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AzTrials

Type 1 Diabetes (T1D)Phase 3PRISE-hATGNCT07670650

PRISE (Personalized Response and Immunologic Surveillance of Endogenous C-Peptide Preservation in New, Recent, and Established Onset Type 1 Diabetes Treated With Human Anti-Thymocyte Globulin [h-ATG]) Study

A Phase 3 study testing SAB-142 in people with Type 1 Diabetes (T1D), run by University of Florida at 4 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This Phase 3, multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety, and tolerability of SAB-142, a fully human anti-thymocyte globulin (h-ATG), in participants aged 5 to 40 years with Stage 3 type 1 diabetes (T1D). Read more about this study

Who is it for?
Ages 5 to 40 years
Conditions the study is for
Type 1 Diabetes (T1D)
What is being tested?
SAB-142
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
108 participants
Where
4 sitesUnited States
Study dates
1 Sep 2026to 1 Sep 2030
Phase
Phase 3
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 5 to 40 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Participant and/or appropriate legal guardian for participants below the legal age of consent must have given written informed consent and/or assent according to local, regional and/or country specific guidance before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. Participants and legal guardians must be capable of providing informed consent and not be incapacitated.
  • Males and females 5-40 years old*, inclusive, at the time of randomisation.
  • Note: Age step-down rules apply, as described in protocol Section 6.1.
  • Weight ≥16.0 kg at time of randomisation. Participants age 18-40 will have a body mass index (BMI) between 16 to 32 (inclusive).
  • Participant has received a diagnosis of T1D according to American Diabetes Association criteria (refer Section 22.1) as following:
  • For Cohort 2: within >100 days but <1 year (365 days) of randomisation;
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  • For Cohort 3: within ≥1 year (365 days) but <2 years (730 days) of randomisation. For participants who were initially misdiagnosed with Type 2 diabetes (T2D), time from misdiagnosis with T2D to randomisation is up to 1 and 2 years.
  • Note: Unless previously diagnosed with preclinical (Stage 1 or Stage 2 T1D), participant must have initiated insulin therapy the time of randomisation.
  • Participant has random C-peptide levels of >0.2 nmol/L, measured during Screening. One random C-peptide retest during screening period is allowed.
  • Participant completed all scheduled samples for C-peptide collected during the MMTT test during Screening.
  • Participant has a positive result on testing for at least one of the following T1D-related autoantibodies during screening:
  • Glutamic acid decarboxylase 65 (GAD65)
  • Islet antigen 2 (IA-2)
  • Zinc transporter 8 (ZnT8)
  • Insulin autoantibodies (if testing within the first 14 days of insulin treatment)
  • Female participants:
  • Must be of nonchildbearing potential, i.e., pre-pubertal*, surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the screening, or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle -stimulating hormone [FSH] level consistent with postmenopausal status, per local laboratory guidelines), or
  • If of childbearing potential, must:
  • i.Have a negative result on a serum (beta human chorionic gonadotropin [β-hCG]) at screening and a negative urine β-hCG pregnancy test prior to study drug administration on Day 1 of both treatment periods.
  • ii.Agree not to become pregnant or donate ova from the time of signing the consent form until the end of the study visit.
  • iii.If not exclusively in a same-sex relationship or abstinent as a committed lifestyle, must agree to use adequate contraception (which is defined as use of a condom by the male partner combined with use of a highly effective method of contraception [Section 11.3.1]) from the time of signing the consent and for the duration of the study.
  • Note: Female participants will be considered to be pre-pubertal (and of nonchildbearing potential) if they have not yet started menstruation. This should also be verified by the parent(s)/guardian(s). If a female participant reaches menarche during the study, then she is to be considered as a woman of childbearing potential from that time forwards, and contraceptive requirements will apply.
  • Male participants, if not biologically or surgically sterilised, must:
  • Agree not to donate sperm from the time of signing the consent form until End of Study (EOS).
  • If engaging in sexual intercourse with a female partner who could become pregnant, agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception [refer to Section 11.3.1]) from the time of signing the consent form until EOS.
  • If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, agree to use a condom from the time of signing the consent form until EOS.
  • Prior to receiving study drug, participant must agree to receive locally, regionally and/or country-specific required age-appropriate immunisations. Participants are advised but not required to comply with the guidelines for immunosuppressed individuals and those with chronic disease (diabetes mellitus) according to current local, regional and/or country-specific guidelines. Note: Vaccines are permitted within the timeframes specified in exclusion criterion #17.
  • Participant agrees not to receive other forms of experimental treatment from the time of signing informed consent and for the duration of the study, particularly agents that may be immune modulatory in nature and/or stimulate pancreatic β cell regeneration or insulin secretion.
  • Participant has suitable venous access for blood sampling.
  • Participant is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.

