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Type 1 Diabetes MellitusPhase 2FABULINUSNCT06111586

Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults and Adolescents on Top of Insulin Therapy (FABULINUS)

A Phase 2 study testing Frexalimab and Insulin in people with Type 1 Diabetes Mellitus, run by Sanofi at 79 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a randomized, parallel group, double-blind Phase 2 study with a blinded extension evaluating the safety and efficacy of 3 dose levels of frexalimab in comparison with placebo in participants with newly diagnosed T1D on insulin treatment. Read more about this study

Who is it for?
Ages 12 to 35 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Frexalimab and Insulin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
197 participants
Where
79 sitesin 16 countries
Study dates
11 Dec 2023to 29 Oct 2030
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 12 to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Participants who meet the criteria of T1D according to American Diabetes Association
  • Initiated exogenous insulin replacement therapy not longer than 90 days prior to screening visit at which random C-peptide will be assessed (V1).
  • Receiving at least one of the following T1D standard of care (SOC), insulin hormone replacement therapy
  • one or multiple daily injections (MDI) of basal insulin, prandial insulin and/or premixed insulin, or
  • continuous subcutaneous insulin infusion (CSII)
  • Participants must be positive for at least 1 of the following T1D autoantibodies confirmed by medical history and/or obtained at study screening:
Show all 14Show fewer
  • Glutamic acid decarboxylase (GAD-65)
  • Insulinoma Antigen-2 (IA-2)
  • Zinc-transporter 8 (ZnT8) or
  • Insulin (if obtained not later than 10 days after exogenous insulin therapy initiation)
  • Have random C-peptide levels ≥ 0.2 nmol/L determined at screening visit.
  • Be vaccinated according to the local vaccination schedule. Any vaccinations should take place at least 28 days prior to randomization for non-live vaccines and at least 3 months prior to randomization for live vaccines.
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
  • Participants body weight at screening must be at least 20kg.

Who cannot join

  • Serious systemic viral, bacterial or fungal infection (eg, pneumonia, pyelonephritis), infection requiring hospitalization or IV antibiotics or significant chronic viral (including history of recurrent or active herpes zoster, acute or active cytomegalovirus (CMV), Epstein-Barr Virus (EBV) as determined at screening), bacterial, or fungal infection (eg, osteomyelitis) 30 days before and during screening.
  • Participants with a history of invasive opportunistic infections, such as, but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, and aspergillosis, regardless of resolution.
  • 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. Blood testing (eg, QuantiFERON® TB Gold test) is strongly preferred; if not available, any local approved TB test is allowed.
  • Evidence of any clinically significant, severe or unstable, acute or chronically progressive, uncontrolled infection, medical or surgical condition (eg, but not limited to, cerebral, cardiac, pulmonary, renal, hepatic, gastrointestinal, neurologic, acquired or inherited bone/skeletal disorders including repeated bone fractures for unknown reason, juvenile osteoporosis, osteogenesis imperfecta, osteochondropathies, or any known immune deficiency), or any condition that may affect participant safety in the judgment of the Investigator (including vaccinations which are not updated based on local regulation).
  • History or current hypogammaglobulinemia.
  • History of a systemic hypersensitivity reaction or significant allergies, other than localized injection site reaction, to any humanized mAb. Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
Show all 20Show fewer
  • Has other autoimmune diseases (eg, rheumatoid arthritis [RA], polyarticular juvenile idiopathic arthritis [pJIA], psoriatic arthritis [PsA], ankylosing spondylitis [AS], MS, SLE), that require treatment with biologic drugs (mono or polyclonal antibodies) or systemic corticosteroid therapy (at discretion of investigator).
  • History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, antiphospholipid syndrome, other prothrombotic disorders and/or participants requiring antithrombotic treatment.
  • Diabetes of forms other than autoimmune T1D that include but is not limited to genetic forms of diabetes, maturity-onset diabetes of the young (MODY), latent autoimmune diabetes of the adult (LADA), secondary to medications or surgery, type 2 diabetes by judgement of the investigator.
  • History of malignancy of any organ system, treated or untreated, within 5 years of screening, regardless of whether there is evidence of local recurrence or metastases.
  • Systemic corticosteroids (duration > 7 days), adrenocorticotropic hormone 1 month prior to screening.
  • Any IV, IM or SC administered biologic treatments, < 3 months or < than 5 half-lives (whichever is longer), prior to randomization.
  • Any live (attenuated or viral-vector) vaccine (including but not limited to varicella zoster, oral polio, nasal influenza, rabies) within 3 months prior to randomization.
  • Any non-live (inactivated, mRNA, recombinant, conjugate, toxoid) vaccine administered less than 28 days prior to randomization.
  • Other medications not compatible or interfering with IMP at discretion of investigator.
  • Any immunosuppressive therapy within 12 weeks prior to randomization.
  • Course of Thymoglobulin®, teplizumab or other immunomodulatory treatments at any time.
  • Any drugs that may be used for treatment of T1D and type 2 diabetes other than insulin including but not limited to metformin, glucagon-like peptide 1 (GLP-1) agonists and sodium-glucose co-transporter-2 and 1 (SGLT2/1) inhibitor and verapamil within 2 weeks prior to screening.
  • Abnormal laboratory test(s) at screening.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

