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NCT Number: NCT06095596

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

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.

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Key information

Conditions

Ulcerative Colitis (UC) Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 501655, China

Location status: Recruiting

Location contact

Jiayin Yao, Professor

CONTACT

[email protected]

13826462890

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Upadacitinib

Drug

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

Other names: Upadacitinib treatment

Vedolizumab

Drug

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

Other names: Vedolizumab treatment

Primary outcomes

  1. 8th-week endoscopic remission rate

    Time frame: 8th-week

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

Secondary outcomes

  1. Clinical remission rate at the 8th week

    Time frame: 8th-week

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

  2. clincial response rate at 8th-week

    Time frame: 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.

  3. Endoscopic response rate at 8th-week

    Time frame: 8th-week

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

  4. normalization rate of CRP at the 8th week

    Time frame: 8th-week

    normalization rate of C reactive protein (CRP)

  5. life quality score at the 8th week

    Time frame: 8th-week

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

  6. Clinical remission rate at the 54th-week

    Time frame: 54th-week

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

  7. Clinical response rate at 54th week

    Time frame: 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.

  8. endoscopic remission rate at 54th-week

    Time frame: 54th-week

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

  9. Endoscopic response rate at 54th-week

    Time frame: 54th-week

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

  10. normalization rate of CRP at the 54th week

    Time frame: 54th-week

    normalization rate of CRP

  11. life quality score at the 54th week

    Time frame: 54th-week

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

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 23, 2023
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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