Who cannot join

  • Participant has known allergy, hypersensitivity or moderate to severe allergic reaction including anaphylaxis to natural or recombinant antibodies, biologic treatments, passive vaccines, pork, or any other component of the study drug formulation (including biologic medications). This includes participants with Hereditary Fructose Intolerance.
  • Participant has a known allergy or hypersensitivity to any of the protocol-required concomitant medications.
  • Participant has been an active participant in a therapeutic drug, invasive medical device, or vaccine clinical trial within 12 weeks before Screening Visit (SV)2.
  • Participant has received teplizumab or any investigational immunomodulatory anti-CD3 treatment within any timeframe prior to screening.
  • Participant has a significant uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, neurologic, haematologic, rheumatologic, oncologic, psychiatric, or immune deficiency that may interfere with the participant's safely participating in the study or with interpretation of the safety and/or efficacy profile of investigational medicinal product (IMP). For any disorders, a participant with a stable, well-controlled condition that is not felt to interfere with study participation may be enrolled.
  • Participant has any autoimmune disease other than T1D (e.g., latent autoimmune diabetes in adults, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythaematosis) that is currently managed with systemic immunotherapy, with the exception of clinically stable thyroid or celiac disease.
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  • Participant is prone to infections, or has chronic, recurrent or opportunistic infectious disease, including but not limited to renal, respiratory or skin infections, Pneumocystis carinii, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis.
  • Participant has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV)-1 or 2, hepatitis B virus (HBV), or hepatitis C virus (HCV) antibodies.
  • Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), and/or TB testing. Note: Blood testing (e.g., QuantiFERON® TB Gold test) is strongly preferred; if not available, any local approved TB test is allowed.
  • Serious systemic viral, bacterial, or fungal infection (e.g., pneumonia, pyelonephritis), infection requiring hospitalisation or IV anti-infective treatments or significant acute or chronic viral (including history of recurrent or active herpes zoster, acute or active CMV, EBV as determined at screening), bacterial, or fungal infection (e.g., osteomyelitis) 30 days before and during screening. Note: Participants with confirmed active EBV or CMV infection based on polymerase chain reaction (PCR) test can be retested; asymptomatic participants with the most recent PCR-negative (defined as PCR <1000 copies/mL or its equivalent in plasma or serum based on the site-specific PCR assay) test are eligible for participation. Participants with an active mild infection at Screening may be enrolled once the symptoms have resolved and all I/E are met. Participants who have an active infection and/or fever ≥38.0°C (100.4°F) within the 48 hours prior to dose administration should not be dosed.
  • Participant has a diagnosis of significant liver disease or at screening ALT and/or AST >2× or total bilirubin of >1.5× of the age- and sex-specific upper limit of normal (ULN) according to the site laboratory and confirmed by repeated tests. Liver function tests can be repeated during screening and if normalised, participant may be eligible for randomisation. Note: Participants with Gilbert's syndrome are allowed to enrol if only total and/or indirect bilirubin are elevated above ULN while ALT, AST, and alkaline phosphatase (ALP) are within the normal laboratory ranges.
  • An individual has any of the following haematologic parameters, confirmed by repeat tests, during Screening:
  • Lymphocyte count: <1000/μL
