A Phase 2/3 interventional study of JTA-004 intra-articular injection and Reference product intra-articular injection in Knee Osteoarthritis, sponsored by Bone Therapeutics S.A. Completed. Open to participants aged 50 Years to 79 Years. Per ClinicalTrials.gov, last updated 2021-12-06.
Sponsored by Bone Therapeutics S.A · Phase 2/3, Interventional, and Treatment
Osteoarthritis (OA) is the most common joint disease affecting millions of people around the world, for which there is unfortunately no cure. Among existing therapies, viscosupplementation, i.e., the injection of hyaluronic acid into the joint, has an established place in the symptomatic treatment of knee OA.
The present Phase IIb/III aiming to assess the safety and efficacy of JTA-004 is organized in two phases. With results obtained in the first phase the best dose of JTA-004 is determined, and the efficacy of the selected dose will then be confirmed in the second phase.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's enrollment of 173 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Bone Therapeutics S.A is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosed with primary knee osteoarthritis, fulfilling the following American College of Rheumatology (ACR) criteria at the target knee:
Exclusion Criteria:
Current symptoms and/or signs related to the disease under study:
Current or previous diagnoses, signs and/or symptoms:
Current or previous treatment:
Treatment:
Safety aspects concerning female subjects of :
Other exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hylan G-F 20
Device: Reference product intra-articular injection
Sodium hyaluronate, plasma proteins and clonidine
Drug: JTA-004 intra-articular injection
Sodium hyaluronate, plasma proteins and clonidine
Drug: JTA-004 intra-articular injection
Sodium hyaluronate, plasma proteins and clonidine
Drug: JTA-004 intra-articular injection
Each patient will undergo a single injection of JTA-004 into the knee joint
Each patient will undergo a single injection of Reference product into the knee joint
Change From Baseline in WOMAC VA3.1 Pain Subscale Score at Month 6
The primary endpoint is the Western Ontario McMaster universities (WOMAC®) VA3.1 Pain Subscale (subscale A): the individual changes in WOMAC® VA3.1 Pain Subscale Score between Baseline and Month 6 were calculated and compared by analysis of covariance (ANCOVA), adjusted for baseline value, to the Reference group. Results are expressed as "adjusted mean" based on the model used for group comparison. WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity ans osteonecrosis symptoms. The WOMAC® Index Pain Subscale (VAS format) was used. The VAS score was determined by measuring in millimetres from the left-hand end of the line to the point that the patient marks (0-100 mm) for 5 questions. Results are summed and normalized on a 100 mm scale: 0 represents no knee pain and 100 extreme knee pain.
Time frame: Baseline and 6 months
WOMAC® Pain Subscale at Month 3
The primary endpoint is the Western Ontario McMaster universities (WOMAC®) VA3.1 Pain Subscale (subscale A): the individual changes in WOMAC® VA3.1 Pain Subscale Score between Baseline and Month 3 were calculated and compared by analysis of covariance (ANCOVA), adjusted for baseline value, to the Reference group. Results are expressed as "adjusted mean" based on the model used for group comparison. WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity ans osteonecrosis symptoms. The WOMAC® Index Pain Subscale (VAS format) was used. The VAS score was determined by measuring in millimetres from the left-hand end of the line to the point that the patient marks (0-100 mm) for 5 questions. Results are summed and normalized on a 100 mm scale: 0 represents no knee pain and 100 extreme knee pain.
Time frame: Baseline and 3 months
WOMAC® Total Score Over Time
The Western Ontario McMaster universities (WOMAC®) VA3.1 Total Score was used: the individual changes in WOMAC VA3.1 Total Score between Baseline and 2 weeks were calculated and compared by Mixed-Effect Model for Repeated Measurements, adjusted for baseline value, to the Reference group. Results are expressed as "adjusted mean" based on the model used for group comparison. WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity and osteonecrosis symptoms. The Total score (VAS format) was determined by measuring in millimetres from the left hand end of the line to the point that the patient marks (0-100 mm) for the pain (5 questions), stiffness (2 questions), and physical function (17 questions). Results are normalized on a 0-100 mm scale format. A higher score represents a higher degree of k
Time frame: Baseline and 2 weeks
WOMAC® Total Score Over Time
The Western Ontario McMaster universities (WOMAC®) VA3.1 Total Score was used: the individual changes in WOMAC VA3.1 Total Score between Baseline and Month 3 were calculated and compared by Mixed-Effect Model for Repeated Measurements, adjusted for baseline value, to the Reference group. Results are expressed as "adjusted mean" based on the model used for group comparison. WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity ans osteonecrosis symptoms. The Total score (VAS format) was determined by measuring in millimetres from the left hand end of the line to the point that the patient marks (0-100 mm) for the pain (5 questions), stiffness (2 questions), and physical function (17 questions). Results are normalized on a 0-100 mm scale format. A higher score represents a higher degree of knee disease severity.
