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Trial record 1 of 2 for:    EP-104IAR
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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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ClinicalTrials.gov Identifier: NCT04120402
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : April 1, 2022
Sponsor:
Collaborator:
NBCD A/S
Information provided by (Responsible Party):
Eupraxia Pharmaceuticals Inc.

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

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: EP-104IAR 25 mg Drug: Vehicle Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized to received either EP-104IAR or placebo (vehicle) in a parallel group fashion.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 10, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: EP-104IAR 25 mg
A single use intra-articular injection containing 25 mg of EP-104IAR
Drug: EP-104IAR 25 mg
Single 5 mL intra-articular injection

Placebo Comparator: Placebo (vehicle)
A single use intra-articular injection containing no active ingredients
Drug: Vehicle
Single 5 mL intra-articular injection




Primary Outcome Measures :
  1. Difference in change from baseline between EP-104IAR and vehicle in WOMAC Pain subscale [ Time Frame: 12 weeks ]
    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 :
  1. Difference in change from baseline between EP-104IAR and vehicle in WOMAC Function subscale [ Time Frame: 12 weeks ]
    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)

  2. Difference between EP-104IAR and vehicle in the area under the curve (AUC) of WOMAC Pain subscale [ Time Frame: 12 weeks ]
    WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index. Pain subscale includes 5 questions related to the pain of osteoarthritis (score range 0-20).

  3. Difference in change from baseline between EP-104IAR and vehicle in WOMAC Pain subscale [ Time Frame: 24 weeks ]
    WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index. Pain subscale includes 5 questions related to the pain of osteoarthritis (score range 0-20).

  4. Difference between EP-104IAR and vehicle in OMERACT-OARSI strict responders [ Time Frame: 12 weeks ]
    OMERACT-OARSI = Outcome Measures in Rheumatology-Osteoarthritis Research Society International



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, diabeties mellitus, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04120402


Contacts
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Contact: Nicola Price 250-590-3968 nprice@eupraxiapharma.com
Contact: Asger Reinstrup Bihlet +45 7370 7900 abi@nbcd.com

Locations
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Czechia
CCR Brno, s.r.o Recruiting
Brno, Czechia
Contact: Věra Mrkvicová       vera.mrkvicova@ccrbrno.cz   
CCR Czech a.s Recruiting
Pardubice, Czechia
Contact: Lukáš Ročňák       lukas.rocnak@ccrpardubice.com   
CCR Prague, s.r.o Recruiting
Prague, Czechia
Contact: Tomas Svoboda       svob.tomas@seznam.cz   
Denmark
Sanos Clinic Nordjylland Recruiting
Gandrup, Denmark
Contact: Camilla Rose       car@sanosclinic.com   
Sanos Clinic Herlev Recruiting
Herlev, Denmark
Contact: Lone Lund Poder       llp@sanosclinic.com   
Sanos Clinic Syddanmark Recruiting
Vejle, Denmark
Contact: Helle Ewan       hew@sanosclinic.com   
Poland
Somed CR Recruiting
Warsaw, Poland
Contact: Adrianna Chromińska       adrianna.chrominska@somed.pl   
Somed CR Recruiting
Łódź, Poland
Contact: Jakub Kierzkowski       Jakub.kierzkowski@somed.pl   
Sponsors and Collaborators
Eupraxia Pharmaceuticals Inc.
NBCD A/S
Investigators
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Study Director: Amanda Malone Eupraxia Pharmaceuticals
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Responsible Party: Eupraxia Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT04120402    
Other Study ID Numbers: EP-104IAR-201
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: April 1, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases