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NCT Number: NCT07550673

Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis(UPRISE)

This clinical trial aims to evaluate the comparative efficacy and safety of upadacitinib versus infliximab as second-line treatments for acute severe ulcerative colitis, addressing the following key questions: (1) Can upadacitinib as a second-line therapy effectively induce remission in acute severe ulcerative colitis with efficacy non-inferior to infliximab? (2) What adverse reactions may occur with upadacitinib in the treatment of acute severe ulcerative colitis? Researchers will also compare the efficacy of upadacitinib with that of corticosteroids to assess its therapeutic effect. Participants will be assigned to either the upadacitinib group (receiving upadacitinib extended-release tablets 45 mg once daily for 8 weeks, followed by 30 mg once daily) or the infliximab group (receiving an initial dose of 5 mg/kg, with additional doses at week 2, week 6, and every 8 weeks thereafter at the same dose). The treatment duration is 3 months, with outpatient visits for examinations and tests every two weeks. Patients will record their bowel movements and symptoms such as abdominal pain, and undergo colonoscopy, ultrasound examinations, and blood tests at specified time points.

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Key information

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 infliximab.
  • 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

receiving upadacitinib extended-release tablets 45 mg once daily for 8 weeks, followed by 30 mg once daily

Infliximab

Drug

receiving an initial dose of 5 mg/kg, with additional doses at week 2, week 6, and every 8 weeks thereafter at the same dose

Primary outcomes

  1. Clinical response by day 7

    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. IBD questionnaire scores

    Time frame: day 0 and day 90

    IBDQ and fatigue questionnaire scores,The total score ranges from 32 to 224 points. The closer the score is to 224, the less the patient is troubled by the disease and the higher their quality of life.

  12. PROMIS-Fatigue SF-7a

    Time frame: day 0 and day 90

    Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a.The total score ranges from 7 to 35 points. The higher the score, the more severe the fatigue caused by the disease, and timely attention to the patient's condition is needed.

Study contacts

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

Yongquan Shi, Ph.D

CONTACT

[email protected]

86-029-84771535

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Registry information

Official study title

Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis: Multicenter, Open-Label, Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 24, 2026
Registry last updated
Apr 24, 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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