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Vedolizumab for the Treatment of Collagenous Gastritis

NCT ID: NCT06317220

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-03

Study Completion Date

2026-10-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Collagenous Gastritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vedolizumab 300mg

* Dose: 300mg
* Administration: Intravenous (IV)
* Frequency: Weeks 0, 2, 6, and then every 8 weeks
* Duration: 54 weeks (1 year)

Group Type EXPERIMENTAL

Vedolizumab

Intervention Type BIOLOGICAL

Administered over 30 minute infusion at MGH main campus

Interventions

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Vedolizumab

Administered over 30 minute infusion at MGH main campus

Intervention Type BIOLOGICAL

Other Intervention Names

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Entyvio

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dana-Farber Cancer Institute

OTHER

Sponsor Role collaborator

Takeda

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Michael Dougan

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2024P000152

Identifier Type: -

Identifier Source: org_study_id