Time frame: Baseline and 3 months
WOMAC® Total Score Over Time
The Western Ontario McMaster universities (WOMAC®) VA3.1 Total Score was used: the individual changes in WOMAC VA3.1 Total Score between Baseline and Month 6 were calculated and compared by Mixed-Effect Model for Repeated Measurements, adjusted for baseline value, to the Reference group. Results are expressed as "adjusted mean" based on the model used for group comparison. WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity ans osteonecrosis symptoms.The Total score (VAS format) was determined by measuring in millimetres from the left hand end of the line to the point that the patient marks (0-100 mm) for the pain (5 questions), stiffness (2 questions), and physical function (17 questions). Results are normalized on a 0-100 mm scale format. A higher score represents a higher degree of knee disease severity.
Time frame: Baseline and 6 months
| Milestone | Reference Product | JTA-004 50 (2 ml) | JTA-004 50 (4 ml) | JTA-004 100 (2 ml) |
|---|---|---|---|---|
| Started | 41 | 41 | 41 | 41 |
| Completed | 39 | 35 | 40 | 33 |
| Not completed | 2 | 6 | 1 | 8 |
| Withdrew: Withdrawal by subject | 1 | 1 | 1 | 0 |
| Withdrew: Lack of efficacy | 0 | 1 | 0 | 4 |
| Withdrew: Lost to follow-up | 1 | 3 | 0 | 3 |
| Withdrew: Adverse event | 0 | 1 | 0 | 1 |
The primary endpoint is the Western Ontario McMaster universities (WOMAC®) VA3.1 Pain Subscale (subscale A): the individual changes in WOMAC® VA3.1 Pain Subscale Score between Baseline and Month 6 were calculated and compared by analysis of covariance (ANCOVA), adjusted for baseline value, to the Reference group. Results are expressed as "adjusted mean" based on the model used for group comparison. WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity ans osteonecrosis symptoms. The WOMAC® Index Pain Subscale (VAS format) was used. The VAS score was determined by measuring in millimetres from the left-hand end of the line to the point that the patient marks (0-100 mm) for 5 questions. Results are summed and normalized on a 100 mm scale: 0 represents no knee pain and 100 extreme knee pain.
| mm | JTA-004 100 (2 mL) | Reference Product |
|---|---|---|
| Change From Baseline in WOMAC VA3.1 Pain Subscale Score at Month 6 | -23.6 ± 4.6 | -14.1 ± 4.3 |
The primary endpoint is the Western Ontario McMaster universities (WOMAC®) VA3.1 Pain Subscale (subscale A): the individual changes in WOMAC® VA3.1 Pain Subscale Score between Baseline and Month 3 were calculated and compared by analysis of covariance (ANCOVA), adjusted for baseline value, to the Reference group. Results are expressed as "adjusted mean" based on the model used for group comparison. WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity ans osteonecrosis symptoms. The WOMAC® Index Pain Subscale (VAS format) was used. The VAS score was determined by measuring in millimetres from the left-hand end of the line to the point that the patient marks (0-100 mm) for 5 questions. Results are summed and normalized on a 100 mm scale: 0 represents no knee pain and 100 extreme knee pain.
| mm | JTA-004 100 (2 mL) | Reference Product |
|---|---|---|
| WOMAC® Pain Subscale at Month 3 | -26.8 ± 3.9 | -15.1 ± 3.7 |
The Western Ontario McMaster universities (WOMAC®) VA3.1 Total Score was used: the individual changes in WOMAC VA3.1 Total Score between Baseline and 2 weeks were calculated and compared by Mixed-Effect Model for Repeated Measurements, adjusted for baseline value, to the Reference group. Results are expressed as "adjusted mean" based on the model used for group comparison. WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity and osteonecrosis symptoms. The Total score (VAS format) was determined by measuring in millimetres from the left hand end of the line to the point that the patient marks (0-100 mm) for the pain (5 questions), stiffness (2 questions), and physical function (17 questions). Results are normalized on a 0-100 mm scale format. A higher score represents a higher degree of k
| mm | JTA-004 100 (2 mL) | Reference Product |
|---|---|---|
| WOMAC® Total Score Over Time | -21.0 ± 3.1 | -19.5 ± 3.1 |
The Western Ontario McMaster universities (WOMAC®) VA3.1 Total Score was used: the individual changes in WOMAC VA3.1 Total Score between Baseline and Month 3 were calculated and compared by Mixed-Effect Model for Repeated Measurements, adjusted for baseline value, to the Reference group. Results are expressed as "adjusted mean" based on the model used for group comparison. WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity ans osteonecrosis symptoms. The Total score (VAS format) was determined by measuring in millimetres from the left hand end of the line to the point that the patient marks (0-100 mm) for the pain (5 questions), stiffness (2 questions), and physical function (17 questions). Results are normalized on a 0-100 mm scale format. A higher score represents a higher degree of knee disease severity.
