Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis（UPRISE）

Recruiting now · Phase 4

Conditions studied: Acute Severe Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT07550673

Run by

Xijing Hospital of Digestive Diseases

People needed

226

Starts

2026-04-20

Expected to finish

2028-11-01

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients diagnosed with ASUC
• Aged 18 years or older.
• No gender restriction.

You may not qualify if…

• Presence of contraindications, allergy, or intolerance to upadacitinib or infliximab.
• Patients requiring immediate colectomy; diagnosis of Crohn's disease; confirmed intestinal infection; hemodynamic instability; clinically significant cytomegalovirus infection; current malignancy.
• Presence of severe underlying systemic diseases involving the heart, lungs, liver, kidneys, hematologic system, or other organ systems.
• Pregnant or breastfeeding women.
• Unwilling to participate in the clinical study.

Where it is running

• Ankang Central Hospital — Ankang, Shaanxi, China (enrolling)
• 3201 Hospital — Hanzhong, Shaanxi, China (enrolling)
• Xijing Hosipital of Digestive Disease — Xi'an, Shaanxi, China (enrolling)
• Shaanxi Provincial Nuclear Industry 215 Hospital — Xianyang, Shaanxi, China (enrolling)

Full record on ClinicalTrials.gov

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