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Ulcerative Colitis (UC)NCT06095596

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

A study testing Upadacitinib and Vedolizumab in people with Ulcerative Colitis (UC), run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

It's of great importance to effectively induce and maintain disease remission in patients with moderate to severe ulcerative colitis (UC). Vedolizumab (VDZ) is known for its high safety profile and confirmed therapeutic efficacy in UC treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis (UC)
What is being tested?
Upadacitinib and Vedolizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
334 participants
Where
1 siteChina
Study dates
1 Nov 2023to 31 Oct 2026
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed UC for at least 3 months, including endoscopic evidence supporting UC and histopathological evidence supporting UC diagnosis
  • Suffering from moderate to severe UC, defined as modified Mayo score ≥ 4 and endoscopic subscale (ESS) ≥ 2
  • Indications for VDZ or UPA application

Who cannot join

  • Patients who are unable to take oral UPA and receive regular intravenous VDZ infusion therapy
  • Evidence of toxic megacolon was found during screening
  • Previously underwent extensive colectomy, subtotal resection, or total colectomy, ileostomy, or colostomy due to UC
  • Subjects who require surgery due to UC or plan to undergo elective surgery during the study period
  • There is evidence indicating that the subjects suffer from severe, progressive, or uncontrolled kidney, liver, blood, endocrine, respiratory, mental, or neurological diseases
  • Evidence of active hepatitis B or C infection during screening

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • the Sixth Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 501655

    Jiayin Yao, Professor, 13826462890, yjyin@mail3.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety Analysis of Sequential Treatment of Moderate to Severe Ulcerative Colitis With Vedolizumab and Upadacitinib: A Multicenter Prospective Randomized Controlled Clinical Study

It's of great importance to effectively induce and maintain disease remission in patients with moderate to severe ulcerative colitis (UC). Vedolizumab (VDZ) is known for its high safety profile and confirmed therapeutic efficacy in UC treatment. However, according to the experience in clinical practice, the effect onset speed of vedolizumab is relatively slow. Upadacitinib (UPA), however, works quickly, which complements the defect of slow onset of VDZ induction. However, the safety of UPA used in situations such as infection and tumors is inferior to that of VDZ, and long-term use requires testing for the risk of adverse events such as deep vein thrombosis. Therefore, if the advantages of long-term maintenance therapy safety of VDZ and rapid induced remission of UPA are fully utilized, the combination of VDZ and UPA induction for 8 weeks, followed by the use of single drug VDZ in maintenance therapy, can maximize the clinical benefits of UC patients. Due to the lack of high-level clinical research data at home and abroad, we plan to conduct a multicenter prospective randomized controlled clinical study to provide the evidence-based basis for the efficacy analysis of the sequential treatment of moderate to severe UC patients with VDZ and UPA.

Being tested
Upadacitinib, Vedolizumab
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UpadacitinibDrug

    Also called Upadacitinib treatment

    Oral upadacitinib 45mg/d for 8 weeks in the induction therapy.

  • VedolizumabDrug

    Also called Vedolizumab treatment

    Vedolizumab 300mg intravenously on weeks 1, 2, 6, and then on every 8-week interval.

Study groups in NCT06095596
Study groupRoleWhat they receive
Combination treatment groupExperimentalA combination treatment of vedolizumab and upadacitinib for 8 weeks in the induction therapy, then followed by a single treatment of vedolizumab in the maintenance therapy
Receives: Drug: Upadacitinib; Drug: Vedolizumab
Single treatment groupPlacebo comparatorsingle treatment of vedolizumab both in the induction and maintenance therapy
Receives: Drug: Vedolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 8th-week endoscopic remission rate

    endoscopic subscale (ESS) =0, which defined as endoscopic remission

    Measured: 8th-week

Secondary outcomes (11)

  1. Clinical remission rate at the 8th week

    Clinical remission is defined as a total Mayo score ≤2, with no individual subscore >1 and a rectal bleeding subscore of 0.

    Measured: 8th-week

  2. clincial response rate at 8th-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.

    Measured: 8th-week

  3. Endoscopic response rate at 8th-week

    Endoscopic response is defined as a decrease in the Mayo endoscopic subscore by ≥1 point from baseline

    Measured: 8th-week

  4. normalization rate of CRP at the 8th week

    normalization rate of C reactive protein (CRP)

    Measured: 8th-week

  5. life quality score at the 8th week

    Inflammatory bowel disease questionnaire (IBDQ), the total score is 32-224, with higher scores indicating better quality of life for patients.

    Measured: 8th-week

  6. Clinical remission rate at the 54th-week

    clincial remisson is defined as a total Mayo score ≤2, with no individual subscore >1 and a rectal bleeding subscore of 0.

    Measured: 54th-week

  7. Clinical response rate at 54th 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.

    Measured: 54th week

  8. endoscopic remission rate at 54th-week

    endoscopic subscale (ESS) =0, which defined as endoscopic remission

    Measured: 54th-week

  9. Endoscopic response rate at 54th-week

    Endoscopic response is defined as a decrease in the Mayo endoscopic subscore by ≥1 point from baseline

    Measured: 54th-week

  10. normalization rate of CRP at the 54th week

    normalization rate of CRP

    Measured: 54th-week

  11. life quality score at the 54th week

    Inflammatory bowel disease questionnaire (IBDQ), the total score is 32-224, with higher scores indicating better quality of life for patients.

    Measured: 54th-week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start1 Nov 2023
  3. Primary completion31 Oct 2025
  4. Study completion31 Oct 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
334 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06095596
Sponsor's protocol ID
2023ZSLYEC-469
Status last verified
Apr 2026
First submitted
11 Oct 2023
Last updated
28 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yao J, Wu H, Wu L, Yu Q, Cao X, Xie T, Zhong X, Chen H, Wu J, Liu X, Shi L, Zhang M, Peng X, Deng J, Wang W, Liu T, Su T, Yang H, Xia D, Zhi M. Combined Upadacitinib and Vedolizumab as 8-Week Induction Therapy for Moderate-to-Severe Ulcerative Colitis: A Multicenter, Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2026 May 22:S1542-3565(26)00388-5. doi: 10.1016/j.cgh.2026.05.010. Online ahead of print.

    PubMed 42173298

Questions about this trial

What is this clinical trial studying?

A study testing Upadacitinib and Vedolizumab in people with Ulcerative Colitis (UC), run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

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 3 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 28 Apr 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 China. 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. Some participants in this study may receive a placebo. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

8th-week endoscopic remission rate (time frame: 8th-week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06095596, which also lists 1 linked publication.

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 28 Apr 2026.

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