Clinical trial NCT06317220: Vedolizumab for the Treatment of Collagenous Gastritis
Official title: Vedolizumab for the Treatment of Collagenous Gastritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Collagenous Gastritis
Keywords: collagenous gastritis, vedolizumab
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: Takeda
First posted: 2024-03-19
Enrollment: 10
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in symtpoms
timeFrame: 12 Weeks
Secondary outcomes:
measure: Response durability
timeFrame: 54 Weeks
measure: Histologic response
timeFrame: 12 weeks (+/- 4 weeks)
measure: Incidence of treatment-emergent adverse events (safety)
timeFrame: 54 Weeks
Other outcomes:
measure: Immunologic response in gastric mucosa
timeFrame: 54 Weeks
measure: Immunologic response in peripheral blood
timeFrame: 54 Weeks
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: