PTG-100 for Patients With Celiac Disease
Primary Purpose
Celiac Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PTG-100
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Celiac Disease
Eligibility Criteria
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.
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PTG-100
Placebo
Arm Description
Patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days.
Patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days.
Outcomes
Primary Outcome Measures
Percentage change in villous height-to crypt ratio
Percentage change from baseline to Week 6 in villous height-to crypt depth (Vh:Cd) ratio
Secondary Outcome Measures
Change in celiac disease antibodies
Changes in anti-tTG antibodies from baseline
Changes in celiac disease antibodies
Changes in anti-DGP antibodies from baseline
CD3- positive intraepithelial lymphocyte density
CD3- positive intraepithelial lymphocyte density
Celiac symptom index (CSI)
Changes in validated celiac symptom index (CSI)
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.
Full Information
NCT ID
NCT04524221
First Posted
August 19, 2020
Last Updated
May 19, 2022
Sponsor
Nielsen Fernandez-Becker
Collaborators
Protagonist Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04524221
Brief Title
PTG-100 for Patients With Celiac Disease
Official Title
A Phase 1b Study of PTG-100 in Patients With Celiac Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 26, 2021 (Actual)
Primary Completion Date
April 3, 2022 (Actual)
Study Completion Date
April 3, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nielsen Fernandez-Becker
Collaborators
Protagonist Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo-controlled
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PTG-100
Arm Type
Experimental
Arm Description
Patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days.
Intervention Type
Drug
Intervention Name(s)
PTG-100
Intervention Description
PTG-100, 600mg taken twice daily in capsule form for 42 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo taken twice daily in capsule form for 42 days
Primary Outcome Measure Information:
Title
Percentage change in villous height-to crypt ratio
Description
Percentage change from baseline to Week 6 in villous height-to crypt depth (Vh:Cd) ratio
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Change in celiac disease antibodies
Description
Changes in anti-tTG antibodies from baseline
Time Frame
42 days
Title
Changes in celiac disease antibodies
Description
Changes in anti-DGP antibodies from baseline
Time Frame
42 days
Title
CD3- positive intraepithelial lymphocyte density
Description
CD3- positive intraepithelial lymphocyte density
Time Frame
42 days
Title
Celiac symptom index (CSI)
Description
Changes in validated celiac symptom index (CSI)
Time Frame
42 days
Title
Characterization of immune modulators underlying mechanism of action in celiac disease.
Description
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.
Time Frame
42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nielsen Q Fernandez-Becker, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PTG-100 for Patients With Celiac Disease
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