Recruiting

UC Management

Sponsor:

University of Chicago

Code:

NCT06693310

Conditions

Ulcerative Colitis (UC)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

de-escalation or discontinuation of therapy

continuation of current therapy

Study Details

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)

Study ID

NCT06693310

Start date

Nov 11, 2025

Status verified date

Apr, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Control group

continuation of current therapy

active comparator: de-escalation group

de-escalation or discontinuation of therapy

Interventions

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.

continuation of current therapy

continuation of current maintenance medical therapy for ulcerative colitis

Primary outcome measure

  • Number of individuals with sustained biochemical remission [ Time Frame: Baseline, 12 months ]
  • Number of individuals with sustained sonographic remission [ Time Frame: Baseline, 12 months ]
  • Number of individuals with sustained clinical remission [ Time Frame: Baseline, 12 months ]
  • Number of individuals with sustained endoscopic remission [ Time Frame: Baseline, 12 months ]

Central Contacts and Locations

Central contacts

Research Coordinator

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

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Principal Investigator:

David T Rubin, MD

More Information

Sponsor

University of Chicago

Last update posted

Apr 6, 2026

Last verified

Apr, 2026

Keywords

  • histological remission
  • de-escalation of therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-04-06.