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

Sponsor: University of Chicago • ClinicalTrials.gov ID: NCT06693310

Registry updated: 2026-10-19

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Description

The goal of this study is to better understand treatment strategies for people with ulcerative colitis (UC). Researchers will compare patients with UC in histologic remission (no evidence of inflammation or active disease on endoscopy and biopsies) who continue to take medical therapy to patients with UC who de-escalate (decrease or discontinue) medical therapy. Both treatment strategies are considered within regular medical practice. Researchers want to find out whether remission can be maintained after de-escalation of therapy. Participants will be: * either be randomly assigned to continue medical therapy or de-escalate medical therapy -OR- be assigned per the participant's preference * clinically managed according to regular medical care * asked to provide blood, stool (poop), and tissue samples for study purposes

Interventions

de-escalation or discontinuation of therapy (Other)
De-escalation of therapy, defined as a step-down from maintenance with advanced therapy (biologic or synthetic small molecule) to oral aminosalicylate-based therapy or complete discontinuation of therapy if they are allergic or intolerant to aminosalicylate-based therapy. If patients are receiving immunomodulator or oral aminosalicylate maintenance therapy, they will be de-escalated to complete discontinuation of therapy.
continuation of current therapy (Other)
continuation of current maintenance medical therapy for ulcerative colitis

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.

Conditions

Ulcerative Colitis (UC)

Locations

University of Chicago — Chicago, Illinois, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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