Actively Recruiting

Phase 4
Age: 18Years - 85Years
All Genders
NCT07546097

Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis(UPFRONT)

Led by Yongquan Shi · Updated on 2026-04-22

46

Participants Needed

4

Research Sites

66 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis(UPFRONT)

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with ASUC
  • Aged 18 years or older
  • No gender restriction
Not Eligible

You will not qualify if you...

  • Contraindication, allergy, or intolerance to upadacitinib or glucocorticoids
  • Need for immediate colectomy
  • Diagnosis of Crohn's disease
  • Confirmed intestinal infection
  • Hemodynamic instability
  • Clinically significant cytomegalovirus infection
  • Current malignancy
  • Severe systemic diseases involving heart, lungs, liver, kidneys, hematologic system, or other organs
  • Pregnant or breastfeeding women
  • Unwilling to participate in the clinical study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 4 locations

1

Ankang Central Hospital

Ankang, Shaanxi, China, 710005

Actively Recruiting

2

3201 Hospital

Hanzhong, Shaanxi, China, 710005

Actively Recruiting

3

Xijing Hospital

Xi'an, Shaanxi, China, 710005

Actively Recruiting

4

Shaanxi Provincial Nuclear Industry 215 Hospital

Xianyang, Shaanxi, China, 710005

Actively Recruiting

Loading map...

Research Team

Y

Yongquan Shi

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis(UPFRONT) | DecenTrialz