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

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years 11 months later Nov 2026 → Nov 2029
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Record History

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  1. Primary completion pushed from Nov 2026 to Nov 2029 Show 4 more changesShow less
    • Study completion pushed from Nov 2027 to Nov 2030
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 5 of 10 entries
    • Study description revised
  2. Re-verified, no change to tracked fieldsv9
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2025 to Nov 11, 2025
    • Site details revised
    v8
  4. Primary completion date: Oct 2026 to Nov 2026
    • Study completion date: Oct 2027 to Nov 2027
    • Start date: Oct 2025 to Nov 2025
    v7
  5. Primary completion date: Sep 2026 to Oct 2026
    • Study completion date: Sep 2027 to Oct 2027
    • Eligibility criteria expanded, about 61 words
    • Study description expanded, about 74 words
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Jul 2025 to Oct 2025
    • Primary completion date: Jul 2026 to Sep 2026
    • Study completion date: Jul 2027 to Sep 2027
    v5
  2. Start date: Mar 2025 to Jul 2025
    • Primary completion date: Mar 2026 to Jul 2026
    • Study completion date: Mar 2027 to Jul 2027
    v4
  3. Primary completion date: Jan 2026 to Mar 2026
    • Study completion date: Jan 2027 to Mar 2027
    • Start date: Jan 2025 to Mar 2025
    v3
  4. Start date: Nov 2024 to Jan 2025
    • Primary completion date: Nov 2026 to Jan 2026
    • Study completion date: Nov 2027 to Jan 2027
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06693310
Lead Sponsor University of Chicago
Conditions
(from sponsor)		 Ulcerative Colitis (UC)
Related terms Colitis, Ulcerative
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov