PTG-100 for Patients With Celiac Disease
- Registration Number
- NCT04524221
- Lead Sponsor
- Nielsen Fernandez-Becker
- Brief Summary
The goal of this study is to learn whether or not the drug PTG-100 can reduce or prevent inflammatory injury to the small intestine that occurs when people with celiac disease eat food products containing gluten.
This is a clinical research study to determine the safety and efficacy of PTG-100 in preventing gluten-induced inflammatory injury to the small intestine in patients with celiac disease. 30 patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days. They will also receive a gluten challenge twice daily in the form of a cookie or equivalent. An upper gastrointestinal endoscopy and exam including small bowel mucosa biopsy will be performed at the start of the treatment period and again at the end. Blood samples will be routinely taken to evaluate safety and the drug's mechanism of action throughout the study, and symptoms will be recorded using the celiac symptoms index (CSI) survey.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- Diagnosis of celiac disease
- Active GI disease or history of clinically significant diseases
- Diagnosis of Crohn's disease or ulcerative colitis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PTG-100 PTG-100 Patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days. Placebo Placebo Patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days.
- Primary Outcome Measures
Name Time Method Percentage change in villous height-to crypt ratio 42 days Percentage change from baseline to Week 6 in villous height-to crypt depth (Vh:Cd) ratio
- Secondary Outcome Measures
Name Time Method Celiac symptom index (CSI) 42 days Changes in validated celiac symptom index (CSI)
CD3- positive intraepithelial lymphocyte density 42 days CD3- positive intraepithelial lymphocyte density
Changes in celiac disease antibodies 42 days Changes in anti-DGP antibodies from baseline
Change in celiac disease antibodies 42 days Changes in anti-tTG antibodies from baseline
Characterization of immune modulators underlying mechanism of action in celiac disease. 42 days Identification of immune cell populations targeted by PTG-100 to better understand mechanism of action in celiac disease in both blood and tissue temporally following exposure to drug.
Trial Locations
- Locations (1)
Stanford University
🇺🇸Redwood City, California, United States