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| ID | Type | Description | Link |
|---|---|---|---|
| PTG-100-05-CeD | Other Identifier | Stanford University |
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| Name | Class |
|---|---|
| Protagonist Therapeutics, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTG-100 | Experimental | Patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days. |
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| Placebo | Placebo Comparator | Patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTG-100 | Drug | PTG-100, 600mg taken twice daily in capsule form for 42 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in villous height-to crypt ratio | Percentage change from baseline to Week 6 in villous height-to crypt depth (Vh:Cd) ratio | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in celiac disease antibodies | Changes in anti-tTG antibodies from baseline | 42 days |
| Changes in celiac disease antibodies | Changes in anti-DGP antibodies from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nielsen Q Fernandez-Becker, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Redwood City | California | 94063 | United States |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000722269 | PTG-100 peptide |
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Randomized, double-blind, placebo-controlled
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Double-blind
| Placebo |
| Drug |
Placebo taken twice daily in capsule form for 42 days |
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| 42 days |
| CD3- positive intraepithelial lymphocyte density | CD3- positive intraepithelial lymphocyte density | 42 days |
| Celiac symptom index (CSI) | Changes in validated celiac symptom index (CSI) | 42 days |
| Characterization of immune modulators underlying mechanism of action in celiac disease. | 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. | 42 days |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |