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Status:

COMPLETED

Study to Evaluate the Efficacy and Safety of EP-104IAR in Patients With Osteoarthritis of the Knee

Lead Sponsor:

Eupraxia Pharmaceuticals Inc.

Collaborating Sponsors:

NBCD A/S

Conditions:

Osteoarthritis, Knee

Eligibility:

All Genders

40+ years

Phase:

PHASE2

Brief Summary

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics (PK) of EP-104IAR in patients with osteoarthritis (OA) of the knee

Detailed Description

This is a randomized, double-blind, placebo-controlled, single injection, 24-week study to evaluate the safety, efficacy and PK of EP-104IAR in subjects with osteoarthritis knee pain Following screen...

Eligibility Criteria

Inclusion

  • Key
  • Males or females, aged ≥40 years
  • Body Mass Index (BMI) ≤ 40.0 kg/m2
  • Diagnosis of primary OA of the Index knee, with symptoms present for at least 6 months
  • OA severity Grade 2 or 3 (based on Kellgren Lawrence Grading Scale)
  • Unsatisfactory pain relief from at least 2 prior standard OA treatments
  • Qualifying pain in the Index knee during the baseline period
  • Ambulatory (without the need for a cane/other walking aide)
  • Female subjects willing to use highly effective birth control methods to prevent pregnancy
  • Willing and able to comply with study procedures and restrictions, including abstaining from use of restricted medications.
  • Key

Exclusion

  • OA of the Index knee due to acute injury or trauma, or unstable joint
  • X-ray evidence of chondrocalcinosis
  • Diagnosed or suspected ipsilateral hip OA
  • Knee pain that is not attributable to OA of the knee
  • Any other disorders that impact mobility, strength or sensation, or are a co-existent source of pain or inflammation that interfere with assessment of knee pain and function
  • History of infection in the Index knee
  • Skin breakdown on the Index knee where the injection will take place
  • Total Knee Replacement, or any other surgery (including arthroscopy) for the Index knee within prior 12 months, or planned surgery during the study
  • Total Knee Replacement Surgery of the non-Index knee within prior 6 months, or planned surgery (any location) during the study that would require a restricted medication
  • IA injection of corticosteroids in any joint within prior 3 months or IA injection of extended-release corticosteroids in any joint within prior 6 months
  • IA injection in the Index knee of platelet rich plasma, or other prolotherapy within prior 3 months, or hyaluronic acid within prior 6 months
  • Recent, current or planned use of corticosteroids for any indication (except for permitted uses)
  • Recent, current or planned use of prohibited medications (including analgesics, marijuana, investigational drugs and devices, immunosuppressive therapy), or unwilling or unable to stop using prohibited medications during the study.
  • Conditions including: sarcoidosis, amyloidosis, osteomyelitis, Cushing's Syndrome, hepatic or renal disease, Psychotic disorder, bipolar disorder, symptomatic depressive or anxiety disorders.
  • Current malignancy of any type, or history of a malignancy within prior 12 months
  • Active or quiescent systemic fungal, bacterial (including tuberculosis) viral (including HIV, Hepatitis B or C) or parasitic infections, or ocular herpes simplex, or any recent infection requiring IV or oral antibiotics
  • Laboratory results indicative of adrenal insufficiency, diabetes or renal or hepatic disease.
  • Positive urine drug screen for a substance of abuse
  • Females who are pregnant, lactating
  • Known or suspected hypersensitivity or contraindication to ingredients in the study drug

Key Trial Info

Start Date :

September 10 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2023

Estimated Enrollment :

318 Patients enrolled

Trial Details

Trial ID

NCT04120402

Start Date

September 10 2021

End Date

June 1 2023

Last Update

June 25 2024

Active Locations (12)

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Page 1 of 3 (12 locations)

1

CCR Brno, s.r.o

Brno, Czechia

2

CCR Czech a.s

Pardubice, Czechia

3

CCR Prague, s.r.o

Prague, Czechia

4

The Parker Institute, Frederiksberg Hospital

Frederiksberg, Denmark