Vedolizumab for the Treatment of Collagenous Gastritis

The goal of this clinical trial is to learn about how vedolizumab may affect patients with collagenous gastritis (CG). The main questions it aims to answer are:

• Whether vedolizumab can reduce CG symptoms
• Whether vedolizumab is safe to take for patients with CG

Participants in this study will:

• Receive vedolizumab through an IV ("infusion")
• Complete a survey at each infusion visit
• Have blood collected at each infusion visit
• Undergo an endoscopy with biopsy at 2 timepoints

Study Overview

• Status: Active, not recruiting
• Conditions: Collagenous Gastritis
• Intervention / Treatment: Biological: Vedolizumab

Detailed Description

Eligible participants will receive vedolizumab through an IV ("infusion") at week 0, then week 2, then week 6. Participants who respond well to the treatment after the first 3 infusions and are interested in continuing will receive vedolizumab every 8 weeks for about 1 year. At each visit, participants will be asked about their collagenous gastritis symptoms and any changes in their health or medications.

Blood samples will be collected from participants at every vedolizumab infusion. Some of these samples will be collected for safety purposes, some will be collected to monitor CG progression, and some will be collected for research purposes.

During the screening period and a few months after beginning treatment, the study doctor will perform an upper endoscopy to help determine whether vedolizumab has improved each participant's CG. An upper endoscopy is a procedure where the doctor inserts a small tube with a camera through the mouth and down the throat to look at the upper gastrointestinal tract (the esophagus, stomach, and part of the small intestine). During the procedure, biopsies will be collected to monitor CG and for research purposes. All participants will be given medication to make them comfortable throughout the duration of the procedure, which lasts approximately 10 to 30 minutes.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 14 or older
• Weight of at least 40kg
• Has a biopsy-confirmed diagnosis of collagenous gastritis
• Agrees to all required study procedures
• Presence of one or more collagenous gastritis symptom at a severity of Grade 1 or higher at the time of enrollment: abdominal pain, nausea, diarrhea, bloating, vomiting, flatulence, constipation, fatigue, headache, rash

Exclusion Criteria:

• Unable to independently provide informed consent or assent
• Allergic to vedolizumab or any of its components

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vedolizumab 300mg; Dose: 300mg; Administration: Intravenous (IV); Frequency: Weeks 0, 2, 6, and then every 8 weeks; Duration: 54 weeks (1 year)	Biological: Vedolizumab; Administered over 30 minute infusion at MGH main campus; Other Names: Entyvio

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in symtpoms	Change in symptoms associated with collagenous gastritis after 12 weeks of vedolizumab treatment, measured via patient-reported symptom questionnaire scores collected at each visit. Response is defined as a decrease of at least 1 Grade (DAIDS) in the most severe symptom reported at baseline. Surveys will be scored from 0 to 38, with higher scores indicating more severe symptoms and lower outcomes indicating no symptoms or more mild symptoms.	12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response durability	Durability of symptomatic response to vedolizumab over the first year of treatment will be measured via patient-reported symptom questionnaire scores collected at each visit. Surveys will be scored from 0 to 38, with higher scores indicating more severe symptoms and lower outcomes indicating no symptoms or more mild symptoms.	54 Weeks
Histologic response	Histologic response to vedolizumab will be assessed by comparing gastric histology from on-treatment biopsies and, if available, compared to baseline (within 1 year) gastric histology	12 weeks (+/- 4 weeks)
Incidence of treatment-emergent adverse events (safety)	Safety will be assessed by adverse event (AE) rates throughout the first year of treatment. Severity will be graded according to the DAIDS grading table (v2.1).	54 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunologic response in gastric mucosa	Immunologic response in the gastric mucosa will be assessed via flow cytometry and scRNA-seq of gastric biopsies and, if available, compared to baseline (within 1 year) gastric biopsies	54 Weeks
Immunologic response in peripheral blood	Immunologic response in peripheral blood will be assessed via flow cytometry and scRNA-seq of peripheral blood mononuclear cells as well as serum proteomics	54 Weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Dana-Farber Cancer Institute; Takeda

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: collagenous gastritis, vedolizumab
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis; Gastrointestinal Agents; vedolizumab
• Other Study ID Numbers: 2024P000152

Drug and device information, study documents

• 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