| mm | JTA-004 100 (2 ml) | Reference Product |
|---|---|---|
| WOMAC® Total Score Over Time | -22.3 ± 3.8 | -19.4 ± 3.6 |
The Western Ontario McMaster universities (WOMAC®) VA3.1 Total Score was used: the individual changes in WOMAC VA3.1 Total Score between Baseline and Month 6 were calculated and compared by Mixed-Effect Model for Repeated Measurements, adjusted for baseline value, to the Reference group. Results are expressed as "adjusted mean" based on the model used for group comparison. WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity ans osteonecrosis symptoms.The Total score (VAS format) was determined by measuring in millimetres from the left hand end of the line to the point that the patient marks (0-100 mm) for the pain (5 questions), stiffness (2 questions), and physical function (17 questions). Results are normalized on a 0-100 mm scale format. A higher score represents a higher degree of knee disease severity.
| mm | JTA-004 100 (2 ml) | Reference Product |
|---|---|---|
| WOMAC® Total Score Over Time | -23.7 ± 4.3 | -16.5 ± 4.1 |
The Western Ontario McMaster universities (WOMAC®) VA3.1 Total Score was used: the individual changes in WOMAC VA3.1 Total Score between Baseline and Month 3 were calculated and compared by analysis of covariance (ANCOVA), adjusted for baseline value, to the Reference group. Results are expressed as "adjusted mean" based on the model used for group comparison. WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity and osteonecrosis symptoms. The Total score (VAS format) was determined by measuring in mm from the left hand end of the line to the point that the patient marks (0-100 mm) for the pain (5 questions), stiffness (2 questions), and physical function (17 questions). Results are normalized on a 0-100 mm scale format. A higher score represents a higher degree of knee disease severity.
| mm | JTA-004 (All Strenghts) | Reference Product |
|---|---|---|
| WOMAC® Total Score Over Time From Pooled JTA-004 Treatment Groups | -26.3 ± 2.2 | -19.7 ± 3.7 |
The Western Ontario McMaster universities (WOMAC®) VA3.1 Total Score was used: the individual changes in WOMAC Total Score between Baseline and Month 6 were calculated and compared by analysis of covariance (ANCOVA), adjusted for baseline value, to the Reference group. Results are expressed as "adjusted mean" based on the model used for group comparison. WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity and osteonecrosis symptoms. The Total score (VAS format) was determined by measuring in millimetres from the left hand end of the line to the point that the patient marks (0-100 mm) for the pain (5 questions), stiffness (2 questions), and physical function (17 questions). Results are normalized on a 0-100 mm scale format. A higher score represents a higher degree of knee disease severity.
| mm | JTA-004 (All Strenghts) | Reference Product |
|---|---|---|
| WOMAC® Total Score Over Time From Pooled JTA-004 Treatment Groups | -26.2 ± 2.4 | -17.3 ± 4.1 |
The primary endpoint is the Western Ontario McMaster universities (WOMAC®) VA3.1 Pain Subscale A: the individual changes in WOMAC® Pain Subscale Score between Baseline and Month 3 were calculated and compared by analysis of covariance (ANCOVA), adjusted for baseline value, to the Reference group. Results are expressed as "adjusted mean" based on the model used for group comparison. WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity ans osteonecrosis symptoms. The WOMAC® Index Pain Subscale (VAS format) was used. The VAS score was determined by measuring in millimetres from the left-hand end of the line to the point that the patient marks (0-100 mm) for 5 questions. Results are summed and normalized on a 100 mm scale: 0 represents no knee pain and 100 extreme knee pain.
| mm | JTA-004 (All Strenghts) | Reference Product |
|---|---|---|
| WOMAC® Pain Subscale Over Time From Pooled JTA-004 Treatment Groups | -27.2 ± 2.2 | -16.4 ± 3.7 |
The Western Ontario McMaster universities (WOMAC®) VA3.1 Total Score was used: the individual changes in WOMAC Total Score between Baseline and M6 were calculated and compared by analysis of covariance (ANCOVA), adjusted for baseline value, to the Reference group. Results are expressed as "adjusted mean" based on the model used for group comparison. WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity and osteonecrosis symptoms. . The Total score (VAS format) was determined by measuring in millimetres from the left hand end of the line to the point that the patient marks (0-100 mm) for the pain (5 questions), stiffness (2 questions), and physical function (17 questions). Results are normalized on a 0-100 mm scale format. A higher score represents a higher degree of knee disease severity.
