Behcet's DiseasePhase 2NCT06902428
Evaluating the Efficacy and Safety of of HSK44459 in Patients With Behçet's Disease
A Phase 2 study testing HSK44459 in people with Behcet's Disease, run by Haisco Pharmaceutical Group Co., Ltd..
Trial summary
This is a phase 2, multi-center, randomised, double-blind, placebo-controlled study with an equal randomization among the HSK44459 dose 1, dose 2 and placebo treatment groups. The main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Behcet's Disease
- What is being tested?
- HSK44459
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 24 Mar 2025to 3 Jul 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged between 18 and 75 years (inclusive) at the time of signing the informed consent document.
- Diagnosed with Behçet's disease (BD) meeting the International Criteria for Behçet's Disease (ICBD, ICBD-2013) criteria.
- Suffered from at least 3 episodes of oral ulcers within 12 months prior to randomization.
- Had at least 2 oral ulcers present during the Screening Phase.
- Had received drug treatment for Behçet's disease.
- Eligible for systemic treatment of oral ulcers.
- Consented to participate in this trial, and voluntarily signed the informed consent form.
Who cannot join
- Active involvement of major organs related to Behçet's disease - pulmonary (eg, pulmonary artery aneurysms), vascular (eg, thrombophlebitis), gastrointestinal (eg, gastrointestinal ulcers), and central nervous system (eg, meningoencephalitis) manifestations, and ocular lesions (eg, uveitis) requiring immunosuppressive treatment.
- Subjects who have received the following immunomodulatory treatments, including:
- Hydroxychloroquine was used within 5 days prior to randomization;
- Colchicine was used within 7 days prior to randomization;
- Azathioprine, mycophenolate mofetil, baricitinib, or tofacitinib was used within 10 days prior to randomization;
- Cyclosporine, methotrexate, cyclophosphamide, thalidomide, or dapsone was used within 4 weeks (28 days) prior to randomization;
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- Biological agents were used within 5 half-lives prior to randomization;
- Subjects who have received systemic corticosteroid treatment prior to randomization;
- Subjects who have used traditional Chinese patent medicines with immunomodulatory effects within 2 weeks prior to randomization; those who have taken traditional Chinese patent medicines that may affect the efficacy within 2 weeks prior to randomization;
- Patients who have previously received systemic treatment with phosphodiesterase 4 (PDE4) inhibitors;
- Patients who have used a strong CYP3A4 inhibitor or inducer within 14 days prior to randomization or within 5 pharmacokinetic half-lives (whichever is longer); and patients who insist on taking a strong CYP3A4 inhibitor or inducer during the study period;
- Subjects who have used any investigational medicinal product within 4 weeks prior to randomization or within 5 pharmacokinetic half-lives (whichever is longer);
- Laboratory tests during the screening period:
- Hemoglobin ≤ 90g/L;
- White blood cell count < 3.0×10⁹/L or white blood cell count > 14×10⁹/L;
- Platelets < 100×10⁹/L;
- Estimated Glomerular Filtration Rate (eGFR) ≤ 45 ml/min/1.73 m²;
- Total bilirubin > 1.5×ULN;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are both > 1.5×ULN;
- Subjects with clinically significant abnormalities in chest X-ray or CT examination at the time of screening, and as judged by the investigator, may place the subject at safety risk;
- Subjects with a history of active or recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis and atypical mycobacteriosis, hepatitis B and C, and herpes zoster, but excluding onychomycosis) at the time of screening, or any episode of severe infection within 4 weeks prior to screening that required hospitalization or treatment with intravenous or oral antibiotics;
- Subjects with other autoimmune diseases or immune-related chronic inflammatory diseases at the time of screening, such as rheumatic fever, rheumatoid arthritis, systemic lupus erythematosus, etc.;
- Subjects who have undergone or plan to undergo major surgery (evaluated as major surgery by the investigator) within 3 months prior to screening or during the study period;
- Subjects whose blood pressure was still not controlled after treatment with antihypertensive drugs within 3 months prior to screening, and whose blood pressure was ≥ 160/100 mmHg during the screening period;
- Subjects who had a thromboembolic event (including stroke and transient ischemic attack) within 6 months prior to screening;
