Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease

NCT06780683 | Recruiting DMC

• 1 other identifier: 2024ZSLYEC-250
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Clinical Remission Rate

  Clinical remission rate in patients with ulcerative Colitis or Crohn's Disease.

  52 weeks

Study Arms (2)

Crohn's disease

Drug: Upadacitinib

ulcerative colitis

Drug: Upadacitinib

Interventions

Upadacitinib DRUG

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.

Crohn's disease; ulcerative colitis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population was derived from IBD centers in China.

Sponsors & Collaborators

• Xiang Gao: lead

Study Sites (6)

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510000, China

RECRUITING

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

Meizhou People's Hospital

Meizhou, Guangdong, 514000, China

RECRUITING

The Eighth Affiliated Hospital, Sun Yat-Sen University

Shenzhen, Guangdong, 518000, China

RECRUITING

Liuzhou People's Hospital

Liuchow, Guangxi, 545000, China

RECRUITING

Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine

Nanning, Guangxi, 530000, China

RECRUITING

Related Publications (2)

• Loftus EV Jr, Panes J, Lacerda AP, Peyrin-Biroulet L, D'Haens G, Panaccione R, Reinisch W, Louis E, Chen M, Nakase H, Begun J, Boland BS, Phillips C, Mohamed MF, Liu J, Geng Z, Feng T, Dubcenco E, Colombel JF. Upadacitinib Induction and Maintenance Therapy for Crohn's Disease. N Engl J Med. 2023 May 25;388(21):1966-1980. doi: 10.1056/NEJMoa2212728.

  PMID: 37224198 BACKGROUND

• Danese S, Vermeire S, Zhou W, Pangan AL, Siffledeen J, Greenbloom S, Hebuterne X, D'Haens G, Nakase H, Panes J, Higgins PDR, Juillerat P, Lindsay JO, Loftus EV Jr, Sandborn WJ, Reinisch W, Chen MH, Sanchez Gonzalez Y, Huang B, Xie W, Liu J, Weinreich MA, Panaccione R. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022 Jun 4;399(10341):2113-2128. doi: 10.1016/S0140-6736(22)00581-5. Epub 2022 May 26.

  PMID: 35644166 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples, serum samples, and tissue samples.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Central Study Contacts

Lang Lin

CONTACT

+86-020-38663423; linlang3@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Gastroenterology

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 17, 2025

Record last verified: 2024-05

Locations

CN (6)