  • Neutrophil count: <1500/μL
  • Platelet count: <100 000 platelets/μL
  • Haemoglobin: <10 g/dL
  • Note: Specific haematologic, oncologic or other systemic conditions that might otherwise result in exclusion and/or is heretofore unrecognised should be considered in individuals who have one or more blood cell counts below or above the references ranges.
  • Current or prior (within 5× half-lives before SV2) treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status, including systemic glucocorticoids, verapamil, baricitinib, and others. Note: Inhaled and topical corticosteroids are allowed. Short courses, i.e., approximately 2 weeks or less, of systemic corticosteroids for transient conditions are allowed.
  • Current or prior (within 5× half-lives before SV2) use of drugs other than insulin to treat hyperglycaemia (e.g., metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, glucagon-like peptide 1 agonists [glucagon-like peptide-1], dipeptidyl peptidase-4 [DPP-IV] inhibitors, or amylin).
  • Current or prior (within 5× half-lives before SV2) use of any medication known to significantly influence glucose tolerance (e.g., atypical antipsychotics, diphenylhydantoin, niacin).
  • Current or planned highly restrictive dietary regimen(s) that would interfere with participant well-being or impact on the investigational drug.
  • Recent or planned vaccinations as follows:
  • Countries within the EU member states only:
  • Live vaccines (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox): from 30 days before dosing through 6 months following administration of SAB-142 for each TP;
  • Recombinant, inactivated or otherwise "non-live" vaccines: from 30 days before dosing or within 60 days following dosing; or planned/required within 30 days prior to or 60 days following Day 1 of TP2.
  • Live vaccines (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox): Within the 30 days before dosing or within 30 days following dosing; or planned/required within 30 days prior to or 30 days following Day 1 of each TP.
  • Recombinant, inactivated or otherwise "non-live" vaccines: Within the 30 days before dosing or within 30 days following dosing; or planned/required within 30 days prior to or 30 days following Day 1 of each TP.
  • Female is lactating and/or plans to lactate with the intent to provide her own breast milk to a baby at any point during the study.
  • An individual who has a history of alcohol, drug, or chemical abuse within 12 months prior to study screening (positive tetrahydrocannabinol is allowed) Note: Abuse is defined according to local, regional and/or country specific guidance. Participants who are tested positive for illicit substances but have a prescription medication to manage their concomitant conditions such as attention-deficit/hyperactivity disorder (ADHD) or others are allowed to participate in the study.
  • An individual who has a medical, psychological or social condition that, in the opinion of the Investigator, would interfere with safe and proper completion of the trial.
  • An individual who is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site. Note: Investigators should ensure that all study inclusion criteria and no study exclusion criteria have been met at screening. If a participant's clinical status changes (including any available laboratory results or receipt of additional medical records) after screening but before the first dose of study drug is given such that he or she no longer meets all eligibility criteria, then the participant should be excluded from participation in the study.
  • An individual who is considered failing to thrive or extremely obese may be excluded based on assessment by the PI or if participation in the study may place the participant at risk.
  • An individual who has been placed in an institution by official or court order.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Michael JH Haller, MD contact