- Subjects who had any clinically significant heart disease (such as but not limited to unstable ischemic heart disease, NYHA class III/IV left ventricular failure, or myocardial infarction) discovered within 6 months prior to screening or those with clinically significant 12-lead electrocardiogram abnormalities, and as judged by the investigator, may place the subject at safety risk or may interfere with the study evaluation;
- Subjects with a history of attempted suicide within 2 years prior to screening, or a history of major psychiatric illness requiring hospitalization within 3 years prior to screening;
- Subjects with a history of malignant tumor within 5 years prior to screening (except for patients with treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin, or in situ cervical cancer);
- History of gastrointestinal surgery or diseases (excluding appendectomy or simple hernia repair) that may interfere with the pharmacokinetics (PK) of the investigational drug;
- Subjects with active hepatitis B (positive for hepatitis B surface antigen (HBsAg) and hepatitis B virus DNA (HBV-DNA) higher than the upper limit of the normal range), positive for hepatitis C antibody, syphilis infection (positive for anti-TP test), or human immunodeficiency virus (HIV) infection (positive for anti-HIV) during the screening period;
- Subjects with a history of drug abuse, drug use, or excessive alcohol consumption within 3 months prior to screening. Excessive alcohol consumption means an average daily alcohol intake of > 2 units of alcohol;
- Subjects with a history of severe drug allergy or those allergic to the investigational medicinal product specified in the protocol;
- Pregnant and lactating women, or women who plan to become pregnant or breastfeed during the study period;
- Subjects whom the investigator deems to have any other factors that make them unsuitable for participating in this clinical study.
About this study
Official title: A Multi-center, Randomised, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of HSK44459 Tablets in Patients With Behçet's Disease
This is a phase 2, multi-center, randomised, double-blind, placebo-controlled study with an equal randomization among the HSK44459 dose 1, dose 2 and placebo treatment groups. The main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic.
Read the detailed description
This study is a phase 2, multi-center, randomized, double - blind, placebo - controlled study designed to evaluate the efficacy and safety of HSK44459 in the treatment of patients with Behçet Disease (BD). Approximately 120 subjects will be randomized into this study.
The entire study will consist of 3 phases: a screening phase, a 12-week treatment phase, and a 4-week follow-up phase.
Screening: All subjects will undergo a screening period of up to 6 weeks before the first dose (Visit 3, Day 1).
Treatment phase: Eligible BD patients will be randomly assigned to the HSK44459 dose 1 group, the HSK44459 dose 2 group, or the placebo group. During the treatment period, HSK44459 or placebo will be administered twice daily for 12 weeks.
Follow-up phase: Subjects in the study (including those who withdraw from treatment for any reason) will have an additional 4 - week follow-up after the end of the last administration.
- Conditions
- Behcet's Disease
- Being tested
- HSK44459, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK44459Drug
HSK44459, bid p.o.
PlaceboDrug
Placebo, bid p.o.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | In treatment period, subject will take placebo matching HSK44459 twice daily in the morning and in the evening for 12 weeks. The administration time of the drug should be relatively fixed every day. Receives: Drug: Placebo |
| HSK44459 dose 1 | Experimental | In treatment period, subject will take higher dose of HSK44459 twice daily in the morning and in the evening for 12 weeks. The administration time of the drug should be relatively fixed every day. Receives: Drug: HSK44459 |
| HSK44459 dose 2 | Experimental | In treatment period, subject will take lower dose of HSK44459 twice daily in the morning and in the evening for 12 weeks. The administration time of the drug should be relatively fixed every day. Receives: Drug: HSK44459 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve for the Number of Oral Ulcers From Baseline Through treatment period.
For the analysis of the primary endpoint, the count of oral ulcers included both existing and recurrent ulcers at each time point.
