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OsteoarthrosisPhase 2NCT05697952

E1K Intra Articular(IA) Treatment for Knee Osteoarthritis

A Phase 2 study testing E1K 1,200 ㎍/joint and E1K 2,400 ㎍/joint in people with Osteoarthrosis, run by Ensol Bioscience at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Osteoarthrosis
What is being tested?
E1K 1,200 ㎍/joint and E1K 2,400 ㎍/joint
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteSouth Korea
Study dates
13 Jun 2022to 29 Nov 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul

Other trials in South Korea

About this study

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

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.

Conditions
Osteoarthrosis
Being tested
E1K 1,200 ㎍/joint, E1K 2,400 ㎍/joint, placebo
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E1K 1,200 ㎍/jointDrug

    Injection of E1K 1,200 ㎍/joint/ml on target lesion

  • E1K 2,400 ㎍/jointDrug

    Injection of E1K 2,400 ㎍/joint/ml on target lesion

  • placeboDrug

    Injection of 3ml saline on target lesion

Study groups in NCT05697952
Study groupRoleWhat they receive
E1K 1,200 ㎍/jointExperimentalInjected 1,200 ㎍/joint/3 mL on target lesion
Receives: Drug: E1K 1,200 ㎍/joint
E1K 2,400 ㎍/jointExperimentalInjected 2,400 ㎍/joint/3 mL on target lesion
Receives: Drug: E1K 2,400 ㎍/joint
PlaceboPlacebo comparatorInjected 3ml of saline on target lesion
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index)

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

    Measured: 12 weeks after administration of IP versus baseline

Secondary outcomes (6)

  1. Pain VAS 100mm

    Changes in 100 mm Pain VAS (Pain during activity and at rest during the last 24 hours) scores

    Measured: at 4, 8, and 12 weeks after administration of IP versus baseline

  2. WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index)

    Changes in scores by WOMAC questionnaire total score and Sub-Scale (physical function, stiffness)

    Measured: at 4, 8, and 12 weeks after IP administration compared to baseline

  3. WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index)

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

    Measured: at 4 to 8 weeks after administration of IP compared to the baseline

  4. KOOS

    Changes in KOOS questionnaire scores

    Measured: at 4, 8, and 12 weeks after administration of IP compared to baseline

  5. Quality of life(EQ-5D-5L)

    Changes in EQ-5D-5L questionnaire scores

    Measured: at 4, 8, and 12 weeks after administration of IP compared to baseline

  6. Frequency of Rescue drug

    Percentage and number of subjects who took the rescue medication during the clinical trial period

    Measured: Day 0 to Day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2023
  2. Study start13 Jun 2022
  3. Primary completion29 Nov 2023
  4. Study completion29 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05697952
Sponsor's protocol ID
E1K-201
Status last verified
Jan 2024
First submitted
15 Jan 2023
Last updated
4 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing E1K 1,200 ㎍/joint and E1K 2,400 ㎍/joint in people with Osteoarthrosis, run by Ensol Bioscience at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index) (time frame: 12 weeks after administration of IP versus baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05697952.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.

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