Phase 4 Trial Compares Upadacitinib to Corticosteroids for Acute Severe Ulcerative Colitis
Summary
A Phase 4 clinical trial (NCT07546097) comparing upadacitinib extended-release tablets against methylprednisolone/prednisone as first-line therapy for acute severe ulcerative colitis has been registered with an anticipated start date of April 22, 2026. The open-label, non-masked trial aims to determine whether upadacitinib at 45 mg daily for 8 weeks, then 30 mg daily, achieves non-inferior efficacy to corticosteroids in inducing clinical remission. Participants in both arms will attend clinic visits every 2 weeks for 3 months with colonoscopy, ultrasound, and blood testing at specified intervals.
“Whether upadacitinib can effectively induce remission in acute severe ulcerative colitis with an efficacy non-inferior to that of corticosteroids.”
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What changed
A new Phase 4 clinical trial has been registered on ClinicalTrials.gov comparing upadacitinib (Rinvoq) to standard corticosteroid therapy as first-line treatment for acute severe ulcerative colitis. The trial will enroll participants receiving either upadacitinib 45 mg once daily for 8 weeks followed by 30 mg once daily, or methylprednisolone 60 mg/day with an oral prednisone taper and mesalazine maintenance. The primary endpoint is clinical remission at 8 weeks. Secondary endpoints include assessment of adverse reactions with upadacitinib treatment.
For clinical investigators and gastroenterology trial sponsors, this trial represents a regulatory-registered comparative effectiveness study that may generate data relevant to formulary positioning and treatment pathway decisions. The open-label, non-masked design means both investigators and participants are aware of treatment assignments, which may influence endpoint interpretation.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis（UPFRONT）
Phase 4 NCT07546097 Kind: PHASE4 Apr 22, 2026
Abstract
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:
- Whether upadacitinib can effectively induce remission in acute severe ulcerative colitis with an efficacy non-inferior to that of corticosteroids.
- 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:
- Upadacitinib group: Upadacitinib extended-release tablets 45 mg once daily for 8 weeks, then adjusted to 30 mg once daily.
- 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.
- Take drug Upadacitinib or Corticosteroid every day for 3 months
- Visit the clinic once every 2 weeks for checkups and tests
- 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: Upadacitinib, Corticosteroid
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