UCRecruiting
STOP-UC: De-escalation of Therapy in Patients With Ulcerative Colitis With Histological Remission
Not applicable · Testing de-escalation or discontinuation of therapy and continuation of current therapy · 1 site · University of Chicago
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing de-escalation or discontinuation of therapy and continuation of current therapy. Condition(s) listed: Ulcerative Colitis (UC).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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…
- 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…
Plus 1 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 200 participants are expected to take part.
- Start date: 2025-11-11.
- Main results expected around 2026-11 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Number of individuals with sustained biochemical remission (Baseline, 12 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC) |
| Lead sponsor | University of Chicago |
| Enrollment | 200 (estimated) |
| Start date | 2025-11-11 |
| Primary completion (est.) | 2026-11 |
| First posted | 2024-11-18 |
| Last updated | 2026-04-06 |
| Official title | STOP-UC: De-escalation of Therapy in Patients With Ulcerative Colitis With Histological Remission |
| ClinicalTrials.gov ID | NCT06693310 |
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 di… - continuation of current therapy (Other)
continuation of current maintenance medical therapy for ulcerative colitis
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Consenting patients aged 18 to 75 years with an established diagnosis of ulcerative colitis (UC) for at least 3 years. 2. 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. 3. Patients in clinical, biochemical (fecal calprotectin <100), radiologic and endoscopic remission since the last colonoscopy. Exclusion Criteria: 1. Any noted active inflammation \[clinical, sonographic, biochemical, endoscopic (in any colonic segment)\]. 2. Patients with any changes in therapy after colonoscopy showing histological normalization or quiescence. 3. Corticosteroid use after colonoscopy showing histologic normalization or quiescence. 4. Patients with any noted history of primary sclerosing cholangitis or invisible or unresected high-grade dysplasia (suspected or confirmed). 5. Pregnancy or actively trying to conceive 6. Inability to follow the proposed sample collection and monitoring protocol.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University of Chicago | Chicago, Illinois | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.