NCT07550673

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for phase_4

Timeline
30mo left

Started Apr 2026

Typical duration for phase_4

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Apr 2026Nov 2028

First Submitted

Initial submission to the registry

April 14, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 14, 2026

Last Update Submit

April 21, 2026

Conditions

Acute Severe Ulcerative Colitis

Keywords

Acute severe ulcerative colitisUpadacitinibsecond-line treatmentsinfliximabRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Clinical response by day 7

    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).

    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.

Secondary Outcomes (12)

  • clinical response by day 14

    day 14

  • clinical remission by day 28, day 42, and day 90

    day 28, day 42, and day 90

  • Endoscopic response by day 90

    day 90

  • Endoscopic remission by day 90

    day 90

  • Endoscopic+clinical response

    day 90

  • +7 more secondary outcomes

Study Arms (2)

Upadacitinib group

EXPERIMENTAL

Upadacitinib extended-release tablets 45 mg once daily for 8 weeks, then adjusted to 30 mg once daily.

Drug: upadacitinib

Infliximab group

ACTIVE COMPARATOR

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

Drug: Infliximab

Interventions

upadacitinibDRUG

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

Upadacitinib group
InfliximabDRUG

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

Infliximab group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with ASUC
  • Aged 18 years or older.
  • No gender restriction.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Ankang Central Hospital

Ankang, Shaanxi, 725000, China

RECRUITING

3201 Hospital

Hanzhong, Shaanxi, 710005, China

RECRUITING

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710005, China

RECRUITING

Shaanxi Provincial Nuclear Industry 215 Hospital

Xianyang, Shaanxi, 712000, China

RECRUITING

Related Publications (2)

  • Honap S, St-Pierre J, Colwill M, Patel K, Le Berre C, Caron B, Nogami A, Kobayashi T, Altwegg R, Laharie D, Hebuterne X, Nachury M, Roblin X, Uzzan M, Kotze PG, Lukas M, Vieujean S, D'Amico F, Albshesh A, Guillo L, Fumery M, Nancey S, Ye BD, Bergemalm D, Halfvarson J, Buisson A, Karmiris K, Rubin DT, Vicaut E, Peyrin-Biroulet L; ATTRACT Study Group. Comparative Effectiveness of Tofacitinib vs Upadacitinib for the Treatment of Acute Severe Ulcerative Colitis. Clin Gastroenterol Hepatol. 2026 Mar;24(3):784-793. doi: 10.1016/j.cgh.2025.07.025. Epub 2025 Jul 26.

    PMID: 40721074BACKGROUND

  • Choy MC, Li Wai Suen CFD, Con D, Boyd K, Pena R, Burrell K, Rosella O, Proud D, Brouwer R, Gorelik A, Liew D, Connell WR, Wright EK, Taylor KM, Pudipeddi A, Sawers M, Christensen B, Ng W, Begun J, Radford-Smith G, Garg M, Martin N, van Langenberg DR, Ding NS, Beswick L, Leong RW, Sparrow MP, De Cruz P. Intensified versus standard dose infliximab induction therapy for steroid-refractory acute severe ulcerative colitis (PREDICT-UC): an open-label, multicentre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2024 Nov;9(11):981-996. doi: 10.1016/S2468-1253(24)00200-0. Epub 2024 Sep 2.

    PMID: 39236736BACKGROUND

MeSH Terms

Interventions

upadacitinibInfliximab

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Yongquan Shi, Ph.D

CONTACT

86-029-84771535shiyquan@fmmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 14, 2026

First Posted

April 24, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)