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AzTrials

Coeliac DiseasePhase 2NCT06557772

A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease

A Phase 2 study testing Amlitelimab, SIGE and Gluten-free product (GFP) in people with Coeliac Disease and Celiac Disease, run by Sanofi at 118 sites in 21 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 Phase 2a/b, randomized, double-blind, placebo-controlled, parallel-group, 6-arm study to evaluate the efficacy and safety of amlitelimab in adult participants with non-responsive celiac disease (NRCD) who are on a gluten free diet (GFD) with and without simulated inadvertent gluten exposure (SIGE). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Coeliac Disease, Celiac Disease
What is being tested?
Amlitelimab, SIGE and Gluten-free product (GFP)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
229 participants
Where
118 sitesin 21 countries
Study dates
29 Aug 2024to 10 Apr 2029
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

  • Participants must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
  • Participants with physician-diagnosed celiac disease with documented history of biopsy-proven celiac disease confirmed by medical records or physician statement.
  • Participants who have self-reported attempt to maintain a GFD (and confirmed via questionnaire) for at least 12 consecutive months and must be willing to maintain their current diet for the duration of study participation.
  • Participants have an adequate comprehension of a GFD as assessed by the Investigator.
  • Participants willing to undergo all assessments in the protocol, including 2 esophagogastroduodenoscopies with duodenal biopsies.
  • Participants who completed CDSD with ≥ 75% compliance from screening until randomization.
  • During screening, participants must have at least one gastrointestinal symptom (i.e., diarrhea, abdominal pain, bloating, or nausea) of moderate or greater severity, as measured by the CDSD Gastrointestinal Domain, on at least 3 days out of any consecutive 7-day period considered by the investigator to be related to gluten exposure (i.e., due to celiac disease). The symptom can vary, but severity must be moderate or greater on three or more days. Participants must meet symptom criteria to undergo baseline esophagogastroduodenoscopy (EGD).

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • A diagnosis of any severe complication of celiac disease, such as refractory celiac disease type 1 (RCD I) requiring immune suppressive medication, or type 2 (RCD II), enteropathy associated T-cell lymphoma (EATL), ulcerative jejunitis, or recent (within 12 months of screening) GI perforation.
  • Presence of other active inflammatory GI disorders, including but not limited to the following: inflammatory bowel disease, eosinophilic esophagitis, diverticulitis, helicobacter infection, gastroenteritis or colitis, and microscopic colitis (requiring treatment) in the 6 months before screening. A history of treated erosive esophagitis is not an exclusion. Abnormalities found during baseline EGD or biopsy that are consistent with an inflammatory GI disorder other than celiac disease are exclusionary.
  • Presence of other systemic autoimmune diseases including scleroderma, psoriatic or rheumatoid arthritis, and lupus. Participants with thyroid disease that has been well-controlled for at least 6 months, prior to screening, and participants with well-controlled type 1 diabetes (glycosylated hemoglobin < 9 % and no hospitalization or emergency room visit in the last 12 months for hyperglycemia or hypoglycemia) can be included per investigator judgement.
  • Known or suspected severe enteric infection (viral, bacterial, or parasitic) within 6 months before screening. Severe enteric infection is defined as requiring a visit to the emergency room, hospitalization, or treatment with antibiotics or anti-infectives due to infection. Non-enteric viral infections, either resolved or well-controlled are not exclusionary.
  • Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to screening (1 week in the event of superficial skin infections).
Show all 16Show fewer
  • Known history of or suspected significant current immunosuppression or hyposplenism, including history of invasive opportunistic or invasive helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
  • Any malignancies or history of malignancies prior to enrollment (except for non-melanoma skin cancer that has been excised and completely cured for more than 5 years prior to enrollment).
  • History of solid organ or stem cell transplant.
  • Ongoing use, or use in the 3 months before screening, of medications known to cause villus abnormalities (eg, mycophenolate mofetil, azathioprine, methotrexate, olmesartan (other angiotensin receptor blockers are allowed), CTLA4 inhibitors, and PD-1/PD-L1 inhibitors).
  • Ongoing chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) of more than 2 doses per week, except acetylsalicylic acid/aspirin ≤100 mg daily for prophylactic use.
  • Any ongoing treatment with systemic immunosuppressants, systemic corticosteroids, or use of oral budesonide in the 12 weeks before screening.
  • Ongoing use of over-the-counter digestive enzymes or supplements, other than lactase, including those for gluten digestion and oral pharmaceutical probiotic supplements. Probiotics in foods (e.g., yogurt) are permitted.
  • Concurrent participation in any other clinical study, including non-interventional studies.
  • Prior administration of investigational agents to treat celiac disease within 5 half-lives of any agent, or one year from any tolerogenic agent.
  • 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

118 sites in 21 countries.

