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

NCT06693310 | Recruiting DMC

• 1 other identifier: IRB24-0008
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

histological remission; de-escalation of therapy

Outcome Measures

Primary Outcomes (4)

• Number of individuals with sustained biochemical remission

  Biochemical remission defined as fecal calprotectin (FCP) level less than 150 and C-reactive protein (CRP) level less than the predetermined normal range according to the test manufacturer (typically less than 5.0mg/dL).

  Baseline, 12 months

• Number of individuals with sustained sonographic remission

  Sonographic remission defined as bowel wall thickness (BWT) less than 4 millimeters(mm) in rectum and BWT less than 3 mm in the remainder of the bowel; measured by intestinal ultrasound

  Baseline, 12 months

• Number of individuals with sustained clinical remission

  Clinical remission defined as Patient-Reported Outcome (PRO-2) score less than 1. The PRO-2 questionnaire measures patient-reported stool frequency and rectal bleeding in UC; scores range from 0-3, with higher scores indicating more severe symptoms.

  Baseline, 12 months

• Number of individuals with sustained endoscopic remission

  Endoscopic remission defined as Mayo endoscopic subscore equal to 0 or 1. The Mayo endoscopic subscore is a physician-reported measure of mucosal appearance at endoscopy. Scores range from 0-3, with higher scores indicating more disease activity.

  Baseline, 12 months

Secondary Outcomes (10)

• Proportion of individuals maintaining corticosteroid-free remission

  12 months

• Change in host metabolites in states of deep remission

  Baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)

• Change in microbial metabolites in states of deep remission

  Baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)

• Change in host metabolites in states of disease relapse

  Baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)

• Change in microbial metabolites in states of disease relapse

  Baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)

Study Arms (2)

Control group

ACTIVE COMPARATOR

continuation of current therapy

Other: continuation of current therapy

de-escalation group

ACTIVE COMPARATOR

de-escalation or discontinuation of therapy

Other: de-escalation or discontinuation of therapy

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.

de-escalation group

continuation of current therapy OTHER

continuation of current maintenance medical therapy for ulcerative colitis

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Patients in clinical, biochemical (fecal calprotectin \<100), radiologic and endoscopic remission since the last colonoscopy.

You may not qualify if:

• 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.
• Corticosteroid use after colonoscopy showing histologic normalization or quiescence.
• Patients with any noted history of primary sclerosing cholangitis or invisible or unresected high-grade dysplasia (suspected or confirmed).
• Pregnancy or actively trying to conceive
• Inability to follow the proposed sample collection and monitoring protocol.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• David T Rubin, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Coordinator

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 18, 2024
• Study Start: November 11, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

US (1)