A Multicenter, Randomized, Double-blinded, Placebo-controlled, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of E1K After Single Dose in Patients With Knee Osteoarthritis

Ensol Bioscience1 site in 1 country120 target enrollmentJune 13, 2022

ConditionsOsteoarthrosis

InterventionsE1K 1,200 ㎍/joint E1K 2,400 ㎍/joint placebo

DrugsE1K 1,200 ㎍/joint E1K 2,400 ㎍/joint placebo

Overview

Phase: Phase 2
Intervention: E1K 1,200 ㎍/joint
Conditions: Osteoarthrosis
Sponsor: Ensol Bioscience
Enrollment: 120
Locations: 1
Primary Endpoint: WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the efficacy and safety of pain relief treatment on knee osteoarthritis when administered E1K or placebo in patients with knee osteoarthritis aged 40 to 70 to determine the optimal dose.

Registry

clinicaltrials.gov

Start Date

June 13, 2022

End Date

November 29, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ensol Bioscience

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female adult, who is 40 years\~70 years of age(inclusive of both age) at the date of consent
•Subject who diagnosed knee osteoarthritis according to ACR criteria at screening visit, having pain in the knee and osteophyte formation in the X-ray, and one or more criteria as follows :
•Aged \>50
•Morning stiffness \< 30 minutes
•Crepitus on knee motion
•Prior to administration of IP, Subject with 50mm\~70mm of 100mm Pain Visual Analog Scale (VAS) during activity of the knee of osteoarthritis(target lesion).
•Subject with Grade 2 or Grade 3 on the knee osteoarthritis(target lesion) by Kellgren \& Lawrence radiographic grading system
•Subject who has pain on the knee osteoarthritis at least for 6 months before screening visit.
•Subject who agrees not to use rescue medication within 48-hour of regular visit date.
•Subject who agrees not to have ancillary physiotherapy

Exclusion Criteria

•Subject who has secondary knee osteoarthritis such as inflammatory or infectious joint disease or rheumatoid arthritis.
•Subject who has surgical history(ex. knee replacement surgery) on the knee osteoarthritis lesion(target lesion).
•Subject who has conditions that can affect the joints(gout, recurrent caustic gout, joint fracture, primary osteochondrosis, Paget's disease, ochronosis, acromegaly, hematochromatosis, Wilson's disease, genetic disease(ex: hyperkinesia) and collagen gene related disorders.
•Subject whose BMI greater than or equal to 30kg/m2 at screening.
•Subject who is applicable to the followings prior to first day of IP administration.
•Intra-articular injected hyaluronic acid, cell therapy and gene therapy within 6 months prior to IP administration
•Intra-articular injected steroids into the knee osteoarthritis lesion(target lesion) within 3 months prior to IP administration
•Administered NSAIDs or glucosamine, chondroitin sulfate, oral steroid within 14 days prior to IP administration.
•Administered analgesics within 1 days prior to IP administration
•Subject who has a psychological disorder(alcohol or drug addiction) and is judged by the investigator to have problems with the safety of the subject or to cause confusion in the interpretation of clinical trial results

Arms & Interventions

E1K 1,200 ㎍/joint

Injected 1,200 ㎍/joint/3 mL on target lesion

Intervention: E1K 1,200 ㎍/joint

E1K 2,400 ㎍/joint

Injected 2,400 ㎍/joint/3 mL on target lesion

Intervention: E1K 2,400 ㎍/joint

Placebo

Injected 3ml of saline on target lesion

Intervention: placebo

Outcomes

Primary Outcomes

WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index)

Time Frame: 12 weeks after administration of IP versus baseline

Changes in the Sub-Scale(Pain) score of the WOMAC questionnaire

Secondary Outcomes

WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index)(at 4 to 8 weeks after administration of IP compared to the baseline)
KOOS(at 4, 8, and 12 weeks after administration of IP compared to baseline)
Frequency of Rescue drug(Day 0 to Day 84)
Quality of life(EQ-5D-5L)(at 4, 8, and 12 weeks after administration of IP compared to baseline)
Pain VAS 100mm(at 4, 8, and 12 weeks after administration of IP versus baseline)