PTG-100 for Patients With Celiac Disease

NCT04524221 | Completed Phase 1 FDA Drug

• 2 other identifiers: 57613PTG-100-05-CeD
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in celiac disease antibodies

  42 days

• Changes in celiac disease antibodies

  42 days

• CD3- positive intraepithelial lymphocyte density

  42 days

• Celiac symptom index (CSI)

  42 days

• Characterization of immune modulators underlying mechanism of action in celiac disease.

  42 days

Study Arms (2)

PTG-100

EXPERIMENTAL

Patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days.

Drug: PTG-100

Placebo

PLACEBO COMPARATOR

Patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days.

Drug: Placebo

Interventions

PTG-100 DRUG

PTG-100, 600mg taken twice daily in capsule form for 42 days

PTG-100

Placebo DRUG

Placebo taken twice daily in capsule form for 42 days

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of celiac disease

You may not qualify if:

• Active GI disease or history of clinically significant diseases
• Diagnosis of Crohn's disease or ulcerative colitis.

Sponsors & Collaborators

• Nielsen Fernandez-Becker: lead
• Protagonist Therapeutics, Inc.: collaborator

Study Sites (1)

Stanford University

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Celiac Disease

Interventions

PTG-100 peptide

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nielsen Q Fernandez-Becker, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor, Medicine

Model Details: Randomized, double-blind, placebo-controlled

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 24, 2020
• Study Start: February 26, 2021
• Primary Completion: April 3, 2022
• Study Completion: April 3, 2022
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)