Measured: 12 weeks
Secondary outcomes (16)
Percentage of Participants Who Experienced an Oral Ulcer Complete Response at Week 12
A complete response at week 12 was defined as participants being free of oral ulcers at that time point.
Measured: 12 weeks
Baseline in Oral Ulcer Pain as Measured by Visual Analog Scale at Week 12
The pain of oral ulcers was gauged via a 100-millimeter Visual Analog Scale. Participants were instructed to mark a single perpendicular line across the VAS at a position that corresponded to the intensity of their oral-ulcer pain experienced in the preceding 2 weeks. On this scale, 0 mm (the left-hand extremity) signified the absence of pain, while 100 mm (the right-hand extremity) represented the most excruciating pain one could envision. The measurement from the left-hand end of the scale to the perpendicular line was documented.
Measured: 12 weeks
Percentage of Participants Who Experienced a Complete Response For Genital Ulcers at Week 12
A complete response at week 12 was defined as participants being free of genital ulcers at that time point.
Measured: 12 weeks
Change From Baseline in Genital Ulcer Pain as Measured by VAS Score at Week 12
The pain of genital ulcers was gauged via a 100-millimeter Visual Analog Scale. Participants were instructed to mark a single perpendicular line across the VAS at a position that corresponded to the intensity of their genital-ulcer pain experienced in the preceding 2 weeks. On this scale, 0 mm (the left-hand extremity) signified the absence of pain, while 100 mm (the right-hand extremity) represented the most excruciating pain one could envision. The measurement from the left-hand end of the scale to the perpendicular line was documented.
Measured: 12 weeks
Change From Baseline in Disease Activity as Measured by Behçet's Disease Current Activity Form (BDCAF) at Week 12
The Behçet's Disease Current Activity Form (BDCAF) is composed of three component scores, namely the Behçet's Disease Current Activity Index (BDCAI) score, the Patient's Perception of Disease Activity, and the Clinician's Overall Perception of Disease Activity. The BDCAI encompasses 12 questions that focus on disease manifestations occurring within the past 4 weeks. These manifestations include the activity of oral and genital diseases, along with other symptoms of Behçet's Disease (BD) affecting the skin, joints, gastrointestinal (GI) tract, eyes, nervous system, and vascular system. The BDCAI score is calculated as the sum of the scores for these 12 items and can range from 0 to 12. A higher score on the BDCAI indicates a more severe level of disease activity (i.e., the condition is worsening).
Measured: 12 weeks
Change From Baseline in Disease Activity as Measured by Behçet's Syndrome Activity Score (BSAS) at Week 12
The Behçet's Syndrome Activity Score (BSAS) is composed of 10 questions that assess the number of new oral and genital ulcers and skin lesions, GI, CNS, vascular, and ocular involvement, and the participant's current level of discomfort. The Behçet's Syndrome Activity Score spans from 0 to 100. A higher score on this scale corresponds to a more severe level of disease activity. When there is a decrease in the score compared to the baseline value, it indicates an improvement in the patient's condition.
Measured: 12 weeks
Change From Baseline in Behçet's Disease Quality of Life (BD Qol) Scores at Week 12
The Behçet's Disease Quality of Life (BDQoL) questionnaire was designed to assess the impact of Behçet's disease on a participant's daily life. It includes 30 self-administered questions that evaluate the limitations imposed by the disease on the participant's activities and their emotional reactions to these limitations. The overall score is calculated by summing the responses to all 30 items, where each "yes" response is scored as 1 and each "no" response as 0. A total score of 0 indicates no effect of Behçet's disease on the participant's quality of life, while a score of 30 reflects the most significant impact. A decrease in the score from baseline signifies an improvement in the participant's quality of life.
Measured: 12 weeks
Change From Baseline in Quality of Life as Measured by Short Form 36 Health Survey
The SF-36 is a validated, self-administered 36-item general health status instrument often used in clinical trials and health services research. It consists of 8 scales: physical function (PF), role-physical (RP), vitality (VT), general health (GH), bodily pain (BP), social function (SF), role-emotional (RE), and mental health (MH).
