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

Eupraxia Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Osteoarthritis, Knee

Treatments

Drug: Vehicle

Drug: EP-104IAR

Study type

Interventional

Funder types

Industry

Identifiers

NCT02609126

EP-104IAR-101

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No 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