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

NCT06693310 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-04-06

No results posted yet for this study

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

Conditions

  • Ulcerative Colitis (UC)

Interventions

OTHER

de-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.

OTHER

continuation of current therapy

continuation of current maintenance medical therapy for ulcerative colitis

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • David T Rubin, MD · University of Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-11
Primary Completion
2026-11-30
Completion
2027-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06693310 on ClinicalTrials.gov