Symptomatic Osteoarthritis of the KneePhase 3JTA-KOA2NCT04333160
Phase III Study on the Safety and Efficacy of a Single Intra-articular Administration of JTA-004 in Symptomatic Knee Osteoarthritis
A Phase 3 study testing JTA-004 and Hylan G-F 20 in people with Symptomatic Osteoarthritis of the Knee, run by Bone Therapeutics S.A at 22 sites in 7 countries.
Trial summary
Osteoarthritis is a degenerative, chronic, and progressive joint disease considered as the most common joint disorder worldwide. In healthy joints, there is a continuous process of natural breakdown and repair of cartilage. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Symptomatic Osteoarthritis of the Knee
- What is being tested?
- JTA-004 and Hylan G-F 20
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 746 participants
- Where
- 22 sitesin 7 countries
- Study dates
- 10 Mar 2020to 9 Dec 2021
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory (able to walk unassisted, the use of a crutch or a walking stick (only one) is allowed if already used at screening but should be avoided during the study up to the 6-month follow-up visit)
- Diagnosed with primary knee OA, fulfilling the following American College of Rheumatology (ACR) criteria at the target knee:
- Pain present for most days of the preceding month
- Morning stiffness < 30 minutes
- Kellgren-Lawrence grade II or III (confirmed by appropriate X-rays taken within 6 months prior to screening visit)
- Target knee pain ≥ 200 mm and ≤ 400 mm out of 500 mm on the WOMAC® VA3.1 pain questionnaire (sum of 5 questions) at screening and baseline
Show all 9Show fewer
- Insufficient/failed response or intolerance to analgesics and/or non-steroidal anti-inflammatory drugs (NSAIDs) as reported by the subject
- Willing and able to abstain from initiation of physical therapy and of use of knee braces at the target knee up to the 6-month follow-up visit (a subject undergoing physical therapy or using knee braces at a stable frequency for at least 2 weeks prior to screening is allowed to continue at same frequency (frequency increase is not allowed))
- Capable to understand and comply with study requirements and to provide a written, dated, and signed informed consent prior to any study procedure for participation in the study and transmission of personal "pseudo-anonymized" data
Who cannot join
- History of trauma or surgery or arthroscopy at the target knee within 12 months before inclusion
- Concomitant inflammatory disease or other conditions affecting the joints (e.g., infectious arthritis, rheumatoid arthritis, psoriatic arthritis or spondyloarthropathy, Paget's disease, hemochromatosis…)
- Any target knee abnormality that could impact safety or efficacy assessment
- Microcrystalline arthropathies: chondrocalcinosis/calcium pyrophosphate dihydrate disease (pseudo-gout) or gout if believed likely to interfere with the study endpoints, in the opinion of the Investigator
- Clinically significant valgus/varus deformities at the Investigator's discretion
- Any musculoskeletal condition (such as symptomatic hip OA, amputation, neurologic disorder, chronic back pain with or without radiculopathy, sciatica) that would impede measurement of efficacy at target knee
Show all 37Show fewer
- Contralateral knee pain equal to or exceeding the pain in the target knee (on the WOMAC® VA3.1 pain questionnaire) at screening and/or baseline
- Knee arthroplasty planned within 12 months after the screening visit Current or previous diagnoses, signs and/or symptoms
- Uncontrolled diabetes mellitus (hemoglobin A1c [HbA1c] > 10% or > 86 mmol/mol), end-stage hepatic or renal disease (severe and clinically significant abnormalities according to local laboratory ranges) documented in the subject's file
- Any relevant cardiovascular disease (severe coronary insufficiency, conduction disturbances, recent myocardial infarction, cerebrovascular disease) or any clinically significant electrocardiogram (ECG) abnormality as judged by the Investigator
- Subject with neuropathic pain or chronic pain syndrome including fibromyalgia
- Current (or within the last 5 years prior to entering the study) history of solid or hematological neoplasia or bone marrow transplantation (except for basal cell carcinoma and completely excised squamous cell carcinoma)
