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PTG-100 for Patients With Celiac Disease

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ClinicalTrials.gov Identifier: NCT04524221
Recruitment Status : Recruiting
First Posted : August 24, 2020
Last Update Posted : April 23, 2021
Sponsor:
Collaborator:
Protagonist Therapeutics, Inc.
Information provided by (Responsible Party):
Nielsen Fernandez-Becker, Stanford University

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.


Condition or disease Intervention/treatment Phase
Celiac Disease Drug: PTG-100 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo-controlled
Masking: Double (Participant, Investigator)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A Phase 1b Study of PTG-100 in Patients With Celiac Disease
Actual Study Start Date : February 26, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
Experimental: PTG-100
Patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days.
Drug: PTG-100
PTG-100, 600mg taken twice daily in capsule form for 42 days

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




Primary Outcome Measures :
  1. Percentage change in villous height-to crypt ratio [ Time Frame: 42 days ]
    Percentage change from baseline to Week 6 in villous height-to crypt depth (Vh:Cd) ratio


Secondary Outcome Measures :
  1. Change in celiac disease antibodies [ Time Frame: 42 days ]
    Changes in anti-tTG antibodies from baseline

  2. Changes in celiac disease antibodies [ Time Frame: 42 days ]
    Changes in anti-DGP antibodies from baseline

  3. CD3- positive intraepithelial lymphocyte density [ Time Frame: 42 days ]
    CD3- positive intraepithelial lymphocyte density

  4. Celiac symptom index (CSI) [ Time Frame: 42 days ]
    Changes in validated celiac symptom index (CSI)

  5. Characterization of immune modulators underlying mechanism of action in celiac disease. [ Time Frame: 42 days ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04524221


Contacts
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Contact: Aubrey Adiao, BS (650) 721-3177 aadiao@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Redwood City, California, United States, 94063
Sponsors and Collaborators
Nielsen Fernandez-Becker
Protagonist Therapeutics, Inc.
Investigators
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Principal Investigator: Nielsen Q Fernandez-Becker, MD, PhD Stanford University
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Responsible Party: Nielsen Fernandez-Becker, Clinical Associate Professor, Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT04524221    
Other Study ID Numbers: 57613
PTG-100-05-CeD ( Other Identifier: Stanford University )
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases