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Switching treatments for better endoscopic remission in IBD patients

Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission

Not applicable Interventional University of California, San Diego · NCT05230173

This study is testing if switching to a different medication can help people with inflammatory bowel disease who have some inflammation while feeling better, compared to sticking with their current treatment.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity of California, San Diego Academic / other
Drugs / interventionsustekinumab, vedolizumab
Locations22 sites (Irvine, California and 21 other locations)
Trial IDNCT05230173 on ClinicalTrials.gov

What this trial studies

This study compares the effectiveness and safety of switching to an alternative targeted immunomodulator therapy versus continuing the current treatment in patients with inflammatory bowel disease (IBD) who are in symptomatic remission but have moderate to severe endoscopic inflammation. It is a pragmatic, open-label, multicenter randomized control trial involving approximately 250 participants across the United States and Canada. Patients will be followed for 2 years to assess treatment outcomes, including the time to treatment failure and other related complications. The trial aims to provide insights into optimizing treatment strategies for IBD.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of Crohn's disease or ulcerative colitis who are currently on a stable treatment regimen but still exhibit moderate to severe endoscopic inflammation.

Not a fit: Patients who are not currently experiencing symptoms or those who have mild endoscopic inflammation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies that achieve better endoscopic remission for patients with IBD.

How similar studies have performed: Other studies have shown promising results with similar treatment strategies, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
INCLUSION CRITERIA:

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:

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.

Where this trial is running

Irvine, California and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ulcerative ColitisCrohn Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.