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Trial · NCT06095596

Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis

NCT06095596, Not applicable, Recruiting, Sixth Affiliated Hospital, Sun Yat-sen University

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis. Trials, record NCT06095596. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06095596

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis
NCT number
NCT06095596
Status
Recruiting
Phases
Not applicable
Enrollment
334 participants, estimated
Lead sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions
Ulcerative Colitis (UC)
Interventions
Upadacitinib, Vedolizumab
First posted
2023-10-23
Last updated
2026-04-28

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primary8th-week endoscopic remission rate8th-weekendoscopic subscale (ESS) =0, which defined as endoscopic remission
SecondaryClinical remission rate at the 8th week8th-weekClinical remission is defined as a total Mayo score ≤2, with no individual subscore \>1 and a rectal bleeding subscore of 0.
Secondaryclincial response rate at 8th-week8th-week
Clinical response is defined as a decrease in total Mayo score by ≥3 points and ≥30% from baseline, with a decrease in rectal bleeding subscore by ≥1 point or an absolute rectal bleeding subscore of 0 or 1.
SecondaryEndoscopic response rate at 8th-week8th-weekEndoscopic response is defined as a decrease in the Mayo endoscopic subscore by ≥1 point from baseline
Secondarynormalization rate of CRP at the 8th week8th-weeknormalization rate of C reactive protein (CRP)
Secondarylife quality score at the 8th week8th-weekInflammatory bowel disease questionnaire (IBDQ), the total score is 32-224, with higher scores indicating better quality of life for patients.
SecondaryClinical remission rate at the 54th-week54th-weekclincial remisson is defined as a total Mayo score ≤2, with no individual subscore \>1 and a rectal bleeding subscore of 0.
SecondaryClinical response rate at 54th week54th week
Clinical response is defined as a decrease in total Mayo score by ≥3 points and ≥30% from baseline, with a decrease in rectal bleeding subscore by ≥1 point or an absolute rectal bleeding subscore of 0 or 1.
Secondaryendoscopic remission rate at 54th-week54th-weekendoscopic subscale (ESS) =0, which defined as endoscopic remission
SecondaryEndoscopic response rate at 54th-week54th-weekEndoscopic response is defined as a decrease in the Mayo endoscopic subscore by ≥1 point from baseline

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
42173298DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT06095596

GET https://conductscience.org/api/trials/v1/NCT06095596/registered