Collagenous GastritisPhase 2NCT06317220
Vedolizumab for the Treatment of Collagenous Gastritis
A Phase 2 study testing Vedolizumab in people with Collagenous Gastritis, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Collagenous Gastritis
- What is being tested?
- Vedolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2024to Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to independently provide informed consent or assent
- Allergic to vedolizumab or any of its components
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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
Read the 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.
- Conditions
- Collagenous Gastritis
- Being tested
- Vedolizumab
- Keywords
- collagenous gastritis, vedolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VedolizumabBiological
Also called Entyvio
Administered over 30 minute infusion at MGH main campus
| Study group | Role | What they receive |
|---|---|---|
| Vedolizumab 300mg | Experimental | * Dose: 300mg
* Administration: Intravenous (IV)
* Frequency: Weeks 0, 2, 6, and then every 8 weeks
* Duration: 54 weeks (1 year) Receives: Biological: Vedolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Weeks
Secondary outcomes (3)
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.
Measured: 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
Measured: 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).
Measured: 54 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start3 Dec 2024
- Primary completion17 Feb 2026
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Collagenous GastritisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Takeda
- Responsible party
- Principal investigator, Long Nguyen, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317220
- Sponsor's protocol ID
- 2024P000152
- Status last verified
- Oct 2026
- First submitted
- 5 Mar 2024
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vedolizumab for the Treatment of Collagenous Gastritis
- ClinicalTrials.gov ID
- NCT06317220
- Acronym / sponsor ID
- 2024P000152
- Conditions
- Collagenous Gastritis
- Keywords
- collagenous gastritis, vedolizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Takeda
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 17 Feb 2026 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vedolizumab 300mg | Experimental | Biological: Vedolizumab* Dose: 300mg * Administration: Intravenous (IV) * Frequency: Weeks 0, 2, 6, and then every 8 weeks * Duration: 54 weeks (1 year) |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to independently provide informed consent or assent
- Allergic to vedolizumab or any of its components
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VedolizumabAlso: EntyvioAdministered over 30 minute infusion at MGH main campus | Biological | Vedolizumab 300mg |
Primary outcome
Change in symtpoms
Time frame: 12 Weeks
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.
3 secondary outcomes
Response durability
Time frame: 54 Weeks
Histologic response
Time frame: 12 weeks (+/- 4 weeks)
Incidence of treatment-emergent adverse events (safety)
Time frame: 54 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vedolizumab in people with Collagenous Gastritis, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symtpoms (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.