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Can switching IBD meds heal the gut when symptoms are quiet?

NCT ID NCT05230173

Disease control Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This study looks at people with inflammatory bowel disease (Crohn's or ulcerative colitis) who feel fine but still have moderate to severe inflammation inside their gut. It compares two approaches: switching to a different targeted medication versus staying on the current one. The goal is to see which strategy better achieves endoscopic remission—healing of the gut lining—and reduces the risk of flares, hospitalizations, or surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Switching to an alternative targeted immunomodulator (TIM) therapy
What this could lead to
If switching therapies works, it could offer a better way to heal the gut lining and prevent flares, hospitalizations, or surgery in people with IBD.
What could go wrong
This is a real-world study, not a controlled drug trial, so results may vary. Switching meds could cause side effects or fail to improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 216 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

INCLUSION CRITERIA: Participants must meet all of the following criteria for enrolment into the study. 1. Male or nonpregnant, nonlactating females, ≥ 18 years of age. 2. An established diagnosis of CD or UC for at least 6 months based on standard clinical criteria, confirmed by the treating provider. 3. Current treatment with an approved TIM for treatment of IBD, including biologic agents (e.g., TNFα antagonists, ustekinumab, vedolizumab) and small molecule inhibitors (e.g., Janus kinase inhibitors, ozanimod), including future TIMs that become commercially available during the conduct of the trial. 4. Dose of TIM should be stable for 3 or more months prior to qualifying endoscopy/radiology. No treatment escalation of TIM or addition of IMM, corticosteroid, or mesalamines after the qualifying endoscopy/radiology procedure up to randomization is permitted. Dose de-escalation after qualifying procedure is permissible at the discretion of the treating provider. 5. In corticosteroid-free symptomatic remission based on validated PROs (PRO2 score) and deemed to be experiencing no other IBD-related symptoms in the opinion of the treating provider. Includes patients who may be in medically induced remission (on index TIM); or surgically induced remission with post-op initiation of index TIM for prophylaxis and colonoscopy/imaging performed at least 3 months after initiation/optimization of TIM showing moderate-severe bowel inflammation. Validated PROs are defined as: 1. CD: PRO2 (2-item patient reported outcome) mean daily score of abdominal pain score ≤1 and stool frequency score ≤ 3; or 2. UC: PRO2, with absence of rectal bleeding (rectal bleeding score = 0) and with stool frequency score ≤1. 6. Evidence of moderate to severe bowel inflammation on local reading of colonoscopy, flexible sigmoidoscopy, balloon-assisted enteroscopy, capsule endoscopy or MR, CT enterography, or intestinal ultrasound, performed within 6 months prior to screening, defined at the investigator's discretion or as follows: 1. CD: Colonoscopy showing moderately to severely active inflammation based on 1 of the following variables/scores: * Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥7 or score ≥4 for those with isolated ileal disease, or * Presence of mucosal ulcers \>5 mm in size if SES-CD has not been recorded, or * Simplified Endoscopic Mucosal Assessment for Crohn's Disease (SEMA-CD) score ≥2, or * Rutgeerts score i2b or higher for patients in surgically induced remission with post-operative endoscopic recurrence \[Note, either SES-CD or Rutgeerts score can be used for participants with post-operative recurrence\]; or 2. CD: MRE or CTE showing moderately to severely active inflammation based on 1 of the following variables: * Increased bowel wall thickness, or * Mural hyperenhancement, or * Peri-enteric fat stranding, or * Radiographic features of ulceration, or * Intramural T2 signal on fat suppressed images; or 3. CD: Capsule endoscopy showing moderately to severely active small bowel disease based on Lewis score \>790 (in case the disease is not accessible via endoscopy), or per local endoscopist if Lewis score is not reported; or 4. CD: Gastrointestinal ultrasound showing at least 1 of the following variables: * Increased bowel wall thickness \>5 mm, or * Color doppler score \>5/cm2, or * Bowel stenosis, or * Bowel stratification, or * Fatty wrapping; or 5. UC: modified MES score of 2 to 3, or documentation of any endoscopic feature that would define an MES of 2 to 3 (e.g., friability, ulceration, spontaneous bleeding, complete loss of vascular pattern), if an MES has not been recorded. 7. Eligible to receive at least 1 alternative TIM (excluding their index TIM) for the treatment of their disease per approved drug label, based on clinical and reimbursement guidelines. 8. Able to participate fully in all aspects of this clinical trial. 9. Informed consent must be obtained and documented. EXCLUSION CRITERIA: Participants who exhibit any of the following conditions are to be excluded from the study. 1. Presence of ostomy or ileoanal pouches. 2. Serious underlying disease other than UC or CD that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study. 3. History of alcohol or drug abuse or any other medical or health condition that in the opinion of the investigator may interfere with the participant's ability to comply with the study procedures. 4. Prior enrolment in the current study. 5. Mild endoscopic disease activity, where treating providers would not consider switching TIM.

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Conditions

The condition(s) this trial relates to.

Crohn disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease Ulcerative colitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advent Health

    RECRUITING

    Orlando, Florida, 32804, United States

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Cedars-Sinai

    RECRUITING

    Los Angeles, California, 90048, United States

  • Cornell University

    RECRUITING

    New York, New York, 10021, United States

  • Dartmouth Hitchcock

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • GastroOne

    WITHDRAWN

    Germantown, Tennessee, 38138, United States

  • Gastroenterology Associates

    RECRUITING

    Providence, Rhode Island, 02904, United States

  • Hightower Clinical

    ACTIVE_NOT_RECRUITING

    Oklahoma City, Oklahoma, 73102, United States

  • Hoag Hospital

    RECRUITING

    Irvine, California, 92618, United States

  • Mayo Clinic Arizona

    RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • MedStar Georgetown University Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Oregon Clinic

    WITHDRAWN

    Portland, Oregon, 97220, United States

  • Saratoga Schenectady Gastroenterology Associates

    RECRUITING

    Burnt Hills, New York, 12027, United States

  • Sutter Health

    RECRUITING

    Palo Alto, California, 94301, United States

  • UC San Diego Health

    RECRUITING

    La Jolla, California, 92037, United States

  • University of Chicago Medicine

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Rochester

    TERMINATED

    Rochester, New York, 14642, United States

  • University of Texas Southwestern

    RECRUITING

    Dallas, Texas, 75235, United States

  • University of Utah Health

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • University of Virginia

    WITHDRAWN

    Charlottesville, Virginia, 22908, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06510, United States

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