Measured: 12 weeks
Time to Oral Ulcer Complete Response
The time to complete response of oral ulcers was defined as the interval from the date of the first dose to the date when a complete response was first attained during the treatment phase.
Measured: 12 weeks
Percentage of Participants Exhibiting No Oral Ulcers After a Complete Response
The definition encompasses participants who, subsequent to achieving a complete response (characterized by the absence of oral ulcers) prior to week 12, maintained an oral ulcer-free status throughout the entirety of the period up to and including week 12.
Measured: 12 weeks
Percentage of Participants Who Achieved an Oral Ulcer Complete Response at Week 6 and Remained Oral Ulcer-Free for at Least 6 Additional Weeks
Participants who were oral ulcer-free at week 6 and maintained an oral ulcer-free status throughout the entirety of the period up to and including week 12.
Measured: 12 weeks
Number of recurrences of oral ulcers after complete response through week 12
The number of oral ulcers reported upon the initial loss of complete response. This refers to the first occurrence where, subsequent to achieving complete response, a participant experiences a recurrence of oral ulcers during the treatment phase.
Measured: 12 weeks
The incidence rate and severity of adverse events
An Adverse Event (AE) refers to all adverse medical events that occur to subjects in a clinical study. It can manifest as symptoms/signs, diseases, or abnormal laboratory test results, but it is not necessarily causally related to the investigational medicinal product. In this study, all adverse events that occur from the time of signing the informed consent form until the end of the safety follow-up period will be recorded.
Measured: 16 weeks
Maximum Plasma Concentration (Cmax)
the population pharmacokinetic (popPK) characteristics Cmax of HSK44459 in subjects
Measured: 12 weeks
Elimination half-life (T1/2)
the population pharmacokinetic (popPK) characteristics T1/2 of HSK44459 in subjects
Measured: 12 weeks
Area under drug time curve (AUC)
the population pharmacokinetic (popPK) characteristics AUC of HSK44459 in subjects
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start24 Mar 2025 (estimated)
- Primary completion5 Jun 2026 (estimated)
- Study completion3 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behcet's DiseaseStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902428
- Sponsor's protocol ID
- HSK44459-202
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 30 Mar 2025
- 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 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomised, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of HSK44459 Tablets in Patients With Behçet's Disease
- ClinicalTrials.gov ID
- NCT06902428
- Acronym / sponsor ID
- HSK44459-202
- Conditions
- Behcet's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2025 (estimated)
- Primary completion
- 5 Jun 2026 (estimated)
- Study completion
- 3 Jul 2026 (estimated)
- First posted
- 30 Mar 2025 (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.
This is a phase 2, multi-center, randomised, double-blind, placebo-controlled study with an equal randomization among the HSK44459 dose 1, dose 2 and placebo treatment groups. The main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic.
Detailed description
This study is a phase 2, multi-center, randomized, double - blind, placebo - controlled study designed to evaluate the efficacy and safety of HSK44459 in the treatment of patients with Behçet Disease (BD). Approximately 120 subjects will be randomized into this study.
The entire study will consist of 3 phases: a screening phase, a 12-week treatment phase, and a 4-week follow-up phase.
Screening: All subjects will undergo a screening period of up to 6 weeks before the first dose (Visit 3, Day 1).
Treatment phase: Eligible BD patients will be randomly assigned to the HSK44459 dose 1 group, the HSK44459 dose 2 group, or the placebo group. During the treatment period, HSK44459 or placebo will be administered twice daily for 12 weeks.
Follow-up phase: Subjects in the study (including those who withdraw from treatment for any reason) will have an additional 4 - week follow-up after the end of the last administration.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboIn treatment period, subject will take placebo matching HSK44459 twice daily in the morning and in the evening for 12 weeks. The administration time of the drug should be relatively fixed every day. |
| HSK44459 dose 1 | Experimental | Drug: HSK44459In treatment period, subject will take higher dose of HSK44459 twice daily in the morning and in the evening for 12 weeks. The administration time of the drug should be relatively fixed every day. |
| HSK44459 dose 2 | Experimental | Drug: HSK44459In treatment period, subject will take lower dose of HSK44459 twice daily in the morning and in the evening for 12 weeks. The administration time of the drug should be relatively fixed every day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female subjects aged between 18 and 75 years (inclusive) at the time of signing the informed consent document.
