Safety Study of a Long-Acting Injectable Steroid to Treat Knee Osteoarthritis (STEPUP)
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
EP-104IAR
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring osteoarthritis, knee
Eligibility 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
Sites / Locations
- Rebalance MD
- Centre for Studies in Family Medicine
- Fowler Kennedy Sports Medicine Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
EP-104IAR
Vehicle
Arm Description
15mg EP-104IAR in 4 mL carrier fluid
4 mL carrier fluid
Outcomes
Primary Outcome Measures
Peak Plasma Concentration (Cmax) of fluticasone propionate
Fluticasone propionate concentrations in synovial fluid
Area under the plasma concentration versus time curve (AUC) of fluticasone propionate
Incidence of treatment-emergent adverse events
Change from baseline in clinical laboratory parameters: hematology, chemistry (including cortisol) and urinalysis
Secondary Outcome Measures
Time to baseline pain in patient-reported Pain Numerical Rating Scale for Index knee
Change from baseline in patient-reported Pain Numerical Rating Scale for Index knee
Change from baseline in patient-reported Global Assessment of Arthritis
Change from baseline in patient-reported Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Change from baseline in patient-reported Short Form - 36 quality of life scores
Change from baseline in Physician's Global Assessment of Arthritis
Full Information
NCT ID
NCT02609126
First Posted
November 17, 2015
Last Updated
August 30, 2021
Sponsor
Eupraxia Pharmaceuticals Inc.
Collaborators
Syreon Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02609126
Brief Title
Safety Study of a Long-Acting Injectable Steroid to Treat Knee Osteoarthritis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
December 28, 2017 (Actual)
Study Completion Date
December 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eupraxia Pharmaceuticals Inc.
Collaborators
Syreon Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
osteoarthritis, knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EP-104IAR
Arm Type
Experimental
Arm Description
15mg EP-104IAR in 4 mL carrier fluid
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
4 mL carrier fluid
Intervention Type
Drug
Intervention Name(s)
EP-104IAR
Intervention Description
Single, ultrasound-guided injection of EP-104IAR into the knee
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Single, ultrasound-guided injection of vehicle placebo into the knee
Primary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax) of fluticasone propionate
Time Frame
Up to 42 weeks
Title
Fluticasone propionate concentrations in synovial fluid
Time Frame
Up to 30 weeks
Title
Area under the plasma concentration versus time curve (AUC) of fluticasone propionate
Time Frame
12 weeks
Title
Incidence of treatment-emergent adverse events
Time Frame
Up to 42 weeks
Title
Change from baseline in clinical laboratory parameters: hematology, chemistry (including cortisol) and urinalysis
Time Frame
Up to 42 weeks
Secondary Outcome Measure Information:
Title
Time to baseline pain in patient-reported Pain Numerical Rating Scale for Index knee
Time Frame
Weekly up to 42 weeks
Title
Change from baseline in patient-reported Pain Numerical Rating Scale for Index knee
Time Frame
Weekly up to 42 weeks
Title
Change from baseline in patient-reported Global Assessment of Arthritis
Time Frame
Up to 42 weeks
Title
Change from baseline in patient-reported Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame
Up to 42 weeks
Title
Change from baseline in patient-reported Short Form - 36 quality of life scores
Time Frame
Up to 42 weeks
Title
Change from baseline in Physician's Global Assessment of Arthritis
Time Frame
Up to 42 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Helliwell, MD FRCPC
Organizational Affiliation
Eupraxia Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Rebalance MD
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Centre for Studies in Family Medicine
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada
Facility Name
Fowler Kennedy Sports Medicine Clinic
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Safety Study of a Long-Acting Injectable Steroid to Treat Knee Osteoarthritis
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