Upadacitinib versus corticosteroids for first-line treatment of acute severe ulcerative colitis
Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis: Multicenter, Open-label, Non-inferiority, Randomized Controlled Study
This test will see if upadacitinib works as well as corticosteroids to induce remission in adults with acute severe ulcerative colitis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Xijing Hospital of Digestive Diseases Academic / other |
| Drugs / interventions | upadacitinib, prednisone |
| Locations | 4 sites (Ankang, Shaanxi and 3 other locations) |
| Trial ID | NCT07546097 on ClinicalTrials.gov |
What this trial studies
This is a randomized, head-to-head Phase 4 comparison of upadacitinib extended-release tablets versus standard corticosteroid therapy as first-line treatment for acute severe ulcerative colitis. Participants are assigned to receive upadacitinib 45 mg once daily for 8 weeks then 30 mg daily, or intravenous methylprednisolone 60 mg/day with planned switch to oral prednisone when clinically appropriate. The trial measures clinical remission rates and tracks adverse events to compare safety profiles. Outcomes will inform whether upadacitinib can be used safely and effectively instead of corticosteroids in this acute setting.
Who should consider this trial
Good fit: Adults aged 18 and older diagnosed with acute severe ulcerative colitis who are not pregnant or breastfeeding and who have no contraindication to upadacitinib or corticosteroids may qualify.
Not a fit: People with Crohn's disease, active serious infections (including CMV), immediate need for colectomy, current malignancy, severe organ dysfunction, or who are pregnant or breastfeeding are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could offer an alternative first-line option that achieves similar remission while potentially reducing steroid exposure for some patients.
How similar studies have performed: Upadacitinib has shown efficacy in phase 3 trials for moderate-to-severe ulcerative colitis, but using it as first-line therapy specifically in acute severe ulcerative colitis is a relatively new, less-tested approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ankang, Shaanxi and 3 other locations
- Ankang Central Hospital — Ankang, Shaanxi, China (Recruiting)
- 3201 Hospital — Hanzhong, Shaanxi, China (Recruiting)
- Xijing Hospital — Xi'an, Shaanxi, China (Recruiting)
- Shaanxi Provincial Nuclear Industry 215 Hospital — Xianyang, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Yongquan Shi
- Email: von15991351319@163.com
- Phone: +8602984771535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.