- Other severe acute or chronic medical or psychiatric conditions or pre-dispositions or laboratory abnormalities, as judged by the Investigator
- Current or past history of coagulation disorders (according to local laboratory ranges), as judged by the Investigator
- Hypersensitivity to any components of hyaluronic acid (HA)-based injection products
- Hypersensitivity to human biological material including blood and blood-derived products, potential excipients and residues from manufacturing process, documented clinically or by laboratory tests
- Hypersensitivity to avian proteins Current or previous treatment
- Participation in another clinical trial within 3 months prior to screening (within 1 year prior to screening if disease-modifying OA drug (DMOAD) received and if the Investigator considers it could impact the safety or efficacy assessment)
- Subject previously treated with JTA-004 within 2 years prior to screening
- Subject treated with intra-articular viscosupplement or blood-derived product (e.g., platelet-rich plasma) injection in the target knee within 6 months prior to screening
- Subject treated with intra-articular glucocorticoid injection in the target knee within 4 months prior to screening
- Subject having started the use of slow acting drugs for OA such as glucosamine, glucosamine sulfate, chondroitin sulfate, diacerein, curcumin, soybean/avocado extracts or related products within 1 month prior to screening
- Current chemo-, radio- or immuno-cancer-therapy or immunosuppressive therapy
- Chronic (≥ 3 days/week within the last 3 months) use of opioids other than weak opioids (such as codeine, dihydrocodeine, tramadol…)
- Chronic (> 15 consecutive days) use of systemic steroids Safety aspects concerning female subjects of childbearing potential
- Breast-feeding
- Pregnancy
- Woman with positive pregnancy test
- Woman not willing or not able to use a highly effective contraceptive method during the 6-month active follow-up period. Highly effective birth control methods are:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
- Intrauterine device
- Intrauterine hormone-releasing system
- Bilateral tubal occlusion Other exclusion criteria
- Body Mass Index (BMI) of 40 kg/m2 or greater at baseline
- Signs of an active drug or alcohol dependence, serious current illness, mental illness or any other factors which may interfere with subject's ability to understand and comply with study requirements, as judged by the Investigator
- Life expectancy less than 12 months at screenin
Trial locations and contacts
22 sites in 7 countries.
22 sites in 7 countries
Poland7 sites
PL35
Bytom
PL37
Gdansk
PL36
Katowice
PL31
Nadarzyn
PL32
Poznan
PL33
Poznan
PL34
Swidnica
Belgium4 sites
Cliniques universitaires Saint-Luc (UCL)
Brussels, 1200
UZ Leuven University Hospitals Leuven
Leuven, 3000
CHU Liège
Liège, 4020
CHU Ambroise Paré
Mons, 7000
Denmark4 sites
The Parker Institute
Frederiksberg, 2000
Sanos Clinic
Gandrup
Sanos Clinic
Herlev, 2730
Sanos Clinic
Vejle, 7100
Czechia3 sites
CCR Brno, s.r.o
Brno, 60200
CCR Czech, a.s
Pardubice, 53002
CCR Prague s.r.o
Prague, 13000
Moldova2 sites
"Timofei Mosneaga" Republican Clinical Hospital, Sectia Reumatologie,
Chisinau, 2025
RTL SM SRL / Institutul de Cardiologie, sectia consultativa
Chisinau, 2025
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo- and Active-Controlled Phase III Study on the Safety and Efficacy of a Single Intra-articular Administration of JTA-004 in Symptomatic Knee Osteoarthritis
Osteoarthritis is a degenerative, chronic, and progressive joint disease considered as the most common joint disorder worldwide. In healthy joints, there is a continuous process of natural breakdown and repair of cartilage. This process becomes disrupted in OA, leading to degeneration and loss of articular cartilage, along with other joint changes, including subchondral bone remodeling, osteophyte formation, thickening of the capsule and sometimes inflammation of the synovia. JTA-004 is a plasma protein solution supplemented with HA and clonidine developed as a single IA injection for the treatment of knee OA. Local administration of JTA-004 into the joint cavity is intended to relieve chronic pain in subjects suffering from knee OA and discomfort associated with the IA administration.
