PTG-100 for Patients With Celiac Disease

Celiac Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04524221
• Other study ID #: 57613
• Secondary ID: PTG-100-05-CeD
• Status: Completed
• Phase: Phase 1
• Start date: February 26, 2021
• Est. completion date: April 3, 2022

Study information

• Verified date: May 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 3, 2022
• Est. primary completion date: April 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Stanford University	Redwood City	California

Sponsors (2)

Lead Sponsor	Collaborator
Nielsen Fernandez-Becker	Protagonist Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Change in celiac disease antibodies	Changes in anti-tTG antibodies from baseline	42 days
Secondary	Changes in celiac disease antibodies	Changes in anti-DGP antibodies from baseline	42 days
Secondary	CD3- positive intraepithelial lymphocyte density	CD3- positive intraepithelial lymphocyte density	42 days
Secondary	Celiac symptom index (CSI)	Changes in validated celiac symptom index (CSI)	42 days
Secondary	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