Upadacitinib versus infliximab for second-line treatment of acute severe ulcerative colitis
Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis: Multicenter, Open-Label, Randomized Controlled Trial
This trial will see if upadacitinib or infliximab works better to induce remission in adults with acute severe ulcerative colitis who need second-line therapy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 226 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Xijing Hospital of Digestive Diseases Academic / other |
| Drugs / interventions | infliximab, upadacitinib |
| Locations | 4 sites (Ankang, Shaanxi and 3 other locations) |
| Trial ID | NCT07550673 on ClinicalTrials.gov |
What this trial studies
This phase 4 randomized comparison assigns adults with acute severe ulcerative colitis who require second-line therapy to either oral upadacitinib (45 mg daily for 8 weeks then 30 mg daily) or intravenous infliximab (5 mg/kg at weeks 0, 2, 6 and then every 8 weeks) and follows them for three months. Patients attend outpatient visits for clinical assessments, lab tests, and safety monitoring, with outcomes including remission rates, adverse events, and need for colectomy. The protocol includes specific safety surveillance for infections and organ-specific toxicities given the immune-modulating nature of both drugs. The trial will directly compare effectiveness and tolerability of an oral JAK inhibitor versus an IV anti-TNF biologic as second-line options.
Who should consider this trial
Good fit: Adults aged 18 or older with acute severe ulcerative colitis who require second-line therapy after initial corticosteroids and who have no contraindications to upadacitinib or infliximab are ideal candidates.
Not a fit: Patients requiring immediate colectomy, with confirmed severe infections, active malignancy, significant organ dysfunction, pregnancy, or intolerance to the study drugs are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could provide an effective oral alternative to infliximab for inducing remission in acute severe ulcerative colitis with comparable safety.
How similar studies have performed: JAK inhibitors and infliximab have individually shown benefit as rescue therapies in severe ulcerative colitis, but direct head-to-head comparisons of upadacitinib versus infliximab in this setting are novel.
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 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.
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 Hosipital of Digestive Disease — Xi'an, Shaanxi, China (Recruiting)
- Shaanxi Provincial Nuclear Industry 215 Hospital — Xianyang, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Yongquan Shi, Ph.D
- Email: shiyquan@fmmu.edu.cn
- Phone: 86-029-84771535
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.