NCT07550673RecruitingPhase 4
Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis（UPRISE）
Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis: Multicenter, Open-Label, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 226 (estimated)
- First submitted
- 14 Apr 2026
- Start date
- 20 Apr 2026
- Primary completion date
- 1 Apr 2028
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Diseases
- Ulcerative colitis
- NCT number
- NCT07550673
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 226
- From 20 Apr 2026 to the primary completion date, 1 Apr 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Pregnant or breastfeeding women.
- Unwilling to participate in the clinical study.
Who the study is looking for
- Patients diagnosed with ASUC
- Aged 18 years or older.
- No gender restriction.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ankang Central Hospital Coordinator of this site? Confirm its status | Ankang | China | Recruiting |
| 3201 Hospital Coordinator of this site? Confirm its status | Hanzhong | China | Recruiting |
| Xijing Hosipital of Digestive Disease Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
| Shaanxi Provincial Nuclear Industry 215 Hospital Coordinator of this site? Confirm its status | Xianyang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.