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A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease
204 patients around the world
Available in Chile
Sanofi
204Patients around the world
This study is for people with
Celiac disease
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- 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 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. 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).
- A diagnosis of any severe complication of celiac disease, such as refractory celiac disease type 1 requiring immune suppressive medication, or type 2, enteropathy associated T-cell lymphoma, ulcerative jejunitis, or recent GI perforation.Presence of other active inflammatory GI disorders, including but not limited to 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 can be included per investigator judgement.Known or suspected severe enteric infection 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.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 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.
SponsorSanofi
Conditions
Celiac disease
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06557772