118 sites in 21 countries

United States35 sites

  • FOMAT Medical Research - inSite Digestive Health Care - Arcadia- Site Number : 8400052

    Arcadia, California, 91006

  • Treasure Valley Medical Research- Site Number : 8400006

    Boise, Idaho, 83706

  • Boston Specialists- Site Number : 8400051

    Boston, Massachusetts, 02111

  • Texas Digestive Disease Consultants - Cedar Park- Site Number : 8400030

    Cedar Park, Texas, 78613

  • M3 Wake Research - Chattanooga- Site Number : 8400012

    Chattanooga, Tennessee, 37421

  • Advanced Research Institute - Denver- Site Number : 8400048

    Denver, Colorado, 80218

  • Velocity Clinical Research - Providence- Site Number : 8400002

    East Greenwich, Rhode Island, 02818

  • Sanmora Bespoke Clinical Research Solutions- Site Number : 8400015

    East Orange, New Jersey, 07018

  • Allied Digestive Health - Middlesex Monmouth Gastroenterology- Site Number : 8400053

    Freehold, New Jersey, 07728

  • MedCare Pharma - Houston - Cypress Creek Parkway- Site Number : 8400016

    Houston, Texas, 77090

  • Hutchinson Clinic- Site Number : 8400020

    Hutchinson, Kansas, 67502

  • University of Kansas Medical Center- Site Number : 8400041

    Kansas City, Kansas, 66160

  • Om Research- Site Number : 8400001

    Lancaster, California, 93534

  • United Medical Doctors - Los Alamitos- Site Number : 8400014

    Los Alamitos, California, 90720

  • Gastroenterology Associates of Central Virginia- Site Number : 8400057

    Lynchburg, Virginia, 24502

  • Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400040

    Miami Lakes, Florida, 33016

  • Quality Medical Research- Site Number : 8400018

    Nashville, Tennessee, 37211

  • Advanced Research Institute - Odgen- Site Number : 8400044

    Ogden, Utah, 84405

  • Center for Digestive Health- Site Number : 8400013

    Orlando, Florida, 32803

  • Om Research- Site Number : 8400010

    Oxnard, California, 93030

  • LinQ Research - Smith Ranch Road- Site Number : 8400028

    Pearland, Texas, 77584

  • Thomas Jefferson University Hospital- Site Number : 8400056

    Philadelphia, Pennsylvania, 19107

  • Berkshire Medical Center- Site Number : 8400017

    Pittsfield, Massachusetts, 01201

  • M3 Wake Research- Site Number : 8400008

    Raleigh, North Carolina, 27612

  • Advanced Research Institute - Reno- Site Number : 8400036

    Reno, Nevada, 89511

  • Clinical Research Partners - Richmond - Forest Avenue- Site Number : 8400011

    Richmond, Virginia, 23220

  • Mayo Clinic in Rochester - Minnesota- Site Number : 8400049

    Rochester, Minnesota, 55905

  • Advanced Research Institute - Sandy - South 1300 East- Site Number : 8400046

    Sandy City, Utah, 84094

  • One of a Kind Clinical Research Center - Scottsdale- Site Number : 8400055

    Scottsdale, Arizona, 85253

  • Washington University- Site Number : 8400025

    St Louis, Missouri, 63110

  • GI Alliance - Tacoma- Site Number : 8400033

    Tacoma, Washington, 98405

  • GCP Clinical Research- Site Number : 8400007

    Tampa, Florida, 33609

  • DM Clinical Research - Tomball- Site Number : 8400042

    Tomball, Texas, 77375

  • Velocity Clinical Research - Salt Lake City- Site Number : 8400023

    West Jordan, Utah, 84088

  • Gastroenterology Associates of Western Michigan - Wyoming- Site Number : 8400004

