RecruitingNot ApplicableNCT06693310

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

Sponsor

University of Chicago

Enrollment

200 participants

Start Date

Nov 11, 2025

Study Type

INTERVENTIONAL

Conditions

Ulcerative Colitis (UC)

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether patients with ulcerative colitis (UC) — a chronic inflammatory bowel disease — who have been in deep, sustained remission can safely reduce or stop their medication without the disease coming back. This approach, called de-escalation, could help patients avoid long-term medication side effects. **You may be eligible if...** - You are between 18 and 75 years old - You have had a confirmed UC diagnosis for at least 3 years - Your colonoscopy in the past year showed no signs of active inflammation, including on microscopic examination of tissue samples - You are currently in clinical and biochemical remission (including a stool marker called calprotectin below 100) **You may NOT be eligible if...** - There is any sign of active inflammation in your bowel - Your medication has changed since your last colonoscopy showed remission - You have taken steroids since going into remission - You have a history of a liver condition linked to IBD (primary sclerosing cholangitis) or have had high-grade tissue changes in the colon - You are pregnant or trying to conceive Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERde-escalation or discontinuation of therapy

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.

OTHERcontinuation of current therapy

continuation of current maintenance medical therapy for ulcerative colitis