Ulcerative Colitis (UC)NCT06693310
STOP-UC: De-escalation of Therapy in Patients With Ulcerative Colitis With Histological Remission
A study testing de-escalation or discontinuation of therapy and continuation of current therapy in people with Ulcerative Colitis (UC), run by University of Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis (UC)
- What is being tested?
- de-escalation or discontinuation of therapy and continuation of current therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2025to Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
David T Rubin, MD
About this study
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
Read the 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)
- Being tested
- de-escalation or discontinuation of therapy, continuation of current therapy
- Keywords
- histological remission, de-escalation of therapy
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
de-escalation or discontinuation of therapyOther
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 therapyOther
continuation of current maintenance medical therapy for ulcerative colitis
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | continuation of current therapy Receives: Other: continuation of current therapy |
| de-escalation group | Active comparator | de-escalation or discontinuation of therapy Receives: Other: de-escalation or discontinuation of therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline, 12 months
Secondary outcomes (10)
Proportion of individuals maintaining corticosteroid-free remission
Calculated by dividing the number of individuals maintaining remission without the need for corticosteroid medications by the total number of individuals in the study
Measured: 12 months
Change in host metabolites in states of deep remission
Measured by mass spectrometry, flow cytometry, enzyme-linked immunosorbent assay (ELISA)-based assays and/or real-time polymerase chain reaction (RT-PCR)-based assays
Measured: 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
Quantitative measurement of host metabolites using mass spectrometry, flow cytometry, enzyme-linked immunosorbent assays (ELISA), and/or real-time polymerase chain reaction (RT-PCR)-based assays to characterize biochemical changes associated with deep remission
Measured: 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
Measured by mass spectrometry, flow cytometry, ELISA-based assays and/or RT-PCR-based assays
Measured: 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
Measured by mass spectrometry, flow cytometry, ELISA-based assays and/or RT-PCR-based assays
Measured: 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 composition in states of deep remission
Measured by mass spectrometry and RT-PCR-based assays
Measured: 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 abundance in states of deep remission
Measured by RT-PCR-based assays
Measured: 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 composition in states of disease relapse
Measured by RT-PCR-based assays
Measured: 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 abundance in states of disease relapse
Measured by RT-PCR-based assays
Measured: Baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)
Number of individuals with long-term remission
Remission defined as an individual with all of the following:
- Clinical remission: PRO-2 less than 1
- Biochemical remission: FCP less than 150, CRP less than 1.0 mg/dL
- Sonographic remission: BWT ultrasound assessment less than 4mm in Rectum; less than 3mm in remainder of Bowel
- Endoscopic remission: Mayo Endoscopic Subscore equals 0 or 1
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start11 Nov 2025
- Primary completionNov 2029 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David T Rubin, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693310
- Sponsor's protocol ID
- IRB24-0008
- Status last verified
- Oct 2026
- First submitted
- 7 Nov 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STOP-UC: De-escalation of Therapy in Patients With Ulcerative Colitis With Histological Remission
- ClinicalTrials.gov ID
- NCT06693310
- Acronym / sponsor ID
- IRB24-0008
- Conditions
- Ulcerative Colitis (UC)
- Keywords
- histological remission, de-escalation of therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: continuation of current therapycontinuation of current therapy |
| de-escalation group | Active comparator | Other: de-escalation or discontinuation of therapyde-escalation or discontinuation of therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- Patients in clinical, biochemical (fecal calprotectin <100), radiologic and endoscopic remission since the last colonoscopy.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| de-escalation or discontinuation of therapyDe-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 | de-escalation group |
| continuation of current therapycontinuation of current maintenance medical therapy for ulcerative colitis | Other | Control group |
Primary outcome
Number of individuals with sustained biochemical remission
Time frame: Baseline, 12 months
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).
Number of individuals with sustained sonographic remission
Time frame: Baseline, 12 months
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
Number of individuals with sustained clinical remission
Time frame: Baseline, 12 months
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.
Number of individuals with sustained endoscopic remission
Time frame: Baseline, 12 months
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.
10 secondary outcomes
Proportion of individuals maintaining corticosteroid-free remission
Time frame: 12 months
Change in host metabolites in states of deep remission
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 composition in states of deep remission
Time frame: 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 abundance in states of deep remission
Time frame: 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 composition in states of disease relapse
Time frame: 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 abundance in states of disease relapse
Time frame: Baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)
Number of individuals with long-term remission
Time frame: Month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
Related trials for Ulcerative Colitis (UC)
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
Not yet recruitingObservational study
Non-Invasive Biomarker Monitoring in UC on Biologics
Ulcerative Colitis
RecruitingPhase 2
LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
RecruitingPhase 1/2
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
RecruitingPhase 1/2
Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
Ulcerative Colitis (UC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David T Rubin, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing de-escalation or discontinuation of therapy and continuation of current therapy in people with Ulcerative Colitis (UC), run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Coordinator (215-596-9715, Alex.Mathew@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of individuals with sustained biochemical remission (time frame: Baseline, 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.