Ulcerative Colitis Clinical Trials

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Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis: Multicenter, Open-Label, Randomized Controlled Trial

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This clinical trial aims to evaluate the comparative efficacy and safety of upadacitinib versus infliximab as second-line treatments for acute severe ulcerative colitis, addressing the following key questions: (1) Can upadacitinib as a second-line therapy effectively induce remission in acute severe ulcerative colitis with efficacy non-inferior to infliximab? (2) What adverse reactions may occur with upadacitinib in the treatment of acute severe ulcerative colitis? Researchers will also compare the efficacy of upadacitinib with that of corticosteroids to assess its therapeutic effect. Participants will be assigned to either the upadacitinib group (receiving upadacitinib extended-release tablets 45 mg once daily for 8 weeks, followed by 30 mg once daily) or the infliximab group (receiving an initial dose of 5 mg/kg, with additional doses at week 2, week 6, and every 8 weeks thereafter at the same dose). The treatment duration is 3 months, with outpatient visits for examinations and tests every two weeks. Patients will record their bowel movements and symptoms such as abdominal pain, and undergo colonoscopy, ultrasound examinations, and blood tests at specified time points.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Patients diagnosed with ASUC

• Aged 18 years or older.

• No gender restriction.

Locations
Other Locations
China
Ankang Central Hospital
RECRUITING
Ankang
3201 Hospital
RECRUITING
Hanzhong
Xijing Hosipital of Digestive Disease
RECRUITING
Xi'an
Shaanxi Provincial Nuclear Industry 215 Hospital
RECRUITING
Xianyang
Contact Information
Primary
Yongquan Shi, Ph.D
shiyquan@fmmu.edu.cn
86-029-84771535
Time Frame
Start Date: 2026-04-20
Estimated Completion Date: 2028-11-01
Participants
Target number of participants: 226
Treatments
Experimental: Upadacitinib group
Upadacitinib extended-release tablets 45 mg once daily for 8 weeks, then adjusted to 30 mg once daily.
Active_comparator: Infliximab group
receiving an initial dose of 5 mg/kg, with additional doses at week 2, week 6, and every 8 weeks thereafter at the same dose
Sponsors
Leads: Xijing Hospital of Digestive Diseases

This content was sourced from clinicaltrials.gov