NCT04524221

PTG-100 for Patients With Celiac Disease

A Phase 1b Study of PTG-100 in Patients With Celiac Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Nielsen Fernandez-Becker · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Celiac Disease

Interventions

Type	Name	Description
DRUG	PTG-100	PTG-100, 600mg taken twice daily in capsule form for 42 days
DRUG	Placebo	Placebo taken twice daily in capsule form for 42 days

Timeline

• Start date: 2021-02-26
• Primary completion: 2022-04-03
• Completion: 2022-04-03
• First posted: 2020-08-24
• Last updated: 2022-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study