OsteoarthritisPhase 3NCT03383471
The Efficacy and Safety of Invossa K Injection in Patients Diagnosed With Knee Osteoarthritis
A Phase 3 study testing Invossa K Inj. in people with Osteoarthritis, run by Kolon Life Science at 17 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of intraarticular Invossa K Injection patients diagnosed with Kellgren \& Lawrence grade 2 knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Invossa K Inj.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 17 sitesSouth Korea
- Study dates
- 12 Feb 2018to 30 Mar 2020
- Phase
- Phase 3
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 19 and older
- Patients with IKDC Subjective Knee Evaluation of ≤ 60 of the target knee.
- Patients with a score of ≥ 40 on the 100 mm pain VAS of the target knee.
- Patients with grade 2 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence
- BMI should fall between 18.5 and 30
- Patients who satisfies the clinical/radiational criteria by the American College of Rheumatology guidelines, and applies to one of the following.
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- Age > 50 years old
- Morning stiffness < 30 minutes
- Crepitus and Osteophytes
- With major lesions concentrated in one section of the knee, and with the major lesions considered the main cause of the clinical symptoms
- Patients with persistent symptoms in spite of conservative therapy for more than 3 months : Improvement of 100 mm VAS are less than 10 mm after 3 months
- Healthy, with no major findings from the physical examination, hematology, serum chemistry, and urine tests, and no significant medical history
- Agreed to use an effective contraceptive method during the study period
- Voluntarily agreed to participate in this study, and signed the informed consent form
Who cannot join
- Patients who had been administered with drugs such as oriental medicine, glucosamine and chondroitin within 14 days of baseline visit (But, possible to include after 14 days of wash-out period)
- Patients taking steroidal anti-inflammatory medications within 14 days of baseline visit (But, possible to include after 14 days of wash-out period)
- Patients with severe pain in other areas that could effect the diagnosis of the symptoms
- Patients over Grade 3 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence
- History of surgery like arthroendoscopy within the past 6 months on the target knee
- Patients who had been administered with immunosuppressants, including antirheumatic drugs (including methotrexate or antimetabolite), within the past 3 months
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- History of injection within the past 3 months on the target knee
- Pregnant or breastfeeding female
- With another joint disease apart from degenerative arthritis
- Patients with hepatitis including carrier
- Patients with HIV and an infectious disease which is clinically uncontrolled
- Patients who have any of the following clinically significant diseases or have a medical history within 6 months :
- Clinically significant heart diseases which are considered by the investigator
- Uncontrolled hypertension : if the systolic blood pressure exceeds 160 mmHg or diastolic blood pressure exceeds 100 mmHg in a sitting position
- Kidney disease
- Liver disease
- Endocrine disease
- Uncontrolled diabetes mellitus : HbA1c ≥ 9%
- Paget's disease, ochronosis, acromegaly, hemochromatosis, Wilson's disease
- Genetic diseases (hyperkinesia, collagen gene abnormality)
- Medical history of past or current malignant tumor
- Patients with a history of anaphylactic reactions
- Patients with a history of hypersensitivity reactions to the components of this drug, including dimethylsulfoxide, mannitol, dextran 40 or bovine proteins
- Participated in another clinical trial (using the investigational drug or a medical device) within 30 days before enrollment in this study
- Patients who administered the INVOSSA K inj.
- Considered inappropriate by the investigator for participation in this study
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
South Korea17 sites
Korea University Anam Hospital
Ansan
Inje University Busan Paik Hospital
Busan
Kyungpook National University School of Medicine
Daegu
Chungnam National University School of Medicine
Daejeon
Chonnam National University Hwasun Hospital
Hwasun
Inha University Hospital
Incheon
Asan Medical Center
Seoul
College of Medicine, Hanyang University
Seoul
Ewha Womans University Mokdong Hospital
Seoul
Konkuk University Medical Center
Seoul
Samsung Medical Center
Seoul
School of Medicine, Kyung Hee University
Seoul
Seoul National University Borame Medical Center
Seoul
Seoul National University Hospital
Seoul
The Catholic University of Korea College of Medicine
Seoul
Yonsei University School of Medicine
Seoul
Ajou University School of Medicine
Suwon
About this study
Official title: A Multicenter, Randomized, Placebo Controlled, Double-blind, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Invossa K Injection in Patients Diagnosed as Knee Osteoarthritis With Kellgren & Lawrence Grade 2
The purpose of this study is to evaluate the efficacy and safety of intraarticular Invossa K Injection patients diagnosed with Kellgren \& Lawrence grade 2 knee osteoarthritis.
- Conditions
- Osteoarthritis
- Being tested
- Invossa K Inj., Placebo
- Keywords
- chondrocyte cells, osteoarthritis, gene therapy
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invossa K Inj.Biological
Invossa K Inj.