    Wyoming, Michigan, 49519

Other trials in United States

Argentina9 sites

  • Investigational Site Number : 0320012

    Buenos Aires, Buenos Aires F.D., 1061

  • Investigational Site Number : 0320007

    Buenos Aires, 1006

  • Investigational Site Number : 0320009

    Buenos Aires, 1119

  • Investigational Site Number : 0320001

    Buenos Aires, 1128

  • Investigational Site Number : 0320003

    Córdoba, 5000

  • Investigational Site Number : 0320010

    Quilmes, Buenos Aires, 1878

  • Investigational Site Number : 0320005

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320008

    San Isidro, Buenos Aires, 1642

  • Investigational Site Number : 0320002

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Spain9 sites

  • Investigational Site Number : 7240006

    Barcelona, Barcelona [Barcelona], 08035

  • Investigational Site Number : 7240009

    Chiclana de la Frontera, Cádiz, 11139

  • Investigational Site Number : 7240011

    Las Palmas de Gran Canaria, Las Palmas, 35010

  • Investigational Site Number : 7240007

    Madrid, 28003

  • Investigational Site Number : 7240003

    Madrid, 28034

  • Investigational Site Number : 7240004

    Málaga, 29010

  • Investigational Site Number : 7240002

    Seville, Sevilla, 41013

  • Investigational Site Number : 7240008

    Seville, 41012

  • Investigational Site Number : 7240010

    Seville, 41012

Other trials in Spain

Brazil6 sites

  • Chronos Pesquisa Clínica- Site Number : 0760002

    Brasília, Federal District, 72145-450

  • Hospital Moinhos de Vento- Site Number : 0760004

    Porto Alegre, Rio Grande do Sul, 90035-902

  • Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital Sao Rafael- Site Number : 0760005

    Salvador, Estado de Bahia, 41253-190

  • Centro de Pesquisas da Clínica IBIS- Site Number : 0760006

    Salvador, Estado de Bahia, 41820-020

  • Praxis Pesquisas Medicas- Site Number : 0760008

    Santo André, São Paulo, 09090-790

Other trials in Brazil

Chile6 sites

  • Investigational Site Number : 1520006

    Concepción, Biobio, 4070038

  • Investigational Site Number : 1520007

    Santiago, Reg Metropolitana de Santiago, 7510086

  • Investigational Site Number : 1520004

    Santiago, Reg Metropolitana de Santiago, 7620001

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8330034

  • Investigational Site Number : 1520008

    Santiago, Reg Metropolitana de Santiago, 8331143

  • Investigational Site Number : 1520005

    Talcahuano, Biobio, 2687000

Other trials in Chile

Israel6 sites

  • Investigational Site Number : 3760002

    Afula, 1834111

  • Investigational Site Number : 3760006

    Beersheba, 8457108

  • Investigational Site Number : 3760004

    Jerusalem, 9103102

  • Investigational Site Number : 3760003

    Petah Tikva, 4941492

  • Investigational Site Number : 3760007

    Ramat HaSharon, 4731001

  • Investigational Site Number : 3760001

    Rehovot, 7610001

Other trials in Israel

Turkey (Türkiye)6 sites

  • Investigational Site Number : 7920004

    Antalya, 07100

  • Investigational Site Number : 7920003

    Gaziantep, 27310

  • Investigational Site Number : 7920006

    Istanbul, 34899

  • Investigational Site Number : 7920007

    Izmir, 35100

  • Investigational Site Number : 7920001

    Mersin, 33070

  • Investigational Site Number : 7920005

    Sanliurfa, 63290

Other trials in Turkey (Türkiye)

