short Form - 36 quality of life scores [Time Frame: Up to 42 weeks]

Change from baseline in patient-reported Pain Numerical Rating Scale for Index knee [Time Frame: Weekly up to 42 weeks]

Change from baseline in Physician's Global Assessment of Arthritis [Time Frame: Up to 42 weeks]

Secondary ID(s)

EP-104IAR-101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Syreon Corporation