79 sites in 16 countries.

79 sites in 16 countries

United States14 sites

  • University of Colorado - Anschutz Medical Campus- Site Number : 8400003

    Aurora, Colorado, 80045

  • Joslin Diabetes Center - Boston- Site Number : 8400015

    Boston, Massachusetts, 02215

  • University at Buffalo - Downtown Campus- Site Number : 8400004

    Buffalo, New York, 14203

  • University of North Carolina at Chapel Hill- Site Number : 8400001

    Chapel Hill, North Carolina, 27514

  • Cincinnati Children's Hospital Medical Center- Site Number : 8400019

    Cincinnati, Ohio, 45229

  • University of Texas - Southwestern Medical Center- Site Number : 8400011

    Dallas, Texas, 75390

  • University of Florida College of Medicine- Site Number : 8400010

    Gainesville, Florida, 32610

  • Rocky Mountain Diabetes and Osteoporosis Center- Site Number : 8400009

    Idaho Falls, Idaho, 83404

  • University of Miami Hospital- Site Number : 8400013

    Miami, Florida, 33136

  • AdventHealth Orlando- Site Number : 8400002

    Orlando, Florida, 32803

  • The Children's Hospital of Philadelphia Site Number : 8400005

    Philadelphia, Pennsylvania, 19104

  • University of California San Francisco - Mission Bay- Site Number : 8400012

    San Francisco, California, 94158

  • Benaroya Research Institute at Virginia Mason- Site Number : 8400016

    Seattle, Washington, 98101

  • NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400007

    Skokie, Illinois, 60077

Other trials in United States

Italy8 sites

  • Azienda Ospedaliera Universitaria Meyer IRCCS-Site Number : 3800003

    Florence, Firenze, 50139

  • IRCCS Ospedale San Raffaele-Site Number : 3800006

    Milan, Milano, 20132

  • Azienda Ospedaliera Universitaria 'Federico II'-Site Number : 3800009

    Naples, Napoli, 80131

  • Azienda Ospedaliero-Universitaria Maggiore Della Carità-Site Number : 3800001

    Novara, 28100

  • Ospedale Pediatrico Bambin Gesu IRCCS-Site Number : 3800007

    Rome, Roma, 00165

  • AOU delle Marche - Ospedale G. Salesi-Site Number : 3800008

    Torette, Ancona, 60020

  • Azienda Socio Sanitaria Territoriale Dei Sette Laghi - Ospedale Filippo del Ponte-Site Number : 3800002

    Varese, 21100

  • Azienda Ospedaliera Universitaria Integrata Verona - Centro regionale di Diabetologia Pediatrica-Site Number : 3800004

