Vedolizumab for the Treatment of Collagenous Gastritis

NCT06317220 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 2024P000152
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Collagenous Gastritis

Keywords

collagenous gastritis, vedolizumab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Response durability

  54 Weeks

• Histologic response

  12 weeks (+/- 4 weeks)

• Incidence of treatment-emergent adverse events (safety)

  54 Weeks

Other Outcomes (2)

• Immunologic response in gastric mucosa

  54 Weeks

• Immunologic response in peripheral blood

  54 Weeks

Study Arms (1)

Vedolizumab 300mg

EXPERIMENTAL

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

Biological: Vedolizumab

Interventions

Vedolizumab BIOLOGICAL

Administered over 30 minute infusion at MGH main campus

Also known as: Entyvio

Vedolizumab 300mg

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Takeda: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

vedolizumab

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 19, 2024
• Study Start: December 3, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)