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NCT05230173

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

Recruiting
NAAges 18+Interventional
Mayo Clinic
~216 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:Pragmatic

At a glance

Recruiting sites
19 of 24 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to Treatment Failure
Measured over From randomization up to 104 weeks

Conditions

Ulcerative Colitis
Crohn Disease

Explore related trials

Crohn DiseaseUlcerative Colitis

Where it's being run

24 sites across 16 states
California4
New York4
Florida2
Texas2
Arizona1
Colorado1
Connecticut1
District of Columbia1

Study leadership

  • Siddharth Singh, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Siddharth Singh, MD
[email protected]
480-301-8000
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Eligibility criteria

Inclusion

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.

What this trial measures

  • Time to Treatment FailureFrom randomization up to 104 weeks

    Time to treatment failure, as a composite of: (1) moderate severe symptomatic relapse based on PRO2, with objective confirmation of inflammation within 2 months of event (FC \>250 mcg/g, or CRP \>5mg/L, or endoscopy showing moderate-severe inflammation, or MRE/CTE/IUS showing active inflammation) with need for escalation of therapy; (2) need for rescue therapy with corticosteroids for a documented symptomatic IBD flare; (3) IBD related hospitalization; (4) IBD-related surgery; (5) IBD-related structural complications (CD: symptomatic stricture, fistula or abscess; UC: symptomatic stricture); (6) treatment-emergent adverse event requiring drug discontinuation