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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
EP-104IAR 25 mg
Vehicle
Sponsored by
Eupraxia Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • 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 Criteria:

  • 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

Sites / Locations

  • CCR Brno, s.r.o
  • CCR Czech a.s
  • CCR Prague, s.r.o
  • The Parker Institute, Frederiksberg Hospital
  • Sanos Clinic Nordjylland
  • Sanos Clinic Herlev
  • Sanos Clinic Syddanmark
  • NZOZ BIF-MED s.c
  • Medyczne Centrum Hetmańska
  • Somed CR
  • Somed CR
  • DC-MED

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EP-104IAR 25 mg

Placebo (vehicle)

Arm Description

A single use intra-articular injection containing 25 mg of EP-104IAR

A single use intra-articular injection containing no active ingredients

Outcomes

Primary Outcome Measures

Difference in change from baseline between EP-104IAR and vehicle in WOMAC Pain subscale
WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index. Pain subscale includes 5 questions related to the pain of osteoarthritis (score range 0-20).

Secondary Outcome Measures

Difference in change from baseline between EP-104IAR and vehicle in WOMAC Function subscale
WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index. Function subscale includes 17 questions related to the physical functioning of osteoarthritis e.g. stair use, standing, walking etc. (score range 0-68)
Difference between EP-104IAR and vehicle in the area under the curve (AUC) of WOMAC Pain subscale
WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index. Pain subscale includes 5 questions related to the pain of osteoarthritis (score range 0-20).
Difference in change from baseline between EP-104IAR and vehicle in WOMAC Pain subscale
WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index. Pain subscale includes 5 questions related to the pain of osteoarthritis (score range 0-20).
Difference between EP-104IAR and vehicle in OMERACT-OARSI strict responders
OMERACT-OARSI = Outcome Measures in Rheumatology-Osteoarthritis Research Society International

Full Information

First Posted
October 7, 2019
Last Updated
June 6, 2023
Sponsor
Eupraxia Pharmaceuticals Inc.
Collaborators
NBCD A/S
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1. Study Identification

Unique Protocol Identification Number
NCT04120402
Brief Title
Study to Evaluate the Efficacy and Safety of EP-104IAR in Patients With Osteoarthritis of the Knee
Official Title
A Phase 2, Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety, Efficacy and Pharmacokinetics of Single Dose EP-104IAR for 24 Weeks in Patients With Osteoarthritis of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
May 17, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eupraxia Pharmaceuticals Inc.
Collaborators
NBCD A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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 screening and baseline assessments to determine eligibility, each participant will receive a single IA injection of either EP-104IAR or placebo (vehicle). Participants will be followed up for 24 weeks following the injection for safety, PK and efficacy assessments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized to received either EP-104IAR or placebo (vehicle) in a parallel group fashion.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
318 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EP-104IAR 25 mg
Arm Type
Experimental
Arm Description
A single use intra-articular injection containing 25 mg of EP-104IAR
Arm Title
Placebo (vehicle)
Arm Type
Placebo Comparator
Arm Description
A single use intra-articular injection containing no active ingredients
Intervention Type
Drug
Intervention Name(s)
EP-104IAR 25 mg
Intervention Description
Single 5 mL intra-articular injection
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Single 5 mL intra-articular injection
Primary Outcome Measure Information:
Title
Difference in change from baseline between EP-104IAR and vehicle in WOMAC Pain subscale
Description
WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index. Pain subscale includes 5 questions related to the pain of osteoarthritis (score range 0-20).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Difference in change from baseline between EP-104IAR and vehicle in WOMAC Function subscale
Description
WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index. Function subscale includes 17 questions related to the physical functioning of osteoarthritis e.g. stair use, standing, walking etc. (score range 0-68)
Time Frame
12 weeks
Title
Difference between EP-104IAR and vehicle in the area under the curve (AUC) of WOMAC Pain subscale
Description
WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index. Pain subscale includes 5 questions related to the pain of osteoarthritis (score range 0-20).
Time Frame
12 weeks
Title
Difference in change from baseline between EP-104IAR and vehicle in WOMAC Pain subscale
Description
WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index. Pain subscale includes 5 questions related to the pain of osteoarthritis (score range 0-20).
Time Frame
24 weeks
Title
Difference between EP-104IAR and vehicle in OMERACT-OARSI strict responders
Description
OMERACT-OARSI = Outcome Measures in Rheumatology-Osteoarthritis Research Society International
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Malone
Organizational Affiliation
Eupraxia Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
CCR Brno, s.r.o
City
Brno
Country
Czechia
Facility Name
CCR Czech a.s
City
Pardubice
Country
Czechia
Facility Name
CCR Prague, s.r.o
City
Prague
Country
Czechia
Facility Name
The Parker Institute, Frederiksberg Hospital
City
Frederiksberg
Country
Denmark
Facility Name
Sanos Clinic Nordjylland
City
Gandrup
Country
Denmark
Facility Name
Sanos Clinic Herlev
City
Herlev
Country
Denmark
Facility Name
Sanos Clinic Syddanmark
City
Vejle
Country
Denmark
Facility Name
NZOZ BIF-MED s.c
City
Bytom
Country
Poland
Facility Name
Medyczne Centrum Hetmańska
City
Poznań
Country
Poland
Facility Name
Somed CR
City
Warsaw
Country
Poland
Facility Name
Somed CR
City
Łódź
Country
Poland
Facility Name
DC-MED
City
Świdnica
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

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

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