Czechia5 sites

  • Investigational Site Number : 2030002

    Brno, 636 00

  • Investigational Site Number : 2030006

    Havířov, 736 01

  • Investigational Site Number : 2030005

    Klatovy, 339 01

  • Investigational Site Number : 2030001

    Prague, 118 33

  • Investigational Site Number : 2030003

    Prague, 150 06

Other trials in Czechia

Germany4 sites

  • Investigational Site Number : 2760006

    Berlin, 10117

  • Investigational Site Number : 2760004

    Berlin, 12203

  • Investigational Site Number : 2760001

    Halle, 06108

  • Investigational Site Number : 2760002

    Mainz, 55131

Other trials in Germany

Poland4 sites

  • Investigational Site Number : 6160001

    Krakow, Lesser Poland Voivodeship, 31-501

  • Investigational Site Number : 6160004

    Poznan, Greater Poland Voivodeship, 60-529

  • Investigational Site Number : 6160002

    Warsaw, Masovian Voivodeship, 02-507

  • Investigational Site Number : 6160005

    Wroclaw, Lower Silesian Voivodeship, 50-088

Other trials in Poland

Sweden4 sites

  • Investigational Site Number : 7522001

    Linköping, 582 16

  • Investigational Site Number : 7521001

    Mölndal, 431 53

  • Investigational Site Number : 7520003

    Stockholm, 116 91

  • Investigational Site Number : 7520001

    Uppsala, 752 37

Other trials in Sweden

Australia3 sites

  • Investigational Site Number : 0360001

    Mackay, Queensland, 4740

  • Investigational Site Number : 0360005

    Melbourne, Victoria, 3128

  • Investigational Site Number : 0360002

    Sydney, New South Wales, 2560

Other trials in Australia

Finland3 sites

  • Investigational Site Number : 2460002

    Helsinki, 00180

  • Investigational Site Number : 2460003

    Helsinki, 00270

  • Investigational Site Number : 2460001

    Turku, 20520

Other trials in Finland

Italy3 sites

  • Ospedale Maggiore Policlinico Milano-Site Number : 3800002

    Milan, Milano, 20122

  • Azienda Ospedaliera di Padova-Site Number : 3800004

    Padua, Padova, 35128

  • Ospedale di Cisanello-Site Number : 3800003

    Pisa, 56124

Other trials in Italy

Slovakia3 sites

  • Investigational Site Number : 7030001

    Košice, 040 13

  • Investigational Site Number : 7030003

    Nitra, 950 01

  • Investigational Site Number : 7030004

    Šahy, 936 01

Other trials in Slovakia

Belgium2 sites

  • Investigational Site Number : 0560002

    Brussels, 1200

  • Investigational Site Number : 0560001

    Leuven, 3000

Other trials in Belgium

Canada2 sites

  • Investigational Site Number : 1240001

    Vancouver, British Columbia, V6Z 2K5

  • Investigational Site Number : 1240002

    Victoria, British Columbia, V8V 3M9

Other trials in Canada

France2 sites

  • Investigational Site Number : 2500002

    Nice, 06202

  • Investigational Site Number : 2500001

    Paris, 75015

Other trials in France

Greece2 sites

  • Investigational Site Number : 3000001

    Athens, 106 76

  • Investigational Site Number : 3000002

    Athens, 115 27

Other trials in Greece

Netherlands2 sites

  • Investigational Site Number : 5280001

    Amsterdam, 1081 HV

  • Investigational Site Number : 5280002

    Arnhem, 6815 AD

Other trials in Netherlands

United Kingdom2 sites

  • Investigational Site Number : 8260001

    Oxford, Oxfordshire, OX3 9DU

  • Investigational Site Number : 8260002

    Sheffield, S5 7AU

Other trials in United Kingdom

About this study

Official title: A Phase 2a/b, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Subcutaneous Amlitelimab in Adult Patients With Nonresponsive Celiac Disease as an Adjunct to a Gluten-free Diet

This is a Phase 2a/b, randomized, double-blind, placebo-controlled, parallel-group, 6-arm study to evaluate the efficacy and safety of amlitelimab in adult participants with non-responsive celiac disease (NRCD) who are on a gluten free diet (GFD) with and without simulated inadvertent gluten exposure (SIGE).

The primary purpose of this study is to demonstrate the efficacy of subcutaneous (SC) amlitelimab in male and female participants (aged 18 to 75 years, inclusive) with NRCD. The study will assess the effect of amlitelimab when compared to placebo on gluten induced changes in the intestinal mucosa as measured by the villous height to crypt depth (Vh:Cd) ratio. The effect of amlitelimab on participant-reported celiac signs and symptoms along with the safety, tolerability, and pharmacokinetics of amlitelimab will also be studied.

