NCT07546097RecruitingPhase 4
Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis（UPFRONT）
Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis: Multicenter, Open-label, Non-inferiority, Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
The goal of this clinical trial is to learn comparative effectiveness and safety of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis. The main questions it aims to answer are: 1. Whether upadacitinib can effectively induce remission in acute severe ulcerative colitis with an efficacy non-inferior to that of corticosteroids. 2. What adverse reactions may occur with upadacitinib in the treatment of acute severe ulcerative colitis? Researchers will compare upadacitinib with corticosteroids to evaluate the efficacy of upadacitinib in the treatment of acute severe ulcerative colitis.Participants will: 1. Upadacitinib group: Upadacitinib extended-release tablets 45 mg once daily for 8 weeks, then adjusted to 30 mg once daily. 2. Corticosteroid group: Methylprednisolone for injection 60 mg/day. If clinical response is achieved, switch to oral prednisone acetate tablets after 5 days (calculated at 0.75 mg/kg/day), followed by a weekly prednisone taper of 5 mg. When the dose is reduced to 20 mg, taper by 2.5 mg weekly until discontinued, with mesalazine 4 g/day as maintenance therapy. 3. Take drug Upadacitinib or Corticosteroid every day for 3 months 4. Visit the clinic once every 2 weeks for checkups and tests 5. Record the patient's bowel movements and the presence of symptoms such as abdominal pain, while performing colonoscopy, ultrasound examination, and blood tests at the specified time points.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- First submitted
- 26 Mar 2026
- Start date
- 23 Mar 2026
- Primary completion date
- 30 Mar 2027
- Lead sponsor
- Yongquan Shi
- Diseases
- Ulcerative colitis
- NCT number
- NCT07546097
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 46
- From 23 Mar 2026 to the primary completion date, 30 Mar 2027
- 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 glucocorticoids.
- 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 hospital 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.