Ulcerative Colitis Clinical Trials: Acute Severe UC Studies Recruiting Now
A Phase 4 trial at University of Michigan is testing upadacitinib + corticosteroids vs steroids alone for acute severe ulcerative colitis (ASUC). Learn about this and other recruiting UC trials, eligibility, and how to find a study near you.
Ulcerative Colitis Clinical Trials: Acute Severe UC Studies Recruiting Now
When ulcerative colitis (UC) flares severely—six or more bloody bowel movements daily, fever, anemia, elevated inflammatory markers—it becomes acute severe ulcerative colitis (ASUC), a medical emergency requiring hospitalization. For patients who don't respond to intravenous steroids within 3–5 days, options narrow quickly. Clinical trials are now testing advanced combination therapies that could change the ASUC treatment algorithm.
Understanding Acute Severe Ulcerative Colitis (ASUC)
ASUC affects approximately 15–25% of UC patients at some point in their disease course. The classic definition (Truelove & Witts criteria) includes:
- ≥6 bloody stools/day
- Plus at least one systemic sign: fever (>37.8°C), tachycardia (≥90 bpm), anemia (Hb ≤10.5 g/dL), elevated ESR (≥30 mm/h) or CRP (≥30 mg/L), or high fecal calprotectin
Standard rescue therapy has been IV corticosteroids (methylprednisolone). Non-responders by day 3–5 face a critical decision: escalate to salvage biologics (infliximab, cyclosporine) or consider colectomy. This is where novel trials enter the picture.
Actively Recruiting ASUC Trial: Upadacitinib + Corticosteroids
A Phase 4 trial (NCT07258771) at the University of Michigan (Ann Arbor) is comparing upadacitinib (Rinvoq) + corticosteroids versus corticosteroids alone as induction therapy for ASUC.
Study Design Highlights
- Intervention: Oral upadacitinib (JAK inhibitor) + IV methylprednisolone → oral prednisone taper
- Control: IV methylprednisolone → oral prednisone taper (placebo for upadacitinib)
- Population: Adults 18–75 with ASUC meeting Truelove & Witts criteria
- Cohorts: Inpatient (0–10 days) and outpatient (5 days) arms
- Duration: Acute induction → post-acute (day 56/week 8) → maintenance (week 48)
- Key inclusion: On oral steroids ≥20 mg/day equivalent for ≥7 days in prior month
Why This Matters
Upadacitinib is already FDA-approved for moderately-to-severely active UC (induction and maintenance). This trial tests whether early JAK inhibition combined with steroids achieves faster, deeper remission in the acute severe setting—potentially reducing colectomy rates and shortening hospital stays.
Other UC Trial Categories Actively Recruiting
| Category | Examples | Mechanism |
|---|---|---|
| JAK Inhibitors | Upadacitinib, filgotinib | Block JAK-STAT signaling downstream of multiple cytokines |
| S1P Receptor Modulators | Ozanimod, etrasimod | Sequester lymphocytes in lymph nodes, reducing gut inflammation |
| Anti-TNF + Combination | Infliximab + azathioprine/methotrexate | Dual-pathway suppression |
| IL-23 Inhibitors | Mirikizumab, guselkumab | Target the IL-23/Th17 axis central to UC pathogenesis |
| Sphingosine-1-Phosphate (S1P) | Ozanimod | Lymphocyte trafficking modulation |
| Microbiome Therapies | Fecal microbiota transplantation (FMT), defined consortia | Restore microbial diversity and metabolic function |
Finding the Right UC Trial for You
Eligibility depends on:
- Disease severity (moderate, severe, acute severe/fulminant)
- Prior treatments (steroid-refractory, biologic-experienced, JAK-naïve)
- Disease extent (proctitis, left-sided, extensive/pancolitis)
- Comorbidities (infections, malignancy history, cardiovascular risk)
- Location & travel willingness — many trials are at academic medical centers
Corterve's platform matches your profile to recruiting UC trials by:
- Condition filtering — "ulcerative colitis," "acute severe ulcerative colitis," "proctitis"
- Geographic proximity — trials near your ZIP code with travel radius
- Structured pre-screen — 4–6 questions (age, diagnosis, steroid history, travel)
- Direct site referral — if you pre-qualify, we connect you to the study coordinator
> Note: Pre-qualification identifies potential matches only. The research team conducts full eligibility assessment including endoscopy, labs, and imaging. Discuss all options with your gastroenterologist.
Questions for Your GI Before Trial Enrollment
- Is my current flare considered "acute severe" by Truelove & Witts criteria?
- Have I failed IV steroids (day 3–5 non-response)?
- What biologics/JAK inhibitors have I already tried?
- Am I a candidate for colectomy if medical rescue fails?
- What are the infection risks with JAK inhibitors in ASUC (TB, herpes zoster, CMV)?
- How does the trial's follow-up schedule work with my work/family obligations?
Take Action Now
Search actively recruiting ulcerative colitis trials: Corterve UC Trials
Search specifically for acute severe UC studies: Corterve ASUC Trials
Register for new trial alerts: Get notified when UC studies open at centers near you.
Disclaimer: Corterve is a clinical trial matching platform, not a medical provider. We do not give medical advice, diagnose conditions, or guarantee trial eligibility. All eligibility determinations are made by the study's research team. Acute severe ulcerative colitis is a medical emergency—seek immediate care at an emergency department or contact your gastroenterologist.