De-escalating treatment for ulcerative colitis when biopsies show no inflammation

STOP-UC: De-escalation of Therapy in Patients With Ulcerative Colitis With Histological Remission

This will see if people with ulcerative colitis whose biopsies show no inflammation can safely reduce or stop their medications without losing remission.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University of Chicago (Academic / other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT06693310 on ClinicalTrials.gov

What this trial studies

This is a prospective, partially randomized, patient-preference study at the University of Chicago enrolling adults with long-standing ulcerative colitis in deep clinical, endoscopic, biochemical, and histologic remission. Participants may choose to either continue their current medical therapy or de-escalate (decrease or stop) therapy, and those without a clear preference are randomized 1:1. Subjects are followed with routine clinical management and sampled for blood, stool, and tissue, with active monitoring for 24 months and longer-term data collected up to five years for those who remain in remission. The design is intended to reflect real-world decision making while preserving comparative rigor.

Who should consider this trial

Good fit: Adults aged 18–75 with an established diagnosis of UC for at least three years who are in deep remission—clinical, biochemical (fecal calprotectin <100), endoscopic, and histologic quiescence or normalization on recent biopsies—are ideal candidates.

Not a fit: Patients with any evidence of active inflammation, recent flares, or those requiring ongoing therapy for extraintestinal disease or other indications are unlikely to benefit from de-escalation.

Why it matters

Potential benefit: If successful, this could allow some patients in histologic remission to safely reduce medication exposure, lowering side effects, burden, and cost while keeping disease controlled.

How similar studies have performed: Prior de-escalation studies in UC have shown mixed relapse rates after stopping therapy, and using strict histologic remission to guide de-escalation is a relatively novel approach with limited definitive data.

Eligibility criteria

Inclusion Criteria:

1. Consenting patients aged 18 to 75 years with an established diagnosis of ulcerative colitis (UC) for at least 3 years.
2. Patients in deep remission, defined by the absence of endoscopic and histologic signs of active inflammation (i.e. histological normalization or histological quiescence) in all biopsies obtained during colonoscopy, within the last 12 months.

   * If the most recent colonoscopy is within the last 3 years and demonstrates normalized/quiescent pathology findings (i.e., patient is in stable remission), the patient would not be expected to undergo yearly colonoscopies. Therefore, a persistent normalized calprotectin test will be accepted as sufficient to define deep remission with no change in therapy.
3. Patients in clinical, biochemical (fecal calprotectin \<100), radiologic and endoscopic remission since the last colonoscopy.

Exclusion Criteria:

1. Any noted active inflammation \[clinical, sonographic, biochemical, endoscopic (in any colonic segment)\].
2. Patients with any changes in therapy after colonoscopy showing histological normalization or quiescence.
3. Corticosteroid use after colonoscopy showing histologic normalization or quiescence.
4. Patients with any noted history of primary sclerosing cholangitis or invisible or unresected high-grade dysplasia (suspected or confirmed).
5. Pregnancy or actively trying to conceive
6. Inability to follow the proposed sample collection and monitoring protocol.

Where this trial is running

Chicago, Illinois

• University of Chicago — Chicago, Illinois, United States (Recruiting)

Study contacts

• Principal investigator: David T Rubin, MD — University of Chicago
• Study coordinator: Research Coordinator

Conditions Ulcerative Colitis; histological remission; de-escalation of therapy