    Verona, 37126

Other trials in Italy

Poland7 sites

  • Investigational Site Number : 6160008

    Bialystok, Podlaskie Voivodeship, 15-274

  • Investigational Site Number : 6160002

    Katowice, Silesian Voivodeship, 40-752

  • Investigational Site Number : 6160005

    Lodz, Lódzkie, 92-213

  • Investigational Site Number : 6160009

    Szczecin, West Pomeranian Voivodeship, 71-252

  • Investigational Site Number : 6160006

    Warsaw, Masovian Voivodeship, 02-097

  • Investigational Site Number : 6160004

    Warsaw, Masovian Voivodeship, 02-117

  • Investigational Site Number : 6160007

    Warsaw, Masovian Voivodeship, 04-746

Other trials in Poland

Spain7 sites

  • Investigational Site Number : 7240001

    Barcelona, Barcelona [Barcelona], 08035

  • Investigational Site Number : 7240002

    Esplugues de Llobregat, Barcelona [Barcelona], 08950

  • Investigational Site Number : 7240004

    Málaga, 29010

  • Investigational Site Number : 7240005

    Oviedo, Principality of Asturias, 33011

  • Investigational Site Number : 7240003

    Seville, Sevilla, 41009

  • Investigational Site Number : 7240006

    Valencia, 46010

  • Investigational Site Number : 7240007

    Vitoria-Gasteiz, Álava, 01009

Other trials in Spain

United Kingdom7 sites

  • Investigational Site Number : 8260003

    Birmingham, England, B15 2TH

  • Investigational Site Number : 8260007

    Birmingham, England, B4 6NH

  • Investigational Site Number : 8260001

    Cambridge, Cambridgeshire, CB2 2QQ

  • Investigational Site Number : 8260009

    Dundee, Dundee City, DD1 9SY

  • Investigational Site Number : 8260010

    Glasgow, Glasgow City, G51 4TF

  • Investigational Site Number : 8260006

    Harrow, London, City of, HA1 3UJ

  • Investigational Site Number : 8260004

    Leicester, Leicestershire, LE5 4PW

Other trials in United Kingdom

Canada5 sites

  • Investigational Site Number : 1240007

    London, Ontario, N6a 4l6

  • Investigational Site Number : 1240005

    Montreal, Quebec, H3T 1C5

  • Investigational Site Number : 1240004

    Montreal, Quebec, H4a 3j1

  • Investigational Site Number : 1240003

    Montreal, Quebec, H4A 3T2

  • Investigational Site Number : 1240001

    Vancouver, British Columbia, V5Y 3W2

Other trials in Canada

France5 sites

  • Investigational Site Number : 2500004

    Corbeil-Essonnes, 91106

  • Investigational Site Number : 2500005

    Mont-de-Marsan, 40024

  • Investigational Site Number : 2500006

    Paris, 75679

  • Investigational Site Number : 2500007

    Pontoise, 95300

  • Investigational Site Number : 2500003

    Saint-Herblain, 44800

Other trials in France

Hungary5 sites

  • Investigational Site Number : 3480001

    Balatonfüred, 8230

  • Investigational Site Number : 3480004

    Budapest, 1089

  • Investigational Site Number : 3480002

    Nyíregyháza, 4400

  • Investigational Site Number : 3480003

    Nyíregyháza, 4400

  • Investigational Site Number : 3480006

    Székesfehérvár, 8000

Other trials in Hungary

Finland4 sites

  • Investigational Site Number : 2460001

    Helsinki, 00029

  • Investigational Site Number : 2460004

    Oulu, 90220

  • Investigational Site Number : 2460003

    Tampere, 33520

  • Investigational Site Number : 2460002

    Turku, 20521

Other trials in Finland

Germany4 sites

  • Investigational Site Number : 2760003

    Dresden, 01307

  • Investigational Site Number : 2760001

    Hanover, 30173

  • Investigational Site Number : 2760002

    Oldenburg in Holstein, 23758

  • Investigational Site Number : 2760004

    Ulm, 89081

Other trials in Germany

Austria3 sites

  • Investigational Site Number : 0400002

    Graz, 8036

  • Investigational Site Number : 0400004

    Linz, 4020

  • Investigational Site Number : 0400001

    Vienna, 1090

Other trials in Austria

Czechia3 sites

  • Investigational Site Number : 2030003

    Ostrava, 708 52

  • Investigational Site Number : 2030002

    Prague, 100 34

  • Investigational Site Number : 2030001

    Prague, 150 06

Other trials in Czechia

Sweden3 sites

  • Investigational Site Number : 7520002

    Solna, 171 64

  • Investigational Site Number : 7520001

    Stockholm, 113 65

  • Investigational Site Number : 7520003

    Stockholm, 118 83

Other trials in Sweden

Belgium2 sites

