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

NCT07546097 | Recruiting Phase 4

• 1 other identifier: KY20252556-F-1-1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

Brief 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. 1.Whether upadacitinib can effectively induce remission in acute severe ulcerative colitis with an efficacy non-inferior to that of corticosteroids.
2. 2.What adverse reactions may occur with upadacitinib in the treatment of acute severe ulcerative colitis?
3. 3.Upadacitinib group: Upadacitinib extended-release tablets 45 mg once daily for 8 weeks, then adjusted to 30 mg once daily.
4. 4.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.
5. 5.Take drug Upadacitinib or Corticosteroid every day for 3 months
6. 6.Visit the clinic once every 2 weeks for checkups and tests
7. 7.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

Keywords

acute severe ulcerative colitis; Upadacitinib; Corticosteroids; First-Line Therapy; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure

  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 (11)

• 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

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

Corticosteroid group

ACTIVE COMPARATOR

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.

Drug: Corticosteroid

Interventions

Upadacitinib DRUG

Safety and efficacy of the drug

Upadacitinib group

Corticosteroid DRUG

Safety and efficacy of the drug

Corticosteroid group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 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.

Sponsors & Collaborators

• Yongquan Shi: lead

Study Sites (4)

Ankang Central Hospital

Ankang, Shaanxi, 710005, China

RECRUITING

3201 Hospital

Hanzhong, Shaanxi, 710005, China

RECRUITING

Xijing Hospital

Xi'an, Shaanxi, 710005, China

RECRUITING

Shaanxi Provincial Nuclear Industry 215 Hospital

Xianyang, Shaanxi, 710005, China

RECRUITING

Related Publications (2)

• D'Haens G, Lemmens L, Geboes K, Vandeputte L, Van Acker F, Mortelmans L, Peeters M, Vermeire S, Penninckx F, Nevens F, Hiele M, Rutgeerts P. Intravenous cyclosporine versus intravenous corticosteroids as single therapy for severe attacks of ulcerative colitis. Gastroenterology. 2001 May;120(6):1323-9. doi: 10.1053/gast.2001.23983.

  PMID: 11313301 BACKGROUND

• 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: 39236736 BACKGROUND

MeSH Terms

Interventions

upadacitinib; Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Yongquan Shi

CONTACT

+8602984771535; von15991351319@163.com

Study Design

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

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 22, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)