Celiac Disease
Conditions
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.
Interventions
DRUGPTG-100
PTG-100, 600mg taken twice daily in capsule form for 42 days
DRUGPlacebo
Placebo taken twice daily in capsule form for 42 days
Sponsors
Protagonist Therapeutics, Inc.
Nielsen Fernandez-Becker
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Intervention model description
Randomized, double-blind, placebo-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of celiac disease
Exclusion criteria
* Active GI disease or history of clinically significant diseases * Diagnosis of Crohn's disease or ulcerative colitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in celiac disease antibodies | 42 days | Changes in anti-tTG antibodies from baseline |
| Changes in celiac disease antibodies | 42 days | Changes in anti-DGP antibodies from baseline |
| CD3- positive intraepithelial lymphocyte density | 42 days | CD3- positive intraepithelial lymphocyte density |
| Celiac symptom index (CSI) | 42 days | Changes in validated celiac symptom index (CSI) |
| 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. |
Countries
United States
Outcome results
None listed