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

February 24, 2026 updated by: Sanofi

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

229

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1006
        • Investigational Site Number : 0320007
      • Buenos Aires, Argentina, 1119
        • Investigational Site Number : 0320009
      • Buenos Aires, Argentina, 1128
        • Investigational Site Number : 0320001
      • Córdoba, Argentina, 5000
        • Investigational Site Number : 0320003
    • Buenos Aires
      • Quilmes, Buenos Aires, Argentina, 1878
        • Investigational Site Number : 0320010
      • San Isidro, Buenos Aires, Argentina, 1642
        • Investigational Site Number : 0320008
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, 1061
        • Investigational Site Number : 0320012
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Investigational Site Number : 0320005
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Investigational Site Number : 0320002
  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2560
        • Investigational Site Number : 0360002
    • Queensland
      • Mackay, Queensland, Australia, 4740
        • Investigational Site Number : 0360001
    • Victoria
      • Melbourne, Victoria, Australia, 3128
        • Investigational Site Number : 0360005
  • Belgium
      • Brussels, Belgium, 1200
        • Investigational Site Number : 0560002
      • Leuven, Belgium, 3000
        • Investigational Site Number : 0560001
  • Brazil
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 41253-190
        • Hospital Sao Rafael- Site Number : 0760005
      • Salvador, Estado de Bahia, Brazil, 41820-020
        • Centro de Pesquisas da Clínica IBIS- Site Number : 0760006
    • Federal District
      • Brasília, Federal District, Brazil, 72145-450
        • Chronos Pesquisa Clínica- Site Number : 0760002
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-902
        • Hospital Moinhos de Vento- Site Number : 0760004
    • São Paulo
      • Santo André, São Paulo, Brazil, 09090-790
        • Praxis Pesquisas Medicas- Site Number : 0760008
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Investigational Site Number : 1240001
      • Victoria, British Columbia, Canada, V8V 3M9
        • Investigational Site Number : 1240002
  • Chile
    • Reg Metropolitana de Santiago
      • Santiago, Reg Metropolitana de Santiago, Chile, 7510086
        • Investigational Site Number : 1520007
      • Santiago, Reg Metropolitana de Santiago, Chile, 7620001
        • Investigational Site Number : 1520004
      • Santiago, Reg Metropolitana de Santiago, Chile, 8330034
        • Investigational Site Number : 1520001
      • Santiago, Reg Metropolitana de Santiago, Chile, 8331143
        • Investigational Site Number : 1520008
    • Región del Biobío
      • Concepción, Región del Biobío, Chile, 4070038
        • Investigational Site Number : 1520006
      • Talcahuano, Región del Biobío, Chile, 2687000
        • Investigational Site Number : 1520005
  • Czechia
      • Brno, Czechia, 636 00
        • Investigational Site Number : 2030002
      • Havířov, Czechia, 736 01
        • Investigational Site Number : 2030006
      • Klatovy, Czechia, 339 01
        • Investigational Site Number : 2030005
      • Prague, Czechia, 118 33
        • Investigational Site Number : 2030001
      • Prague, Czechia, 150 06
        • Investigational Site Number : 2030003
  • Finland
      • Helsinki, Finland, 00180
        • Investigational Site Number : 2460002
      • Helsinki, Finland, 00270
        • Investigational Site Number : 2460003
      • Turku, Finland, 20520
        • Investigational Site Number : 2460001
  • France
      • Nice, France, 06202
        • Investigational Site Number : 2500002
      • Paris, France, 75015
        • Investigational Site Number : 2500001
  • Germany
      • Berlin, Germany, 10117
        • Investigational Site Number : 2760006
      • Berlin, Germany, 12203
        • Investigational Site Number : 2760004
      • Halle, Germany, 06108
        • Investigational Site Number : 2760001
      • Mainz, Germany, 55131
        • Investigational Site Number : 2760002
  • Greece
      • Athens, Greece, 115 27
        • Investigational Site Number : 3000002
      • Athens, Greece, 106 76
        • Investigational Site Number : 3000001
  • Israel
      • Afula, Israel, 1834111
        • Investigational Site Number : 3760002
      • Beersheba, Israel, 8457108
        • Investigational Site Number : 3760006
      • Jerusalem, Israel, 9103102
        • Investigational Site Number : 3760004
      • Petah Tikva, Israel, 4941492
        • Investigational Site Number : 3760003
      • Ramat HaSharon, Israel, 4731001
        • Investigational Site Number : 3760007
      • Rehovot, Israel, 7610001
        • Investigational Site Number : 3760001
  • Italy
      • Pisa, Italy, 56124
        • Ospedale di Cisanello-Site Number : 3800003
    • Milano
      • Milan, Milano, Italy, 20122
        • Ospedale Maggiore Policlinico Milano-Site Number : 3800002
    • Padova
      • Padua, Padova, Italy, 35128
        • Azienda Ospedaliera di Padova-Site Number : 3800004
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Investigational Site Number : 5280001
      • Arnhem, Netherlands, 6815 AD
        • Investigational Site Number : 5280002
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-529
        • Investigational Site Number : 6160004
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-501
        • Investigational Site Number : 6160001
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-088
        • Investigational Site Number : 6160005
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-507
        • Investigational Site Number : 6160002
  • Slovakia
      • Košice, Slovakia, 040 13
        • Investigational Site Number : 7030001
      • Nitra, Slovakia, 950 01
        • Investigational Site Number : 7030003
      • Šahy, Slovakia, 936 01
        • Investigational Site Number : 7030004
