A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease
NCT ID: NCT06557772
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
204 participants
INTERVENTIONAL
2024-08-29
2029-04-10
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Amlitelimab dose 1 + Gluten-free product (GFP)
Amlitelimab SC as per protocol + GFP
Amlitelimab
Pharmaceutical form: Injection solution Route of administration: SC injection
Gluten-free product (GFP)
Pharmaceutical form: Capsule Route of administration: Oral
Amlitelimab dose 2 + GFP
Amlitelimab SC as per protocol + GFP
Amlitelimab
Pharmaceutical form: Injection solution Route of administration: SC injection
Gluten-free product (GFP)
Pharmaceutical form: Capsule Route of administration: Oral
Amlitelimab dose 3 + GFP
Amlitelimab SC as per protocol + GFP
Amlitelimab
Pharmaceutical form: Injection solution Route of administration: SC injection
Gluten-free product (GFP)
Pharmaceutical form: Capsule Route of administration: Oral
Amlitelimab dose 1 + SIGE
Amlitelimab SC as per protocol + SIGE
Amlitelimab
Pharmaceutical form: Injection solution Route of administration: SC injection
SIGE
Pharmaceutical form: Capsule Route of administration: Oral
Placebo + GFP
Placebo SC as per protocol + GFP
Placebo
Pharmaceutical form: Injection solution Route of administration: SC injection
Gluten-free product (GFP)
Pharmaceutical form: Capsule Route of administration: Oral
Placebo + SIGE
Placebo SC as per protocol + SIGE
Placebo
Pharmaceutical form: Injection solution Route of administration: SC injection
SIGE
Pharmaceutical form: Capsule Route of administration: Oral
Interventions
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Amlitelimab
Pharmaceutical form: Injection solution Route of administration: SC injection
Placebo
Pharmaceutical form: Injection solution Route of administration: SC injection
SIGE
Pharmaceutical form: Capsule Route of administration: Oral
Gluten-free product (GFP)
Pharmaceutical form: Capsule Route of administration: Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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One of a Kind Clinical Research Center - Scottsdale- Site Number : 8400055
Scottsdale, Arizona, United States
FOMAT Medical Research - inSite Digestive Health Care - Arcadia- Site Number : 8400052
Arcadia, California, United States
Om Research - Lancaster - 15th Street West- Site Number : 8400001
Lancaster, California, United States
United Medical Doctors - Los Alamitos- Site Number : 8400014
Los Alamitos, California, United States
Om Research- Site Number : 8400010
Oxnard, California, United States
Advanced Research Institute - Denver- Site Number : 8400048
Denver, Colorado, United States
Medical Research Center of Connecticut- Site Number : 8400050
Hamden, Connecticut, United States
Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400040
Miami Lakes, Florida, United States
GI Pros- Site Number : 8400034
Naples, Florida, United States
Center for Digestive Health- Site Number : 8400013
Orlando, Florida, United States
GCP Clinical Research- Site Number : 8400007
Tampa, Florida, United States
Treasure Valley Medical Research- Site Number : 8400006
Boise, Idaho, United States
Hutchinson Clinic- Site Number : 8400020
Hutchinson, Kansas, United States
University of Kansas Medical Center- Site Number : 8400041
Kansas City, Kansas, United States
Boston Specialists- Site Number : 8400051
Boston, Massachusetts, United States
Berkshire Medical Center- Site Number : 8400017
Pittsfield, Massachusetts, United States
Gastroenterology Associates of Western Michigan - Wyoming- Site Number : 8400004
Wyoming, Michigan, United States
Mayo Clinic in Rochester - Minnesota- Site Number : 8400049
Rochester, Minnesota, United States
Washington University- Site Number : 8400025
St Louis, Missouri, United States
Advanced Research Institute - Reno- Site Number : 8400036
Reno, Nevada, United States
Sanmora Bespoke Clinical Research Solutions- Site Number : 8400015
East Orange, New Jersey, United States
Allied Digestive Health - Middlesex Monmouth Gastroenterology- Site Number : 8400053
Freehold, New Jersey, United States
M3 Wake Research- Site Number : 8400008
Raleigh, North Carolina, United States
Thomas Jefferson University- Site Number : 8400056
Philadelphia, Pennsylvania, United States
Velocity Clinical Research - Providence- Site Number : 8400002
East Greenwich, Rhode Island, United States
M3 Wake Research - Chattanooga- Site Number : 8400012
Chattanooga, Tennessee, United States
Quality Medical Research- Site Number : 8400018
Nashville, Tennessee, United States
Texas Digestive Disease Consultants - Cedar Park- Site Number : 8400030
Cedar Park, Texas, United States
MedCare Pharma - Houston - Cypress Creek Parkway- Site Number : 8400016
Houston, Texas, United States
LinQ Research - Smith Ranch Road- Site Number : 8400028
Pearland, Texas, United States
DM Clinical Research - Tomball- Site Number : 8400042
Tomball, Texas, United States
Advanced Research Institute - Odgen- Site Number : 8400044
Ogden, Utah, United States
Advanced Research Institute - Sandy - South 1300 East- Site Number : 8400046
Sandy City, Utah, United States
Velocity Clinical Research - Salt Lake City- Site Number : 8400023
West Jordan, Utah, United States
Gastroenterology Associates of Central Virginia- Site Number : 8400057
Lynchburg, Virginia, United States
Clinical Research Partners - Richmond - Forest Avenue- Site Number : 8400011
Richmond, Virginia, United States
GI Alliance - Tacoma- Site Number : 8400033
Tacoma, Washington, United States
Investigational Site Number : 0320007
CABA, Buenos Aires, Argentina
Investigational Site Number : 0320001
CABA, Buenos Aires, Argentina
Investigational Site Number : 0320010
