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

NCT04120402 | Completed Phase 2 Results FDA Drug

• 1 other identifier: EP-104IAR-201
• Study Type: interventional
• Target: 318
• Locations: 3 countries
• Sites: 12

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

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Pain Subscale

  Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (scores scaled 0-10, with 10 being the worst). Least squares mean from a mixed model for repeated measures (MMRM) for change from baseline with fixed effects for site, treatment, week, treatment-by-week interaction; random effect for subject; and covariate baseline WOMAC pain score.

  12 weeks

Secondary Outcomes (4)

• Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Function Subscale

  12 weeks

• Difference Between EP-104IAR and Vehicle in the Area Under the Curve (AUC) of WOMAC Pain Subscale

  12 weeks

• Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Pain Subscale

  24 weeks

• Difference Between EP-104IAR and Vehicle in OMERACT-OARSI Strict Responders

  12 weeks

Study Arms (2)

EP-104IAR 25 mg

EXPERIMENTAL

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

Drug: EP-104IAR 25 mg

Placebo (vehicle)

PLACEBO COMPARATOR

A single use intra-articular injection containing no active ingredients

Drug: Vehicle

Interventions

EP-104IAR 25 mg DRUG

Single 5 mL intra-articular injection

EP-104IAR 25 mg

Vehicle DRUG

Single 5 mL intra-articular injection

Placebo (vehicle)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eupraxia Pharmaceuticals Inc.: lead
• NBCD A/S: collaborator

Study Sites (12)

CCR Brno, s.r.o

Brno, Czechia

Location

CCR Czech a.s

Pardubice, Czechia

Location

CCR Prague, s.r.o

Prague, Czechia

Location

The Parker Institute, Frederiksberg Hospital

Frederiksberg, Denmark

Location

Sanos Clinic Nordjylland

Gandrup, Denmark

Location

Sanos Clinic Herlev

Herlev, Denmark

Location

Sanos Clinic Syddanmark

Vejle, Denmark

Location

NZOZ BIF-MED s.c

Bytom, Poland

Location

Somed CR

Lodz, Poland

Location

Medyczne Centrum Hetmańska

Poznan, Poland

Location

DC-MED

Swidnica, Poland

Location

Somed CR

Warsaw, Poland

Location

Related Publications (1)

• Malone A, Kowalski MM, Helliwell J, Lynggaard Boll S, Rovsing H, Moriat K, Castillo Mondragon A, Li Y, Prener Miller C, Reinstrup Bihlet A, Dobek C, Peck V, Wilmink M, Simon LS, Conaghan PG. Efficacy and safety of a diffusion-based extended-release fluticasone propionate intra-articular injection (EP-104IAR) in knee osteoarthritis (SPRINGBOARD): a 24-week, multicentre, randomised, double-blind, vehicle-controlled, phase 2 trial. Lancet Rheumatol. 2024 Dec;6(12):e860-e870. doi: 10.1016/S2665-9913(24)00223-6. Epub 2024 Oct 11.

  PMID: 39401503 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: Eupraxia Pharmaceuticals Ltd.

amalone@eupraxiapharma.com

250-590-3968

Study Officials

• Amanda Malone

  Eupraxia Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to received either EP-104IAR or placebo (vehicle) in a parallel group fashion.

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 9, 2019
• Study Start: September 10, 2021
• Primary Completion: May 17, 2023
• Study Completion: June 1, 2023
• Last Updated: June 25, 2024
• Results First Posted: June 25, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (4); CZ (3); PL (5)