Osteoarthritis, KneePhase 3NCT04520607
A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee
A Phase 3 study testing Lorecivivint in people with Osteoarthritis, Knee, run by Biosplice Therapeutics, Inc. at 42 sites in United States.
Trial summary
Study OA-07 was a randomized, double-blind, placebo-controlled, Phase 3, multicenter, 2-year clinical trial that enrolled subjects from the recently completed Study OA-11 (NCT03928184). The first 48 weeks of OA-07 the trial was placebo-controlled with subjects receiving the same randomized treatment received in OA-11. Read more about this study
- Who is it for?
- Ages 41 to 81 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Lorecivivint
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 276 participants
- Where
- 42 sitesUnited States
- Study dates
- 25 Aug 2020to 30 Jun 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 41 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completion of the Study SM04690-OA-11 (NCT03928184)
- Compliance with procedures in study SM04690-OA-11, in the opinion of the Investigator
- Fully understanding study requirements and willingness to comply with study visits and assessments
- Understanding and signing of the informed consent form (ICF) prior to any study-related procedures
Who cannot join
- Any condition that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
- Any contraindications for an intra-articular (IA) injection in the target knee in the opinion of the Investigator
- Any known reason identified by the Investigator or Sponsor that the subject may not be compliant with study visits or may no longer be an appropriate candidate for the study (e.g. planned major surgery, knee replacement during the parent study, planning to move away from the research site, or initiation of a prohibited concomitant medication including, but not limited to, IA injection of glucocorticoids, hyaluronic acid derivatives, platelet-rich plasma, stem cell therapies, or other agents with therapeutic intent into the target knee)
- Participation in a clinical research trial (other than the prior SM04690-OA-11 study) that included the receipt of an investigational product (IP) or any experimental therapeutic procedure within 12 weeks before any study injection, or planned participation in any such trial
- Current or pending disability claim, workers' compensation, or litigation(s) that may compromise response to treatment
- Pregnant women, breastfeeding women, and women who are not post-menopausal (defined as 12 months with no menses without an alternative medical cause) or permanently surgically sterile (includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) who have a positive or indeterminate pregnancy test result at Visit 1E (Day 1)
- Women who are not post-menopausal or permanently surgically sterile who are sexually active, and who are not willing to use birth control (as outlined in the protocol) during the study period
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Research Site
Anaheim, California, 92805
Research Site
Bay City, Michigan, 48706
Research Site
Carrollton, Texas, 75007
Research Site
Charlotte, North Carolina, 28209
Research Site
Charlottesville, Virginia, 22911
Research Site
Cincinnati, Ohio, 45242
Research Site
Columbus, Ohio, 43235
Research Site
Denver, Colorado, 80209
Research Site
Draper, Utah, 84020
Research Site
Fort Mill, South Carolina, 29707
Research Site
Gurnee, Illinois, 60031
Research Site
Hartsdale, New York, 10530
Research Site
Hazelwood, Missouri, 63042
Research Site
Hialeah, Florida, 33016
Research Site
Miami, Florida, 33173
Research Site
Miami Lakes, Florida, 33014
Research Site
Mt. Pleasant, South Carolina, 29464
Research Site
New Orleans, Louisiana, 70124
Research Site
New York, New York, 10016
Research Site
Newnan, Georgia, 30265
Research Site
Oak Brook, Illinois, 60523
Research Site
Oklahoma City, Oklahoma, 73103
Research Site
Omaha, Nebraska, 68114
Research Site
Plano, Texas, 75075
Research Site
Pomona, California, 91767
Research Site
Port Orange, Florida, 32127
Research Site
Rapid City, South Dakota, 57702
Research Site
Rochester, New York, 14609
Research Site
Salisbury, North Carolina, 28144
Research Site
Salt Lake City, Utah, 84107
Research Site
San Antonio, Texas, 78229
Research Site
San Diego, California, 92103
Research Site
St Louis, Missouri, 63141
Research Site
Thousand Oaks, California, 91360
Research Site
Troy, Michigan, 48085
Research Site
Tucson, Arizona, 85712
Research Site
Valparaiso, Indiana, 46383
Research Site
West Palm Beach, Florida, 33409
Research Site
Winston-Salem, North Carolina, 27103
Research Site
Winter Haven, Florida, 33880
Research Site
Winter Park, Florida, 32789
Research Site
Woodstock, Georgia, 30189
About this study
Official title: A Long-Term Extension Study Evaluating the Safety and Efficacy of Lorecivivint in Subjects With Osteoarthritis of the Knee
Study OA-07 was a randomized, double-blind, placebo-controlled, Phase 3, multicenter, 2-year clinical trial that enrolled subjects from the recently completed Study OA-11 (NCT03928184).
The first 48 weeks of OA-07 the trial was placebo-controlled with subjects receiving the same randomized treatment received in OA-11. Investigators, research staff and subjects remained blinded to treatment allocation.
At Week 48, all subjects were administered LOR in the open-label portion of the trial.