The JTA-004 Phase III study is a placebo and active-controlled, randomized, double-blind study to evaluate the potential of a single, intra-articular injection of JTA-004 to reduce osteoarthritic pain in the knee at 3 months compared to placebo or active comparator. The study is expected to enrol 742 patients with mild to moderate symptomatic knee osteoarthritis in 22 centres in 6 European countries and Hong Kong SAR.
- Conditions
- Symptomatic Osteoarthritis of the Knee
- Being tested
- JTA-004, Hylan G-F 20, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JTA-004Drug
Patients will undergo a single intra-articular injection of JTA-004 into the knee joint
Hylan G-F 20Device
Patients will undergo a single intra-articular injection of Hylan G-F 20 into the knee joint
placeboOther
Also called saline solution
Patients will undergo a single intra-articular injection of placebo into the knee joint
| Study group | Role | What they receive |
|---|---|---|
| JTA-004 | Experimental | single knee intra-articular injection of JTA-004 solution (2ml) Receives: Drug: JTA-004 |
| placebo | Placebo comparator | single knee intra-articular injection of saline solution (2ml) Receives: Other: placebo |
| Hylan G-F 20 | Active comparator | single knee intra-articular injection of Hylan G-F 20 (6ml) Receives: Device: Hylan G-F 20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee pain
Difference between JTA-004 and placebo in mean change from baseline in knee pain at Month 3 using the Western Ontario McMaster University (WOMAC®) Visual Analogue 3.1 pain subscale (subscale A; score 0 (no-pain)-100 (worst imaginable pain) mm).
Measured: 3 months
Secondary outcomes (7)
knee pain
Difference between JTA-004 and placebo in mean change from baseline in knee pain at Month 6 using the WOMAC® Visual Analogue 3.1 pain subscale (subscale A; score 0 (no-pain)-100 (worst imaginable pain) mm))
Measured: 6 months
Knee pain
Difference between JTA-004 and active comparator in mean change from baseline in knee pain at Month 3 using the WOMAC® Visual Analogue 3.1 pain subscale (subscale A; score 0 (no-pain)-100 (worst imaginable pain) mm))
Measured: 3 months
knee physical function
Difference between JTA-004 and placebo in mean change from baseline in knee physical function at Month 3 using the WOMAC® Visual Analogue 3.1 physical function subscale (subscale C; score 0 (no-pain)-100 (worst imaginable pain) mm))
Measured: 3 months
Patient Global assessment
Difference between JTA-004 and placebo in mean change from baseline in Patient Global Assessment at Month 3
Measured: 3 months
physical function
Difference between JTA-004 and placebo in mean change from baseline in knee physical function at Month 6 using the WOMAC® Visual Analogue 3.1 physical function subscale (subscale C; 0 (no-pain)-100 (worst imaginable pain) mm))
Measured: 6 months
subject global health and well-being
Difference between JTA-004 and placebo in mean change from baseline in subject global health and well-being score at Month 3 using the EQ-5D-5L questionnaire
Measured: 3 months
responder rate
Difference between JTA-004 and placebo in responder rate (defined as ≥ 30% pain intensity reduction) at Month 3
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start10 Mar 2020
- Primary completion31 Mar 2021
- Study completion9 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Osteoarthritis of the KneeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 746 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bone Therapeutics S.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nordic Bioscience A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333160
- Sponsor's protocol ID
- 000014/BT
- Acronym
- JTA-KOA2
- Status last verified
- Mar 2022
- First submitted
- 1 Apr 2020
- Last updated
- 2 Mar 2022
- 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 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo- and Active-Controlled Phase III Study on the Safety and Efficacy of a Single Intra-articular Administration of JTA-004 in Symptomatic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04333160
- Acronym / sponsor ID
- JTA-KOA2 / 000014/BT
- Conditions
- Symptomatic Osteoarthritis of the Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 746 participants (actual)
- Lead sponsor
- Bone Therapeutics S.AIndustry (pharma, biotech, devices)
- Collaborators
- Nordic Bioscience A/S
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 3 Apr 2020 (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.
