Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease (EaseUpIBD)

January 13, 2025 updated by: Xiang Gao

Efficacy and Safety of Upadacitinib in the Treatment of Inflammatory Bowel Disease in China: a Multicenter, Single-Arm, Prospective, Observational Real-World Study

Inflammatory Bowel Disease (IBD), which encompasses ulcerative Colitis (UC) and Crohn's Disease (CD), has seen significant improvements in patient outcomes with biologic treatments. However, nearly half of the patients are either primary or secondary non-responders to the existing biologics. Upadacitinib is the only oral small molecule targeted drug approved for IBD in China. There is a paucity of research on the efficacy and safety of upadacitinib in treating Chinese patients with UC and CD, and a lack of study data on the Chinese IBD population. This study aims to conduct a multicenter, single-arm, prospective, observational real-world study to analyze the efficacy and safety of upadacitinib in the treatment of Chinese patients with IBD, providing a basis for clinical decision-making.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

174

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • Recruiting
        • Sixth Affiliated Hospital, Sun Yat-sen University
        • Contact:
          • Xiang Gao
        • Contact:
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
        • Contact:
          • Haiyan Zhang
        • Contact:
      • Meizhou, Guangdong, China, 514000
        • Recruiting
        • Meizhou People's hospital
        • Contact:
          • Taofeng Jiang
          • Phone Number: +86-0753-2202723
          • Email: jtf18@163.com
        • Contact:
          • Taofeng Jiang
      • Shenzhen, Guangdong, China, 518000
        • Recruiting
        • The Eighth Affiliated Hospital, Sun Yat-sen University
        • Contact:
        • Contact:
          • Xiaoling Wang
    • Guangxi
      • Liuzhou, Guangxi, China, 545000
        • Recruiting
        • Liuzhou People's Hospital
        • Contact:
        • Contact:
          • Yun He
      • Nanning, Guangxi, China, 530000
        • Recruiting
        • Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine
        • Contact:
          • Tao Zhang
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population was derived from IBD centers in China.

Description

Inclusion Criteria:

  • Inclusion criteria were patients of any gender, diagnosed with ulcerative colitis or Crohn's disease according to current guidelines, requiring initial upadacitinib treatment as judged by the treating physician, and providing signed informed consent.

Exclusion Criteria:

  • Exclusion criteria included current or planned participation in any other clinical study, contraindications to upadacitinib treatment as per the drug's instructions, and patients deemed unsuitable for the study by the researchers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Crohn's disease
Drug: Upadacitinib

Induction Therapy: The dose of upadacitinib for induction therapy is 45mg once daily for a duration of 8 weeks (for ulcerative colitis) or 12 weeks (for Crohn's disease).

Maintenance Therapy: The dose of upadacitinib for maintenance therapy is 15mg once daily; for patients with refractory, severe, or extensive disease, a maintenance dose of 30mg once daily may be considered.
ulcerative colitis
Drug: Upadacitinib

Induction Therapy: The dose of upadacitinib for induction therapy is 45mg once daily for a duration of 8 weeks (for ulcerative colitis) or 12 weeks (for Crohn's disease).

Maintenance Therapy: The dose of upadacitinib for maintenance therapy is 15mg once daily; for patients with refractory, severe, or extensive disease, a maintenance dose of 30mg once daily may be considered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Remission Rate
Time Frame: 52 weeks
Clinical remission rate in patients with ulcerative Colitis or Crohn's Disease.
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiang Gao

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024ZSLYEC-250

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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