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New shot could help celiac patients who still suffer despite strict diet

NCT ID NCT06557772

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 2 times

Summary

This study tests a drug called amlitelimab in adults with celiac disease who still have symptoms even after following a gluten-free diet for at least a year. About 229 participants will receive either the drug or a placebo as a shot under the skin for up to 28 weeks. The goal is to see if the drug can reduce gut damage and improve symptoms like belly pain and bloating.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

229 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

celiac disease refractory celiac disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Celiac disease Coeliac disease

Contacts and locations

Locations

  • Advanced Research Institute - Denver- Site Number : 8400048

    Denver, Colorado, 80218, United States

  • Advanced Research Institute - Odgen- Site Number : 8400044

    Ogden, Utah, 84405, United States

  • Advanced Research Institute - Reno- Site Number : 8400036

    Reno, Nevada, 89511, United States

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

    Sandy City, Utah, 84094, United States

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

    Freehold, New Jersey, 07728, United States

  • Azienda Ospedaliera di Padova-Site Number : 3800004

    Padua, Padova, 35128, Italy

  • Berkshire Medical Center- Site Number : 8400017

    Pittsfield, Massachusetts, 01201, United States

  • Boston Specialists- Site Number : 8400051

    Boston, Massachusetts, 02111, United States

  • Center for Digestive Health- Site Number : 8400013

    Orlando, Florida, 32803, United States

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

    Salvador, Estado de Bahia, 41820-020, Brazil

  • Chronos Pesquisa Clínica- Site Number : 0760002

    Brasília, Federal District, 72145-450, Brazil

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

    Richmond, Virginia, 23220, United States

  • DM Clinical Research - Tomball- Site Number : 8400042

    Tomball, Texas, 77375, United States

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

    Arcadia, California, 91006, United States

  • GCP Clinical Research- Site Number : 8400007

    Tampa, Florida, 33609, United States

  • GI Alliance - Tacoma- Site Number : 8400033

    Tacoma, Washington, 98405, United States

  • Gastroenterology Associates of Central Virginia- Site Number : 8400057

    Lynchburg, Virginia, 24502, United States

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

    Wyoming, Michigan, 49519, United States

  • Hospital Moinhos de Vento- Site Number : 0760004

    Porto Alegre, Rio Grande do Sul, 90035-902, Brazil

  • Hospital Sao Rafael- Site Number : 0760005

    Salvador, Estado de Bahia, 41253-190, Brazil

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

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Hutchinson Clinic- Site Number : 8400020

    Hutchinson, Kansas, 67502, United States

  • Investigational Site Number : 0320001

    Buenos Aires, 1128, Argentina

  • Investigational Site Number : 0320002

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Investigational Site Number : 0320003

    Córdoba, 5000, Argentina

  • Investigational Site Number : 0320005

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number : 0320007

    Buenos Aires, 1006, Argentina

  • Investigational Site Number : 0320008

    San Isidro, Buenos Aires, 1642, Argentina

  • Investigational Site Number : 0320009

    Buenos Aires, 1119, Argentina

  • Investigational Site Number : 0320010

    Quilmes, Buenos Aires, 1878, Argentina

  • Investigational Site Number : 0320012

    Buenos Aires, Buenos Aires F.D., 1061, Argentina

  • Investigational Site Number : 0360001

    Mackay, Queensland, 4740, Australia

  • Investigational Site Number : 0360002

    Sydney, New South Wales, 2560, Australia

  • Investigational Site Number : 0360005

    Melbourne, Victoria, 3128, Australia

  • Investigational Site Number : 0560001

    Leuven, 3000, Belgium

  • Investigational Site Number : 0560002

    Brussels, 1200, Belgium

  • Investigational Site Number : 1240001

    Vancouver, British Columbia, V6Z 2K5, Canada

  • Investigational Site Number : 1240002

    Victoria, British Columbia, V8V 3M9, Canada

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8330034, Chile

  • Investigational Site Number : 1520004

    Santiago, Reg Metropolitana de Santiago, 7620001, Chile

  • Investigational Site Number : 1520005

    Talcahuano, Biobio, 2687000, Chile

  • Investigational Site Number : 1520006

    Concepción, Biobio, 4070038, Chile

  • Investigational Site Number : 1520007

    Santiago, Reg Metropolitana de Santiago, 7510086, Chile

  • Investigational Site Number : 1520008

    Santiago, Reg Metropolitana de Santiago, 8331143, Chile

  • Investigational Site Number : 2030001

    Prague, 118 33, Czechia

  • Investigational Site Number : 2030002

    Brno, 636 00, Czechia

  • Investigational Site Number : 2030003

    Prague, 150 06, Czechia

  • Investigational Site Number : 2030005

    Klatovy, 339 01, Czechia

  • Investigational Site Number : 2030006

    Havířov, 736 01, Czechia

  • Investigational Site Number : 2460001

    Turku, 20520, Finland

  • Investigational Site Number : 2460002

    Helsinki, 00180, Finland

  • Investigational Site Number : 2460003

    Helsinki, 00270, Finland

  • Investigational Site Number : 2500001

    Paris, 75015, France

  • Investigational Site Number : 2500002

    Nice, 06202, France

  • Investigational Site Number : 2760001

    Halle, 06108, Germany

  • Investigational Site Number : 2760002

    Mainz, 55131, Germany

  • Investigational Site Number : 2760004

    Berlin, 12203, Germany

  • Investigational Site Number : 2760006

    Berlin, 10117, Germany

  • Investigational Site Number : 3000001

    Athens, 106 76, Greece

  • Investigational Site Number : 3000002

    Athens, 115 27, Greece

  • Investigational Site Number : 3760001

    Rehovot, 7610001, Israel

  • Investigational Site Number : 3760002

    Afula, 1834111, Israel

  • Investigational Site Number : 3760003

    Petah Tikva, 4941492, Israel

  • Investigational Site Number : 3760004

    Jerusalem, 9103102, Israel

  • Investigational Site Number : 3760006

    Beersheba, 8457108, Israel

  • Investigational Site Number : 3760007

    Ramat HaSharon, 4731001, Israel

  • Investigational Site Number : 5280001

    Amsterdam, 1081 HV, Netherlands

  • Investigational Site Number : 5280002

    Arnhem, 6815 AD, Netherlands

  • Investigational Site Number : 6160001

    Krakow, Lesser Poland Voivodeship, 31-501, Poland

  • Investigational Site Number : 6160002

    Warsaw, Masovian Voivodeship, 02-507, Poland

  • Investigational Site Number : 6160004

    Poznan, Greater Poland Voivodeship, 60-529, Poland

  • Investigational Site Number : 6160005

    Wroclaw, Lower Silesian Voivodeship, 50-088, Poland

  • Investigational Site Number : 7030001

    Košice, 040 13, Slovakia

  • Investigational Site Number : 7030003

    Nitra, 950 01, Slovakia

  • Investigational Site Number : 7030004

    Šahy, 936 01, Slovakia

  • Investigational Site Number : 7240002

    Seville, Sevilla, 41013, Spain

  • Investigational Site Number : 7240003

    Madrid, 28034, Spain

  • Investigational Site Number : 7240004

    Málaga, 29010, Spain

  • Investigational Site Number : 7240006

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7240007

    Madrid, 28003, Spain

  • Investigational Site Number : 7240008

    Seville, 41012, Spain

  • Investigational Site Number : 7240009

    Chiclana de la Frontera, Cádiz, 11139, Spain

  • Investigational Site Number : 7240010

    Seville, 41012, Spain

  • Investigational Site Number : 7240011

    Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

  • Investigational Site Number : 7520001

    Uppsala, 752 37, Sweden

  • Investigational Site Number : 7520003

    Stockholm, 116 91, Sweden

  • Investigational Site Number : 7521001

    Mölndal, 431 53, Sweden

  • Investigational Site Number : 7522001

    Linköping, 582 16, Sweden

  • Investigational Site Number : 7920001

    Mersin, 33070, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    Gaziantep, 27310, Turkey (Türkiye)

  • Investigational Site Number : 7920004

    Antalya, 07100, Turkey (Türkiye)

  • Investigational Site Number : 7920005

    Sanliurfa, 63290, Turkey (Türkiye)

  • Investigational Site Number : 7920006

    Istanbul, 34899, Turkey (Türkiye)

  • Investigational Site Number : 7920007

    Izmir, 35100, Turkey (Türkiye)

  • Investigational Site Number : 8260001

    Oxford, Oxfordshire, OX3 9DU, United Kingdom

  • Investigational Site Number : 8260002

    Sheffield, S5 7AU, United Kingdom

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

    Pearland, Texas, 77584, United States

  • M3 Wake Research - Chattanooga- Site Number : 8400012

    Chattanooga, Tennessee, 37421, United States

  • M3 Wake Research- Site Number : 8400008

    Raleigh, North Carolina, 27612, United States

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

    Rochester, Minnesota, 55905, United States

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

    Houston, Texas, 77090, United States

  • Om Research- Site Number : 8400001

    Lancaster, California, 93534, United States

  • Om Research- Site Number : 8400010

    Oxnard, California, 93030, United States

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

    Scottsdale, Arizona, 85253, United States

  • Ospedale Maggiore Policlinico Milano-Site Number : 3800002

    Milan, Milano, 20122, Italy

  • Ospedale di Cisanello-Site Number : 3800003

    Pisa, 56124, Italy

  • Praxis Pesquisas Medicas- Site Number : 0760008

    Santo André, São Paulo, 09090-790, Brazil

  • Quality Medical Research- Site Number : 8400018

    Nashville, Tennessee, 37211, United States

  • Sanmora Bespoke Clinical Research Solutions- Site Number : 8400015

    East Orange, New Jersey, 07018, United States

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

    Cedar Park, Texas, 78613, United States

  • Thomas Jefferson University Hospital- Site Number : 8400056

    Philadelphia, Pennsylvania, 19107, United States

  • Treasure Valley Medical Research- Site Number : 8400006

    Boise, Idaho, 83706, United States

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

    Los Alamitos, California, 90720, United States

  • University of Kansas Medical Center- Site Number : 8400041

    Kansas City, Kansas, 66160, United States

  • Velocity Clinical Research - Providence- Site Number : 8400002

    East Greenwich, Rhode Island, 02818, United States

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

    West Jordan, Utah, 84088, United States

  • Washington University- Site Number : 8400025

    St Louis, Missouri, 63110, United States

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

    Miami Lakes, Florida, 33016, United States

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