Osteoarthritis is a degenerative, chronic, and progressive joint disease considered as the most common joint disorder worldwide. In healthy joints, there is a continuous process of natural breakdown and repair of cartilage. This process becomes disrupted in OA, leading to degeneration and loss of articular cartilage, along with other joint changes, including subchondral bone remodeling, osteophyte formation, thickening of the capsule and sometimes inflammation of the synovia. JTA-004 is a plasma protein solution supplemented with HA and clonidine developed as a single IA injection for the treatment of knee OA. Local administration of JTA-004 into the joint cavity is intended to relieve chronic pain in subjects suffering from knee OA and discomfort associated with the IA administration.
The JTA-004 Phase III study is a placebo and active-controlled, randomized, double-blind study to evaluate the potential of a single, intra-articular injection of JTA-004 to reduce osteoarthritic pain in the knee at 3 months compared to placebo or active comparator. The study is expected to enrol 742 patients with mild to moderate symptomatic knee osteoarthritis in 22 centres in 6 European countries and Hong Kong SAR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JTA-004 | Experimental | Drug: JTA-004single knee intra-articular injection of JTA-004 solution (2ml) |
| placebo | Placebo comparator | Other: placebosingle knee intra-articular injection of saline solution (2ml) |
| Hylan G-F 20 | Active comparator | Device: Hylan G-F 20single knee intra-articular injection of Hylan G-F 20 (6ml) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ambulatory (able to walk unassisted, the use of a crutch or a walking stick (only one) is allowed if already used at screening but should be avoided during the study up to the 6-month follow-up visit)
- Diagnosed with primary knee OA, fulfilling the following American College of Rheumatology (ACR) criteria at the target knee:
- Target knee pain ≥ 200 mm and ≤ 400 mm out of 500 mm on the WOMAC® VA3.1 pain questionnaire (sum of 5 questions) at screening and baseline
- Insufficient/failed response or intolerance to analgesics and/or non-steroidal anti-inflammatory drugs (NSAIDs) as reported by the subject
- Willing and able to abstain from initiation of physical therapy and of use of knee braces at the target knee up to the 6-month follow-up visit (a subject undergoing physical therapy or using knee braces at a stable frequency for at least 2 weeks prior to screening is allowed to continue at same frequency (frequency increase is not allowed))
Key exclusion criteria (37 listed)
- History of trauma or surgery or arthroscopy at the target knee within 12 months before inclusion
- Concomitant inflammatory disease or other conditions affecting the joints (e.g., infectious arthritis, rheumatoid arthritis, psoriatic arthritis or spondyloarthropathy, Paget's disease, hemochromatosis…)
- Any target knee abnormality that could impact safety or efficacy assessment
- Microcrystalline arthropathies: chondrocalcinosis/calcium pyrophosphate dihydrate disease (pseudo-gout) or gout if believed likely to interfere with the study endpoints, in the opinion of the Investigator
- Clinically significant valgus/varus deformities at the Investigator's discretion
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 |
|---|---|---|
| JTA-004Patients will undergo a single intra-articular injection of JTA-004 into the knee joint | Drug | JTA-004 |
| Hylan G-F 20Patients will undergo a single intra-articular injection of Hylan G-F 20 into the knee joint | Device | Hylan G-F 20 |
| placeboAlso: saline solutionPatients will undergo a single intra-articular injection of placebo into the knee joint | Other | placebo |
Primary outcome
knee pain
Time frame: 3 months
Difference between JTA-004 and placebo in mean change from baseline in knee pain at Month 3 using the Western Ontario McMaster University (WOMAC®) Visual Analogue 3.1 pain subscale (subscale A; score 0 (no-pain)-100 (worst imaginable pain) mm).
7 secondary outcomes
knee pain
Time frame: 6 months
Knee pain
Time frame: 3 months
knee physical function
Time frame: 3 months
Patient Global assessment
Time frame: 3 months
physical function
Time frame: 6 months
subject global health and well-being
Time frame: 3 months
responder rate
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JTA-004 and Hylan G-F 20 in people with Symptomatic Osteoarthritis of the Knee, run by Bone Therapeutics S.A at 22 sites in 7 countries.
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 9 inclusion and 37 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 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Poland, Belgium, Denmark, Czechia, Moldova and 2 more countries. 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?
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?
knee pain (time frame: 3 months). 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 2 Mar 2022.