  • Spain
      • Madrid, Spain, 28034
        • Investigational Site Number : 7240003
      • Madrid, Spain, 28003
        • Investigational Site Number : 7240007
      • Málaga, Spain, 29010
        • Investigational Site Number : 7240004
      • Seville, Spain, 41012
        • Investigational Site Number : 7240008
      • Seville, Spain, 41012
        • Investigational Site Number : 7240010
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Investigational Site Number : 7240006
    • Cádiz
      • Chiclana de la Frontera, Cádiz, Spain, 11139
        • Investigational Site Number : 7240009
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
        • Investigational Site Number : 7240011
    • Sevilla
      • Seville, Sevilla, Spain, 41013
        • Investigational Site Number : 7240002
  • Sweden
      • Linköping, Sweden, 582 16
        • Investigational Site Number : 7522001
      • Mölndal, Sweden, 431 53
        • Investigational Site Number : 7521001
      • Stockholm, Sweden, 116 91
        • Investigational Site Number : 7520003
      • Uppsala, Sweden, 752 37
        • Investigational Site Number : 7520001
  • Turkey (Türkiye)
      • Antalya, Turkey (Türkiye), 07100
        • Investigational Site Number : 7920004
      • Gaziantep, Turkey (Türkiye), 27310
        • Investigational Site Number : 7920003
      • Istanbul, Turkey (Türkiye), 34899
        • Investigational Site Number : 7920006
      • Izmir, Turkey (Türkiye), 35100
        • Investigational Site Number : 7920007
      • Mersin, Turkey (Türkiye), 33070
        • Investigational Site Number : 7920001
      • Sanliurfa, Turkey (Türkiye), 63290
        • Investigational Site Number : 7920005
  • United Kingdom
      • Sheffield, United Kingdom, S5 7AU
        • Investigational Site Number : 8260002
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Investigational Site Number : 8260001
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85253
        • One of a Kind Clinical Research Center - Scottsdale- Site Number : 8400055
    • California
      • Arcadia, California, United States, 91006
        • FOMAT Medical Research - inSite Digestive Health Care - Arcadia- Site Number : 8400052
      • Lancaster, California, United States, 93534
        • Om Research- Site Number : 8400001
      • Los Alamitos, California, United States, 90720
        • United Medical Doctors - Los Alamitos- Site Number : 8400014
      • Oxnard, California, United States, 93030
        • Om Research- Site Number : 8400010
    • Colorado
      • Denver, Colorado, United States, 80218
        • Advanced Research Institute - Denver- Site Number : 8400048
    • Florida
      • Miami Lakes, Florida, United States, 33016
        • Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400040
      • Orlando, Florida, United States, 32803
        • Center for Digestive Health- Site Number : 8400013
      • Tampa, Florida, United States, 33609
        • GCP Clinical Research- Site Number : 8400007
    • Idaho
      • Boise, Idaho, United States, 83706
        • Treasure Valley Medical Research- Site Number : 8400006
    • Kansas
      • Hutchinson, Kansas, United States, 67502
        • Hutchinson Clinic- Site Number : 8400020
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center- Site Number : 8400041
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Boston Specialists- Site Number : 8400051
      • Pittsfield, Massachusetts, United States, 01201
        • Berkshire Medical Center- Site Number : 8400017
    • Michigan
      • Wyoming, Michigan, United States, 49519
        • Gastroenterology Associates of Western Michigan - Wyoming- Site Number : 8400004
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester - Minnesota- Site Number : 8400049
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University- Site Number : 8400025
    • Nevada
      • Reno, Nevada, United States, 89511
        • Advanced Research Institute - Reno- Site Number : 8400036
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • Sanmora Bespoke Clinical Research Solutions- Site Number : 8400015
      • Freehold, New Jersey, United States, 07728
        • Allied Digestive Health - Middlesex Monmouth Gastroenterology- Site Number : 8400053
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • M3 Wake Research- Site Number : 8400008
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital- Site Number : 8400056
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Velocity Clinical Research - Providence- Site Number : 8400002
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • M3 Wake Research - Chattanooga- Site Number : 8400012
      • Nashville, Tennessee, United States, 37211
        • Quality Medical Research- Site Number : 8400018
    • Texas
      • Cedar Park, Texas, United States, 78613
        • Texas Digestive Disease Consultants - Cedar Park- Site Number : 8400030
      • Houston, Texas, United States, 77090
        • MedCare Pharma - Houston - Cypress Creek Parkway- Site Number : 8400016
      • Pearland, Texas, United States, 77584
        • LinQ Research - Smith Ranch Road- Site Number : 8400028
      • Tomball, Texas, United States, 77375
        • DM Clinical Research - Tomball- Site Number : 8400042
    • Utah
      • Ogden, Utah, United States, 84405
        • Advanced Research Institute - Odgen- Site Number : 8400044
      • Sandy City, Utah, United States, 84094
        • Advanced Research Institute - Sandy - South 1300 East- Site Number : 8400046
      • West Jordan, Utah, United States, 84088
        • Velocity Clinical Research - Salt Lake City- Site Number : 8400023
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Gastroenterology Associates of Central Virginia- Site Number : 8400057
      • Richmond, Virginia, United States, 23220
        • Clinical Research Partners - Richmond - Forest Avenue- Site Number : 8400011
    • Washington
      • Tacoma, Washington, United States, 98405
        • GI Alliance - Tacoma- Site Number : 8400033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