PlaceboDrug
Placebo control
| Study group | Role | What they receive |
|---|---|---|
| Invossa K Inj. | Experimental | Invossa K Inj. Receives: Biological: Invossa K Inj. |
| Placebo | Placebo comparator | Placebo control Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
IKDC (International knee documentation committee) Subjective Knee Evaluation
Changes in IKDC Subjective Knee Evaluation (score)
Measured: Week 0 and 52
100 mm VAS (Visual analogue scale)
Changes in 100 mm VAS
Measured: Week 0 and 52
Secondary outcomes (12)
WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index) score
Changes in WOMAC (score)
Measured: Week 0, 26, 39 and 52
IKDC Subjective Knee Evaluation
Changes in IKDC Subjective Knee Evaluation (score)
Measured: Week 0, 26 and 39
100 mm VAS
Changes in 100 mm VAS
Measured: Week 0, 26 and 39
OMERACT-OARSI (Outcome measures in rheumatology-Osteoarthritis research society international) response rate
OMERACT-OARSI response rate after administration (%)
Measured: Week 26, 39 and 52
MRI scan
Changes in MRI scan
Measured: Week 0, and 52
Joint Space Width
Changes in Joint Space Width (mm)
Measured: Week 0, and 52
Biomarker (CTX-I) in blood
Levels of CTX-I in blood (ng/ml)
Measured: Week 0, 26, and 52
Biomarker (CTX-II) in urine
Levels of CTX-II in urine (ng/ml)
Measured: Week 0, 26, and 52
Rescue Medication (Dosage)
Dosage of Rescue Medication (mg)
Measured: Week 0, 4, 12, 26, 39, and 52
Rescue Medication (Frequency)
Frequency of Rescue Medication (number)
Measured: Week 0, 4, 12, 26, 39, and 52
Drop-out rate
Drop-out rate (%)
Measured: Week 0, 4, 12, 26, 39, and 52
Reason of drop-out
Reason of drop-out is recorded in CRF (Case Report Form), when the patient is dropped-out according to drop-out criteria (e.g. Withdraw a consent, Patients who can not continuously participate in study due to adverse events, Impossible to follow-up of the patient. etc.).
Measured: Week 0, 4, 12, 26, 39, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start12 Feb 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kolon Life Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung-Chul Lee, MD, PhD, Principal investigator, Department of Orthopedic Surgery, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383471
- Sponsor's protocol ID
- KS-INV-02-3
- Status last verified
- Mar 2018
- First submitted
- 11 Dec 2017
- Last updated
- 7 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo Controlled, Double-blind, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Invossa K Injection in Patients Diagnosed as Knee Osteoarthritis With Kellgren & Lawrence Grade 2
- ClinicalTrials.gov ID
- NCT03383471
- Acronym / sponsor ID
- KS-INV-02-3
- Conditions
- Osteoarthritis
- Keywords
- chondrocyte cells, osteoarthritis, gene therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Kolon Life ScienceIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of intraarticular Invossa K Injection patients diagnosed with Kellgren \& Lawrence grade 2 knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Invossa K Inj. | Experimental | Biological: Invossa K Inj.Invossa K Inj. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo control |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female aged 19 and older
- Patients with IKDC Subjective Knee Evaluation of ≤ 60 of the target knee.
- Patients with a score of ≥ 40 on the 100 mm pain VAS of the target knee.
- Patients with grade 2 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence
- BMI should fall between 18.5 and 30
Key exclusion criteria (26 listed)
- Patients who had been administered with drugs such as oriental medicine, glucosamine and chondroitin within 14 days of baseline visit (But, possible to include after 14 days of wash-out period)
- Patients taking steroidal anti-inflammatory medications within 14 days of baseline visit (But, possible to include after 14 days of wash-out period)
- Patients with severe pain in other areas that could effect the diagnosis of the symptoms
- Patients over Grade 3 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence
- History of surgery like arthroendoscopy within the past 6 months on the target knee
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invossa K Inj.Invossa K Inj. | Biological | Invossa K Inj. |
| PlaceboPlacebo control | Drug | Placebo |
Primary outcome
IKDC (International knee documentation committee) Subjective Knee Evaluation
Time frame: Week 0 and 52
Changes in IKDC Subjective Knee Evaluation (score)
100 mm VAS (Visual analogue scale)
Time frame: Week 0 and 52
Changes in 100 mm VAS
12 secondary outcomes
WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index) score
Time frame: Week 0, 26, 39 and 52
IKDC Subjective Knee Evaluation
Time frame: Week 0, 26 and 39
100 mm VAS
Time frame: Week 0, 26 and 39
OMERACT-OARSI (Outcome measures in rheumatology-Osteoarthritis research society international) response rate
Time frame: Week 26, 39 and 52
MRI scan
Time frame: Week 0, and 52
Joint Space Width
Time frame: Week 0, and 52
Biomarker (CTX-I) in blood
Time frame: Week 0, 26, and 52
Biomarker (CTX-II) in urine
Time frame: Week 0, 26, and 52
Rescue Medication (Dosage)
Time frame: Week 0, 4, 12, 26, 39, and 52
Rescue Medication (Frequency)
Time frame: Week 0, 4, 12, 26, 39, and 52
Drop-out rate
Time frame: Week 0, 4, 12, 26, 39, and 52
Reason of drop-out
Time frame: Week 0, 4, 12, 26, 39, and 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myung-Chul Lee, MD, PhD principal investigator
Department of Orthopedic Surgery, Seoul National University Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Invossa K Inj. in people with Osteoarthritis, run by Kolon Life Science at 17 sites 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 14 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
IKDC (International knee documentation committee) Subjective Knee Evaluation (time frame: Week 0 and 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2018.