Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2021-02-26
2022-04-03
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PTG-100
Patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days.
PTG-100
PTG-100, 600mg taken twice daily in capsule form for 42 days
Placebo
Patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days.
Placebo
Placebo taken twice daily in capsule form for 42 days
Interventions
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PTG-100
PTG-100, 600mg taken twice daily in capsule form for 42 days
Placebo
Placebo taken twice daily in capsule form for 42 days
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Diagnosis of Crohn's disease or ulcerative colitis.
18 Years
80 Years
ALL
No
Sponsors
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Protagonist Therapeutics, Inc.
INDUSTRY
Nielsen Fernandez-Becker
OTHER
Responsible Party
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Nielsen Fernandez-Becker
Clinical Associate Professor, Medicine
Principal Investigators
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Nielsen Q Fernandez-Becker, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University
Redwood City, California, United States
Countries
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Other Identifiers
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PTG-100-05-CeD
Identifier Type: OTHER
Identifier Source: secondary_id
57613
Identifier Type: -
Identifier Source: org_study_id
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