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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02609126

Acronym

STEPUP

Enrollment

Registered

2015-11-20

Start date

2016-04-30

Completion date

2017-12-28

Last updated

2021-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis, knee

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.

Interventions

DRUGEP-104IAR

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

DRUGVehicle

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

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 Physician's Global Assessment of Arthritis	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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026