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Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of E1K After Single Dose in Patients With Knee Osteoarthritis

Primary Purpose

Osteoarthrosis

Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
E1K 1,200 ㎍/joint
E1K 2,400 ㎍/joint
placebo
Sponsored by
Ensol Bioscience
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthrosis

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 One-sided knee osteoarthritis subject or both-sided knee osteoarthritis subject who can designate the Target Lesion to one side, according to the follow criteria. Designate the one with a higher 100 mm Pain Visual Analog Scale (VAS) than another, as the target lesion. If 100 mm Pain Visual Analog Scale (VAS) is the same, designate the one with a higher Kellgren & Lawrence Grade than another, as the target lesion. If both 100 mm Pain Visual Analog Scale (VAS) and Kellgren & Lawrence Grade are the same, designate the one that causes more clinical symptoms other than pain. If above criteria are all the same, designate the right knee as the target lesion. Subject who has voluntarily written informed consent for study participation. 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 Subject who has osteoarthritis on the other sites not knee(ex. Hip joint) or has pain due to other disorder so that the investigator determined not suitable for participation of the clinical trial. Subject who has uncontrolled type 1 or type 2 diabete mellitus at screening visit(Glycated Hemoglobin (HbA1c) > 8%) Subject has a positive test result for HIV antibody or hepatitis B antigen, hepatitis C antibody. Subject who has malignant tumor history within 5 year prior to screening visit. Subject who is participated in other clinical trials within 30 days prior to screening. As a result of screening examination(laboratory or ECG, vital sign), subject who has clinically significant findings that are not suitable for participation in the clinical trials. Subject who is pregnant or breastfeeding Subject who does not agree to use a medically acceptable method of contraception during clinical trial. Besides, in case investigator determine that subject is unsuitable for study participation.

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

E1K 1,200 ㎍/joint

E1K 2,400 ㎍/joint

Placebo

Arm Description

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

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

Injected 3ml of saline on target lesion

Outcomes

Primary Outcome Measures

WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index)
Changes in the Sub-Scale(Pain) score of the WOMAC questionnaire

Secondary Outcome Measures

Pain VAS 100mm
Changes in 100 mm Pain VAS (Pain during activity and at rest during the last 24 hours) scores
WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index)
Changes in scores by WOMAC questionnaire total score and Sub-Scale (physical function, stiffness)
WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index)
Changes in the Sub-Scale(Pain) score of the WOMAC questionnaire
KOOS
Changes in KOOS questionnaire scores
Quality of life(EQ-5D-5L)
Changes in EQ-5D-5L questionnaire scores
Frequency of Rescue drug
Percentage and number of subjects who took the rescue medication during the clinical trial period

Full Information

First Posted
January 15, 2023
Last Updated
January 15, 2023
Sponsor
Ensol Bioscience
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1. Study Identification

Unique Protocol Identification Number
NCT05697952
Brief Title
Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of E1K After Single Dose in Patients With Knee Osteoarthritis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ensol Bioscience

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
E1K 1,200 ㎍/joint
Arm Type
Experimental
Arm Description
Injected 1,200 ㎍/joint/3 mL on target lesion
Arm Title
E1K 2,400 ㎍/joint
Arm Type
Experimental
Arm Description
Injected 2,400 ㎍/joint/3 mL on target lesion
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Injected 3ml of saline on target lesion
Intervention Type
Drug
Intervention Name(s)
E1K 1,200 ㎍/joint
Intervention Description
Injection of E1K 1,200 ㎍/joint/ml on target lesion
Intervention Type
Drug
Intervention Name(s)
E1K 2,400 ㎍/joint
Intervention Description
Injection of E1K 2,400 ㎍/joint/ml on target lesion
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Injection of 3ml saline on target lesion
Primary Outcome Measure Information:
Title
WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index)
Description
Changes in the Sub-Scale(Pain) score of the WOMAC questionnaire
Time Frame
12 weeks after administration of IP versus baseline
Secondary Outcome Measure Information:
Title
Pain VAS 100mm
Description
Changes in 100 mm Pain VAS (Pain during activity and at rest during the last 24 hours) scores
Time Frame
at 4, 8, and 12 weeks after administration of IP versus baseline
Title
WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index)
Description
Changes in scores by WOMAC questionnaire total score and Sub-Scale (physical function, stiffness)
Time Frame
at 4, 8, and 12 weeks after IP administration compared to baseline
Title
WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index)
Description
Changes in the Sub-Scale(Pain) score of the WOMAC questionnaire
Time Frame
at 4 to 8 weeks after administration of IP compared to the baseline
Title
KOOS
Description
Changes in KOOS questionnaire scores
Time Frame
at 4, 8, and 12 weeks after administration of IP compared to baseline
Title
Quality of life(EQ-5D-5L)
Description
Changes in EQ-5D-5L questionnaire scores
Time Frame
at 4, 8, and 12 weeks after administration of IP compared to baseline
Title
Frequency of Rescue drug
Description
Percentage and number of subjects who took the rescue medication during the clinical trial period
Time Frame
Day 0 to Day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 One-sided knee osteoarthritis subject or both-sided knee osteoarthritis subject who can designate the Target Lesion to one side, according to the follow criteria. Designate the one with a higher 100 mm Pain Visual Analog Scale (VAS) than another, as the target lesion. If 100 mm Pain Visual Analog Scale (VAS) is the same, designate the one with a higher Kellgren & Lawrence Grade than another, as the target lesion. If both 100 mm Pain Visual Analog Scale (VAS) and Kellgren & Lawrence Grade are the same, designate the one that causes more clinical symptoms other than pain. If above criteria are all the same, designate the right knee as the target lesion. Subject who has voluntarily written informed consent for study participation. 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 Subject who has osteoarthritis on the other sites not knee(ex. Hip joint) or has pain due to other disorder so that the investigator determined not suitable for participation of the clinical trial. Subject who has uncontrolled type 1 or type 2 diabete mellitus at screening visit(Glycated Hemoglobin (HbA1c) > 8%) Subject has a positive test result for HIV antibody or hepatitis B antigen, hepatitis C antibody. Subject who has malignant tumor history within 5 year prior to screening visit. Subject who is participated in other clinical trials within 30 days prior to screening. As a result of screening examination(laboratory or ECG, vital sign), subject who has clinically significant findings that are not suitable for participation in the clinical trials. Subject who is pregnant or breastfeeding Subject who does not agree to use a medically acceptable method of contraception during clinical trial. Besides, in case investigator determine that subject is unsuitable for study participation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SunKyu Park
Phone
+82439394530
Email
skpark@ensolbio.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Wan Moon, M.D., Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-Wan Moon, M.D., Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of E1K After Single Dose in Patients With Knee Osteoarthritis

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