NCT07550673 Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis（UPRISE）
| NCT ID | NCT07550673 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Xijing Hospital of Digestive Diseases |
| Condition | Acute Severe Ulcerative Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 226 participants |
| Start Date | 2026-04-20 |
| Primary Completion | 2028-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 226 participants in total. It began in 2026-04-20 with a primary completion date of 2028-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Patients diagnosed with ASUC * Aged 18 years or older. * No gender restriction. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07550673 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Acute Severe Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07550673 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07550673 currently recruiting?
Yes, NCT07550673 is actively recruiting participants. Contact the research team at shiyquan@fmmu.edu.cn for enrollment information.
Where is the NCT07550673 trial being conducted?
This trial is being conducted at Ankang, China, Hanzhong, China, Xi'an, China, Xianyang, China.
Who is sponsoring the NCT07550673 clinical trial?
NCT07550673 is sponsored by Xijing Hospital of Digestive Diseases. The trial plans to enroll 226 participants.
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