  • Investigational Site Number : 0560002

    Brussels, 1090

  • Investigational Site Number : 0560001

    Leuven, 3000

Other trials in Belgium

Denmark1 site

  • Investigational Site Number : 2080005

    Herlev, 2730

Other trials in Denmark

Slovenia1 site

  • Investigational Site Number : 7050001

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Phase 2b Study With a Blinded Extension and an Optional Open-label Extension-Assessing the Safety and Efficacy of Frexalimab, a CD40L-antagonist Monoclonal Antibody, for the Preservation of Pancreatic β-cell Function in Adults and Adolescents With Newly Diagnosed Type 1 Diabetes on Insulin Therapy

This is a randomized, parallel group, double-blind Phase 2 study with a blinded extension evaluating the safety and efficacy of 3 dose levels of frexalimab in comparison with placebo in participants with newly diagnosed T1D on insulin treatment.

Study details include:

Read more

Screening period: at least 3 weeks and up to 5 weeks. Enrollment date of the participant must take into consideration this constraint)

Double-blind treatment period 104 weeks:

Main treatment period: 52 weeks Blinded extension: 52 weeks Optional OLE period: 104 weeks Safety follow-up: 26 weeks The treatment duration will be up to 104 weeks , the total study duration will be up to 135 weeks for Part A and Part B.

If participants enter the OLE period, the treatment duration will be up to approximately 208 weeks , and the total study duration will be 240 weeks approximately .

Being tested
Frexalimab, Placebo, Insulin
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.

  • FrexalimabDrug

    IV Infusion at Day 1 SC Injection from W2 to W102

  • PlaceboDrug

    IV Infusion at Day 1 SC Injection from W2 to W102

  • InsulinDrug

    SC injection, dose and frequency will be established and/or adjusted by investigator

Study groups in NCT06111586
Study groupRoleWhat they receive
Frexalimab Dose 1ExperimentalNot described
Receives: Drug: Frexalimab; Drug: Insulin
Frexalimab Dose 2ExperimentalNot described
Receives: Drug: Frexalimab; Drug: Insulin
Frexalimab Dose 3ExperimentalNot described
Receives: Drug: Frexalimab; Drug: Insulin
PlaceboPlacebo comparatorMatching Placebo
Receives: Drug: Placebo; Drug: Insulin

What is being measured

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

  1. Change in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from AUC from baseline to W52 for Part B (12-21 y.o.)

    mixed meal tolerance test (MMTT) stimulated C-peptide concentration is to be calculated from AUC

    Measured: Baseline to Week 52

Secondary outcomes (27)

  1. Time in range (70-180 mg/dL), assessed by CGM at W52 and W104(part B)

    Measured: At Week 52 and Week 104

  2. Proportion of participants who remain C-peptide positive (mean 2h MMTT stimulated C-peptide concentration ≥0.2 nmol/L) at W52 and W104(part B)

    mixed meal tolerance test (MMTT) stimulated C-peptide concentration is to be calculated from AUC

    Measured: At Week 52 and Week 104

  3. Proportion of participants with reduction from baseline to W52 and W104 of less than 10% in mean 2h MMTT stimulated C-peptide concentration(part B)

    mixed meal tolerance test (MMTT) stimulated C-peptide concentration is to be calculated from AUC

    Measured: From baseline to Week 52 and Week 104

  4. Proportion of participants with partial remission at W52 and W104 (defined as IDAA1c score ≤9.0, where it is calculated as HbA1c [%] + 4x insulin dose [IU/kg/day])(part B)

    Measured: At Week 52 and Week 104

  5. Change from baseline to W52 and W104 in insulin dose [IU/kg/day](part B)

    Measured: From baseline to Week 52 and Week 104

  6. HbA1c level at Week 52 and Week 104(part B)

    Measured: at Week 52 and Week 104

  7. Proportion of participants with HbA1c ≤6.5% and requiring no injections of exogenous insulin at W52 and W104(part B)

    Measured: At Week 52 and Week 104

  8. Proportion of participants with HbA1c ≤6.5% and requiring ≤0.25 IU of insulin at W52 and W104(part B)

    Measured: At Week 52 and Week 104

  9. Proportion of participants with HbA1c <7% at W52 and W104(part B)

    Measured: At Week 52 and Week 104

  10. Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs) and TEAEs leading to treatment discontinuation