Read more

Study details include:

The study duration will be up to 48 weeks (including a 16-week safety follow-up period) with 10 visits for participants who opt not to enter the optional long-term extension.

The study duration will be up to 172 weeks (including an 8-week safety follow-up period) with 22 visits for participants who enter the optional long-term extension.

The double-blind placebo-controlled treatment duration will be up to 28 weeks.

Being tested
Amlitelimab, Placebo, SIGE, Gluten-free product (GFP)
Medical subject headings
Celiac Disease

What participants receive

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

  • AmlitelimabDrug

    Also called SAR445229

    Pharmaceutical form: Injection solution Route of administration: SC injection

  • PlaceboDrug

    Pharmaceutical form: Injection solution Route of administration: SC injection

  • SIGEDietary supplement

    Pharmaceutical form: Capsule Route of administration: Oral

  • Gluten-free product (GFP)Dietary supplement

    Pharmaceutical form: Capsule Route of administration: Oral

Study groups in NCT06557772
Study groupRoleWhat they receive
Amlitelimab dose 1 + Gluten-free product (GFP)ExperimentalAmlitelimab SC as per protocol + GFP
Receives: Drug: Amlitelimab; Dietary Supplement: Gluten-free product (GFP)
Amlitelimab dose 2 + GFPExperimentalAmlitelimab SC as per protocol + GFP
Receives: Drug: Amlitelimab; Dietary Supplement: Gluten-free product (GFP)
Amlitelimab dose 3 + GFPExperimentalAmlitelimab SC as per protocol + GFP
Receives: Drug: Amlitelimab; Dietary Supplement: Gluten-free product (GFP)
Amlitelimab dose 1 + SIGEExperimentalAmlitelimab SC as per protocol + SIGE
Receives: Drug: Amlitelimab; Dietary Supplement: SIGE
Placebo + GFPPlacebo comparatorPlacebo SC as per protocol + GFP
Receives: Drug: Placebo; Dietary Supplement: Gluten-free product (GFP)
Placebo + SIGEPlacebo comparatorPlacebo SC as per protocol + SIGE
Receives: Drug: Placebo; Dietary Supplement: SIGE

What is being measured

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

  1. Change in Villus Height to Crypt Depth Ratio (Vh:Cd) from baseline to Week 28

    Change in Vh:Cd ratio.

    Measured: Baseline to Week 28

Secondary outcomes (6)

  1. Change in Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) symptom severity score

    The CDSD is a patient report outcome instrument that assesses common celiac symptoms (abdominal pain, bloating, tiredness, nausea, and diarrhea). GI symptom severity score ranges from 0-20 with higher score indicating more severe disease.

    Measured: Baseline to Week 28

  2. Percentage of participants who experienced treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESI) during the placebo-controlled treatment period and the long-term extension

    Measured: Baseline to Week 168

  3. Percentage of participants with potentially clinically significant abnormalities (PCSA) for vital signs and clinical laboratory assessments during the placebo-controlled treatment period and the long-term extension

    Measured: Baseline to Week 168

  4. Percentage of participants discontinued from study treatment due to TEAEs during the placebo-controlled treatment period and the long-term extension

    Measured: Baseline to Week 168

  5. Serum amlitelimab concentrations measured at prespecified timepoints

    Measured: Baseline to Week 168

  6. Incidence of antidrug antibodies (ADAs) of amlitelimab

    Measured: Baseline to Week 168

Timeline

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

  1. First posted16 Aug 2024
  2. Study start29 Aug 2024
  3. Primary completion5 Aug 2026
  4. Study completion10 Apr 2029 (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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
229 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06557772
Sponsor's protocol ID
DRI17963
Other IDs
2024-511213-38, U1111-1298-7193
Status last verified
Aug 2026
First submitted
14 Aug 2024
Last updated
31 Aug 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Amlitelimab, SIGE and Gluten-free product (GFP) in people with Coeliac Disease and Celiac Disease, run by Sanofi at 118 sites in 21 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 7 inclusion and 16 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 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in United States, Argentina, Spain, Brazil, Chile and 16 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 Villus Height to Crypt Depth Ratio (Vh:Cd) from baseline to Week 28 (time frame: Baseline to Week 28). 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 NCT06557772.

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 31 Aug 2026.

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