Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis（UPRISE）
Phase 4 · Testing upadacitinib and Infliximab · 4 sites · Xijing Hospital of Digestive Diseases
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing upadacitinib (a drug) and Infliximab (a drug) as a possible treatment. Condition(s) listed: Acute Severe Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 to 85
- Any sex
Some of the main requirements, copied from the record:
- Patients diagnosed with ASUC
- Aged 18 years or older.
- No gender restriction.
There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 226 participants are expected to take part.
- Start date: 2026-04-20.
- Main results expected around 2028-04-01 (estimate from the record).
- 4 study sites listed (4 marked recruiting) in China.
Main thing being measured
- Clinical response by day 7 (The primary outcome was assessed by the investigator between days 3 and 7, with patients recorded as clinical…)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Acute Severe Ulcerative Colitis |
| Lead sponsor | Xijing Hospital of Digestive Diseases |
| Enrollment | 226 (estimated) |
| Start date | 2026-04-20 |
| Primary completion (est.) | 2028-04-01 |
| First posted | 2026-04-24 |
| Last updated | 2026-04-24 |
| Official title | Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis: Multicenter, Open-Label, Randomized Controlled Trial |
| ClinicalTrials.gov ID | NCT07550673 |
Interventions
- upadacitinib (Drug)
receiving upadacitinib extended-release tablets 45 mg once daily for 8 weeks, followed by 30 mg once daily - Infliximab (Drug)
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
Full eligibility criteria (from the record)
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.
Locations (4)
| Site | City | Country | Site status |
|---|---|---|---|
| Ankang Central Hospital | Ankang, Shaanxi | China | Recruiting |
| 3201 Hospital | Hanzhong, Shaanxi | China | Recruiting |
| Xijing Hosipital of Digestive Disease | Xi'an, Shaanxi | China | Recruiting |
| Shaanxi Provincial Nuclear Industry 215 Hospital | Xianyang, Shaanxi | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.