RecruitingNot Applicable

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

United States200 participantsStarted 2025-11-11

Plain-language 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

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Consenting patients aged 18 to 75 years with an established diagnosis of ulcerative colitis (UC) for at least 3 years.
. 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.
. Patients in clinical, biochemical (fecal calprotectin \<100), radiologic and endoscopic remission since the last colonoscopy.

Exclusion criteria

. Any noted active inflammation \[clinical, sonographic, biochemical, endoscopic (in any colonic segment)\].
. Patients with any changes in therapy after colonoscopy showing histological normalization or quiescence.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of individuals with sustained biochemical remission

Timeframe: Baseline, 12 months

Number of individuals with sustained sonographic remission

Timeframe: Baseline, 12 months

Number of individuals with sustained clinical remission

Timeframe: Baseline, 12 months

Number of individuals with sustained endoscopic remission

Timeframe: Baseline, 12 months

Trial details

NCT IDNCT06693310

SponsorUniversity of Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11

Contact for this trial

Research Coordinator

215-596-9715 Alex.Mathew@bsd.uchicago.edu

View on ClinicalTrials.gov More Ulcerative Colitis (UC) trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Consenting patients aged 18 to 75 years with an established diagnosis of ulcerative colitis (UC) for at least 3 years.
. 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.
. Patients in clinical, biochemical (fecal calprotectin \<100), radiologic and endoscopic remission since the last colonoscopy.

Exclusion criteria

. Any noted active inflammation \[clinical, sonographic, biochemical, endoscopic (in any colonic segment)\].
. Patients with any changes in therapy after colonoscopy showing histological normalization or quiescence.

What they're measuring

Number of individuals with sustained biochemical remission

Timeframe: Baseline, 12 months

Number of individuals with sustained sonographic remission

Timeframe: Baseline, 12 months

Number of individuals with sustained clinical remission

Timeframe: Baseline, 12 months

Number of individuals with sustained endoscopic remission

Timeframe: Baseline, 12 months