Clinical trial NCT04120402: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Lead sponsor: Eupraxia Pharmaceuticals Inc.
Sponsor class: INDUSTRY
Collaborators: name: NBCD A/S
First posted: 2019-10-09
Enrollment: 318
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized to received either EP-104IAR or placebo (vehicle) in a parallel group fashion.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Pain Subscale
timeFrame: 12 weeks
Secondary outcomes:
measure: Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Function Subscale
timeFrame: 12 weeks
measure: Difference Between EP-104IAR and Vehicle in the Area Under the Curve (AUC) of WOMAC Pain Subscale
timeFrame: 12 weeks
measure: Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Pain Subscale
timeFrame: 24 weeks
measure: Difference Between EP-104IAR and Vehicle in OMERACT-OARSI Strict Responders
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: CCR Brno, s.r.o
city: Pardubice
country: Czechia
facility: CCR Czech a.s
city: Prague
country: Czechia
facility: CCR Prague, s.r.o
city: Frederiksberg
country: Denmark
facility: The Parker Institute, Frederiksberg Hospital
city: Gandrup
country: Denmark
facility: Sanos Clinic Nordjylland
city: Herlev
country: Denmark
facility: Sanos Clinic Herlev
city: Vejle
country: Denmark
facility: Sanos Clinic Syddanmark
city: Bytom
country: Poland
facility: NZOZ BIF-MED s.c
city: Poznań
country: Poland
facility: Medyczne Centrum Hetmańska
city: Warsaw
country: Poland
facility: Somed CR
city: Łódź
country: Poland
facility: Somed CR
city: Świdnica
country: Poland
facility: DC-MED
Study officials:
affiliation: Eupraxia Pharmaceuticals
name: Amanda Malone
role: STUDY_DIRECTOR
References: