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

NCT07546097 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-04-22

No results posted yet for this study

Summary

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

  • Acute Severe Ulcerative Colitis

Interventions

DRUG

Upadacitinib

Safety and efficacy of the drug

DRUG

Corticosteroid

Safety and efficacy of the drug

Sponsors & Collaborators

  • Yongquan Shi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-23
Primary Completion
2027-03-30
Completion
2027-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07546097 on ClinicalTrials.gov