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iQualifyCeliac Form
iQualifyCeliac Form
Age
Required
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Do you have biopsy-confirmed celiac disease?
Yes
No
If you are eligible to move forward, can you bring documentation of your intestinal biopsy results to your first study visit?
Yes
No
Unsure
Are you currently on a gluten-free diet?
Yes
No
Following exposure to small amounts of gluten, do you experience symptoms severe enough to require urgent medical care?
Yes
No
Unsure
Have you been diagnosed with any of the following conditions? Select all that apply.
Required
Refractory celiac disease type 2 (RCD-II)
o Moderate or severe dermatitis herpetiformis
HIV
Hepatitis B or C
Active tuberculosis
None of the above
Unsure
7. In the past 5 years, have you been diagnosed with or treated for cancer (other than basal cell carcinoma)?
Yes
No
Unsure
Have you ever received an investigational medication in another clinical study for celiac disease?
Yes
No
Unsure
Are you currently pregnant, breastfeeding, or planning to become pregnant within the next year and a half?
Yes
No
Do you currently live in the United States?
Yes
No
This research study is testing the safety and tolerability of the investigational medication TEV-53408 in adults with celiac disease, before and after eating snacks that contain gluten. Participation in this study will include 13 visits to the study site and 3 phone visits. Participants will receive one injection of TEV-53408 or placebo and then be asked to eat 1 snack containing 3g of gluten every day for 14 weeks. Participants who are not tolerating the gluten snacks and are unable to complete the gluten challenge may stop eating the snacks and remain in the study. Based upon this information, are you interested in being contacted to discuss participating in this study?
Yes
No
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