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).
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amlitelimab dose 1 + Gluten-free product (GFP)
Amlitelimab SC as per protocol + GFP
Drug: Amlitelimab
Pharmaceutical form: Injection solution Route of administration: SC injection
Other Names:
  • SAR445229
Dietary supplement: Gluten-free product (GFP)
Pharmaceutical form: Capsule Route of administration: Oral
Experimental: Amlitelimab dose 2 + GFP
Amlitelimab SC as per protocol + GFP
Drug: Amlitelimab
Pharmaceutical form: Injection solution Route of administration: SC injection
Other Names:
  • SAR445229
Dietary supplement: Gluten-free product (GFP)
Pharmaceutical form: Capsule Route of administration: Oral
Experimental: Amlitelimab dose 3 + GFP
Amlitelimab SC as per protocol + GFP
Drug: Amlitelimab
Pharmaceutical form: Injection solution Route of administration: SC injection
Other Names:
  • SAR445229
Dietary supplement: Gluten-free product (GFP)
Pharmaceutical form: Capsule Route of administration: Oral
Experimental: Amlitelimab dose 1 + SIGE
Amlitelimab SC as per protocol + SIGE
Drug: Amlitelimab
Pharmaceutical form: Injection solution Route of administration: SC injection
Other Names:
  • SAR445229
Dietary supplement: SIGE
Pharmaceutical form: Capsule Route of administration: Oral
Placebo Comparator: Placebo + GFP
Placebo SC as per protocol + GFP
Drug: Placebo
Pharmaceutical form: Injection solution Route of administration: SC injection
Dietary supplement: Gluten-free product (GFP)
Pharmaceutical form: Capsule Route of administration: Oral
Placebo Comparator: Placebo + SIGE
Placebo SC as per protocol + SIGE
Drug: Placebo
Pharmaceutical form: Injection solution Route of administration: SC injection
Dietary supplement: SIGE
Pharmaceutical form: Capsule Route of administration: Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Villus Height to Crypt Depth Ratio (Vh:Cd) from baseline to Week 28
Time Frame: Baseline to Week 28
Change in Vh:Cd ratio.
Baseline to Week 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) symptom severity score
Time Frame: Baseline to Week 28
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.
Baseline to Week 28
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
Time Frame: Baseline to Week 168
Baseline to Week 168
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
Time Frame: Baseline to Week 168
Baseline to Week 168
Percentage of participants discontinued from study treatment due to TEAEs during the placebo-controlled treatment period and the long-term extension
Time Frame: Baseline to Week 168
Baseline to Week 168
Serum amlitelimab concentrations measured at prespecified timepoints
Time Frame: Baseline to Week 168
Baseline to Week 168
Incidence of antidrug antibodies (ADAs) of amlitelimab
Time Frame: Baseline to Week 168
Baseline to Week 168

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2024

Primary Completion (Estimated)

August 5, 2026

Study Completion (Estimated)

April 10, 2029

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

August 14, 2024

First Posted (Actual)

August 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRI17963
  • 2024-511213-38 (Registry Identifier: CTIS)
  • U1111-1298-7193 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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