NCT07402135

Brief Summary

Design: Multicenter, Open-Label, Randomized, Parallel Controlled Allocation: 1:1 Randomization Masking: Open-label (outcome assessors blinded for endoscopy) Primary Purpose: Treatment Strategy Evaluation Phase: Phase IV (Post-Marketing Surveillance)

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Feb 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

July 30, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

February 10, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

July 30, 2025

Last Update Submit

February 9, 2026

Conditions

Noninvasive BiomarkersUlcerative Colitis (UC)

Outcome Measures

Primary Outcomes (1)

  • Time to Treatment Failure (Composite)

    Time to Treatment Failure (Composite): Clinical relapse (pMS increase ≥2 + rectal bleeding ≥1). Need for corticosteroids due to UC relapse. UC-related hospitalization or surgery. Endoscopic worsening (MES \>1).

    week 52

Secondary Outcomes (1)

  • Endoscopic remission rate (MES ≤1).

    week 52

Study Arms (2)

Tight Control (TC) Strategy

EXPERIMENTAL

Fecal calprotectin (FC) and FIT measured at Weeks 0, 12, 24, 36. Action: Preemptive therapy escalation based on preset thresholds (FC \>250 μg/g or FIT \>100 ng/mL) using the FOCUS-UC Ladder: Level 0: Current maintenance therapy. Level 1: Optimize current therapy (e.g., dose increase, TDM-guided adjustment). Level 2: Add combination therapy (e.g., biologics + immunomodulators). Level 3: Switch to advanced therapy (different mechanism). Level 4: Study withdrawal (treatment failure).

Procedure: Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder:

Conventional Management (CM) Strategy

PLACEBO COMPARATOR
Procedure: Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1).

Interventions

Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder:PROCEDURE

Preemptive therapy escalation based on preset thresholds (FC \>250 μg/g or FIT \>100 ng/mL) using the FOCUS-UC Ladder: Level 0: Current maintenance therapy. Level 1: Optimize current therapy (e.g., dose increase, TDM-guided adjustment). Level 2: Add combination therapy (e.g., biologics + immunomodulators). Level 3: Switch to advanced therapy (different mechanism). Level 4: Study withdrawal (treatment failure).

Tight Control (TC) Strategy
Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1).PROCEDURE

Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1).

Conventional Management (CM) Strategy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed UC diagnosis ≥6 months.
  • Clinical remission: Partial Mayo Score (pMS) ≤2, with stool frequency and rectal bleeding subscores ≤1.
  • Endoscopic remission (MES ≤1) confirmed by colonoscopy within 12 weeks pre-screening.
  • Stable maintenance therapy (5-ASA, immunomodulators, biologics, or JAK inhibitors) ≥8 weeks.
  • Written informed consent.

You may not qualify if:

  • Indeterminate colitis or Crohn's disease.
  • History of toxic megacolon, symptomatic colonic stricture, or dysplasia. Prior colectomy.
  • Systemic/local corticosteroid use within 8 weeks.
  • Active gastrointestinal infection or chronic diarrhea from non-UC causes.
  • Pregnancy, lactation, or concurrent interventional trial participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Central Study Contacts

Yan Zhang, M.D

CONTACT

+86 18560089821qlzhangyan@sdu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2025

First Posted

February 11, 2026

Study Start

February 10, 2026

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share