Quilmes, Buenos Aires, Argentina
Investigational Site Number : 0320008
San Isidro, Buenos Aires, Argentina
Investigational Site Number : 0320012
CABA, Buenos Aires F.D., Argentina
Investigational Site Number : 0320009
CABA, Buenos Aires F.D., Argentina
Investigational Site Number : 0320005
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320002
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320003
Córdoba, , Argentina
Investigational Site Number : 0360002
Campbelltown, New South Wales, Australia
Investigational Site Number : 0360001
Mackay, Queensland, Australia
Investigational Site Number : 0360005
Box Hill, Victoria, Australia
Investigational Site Number : 0560002
Brussels, , Belgium
Investigational Site Number : 0560001
Leuven, , Belgium
Hospital Sao Rafael- Site Number : 0760005
Salvador, Estado de Bahia, Brazil
Centro de Pesquisas da Clínica IBIS- Site Number : 0760006
Salvador, Estado de Bahia, Brazil
Chronos Pesquisa Clínica- Site Number : 0760002
Brasília, Federal District, Brazil
Hospital Moinhos de Vento- Site Number : 0760004
Porto Alegre, Rio Grande do Sul, Brazil
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
Porto Alegre, Rio Grande do Sul, Brazil
Praxis Pesquisas Medicas- Site Number : 0760008
Santo André, São Paulo, Brazil
Investigational Site Number : 1240001
Vancouver, British Columbia, Canada
Investigational Site Number : 1240002
Victoria, British Columbia, Canada
Investigational Site Number : 1520007
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520004
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520008
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520006
Concepción, Región del Biobío, Chile
Investigational Site Number : 1520005
Talcahuano, Región del Biobío, Chile
Investigational Site Number : 2030002
Brno, , Czechia
Investigational Site Number : 2030006
Havířov, , Czechia
Investigational Site Number : 2030005
Klatovy, , Czechia
Investigational Site Number : 2030001
Prague, , Czechia
Investigational Site Number : 2030003
Prague, , Czechia
Investigational Site Number : 2460002
Helsinki, , Finland
Investigational Site Number : 2460003
Tampere, , Finland
Investigational Site Number : 2460001
Turku, , Finland
Investigational Site Number : 2500002
Nice, , France
Investigational Site Number : 2500001
Paris, , France
Investigational Site Number : 2760006
Berlin, , Germany
Investigational Site Number : 2760004
Berlin, , Germany
Investigational Site Number : 2760001
Halle, , Germany
Investigational Site Number : 2760002
Mainz, , Germany
Investigational Site Number : 3000001
Athens, , Greece
Investigational Site Number : 3000002
Athens, , Greece
Investigational Site Number : 3760002
Afula, , Israel
Investigational Site Number : 3760006
Beersheba, , Israel
Investigational Site Number : 3760004
Jerusalem, , Israel
Investigational Site Number : 3760003
Petah Tikva, , Israel
Investigational Site Number : 3760007
Ramat HaSharon, , Israel
Investigational Site Number : 3760001
Rehovot, , Israel
Ospedale Maggiore Policlinico Milano-Site Number : 3800002
Milan, Milano, Italy
Azienda Ospedaliera di Padova-Site Number : 3800004
Padua, Padova, Italy
Ospedale di Cisanello-Site Number : 3800003
Pisa, , Italy
Investigational Site Number : 5280001
Amsterdam, , Netherlands
Investigational Site Number : 5280002
Arnhem, , Netherlands
Investigational Site Number : 6160004
Poznan, Greater Poland Voivodeship, Poland
Investigational Site Number : 6160001
Krakow, Lesser Poland Voivodeship, Poland
Investigational Site Number : 6160005
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number : 6160002
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 7030001
Košice, , Slovakia
Investigational Site Number : 7030003
Nitra, , Slovakia
Investigational Site Number : 7030004
Šahy, , Slovakia
Investigational Site Number : 7240006
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240009
Chiclana de la Frontera, Cádiz, Spain
Investigational Site Number : 7240011
Las Palmas de Gran Canaria, Las Palmas, Spain
Investigational Site Number : 7240002
Seville, Sevilla, Spain
Investigational Site Number : 7240007
Madrid, , Spain
Investigational Site Number : 7240003
Madrid, , Spain
Investigational Site Number : 7240004
Málaga, , Spain
Investigational Site Number : 7240008
Seville, , Spain
Investigational Site Number : 7240010
Seville, , Spain
Investigational Site Number : 7522001
Linköping, , Sweden
Investigational Site Number : 7521001
Mölndal, , Sweden
Investigational Site Number : 7520003
Stockholm, , Sweden
Investigational Site Number : 7520001
Uppsala, , Sweden
Investigational Site Number : 7920004
Antalya, , Turkey (Türkiye)
Investigational Site Number : 7920003
Gaziantep, , Turkey (Türkiye)
Investigational Site Number : 7920006
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920007
Izmir, , Turkey (Türkiye)
Investigational Site Number : 7920001
Mersin, , Turkey (Türkiye)
Investigational Site Number : 7920005
Sanliurfa, , Turkey (Türkiye)
Investigational Site Number : 7920002
Zonguldak, , Turkey (Türkiye)
Investigational Site Number : 8260001
Oxford, Oxfordshire, United Kingdom
Investigational Site Number : 8260002
Sheffield, , United Kingdom
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Facility Contacts
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Related Links
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DRI17963 Plain Language Results Summary
Other Identifiers
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2024-511213-38
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1298-7193
Identifier Type: REGISTRY
Identifier Source: secondary_id
DRI17963
Identifier Type: -
Identifier Source: org_study_id
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