NCT06693310

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a prospective, partially-randomized, patient-preference clinical trial conducted at a tertiary academic center \[University of Chicago Medicine Inflammatory Bowel Disease (IBD) Center\]. Patients in clinical, biochemical, and endoscopic remission with biopsies showing histologic quiescence or normalization will be identified and approached after consultation with their IBD care team. Subjects will be given a choice to either de-escalate their therapy (de-escalation group) or continue their current therapy (control group). This study design is to enhance the feasibility and real-world applicability. By permitting participants with strong preferences to choose their assigned strategy, we anticipate higher enrollment and retention among eligible subjects who might otherwise decline participation. Participants without a clear preference will be randomized 1:1 to de-escalation versus continuation, thereby preserving the integrity of comparative analyses. This approach enhances generalizability, respects patient autonomy, and mirrors clinical decision-making in routine clinical practice while maintaining methodological rigor. After enrollment, participants will be monitored for 24 months. After the 24-month period, participants who remain in remission will continue 5 years of longitudinal data collection from routine clinical care.

Conditions

• Ulcerative Colitis (UC)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-11-11
• Primary completion: 2026-11-01
• Completion: 2027-11-01
• First posted: 2024-11-18
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States