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ACTIVE NOT RECRUITING

NCT06557772

PHASE2

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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). 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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

229

Start Date

2024-08-29

Completion Date

2029-04-10

Last Updated

2026-02-25

Healthy Volunteers

Conditions

Coeliac Disease Celiac Disease

Interventions

DRUG

Amlitelimab

Pharmaceutical form: Injection solution Route of administration: SC injection

DRUG

Placebo

Pharmaceutical form: Injection solution Route of administration: SC injection

DIETARY_SUPPLEMENT

SIGE

Pharmaceutical form: Capsule Route of administration: Oral

DIETARY_SUPPLEMENT

Gluten-free product (GFP)

Pharmaceutical form: Capsule Route of administration: Oral

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.

Locations (118)

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- 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

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

Miami Lakes, 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 Hospital- 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 : 0320010

Quilmes, Buenos Aires, Argentina

Investigational Site Number : 0320008

San Isidro, Buenos Aires, Argentina

Investigational Site Number : 0320012

Buenos Aires, 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 : 0320007

Buenos Aires, Argentina

Investigational Site Number : 0320009

Buenos Aires, Argentina

Investigational Site Number : 0320001

Buenos Aires, Argentina

Investigational Site Number : 0320003

Córdoba, Argentina

Investigational Site Number : 0360002

Sydney, New South Wales, Australia

Investigational Site Number : 0360001

Mackay, Queensland, Australia

Investigational Site Number : 0360005

Melbourne, 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

Helsinki, 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 : 8260001

Oxford, Oxfordshire, United Kingdom

Investigational Site Number : 8260002

Sheffield, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (118)