(352) 273-9264

hallemj@peds.ufl.edu

Laura M Jacobsen contact

(352) 265-7337

lauraj@ufl.edu

United States4 sites

  • Barbara Davis Center for Diabetes

    Aurora, Colorado, 80045

  • University of Florida

    Gainesville, Florida, 32610

    Jennifer L Hosford, MPH, 352-294-5759, jennifer.hosford@peds.ufl.edu

    Laura Jacobsen, MD

  • IUH - Riley Hospital for Children - Riley Outpatient Center - Pediatric Diabetes & Endocrinology

    Indianapolis, Indiana, 46202

    Linda DiMeglio, MD, 317-274-7595, dimeglio@iu.edu

  • University of California San Francisco Benioff Children's Hospital

    San Francisco, California, 94158

    Stephen Gitelman, MD, 415-476-3748, Stephen.Gitelman@ucsf.edu

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of SAB-142 for Delaying the Progression of Type 1 Diabetes (T1D) in Patients With Stage 3 New Onset T1D, Recent Onset T1D, and Established T1D

This Phase 3, multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety, and tolerability of SAB-142, a fully human anti-thymocyte globulin (h-ATG), in participants aged 5 to 40 years with Stage 3 type 1 diabetes (T1D). The study will enroll participants with recent-onset T1D (>100 days to <1 year from diagnosis) and established-onset T1D (≥1 year to ≤2 years from diagnosis) who retain residual beta-cell function as demonstrated by stimulated C-peptide levels >0.2 nmol/L. Participants will be randomized in a 2:1 ratio to receive SAB-142 or placebo in addition to standard diabetes care. The primary objective is to determine whether SAB-142 preserves beta-cell function over 12 months as measured by stimulated C-peptide response during a mixed meal tolerance test (MMTT). External data from the SAB-142-201 SAFEGUARD study will be incorporated to include participants with new-onset T1D (<100 days from diagnosis) in the primary efficacy analysis.

Read the detailed description

Type 1 diabetes is an autoimmune disease characterized by progressive destruction of pancreatic beta cells. SAB-142 is a purified fully human multi-specific anti-thymocyte globulin designed to modulate autoimmune responses while potentially avoiding some of the immunogenicity and adverse effects associated with rabbit-derived anti-thymocyte globulin preparations. This study will evaluate whether SAB-142 preserves endogenous insulin production and improves clinical outcomes in participants with Stage 3 T1D who have residual beta-cell function.

The study consists of three disease-duration cohorts:

Cohort 1: New-onset T1D (<100 days from diagnosis; external data from SAB-142-201 SAFEGUARD) Cohort 2: Recent-onset T1D (>100 days to <365 days from diagnosis) Cohort 3: Established-onset T1D (365 to 730 days from diagnosis)

Approximately 72 participants will be enrolled into Cohorts 2 and 3 and randomized 2:1 to SAB-142 or placebo. An additional 36 age-matched participants from SAB-142-201 SAFEGUARD will comprise Cohort 1, resulting in a combined efficacy dataset of approximately 108 participants. Participants will receive an induction treatment period at baseline and a maintenance treatment period at Month 6. Follow-up continues through Month 12.

Being tested
SAB-142, Placebo
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAB-142Drug

    Treatment Period 1 (Induction)

    Day 1: SAB-142 0.5 mg/kg IV Day 2: SAB-142 2.0 mg/kg IV

    Treatment Period 2 (Month 6 Maintenance)

    Day 1: SAB-142 0.5 mg/kg IV Day 2: SAB-142 1.0 mg/kg IV

    Total induction dose: 2.5 mg/kg

    Total maintenance dose: 1.5 mg/kg

  • PlaceboDrug

    Placebo Comparator: Placebo

Study groups in NCT07670650
Study groupRoleWhat they receive
SAB-142ExperimentalSAB-142 in recent and established onset T1D
Receives: Drug: SAB-142
PlaceboPlacebo comparatorPlacebo Comparator
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the concentration-time curve (AUC) of C-peptide after a 2 hour mixed meal tolerance test (MMTT)

    This is a measure of endogenous insulin production and β cell function (change from baseline in C-peptide ln [AUC+1].

    Measured: Dose administration to 12 Months

Secondary outcomes (16)

  1. AUC of C-peptide after a 2-hour MMTT in a priori in vitro identified "responders" and "non-responders"

    This is achange from baseline in C--peptide ln [AUC+1] at 12 months) in a priori in vitro identified "responders" and "non-responders" to SAB-142 and compared to placebo.

    Measured: Baseline, Months 3, 6, 9 and 12

  2. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0

    Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs).

    Measured: Dose administration to 12 Months

  3. To evaluate the pharmacokinetics (PK) of SAB-142

    Evaluate SAB-142 serum concentrations over the infusion

    Measured: Days 1 and 2 of each treatment period (pre- and post-dose/end of infusion [EOI]), plus Week 1 for TP1 (for participants that attend the optional in-clinic visit), Week 4, and Months 3, and 7.

  4. To evaluate the immunogenicity of SAB-142

    Incidence and titres of anti-SAB-142 antibodies in serum including neutralising antibodies (nAbs) if indicated.

    Measured: Baseline, Week 1 (for participants that attend the optional in-clinic visit), Week 4, Months 3, 6, 7, 9, and 12.