    Measured: Until Week 130

  11. Number of participants with at least one hypoglycemic event

    Measured: Until Week 130

  12. Number of participants with at least one hyperglycemic episode

    Measured: Until Week 130

  13. Number of participants with at least one diabetic ketoacidosis (DKA) event

    Measured: Until Week 130

  14. Number of participants with clinically significant changes in vital signs, electrocardiogram (ECG), and/or laboratory evaluation

    Measured: Until Week 130

  15. Height and growth rate over time (for participants <18 y.o. at screening)

    Measured: Until Week 130

  16. Frexalimab plasma concentrations over time

    Measured: Until Week 104

  17. Incidence of anti-drug antibodies (ADAs) over time

    Measured: Until Week 130

  18. Change from baseline to W52 and W104 in PedsQL Diabetes Symptoms domain score (all participants≥8 y.o.) (part B)

    Measured: From baseline to Week 52 and Week 104

  19. Change from baseline to W52 and W104 in Pediatric Quality of Life (PedsQL) Diabetes Management domain score (all participants≥8 y.o.) (part B)

    Measured: From baseline to Week 52 and Week 104

  20. Change from baseline to W52 and W104 in Problem Areas In Diabetes (PAID) total score (all participants)(part B)

    Measured: From baseline to Week 52 and Week 104

  21. Change from baseline to W52 and W104 in Diabetes Treatment Satisfaction Questionnaires (DTSQs) total and item scores (all participants)(part B)

    Measured: From baseline to Week 52 and Week 104

  22. Change from baseline to W52 and W104 in PAID immediate and theoretical domain scores (caregivers of all participants 12-17 y.o.)(part B)

    Measured: From baseline to Week 52 and Week 104

  23. Change from baseline to W52 and W104 in DTSQs Total and item scores (caregivers of all participants 12-17 y.o.)(part B)

    Measured: From baseline to Week 52 and Week 104

  24. Time in tight range (TITR, 70 - 140 mg/dL), assessed by CGM at W52 and W104(part B)

    Measured: Time in tight range (TITR, 70 - 140 mg/dL), assessed by CGM at W52 and W104

  25. Change from baseline to W104 in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from AUC(part B)

    Measured: From baseline to Week 104

  26. Change from baseline to W52 and W104 in IDAA1c score(part B)

    Measured: From baseline to Week 52

  27. HbA1c level change from baseline to Week 52 and Week 104(part B)

    Measured: From baseline to Week 52 and Week 104

Timeline

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

  1. First posted1 Nov 2023
  2. Study start11 Dec 2023
  3. Primary completion28 Apr 2027 (estimated)
  4. Study completion29 Oct 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06111586
Sponsor's protocol ID
DRI17476
Other IDs
U1111-1275-9618, 2022-500531-36
Acronym
FABULINUS
Status last verified
Oct 2026
First submitted
27 Oct 2023
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Cherkas A, Rotthaeuser B, Porksen N, Labard P, Nguyen-Pascal ML, Coudert M, Berthou B, Baccara-Dinet M, Boka G, Peakman M, Reschke F, Haller MJ. A Phase 2 Trial of Frexalimab, a CD40L Antagonist, in Adolescents and Adults With Recent-Onset Type 1 Diabetes (FABULINUS): Rationale and Study Design. Diabetes Obes Metab. 2026 Aug;28(8):6584-6594. doi: 10.1111/dom.70785. Epub 2026 May 27.

    PubMed 42203212

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Frexalimab and Insulin in people with Type 1 Diabetes Mellitus, run by Sanofi at 79 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in United States, Italy, Poland, Spain, United Kingdom and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 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?

Change in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from AUC from baseline to W52 for Part B (12-21 y.o.) (time frame: Baseline to Week 52). 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 NCT06111586, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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