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NCT Number: NCT07546097

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

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.

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Key information

Conditions

Acute Severe Ulcerative Colitis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ankang Central Hospital, Ankang, Shaanxi, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.
  • Pregnant or breastfeeding women.
  • Unwilling to participate in the clinical study.

Treatment and study plan

Upadacitinib

Drug

Safety and efficacy of the drug

Corticosteroid

Drug

Safety and efficacy of the drug

Primary outcomes

  1. Primary Outcome Measure

    Time frame: The primary outcome was assessed by the investigator between days 3 and 7, with patients recorded as clinical responders if they had the primary outcome on any day in this assessment window.

    clinical response by day 7 (defined as a reduction in Lichtiger score to <10 points with a decrease of ≥3 points from baseline improvement in rectal bleeding, and decreased stool frequency to ≤4 per day).

Secondary outcomes

  1. clinical response by day 14

    Time frame: day 14

    Defined as mayo score decrease of ≥30% and ≥3 points from baseline, accompanied by a decrease in the rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of 0 or 1.

  2. clinical remission by day 28, day 42, and day 90

    Time frame: day 28, day 42, and day 90

    Total Mayo score ≤2 points and no individual subscore >1 point.

  3. Endoscopic response by day 90

    Time frame: day 90

    A decrease in MES score of ≥1 point, or a decrease of ≥50% from baseline.

  4. Endoscopic remission by day 90

    Time frame: day 90

    MES score ≤1

  5. Endoscopic+clinical response

    Time frame: day 90

    Partial Mayo score ≤1 and MES ≤1

  6. Clinical +FcP remission

    Time frame: day 90

    Partial Mayo score ≤1 and FcP≤250mg/kg

  7. Clinical +CRP remission

    Time frame: day 90

    Partial Mayo score ≤1 and CRP≤5mg/L

  8. Histologic remission

    Time frame: day 90

    typically defined as the absence of signs of neutrophilic infiltration. The specific criterion is a score below 2B.0, i.e., no increased neutrophils in the lamina propria.

  9. Histologic improvement

    Time frame: day 90

    when assessing treatment efficacy, a score ≤ 3.1 (intraepithelial neutrophilic infiltration involving < 50% of crypts) is used as the threshold for histologic improvement.

  10. Adverse Reactions

    Time frame: day 90

    Adverse Reactions

  11. IBDQ and fatigue questionnaire scores

    Time frame: day 0 and day 90

    IBDQ and fatigue questionnaire scores

Study contacts

Contact information is provided by the study sponsor or research team.

Yongquan Shi

CONTACT

[email protected]

+8602984771535

Sponsors and collaborators

Lead sponsor

Yongquan Shi

Other

Registry information

Official study title

Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis: Multicenter, Open-label, Non-inferiority, Randomized Controlled Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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