- Diagnosed with Behçet's disease (BD) meeting the International Criteria for Behçet's Disease (ICBD, ICBD-2013) criteria.
- Suffered from at least 3 episodes of oral ulcers within 12 months prior to randomization.
- Had at least 2 oral ulcers present during the Screening Phase.
- Had received drug treatment for Behçet's disease.
Key exclusion criteria (34 listed)
- Active involvement of major organs related to Behçet's disease - pulmonary (eg, pulmonary artery aneurysms), vascular (eg, thrombophlebitis), gastrointestinal (eg, gastrointestinal ulcers), and central nervous system (eg, meningoencephalitis) manifestations, and ocular lesions (eg, uveitis) requiring immunosuppressive treatment.
- Subjects who have received the following immunomodulatory treatments, including:
- Subjects who have received systemic corticosteroid treatment prior to randomization;
- Subjects who have used traditional Chinese patent medicines with immunomodulatory effects within 2 weeks prior to randomization; those who have taken traditional Chinese patent medicines that may affect the efficacy within 2 weeks prior to randomization;
- Patients who have previously received systemic treatment with phosphodiesterase 4 (PDE4) inhibitors;
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 |
|---|---|---|
| HSK44459HSK44459, bid p.o. | Drug | HSK44459 dose 1, HSK44459 dose 2 |
| PlaceboPlacebo, bid p.o. | Drug | Placebo |
Primary outcome
Area Under the Curve for the Number of Oral Ulcers From Baseline Through treatment period.
Time frame: 12 weeks
For the analysis of the primary endpoint, the count of oral ulcers included both existing and recurrent ulcers at each time point.
16 secondary outcomes
Percentage of Participants Who Experienced an Oral Ulcer Complete Response at Week 12
Time frame: 12 weeks
Baseline in Oral Ulcer Pain as Measured by Visual Analog Scale at Week 12
Time frame: 12 weeks
Percentage of Participants Who Experienced a Complete Response For Genital Ulcers at Week 12
Time frame: 12 weeks
Change From Baseline in Genital Ulcer Pain as Measured by VAS Score at Week 12
Time frame: 12 weeks
Change From Baseline in Disease Activity as Measured by Behçet's Disease Current Activity Form (BDCAF) at Week 12
Time frame: 12 weeks
Change From Baseline in Disease Activity as Measured by Behçet's Syndrome Activity Score (BSAS) at Week 12
Time frame: 12 weeks
Change From Baseline in Behçet's Disease Quality of Life (BD Qol) Scores at Week 12
Time frame: 12 weeks
Change From Baseline in Quality of Life as Measured by Short Form 36 Health Survey
Time frame: 12 weeks
Time to Oral Ulcer Complete Response
Time frame: 12 weeks
Percentage of Participants Exhibiting No Oral Ulcers After a Complete Response
Time frame: 12 weeks
Percentage of Participants Who Achieved an Oral Ulcer Complete Response at Week 6 and Remained Oral Ulcer-Free for at Least 6 Additional Weeks
Time frame: 12 weeks
Number of recurrences of oral ulcers after complete response through week 12
Time frame: 12 weeks
The incidence rate and severity of adverse events
Time frame: 16 weeks
Maximum Plasma Concentration (Cmax)
Time frame: 12 weeks
Elimination half-life (T1/2)
Time frame: 12 weeks
Area under drug time curve (AUC)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HSK44459 in people with Behcet's Disease, run by Haisco Pharmaceutical Group Co., Ltd..
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 7 inclusion and 34 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: opening soon, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Area Under the Curve for the Number of Oral Ulcers From Baseline Through treatment period. (time frame: 12 weeks). 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 30 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.