  5. Immunophenotyping following SAB-142 administration will be performed on PBMC using flowcytometry

    Changes in immune cell populations following SAB-142 administration will be performed on PBMC using flowcytometry. All data will be reported as a percentage of lymphocytes and compared to baseline analysis. Populations to be tested:

    • CD3+CD4+ Tcells
    • CD3+CD8+ Tcells
    • CD19+ Bcells

    Measured: Baseline (Day 1, pre-dose), Week 4, Months 3, 6, 7, 9 and 12.

  6. Haemoglobin A1c (HbA1c) levels

    Hba1c is a key clinical parameter for looking at improvement in type 1 diabetes .Expressed in % and mmol/molmanagement

    Measured: Baseline, Months 3, 6, 9 and 12

  7. Time in Range (TIR)

    Expressed as a daily average of the percentage of time in a 24-hour day a participant's CGM reading is >70 but ≤180 mg/dL (>3.9 to ≤10.0 mmol/L), assessed by CGM

    Measured: Baseline, Months 3, 6, 9 and 12

  8. Improvement in Time in Tight Range (TITR)

    Expressed as a daily average of the percentage of time in a 24hour day a participant's glucose is >70 but ≤140 mg/dL (>3.9 to ≤7.8 mmol/L), assessed using continuous glucose monitoring (CGM)

    Measured: Baseline, Months 3, 6, 9 and 12

  9. Improvement in Time Below Range on a Continuous Glucose Monitor

    Time Below Range on a continuous glucose monitor is a key clinical indicator for improvement in type 1 diabetes management

    Measured: Baseline, Months 3, 6, 9 and 12

  10. Improvement in Time Above Range on a Continuous Glucose Monitor

    Time Above Range on a continuous glucose monitor is a key clinical indicator for improvement in type 1 diabetes management

    Measured: Baseline, Months 3, 6, 9 and 12

  11. Number of clinically important hypoglycemic episodes

    Defined as the total number of Level 2 and 3 hypoglycaemic events and/or episodes of cognitive impairment requiring external assistance for recovery (participant's diary and CGM-based).

    Measured: Baseline, Months 3, 6, 9 and 12

  12. Exogenous Insulin use

    Defined as a daily average in units per kilogram per day (U/kg/day) (total daily insulin based on participant's diary at predefined study periods).

    Measured: Baseline, Months 3, 6, 9 and 12

  13. Proportion of participants with partial clinical remission

    Defined as an insulin requirement of <0.25 units per kg of body weight per day and HbA1c <6.5% (47 mmol/mol).

    Measured: Baseline, Months 3, 6, 9 and 12

  14. Proportion of participants with partial remission

    Defined as insulin-dose adjusted A1c (IDAA1c) + [4 × insulin dose (units per kilogram per 24 h) ≤9

    Measured: Baseline, Months 3, 6, 9 and 12

  15. Total BETA-2 score

    A score comprised of fasting plasma glucose (mmol/L), HbA1c (%), daily insulin (U/kg), and fasting C-peptide (nmol/L)

    Measured: Baseline, Months 3, 6, 9 and 12

  16. Insulin dose-adjusted A1c (IDAA1C)

    Measured: Baseline, Months 3, 6, 9 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Mar 2029 (estimated)
  4. Study completion1 Sep 2030 (estimated)

Resources

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
Model description
Participants with recent-onset and established-onset Stage 3 T1D will be randomized in a 2:1 ratio to receive SAB-142 or placebo. Data from an external cohort of participants with new-onset T1D enrolled in the SAB-142-201 SAFEGUARD study will be incorporated into the primary efficacy analysis.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07670650
Sponsor's protocol ID
IRB202600427
Other IDs
2025-524787-37-00, U1111-1332-1701, 2025
Acronym
PRISE-hATG
Status last verified
Jun 2026
First submitted
8 Jun 2026
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SAB-142 in people with Type 1 Diabetes (T1D), run by University of Florida at 4 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 30 inclusion and 33 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 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

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?

Contact Michael JH Haller, MD ((352) 273-9264, hallemj@peds.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the concentration-time curve (AUC) of C-peptide after a 2 hour mixed meal tolerance test (MMTT) (time frame: Dose administration to 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07670650.

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 26 Jun 2026.

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