Read the detailed description
At Visit 1E (on Day 1), upon completion of initial study procedures (e.g., informed consent, eligibility requirements, clinical evaluations including pregnancy testing [as applicable], baseline patient-reported outcome [PRO] assessments and safety data collection), subjects received a blinded IA injection of either LOR or PBO (as originally randomized in the parent [OA-11] study) into their target knee.
At Visit 3E (Week 48), upon completion of scheduled clinical, medical, safety and Patient-reported outcome (PRO) assessments, all subjects received an open-label injection of IA LOR into their target knee, such that previously PBO-treated subjects were effectively crossed over to the LOR treatment cohort.
Subjects were given the option to either receive a final injection of IA LOR into their target knee and complete both Visit 6E (Week 100) assessments and End-of-Study Visit assessments, or receive no injection and complete End-of-Study Visit assessments only. Subjects who had completed Visit 6E prior to the announcement of study closure were instructed to return to the clinic for End-of-Study Visit assessments.
Study OA-07's initial study design was to assess the safety and efficacy of additional treatment with LOR compared to PBO over one year and conclude at Visit 3E. The study was amended to become an open-label study at the Visit 3E that included an End-of-Study visit but without a specified time. The study was intended and described in the protocol to be run until such time as the Sponsor chose to close it. Study OA-07 was administratively closed at Visit 6E (Week 100), with no safety concerns, one year into the open-label study. For these reasons, Study OA-07 is considered a completed study.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Placebo, Lorecivivint
- Keywords
- SM04690, DYRK inhibitor, CLK inhibitor, Wnt pathway inhibitor, osteoarthritis, Biosplice Therapeutics, Inc., Samumed, lorecivivint
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Vehicle
Healthcare professional-administered intra-articular injection of vehicle.
LorecivivintDrug
Also called SM04690
Healthcare professional-administered intra-articular injections of lorecivivint.
| Study group | Role | What they receive |
|---|---|---|
| Lorecivivint | Experimental | Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1, at Week 48 and every 52 weeks thereafter. Receives: Drug: Lorecivivint |
| Placebo | Placebo comparator | Subjects assigned to this arm will receive one intra-articular injection of 0 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study) on Day 1, followed by one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle at Week 48 and every 52 weeks thereafter. Receives: Drug: Placebo; Drug: Lorecivivint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From OA-11-study Baseline Medial Joint Space Width (mJSW) in the Target Knee
Change from OA-11-study baseline in mJSW measured in millimeters as documented by radiograph (X-ray) of the target knee. JSW measurements were provided by a blinded, central imaging vendor using landmark-based, computer-assisted proprietary methodology.
Measured: OA-11-study baseline; Visit 3E (Week 48)
Change From OA-07-study Baseline OA Pain in the Target Knee
Change from OA-07-study baseline OA pain the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain).
The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function).
The WOMAC Pain subscore ranges from 0 [no pain] to 100 [pain as bad as it can be].
Measured: OA-07-study baseline; Visit 2E (Week 24)
Change From OA-07-study Baseline OA Function in the Target Knee
Change from OA-07-study baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function).
The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function).
The WOMAC Function subscore ranges from 0 [highest functional status] to 100 [most impaired functional status].
Measured: OA-07-study baseline; Visit 2E (Week 24)
Secondary outcomes (2)
Change From OA-07-study Baseline OA Pain in the Target Knee
Change from OA-07-study baseline OA pain the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain).
The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function).
The WOMAC Pain subscore ranges from 0 [no pain] to 100 [pain as bad as it can be].
Measured: OA-07-study baseline; Visit 3E (Week 48)
Change From OA-07-study Baseline OA Function in the Target Knee
Change from OA-07-study baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function).
The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function).
The WOMAC Function subscore ranges from 0 [highest functional status] to 100 [most impaired functional status].
Measured: OA-07-study baseline; Visit 3E (Week 48)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start25 Aug 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Why it stopped: Study OA-07 was designed to be conducted until the Sponsor closed it. Study OA-07 was administratively closed at Visit 6E (Week 100), with no safety concerns, one year into the open-label study as described in the protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosplice Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ismail Simsek, MD, Study director, Biosplice Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520607
- Sponsor's protocol ID
- SM04690-OA-07
- Status last verified
- Mar 2026
- First submitted
- 14 Aug 2020
- Last updated
- 24 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Extension Study Evaluating the Safety and Efficacy of Lorecivivint in Subjects With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT04520607
- Acronym / sponsor ID
- SM04690-OA-07
- Conditions
- Osteoarthritis, Knee
- Keywords
- SM04690, DYRK inhibitor, CLK inhibitor, Wnt pathway inhibitor, osteoarthritis, Biosplice Therapeutics, Inc., Samumed, lorecivivint
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study OA-07 was designed to be conducted until the Sponsor closed it. Study OA-07 was administratively closed at Visit 6E (Week 100), with no safety concerns, one year into the open-label study as described in the protocol.
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Biosplice Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 20 Aug 2020 (actual)
- Results
- Posted 24 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study OA-07 was a randomized, double-blind, placebo-controlled, Phase 3, multicenter, 2-year clinical trial that enrolled subjects from the recently completed Study OA-11 (NCT03928184).