| mm | JTA-004 (All Strenghts) | Reference Product |
|---|---|---|
| WOMAC® Pain Subscale Score Over Time From Pooled JTA-004 Treatment Groups | -26.1 ± 2.4 | -15.6 ± 4.1 |
Collected over 6 months post injection. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Reference Product | 0/41 (0%) | 2/41 (4.9%) | 11/41 (26.8%) |
| JTA-004 50 (2 ml) | 0/41 (0%) | 4/41 (9.8%) | 3/41 (7.3%) |
| JTA-004 50 (4 ml) | 0/41 (0%) | 1/41 (2.4%) | 12/41 (29.3%) |
| JTA-004 100 (2 ml) | 0/41 (0%) | 2/41 (4.9%) | 8/41 (19.5%) |
| Event | Reference Product | JTA-004 50 (2 ml) | JTA-004 50 (4 ml) | JTA-004 100 (2 ml) |
|---|---|---|---|---|
| Osteomyelitis acuteInfections and infestations | 0/41 | 0/41 | 0/41 | 1/41 |
| Alcohol poisoningInjury, poisoning and procedural complications | 1/41 | 0/41 | 0/41 | 0/41 |
| Squamous cell carcinoma of lungNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/41 | 0/41 | 0/41 | 1/41 |
| Barett's oesophagusGastrointestinal disorders | 0/41 | 1/41 | 0/41 | 0/41 |
| DiaorrheaGastrointestinal disorders | 0/41 | 1/41 | 0/41 | 0/41 |
| Hernia eventrationGastrointestinal disorders | 0/41 | 0/41 | 0/41 | 1/41 |
| RectoceleReproductive system and breast disorders | 0/41 | 1/41 | 0/41 | 0/41 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/41 | 1/41 | 0/41 | 0/41 |
| Osteomyelitis chronicInfections and infestations | 0/41 | 0/41 | 0/41 | 1/41 |
| PneumoniaInfections and infestations | 0/41 | 0/41 | 1/41 | 0/41 |
| Event | Reference Product | JTA-004 50 (2 ml) | JTA-004 50 (4 ml) | JTA-004 100 (2 ml) |
|---|---|---|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 3/41 | 0/41 | 0/41 | 1/41 |
| Procedural hypotensionInjury, poisoning and procedural complications | 0/41 | 0/41 | 3/41 | 0/41 |
| Injection Site PainGeneral disorders | 2/41 | 0/41 | 1/41 | 0/41 |
| Blood and Creatine Phosphokinase IncreasedInvestigations | 2/41 | 0/41 | 0/41 | 0/41 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 1/41 | 0/41 | 1/41 | 0/41 |
| Joint StiffnessMusculoskeletal and connective tissue disorders | 0/41 | 1/41 | 0/41 | 0/41 |
| Pain in ExtremityMusculoskeletal and connective tissue disorders | 0/41 | 0/41 | 1/41 | 0/41 |
| Plantar FasciitisMusculoskeletal and connective tissue disorders | 1/41 | 0/41 | 0/41 | 0/41 |
| TendonitisMusculoskeletal and connective tissue disorders | 0/41 | 0/41 | 1/41 | 0/41 |
| FatigueGeneral disorders | 1/41 | 0/41 | 1/41 | 0/41 |
| Age, Continuous(years) | Reference Product | JTA-004 50 (2 ml) | JTA-004 50 (4 ml) | JTA-004 100 (2 ml) | Total |
|---|---|---|---|---|---|
| Mean | 61.8 ± 7.7 | 64.2 ± 8.0 | 62.9 ± 7.2 | 61.7 ± 7.0 | 62.7 ± 7.5 |
| Sex: Female, Male(Participants) | Reference Product | JTA-004 50 (2 ml) | JTA-004 50 (4 ml) | JTA-004 100 (2 ml) | Total |
|---|---|---|---|---|---|
| Female | 30 | 31 | 27 | 24 | 112 |
| Male | 11 | 10 | 14 | 17 | 52 |
| Race and Ethnicity Not Collected(Participants) | Reference Product | JTA-004 50 (2 ml) | JTA-004 50 (4 ml) | JTA-004 100 (2 ml) | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Region of Enrollment(Participants) | Reference Product | JTA-004 50 (2 ml) | JTA-004 50 (4 ml) | JTA-004 100 (2 ml) | Total |
|---|---|---|---|---|---|
| Belgium | 41 | 41 | 41 | 41 | 164 |
| BMI(kg/m^2) | Reference Product | JTA-004 50 (2 ml) | JTA-004 50 (4 ml) | JTA-004 100 (2 ml) | Total |
|---|---|---|---|---|---|
| Mean | 27.5 ± 4.2 | 29.0 ± 3.9 | 28.0 ± 3.6 | 29.6 ± 3.5 | 28.5 ± 3.9 |
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Bone Therapeutics S.A