NEED PROOF

Ages: 18-75
Gender: Any

Study Description:
This study is testing an investigational injectable medication for participants with non-responsive celiac disease. Participants will receive an injection of either the investigational medication or a placebo once daily for up to 5 and a half months. After the treatment period, participants will be given the opportunity to enroll in a long-term extension period where all participants will receive the investigational injectable medication for 4 months. Additional procedures include vital signs, physical examinations, various endoscopic and biopsy procedures, and e-diary completion. Total participation will last approximately 11 months with up to 10 doctor’s visits throughout the study. Eligibility for the study will be determined by the study doctor following one or more in-person screening visits to the clinic. Trial-related procedures and study medication will be provided at no cost. 


Questions/Answers to Screener:
Have you been diagnosed with Celiac Disease? (ANSWER: YES)

Was your diagnosis confirmed with a biopsy? (ANSWER: YES)

Have you had any other active inflammatory gastrointestinal disorders in the past 6 months?
Examples include but are not limited to:
- Inflammatory bowel disease such as Ulcerative colitis or Crohn's disease
- Eosinophilic esophagitis
- Diverticulitis
- Microscopic colitis requiring treatment
- Gastroenteritis
- Helicobacter infection
- Colitis
[PATIENT NOTE]
Please note that treated erosive esophagitis is not exclusionary.
(ANSWER: NO)

Have you attempted to follow a gluten-free diet for at least 12 consecutive months, and are you willing to maintain your current gluten-free diet for the full duration of the study?
(ANSWER: YES)

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