The first 48 weeks of OA-07 the trial was placebo-controlled with subjects receiving the same randomized treatment received in OA-11. Investigators, research staff and subjects remained blinded to treatment allocation.
At Week 48, all subjects were administered LOR in the open-label portion of the trial.
Detailed description
At Visit 1E (on Day 1), upon completion of initial study procedures (e.g., informed consent, eligibility requirements, clinical evaluations including pregnancy testing [as applicable], baseline patient-reported outcome [PRO] assessments and safety data collection), subjects received a blinded IA injection of either LOR or PBO (as originally randomized in the parent [OA-11] study) into their target knee.
At Visit 3E (Week 48), upon completion of scheduled clinical, medical, safety and Patient-reported outcome (PRO) assessments, all subjects received an open-label injection of IA LOR into their target knee, such that previously PBO-treated subjects were effectively crossed over to the LOR treatment cohort.
Subjects were given the option to either receive a final injection of IA LOR into their target knee and complete both Visit 6E (Week 100) assessments and End-of-Study Visit assessments, or receive no injection and complete End-of-Study Visit assessments only. Subjects who had completed Visit 6E prior to the announcement of study closure were instructed to return to the clinic for End-of-Study Visit assessments.
Study OA-07's initial study design was to assess the safety and efficacy of additional treatment with LOR compared to PBO over one year and conclude at Visit 3E. The study was amended to become an open-label study at the Visit 3E that included an End-of-Study visit but without a specified time. The study was intended and described in the protocol to be run until such time as the Sponsor chose to close it. Study OA-07 was administratively closed at Visit 6E (Week 100), with no safety concerns, one year into the open-label study. For these reasons, Study OA-07 is considered a completed study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lorecivivint | Experimental | Drug: LorecivivintSubjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1, at Week 48 and every 52 weeks thereafter. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: LorecivivintSubjects assigned to this arm will receive one intra-articular injection of 0 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study) on Day 1, followed by one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle at Week 48 and every 52 weeks thereafter. |
Who may qualify
- Ages
- 41 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Completion of the Study SM04690-OA-11 (NCT03928184)
- Compliance with procedures in study SM04690-OA-11, in the opinion of the Investigator
- Fully understanding study requirements and willingness to comply with study visits and assessments
- Understanding and signing of the informed consent form (ICF) prior to any study-related procedures
Key exclusion criteria (7 listed)
- Any condition that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
- Any contraindications for an intra-articular (IA) injection in the target knee in the opinion of the Investigator
- Any known reason identified by the Investigator or Sponsor that the subject may not be compliant with study visits or may no longer be an appropriate candidate for the study (e.g. planned major surgery, knee replacement during the parent study, planning to move away from the research site, or initiation of a prohibited concomitant medication including, but not limited to, IA injection of glucocorticoids, hyaluronic acid derivatives, platelet-rich plasma, stem cell therapies, or other agents with therapeutic intent into the target knee)
- Participation in a clinical research trial (other than the prior SM04690-OA-11 study) that included the receipt of an investigational product (IP) or any experimental therapeutic procedure within 12 weeks before any study injection, or planned participation in any such trial
- Current or pending disability claim, workers' compensation, or litigation(s) that may compromise response to treatment
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 |
|---|---|---|
| PlaceboAlso: VehicleHealthcare professional-administered intra-articular injection of vehicle. | Drug | Placebo |
| LorecivivintAlso: SM04690Healthcare professional-administered intra-articular injections of lorecivivint. | Drug | Lorecivivint, Placebo |
Primary outcome
Change From OA-11-study Baseline Medial Joint Space Width (mJSW) in the Target Knee
Time frame: OA-11-study baseline; Visit 3E (Week 48)
Change from OA-11-study baseline in mJSW measured in millimeters as documented by radiograph (X-ray) of the target knee. JSW measurements were provided by a blinded, central imaging vendor using landmark-based, computer-assisted proprietary methodology.
Change From OA-07-study Baseline OA Pain in the Target Knee
Time frame: OA-07-study baseline; Visit 2E (Week 24)
Change from OA-07-study baseline OA pain the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain). The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore ranges from 0 [no pain] to 100 [pain as bad as it can be].
Change From OA-07-study Baseline OA Function in the Target Knee
Time frame: OA-07-study baseline; Visit 2E (Week 24)
Change from OA-07-study baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function). The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore ranges from 0 [highest functional status] to 100 [most impaired functional status].
2 secondary outcomes
Change From OA-07-study Baseline OA Pain in the Target Knee
Time frame: OA-07-study baseline; Visit 3E (Week 48)
Change From OA-07-study Baseline OA Function in the Target Knee
Time frame: OA-07-study baseline; Visit 3E (Week 48)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ismail Simsek, MD study director
Biosplice Therapeutics, Inc.
42 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 Lorecivivint in people with Osteoarthritis, Knee, run by Biosplice Therapeutics, Inc. at 42 sites in United States.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States. 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?
Yes. Results are posted in the registry (first posted 24 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From OA-11-study Baseline Medial Joint Space Width (mJSW) in the Target Knee (time frame: OA-11-study baseline; Visit 3E (Week 48)). The study lists 3 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 24 Mar 2026.