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

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04120402
• Other study ID #: EP-104IAR-201
• Status: Completed
• Phase: Phase 2
• Start date: September 10, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: Eupraxia Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: June 1, 2023
• Est. primary completion date: May 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• EP-104IAR 25 mg
Single 5 mL intra-articular injection
• Vehicle
Single 5 mL intra-articular injection

Locations

Country	Name	City	State
Czechia	CCR Brno, s.r.o	Brno
Czechia	CCR Czech a.s	Pardubice
Czechia	CCR Prague, s.r.o	Prague
Denmark	The Parker Institute, Frederiksberg Hospital	Frederiksberg
Denmark	Sanos Clinic Nordjylland	Gandrup
Denmark	Sanos Clinic Herlev	Herlev
Denmark	Sanos Clinic Syddanmark	Vejle
Poland	NZOZ BIF-MED s.c	Bytom
Poland	Somed CR	Lódz
Poland	Medyczne Centrum Hetmanska	Poznan
Poland	DC-MED	Swidnica
Poland	Somed CR	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Eupraxia Pharmaceuticals Inc.	NBCD A/S

Countries where clinical trial is conducted

Czechia,  Denmark,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 weeks
Secondary	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)	12 weeks
Secondary	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).	12 weeks
Secondary	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).	24 weeks
Secondary	Difference between EP-104IAR and vehicle in OMERACT-OARSI strict responders	OMERACT-OARSI = Outcome Measures in Rheumatology-Osteoarthritis Research Society International	12 weeks