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Educational tool only. Does not confirm eligibility or provide medical advice. Always consult your physician before pursuing any trial.

GastroenterologyICD-10: K51

Find Recruiting Clinical Trials for Ulcerative Colitis

Search biologic, JAK inhibitor, S1P modulator, and induction/maintenance UC trials matched to your disease extent and treatment history.

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About Ulcerative Colitis

Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) that affects the mucosa of the colon and rectum, causing continuous inflammation that begins in the rectum and extends proximally to involve part or all of the colon. It is distinct from Crohn's disease, which can affect any segment of the gastrointestinal tract and causes transmural (full-thickness) inflammation. UC is characterized by periods of relapse (flares) and remission, with symptoms including bloody diarrhea, rectal urgency, abdominal cramping, and fatigue. Disease extent is classified as proctitis (rectum only), left-sided colitis (to the splenic flexure), and extensive or pancolitis (beyond the splenic flexure, including total colitis). Treatment escalates through 5-aminosalicylates (mesalamine — first-line for mild-moderate), corticosteroids (for induction only), immunomodulators (azathioprine, 6-mercaptopurine), and advanced therapies for moderate-to-severe disease: anti-TNF biologics (infliximab, adalimumab, golimumab), anti-integrin therapy (vedolizumab), anti-IL-12/23 (ustekinumab), anti-IL-23 (risankizumab, mirikizumab, guselkumab), JAK inhibitors (tofacitinib, upadacitinib, filgotinib), and S1P receptor modulators (ozanimod, etrasimod).

What Types of Ulcerative Colitis Clinical Trials Exist?

UC trials typically enroll patients with moderate-to-severe disease activity confirmed by endoscopy and validated scoring tools — most commonly the Mayo Score (total score ≥6 with endoscopic subscore ≥2, indicating active mucosal disease) or the modified Mayo Score. Endoscopic confirmation of active inflammation is almost universally required for screening. Prior treatment history is the primary stratification variable: biologic-naive (never received a biologic or JAK inhibitor) vs. biologic-experienced (prior failure of one or more advanced therapies). Most trials stratify separately by anti-TNF-naive and anti-TNF-experienced status. Current areas of active development include TL1A inhibitors (tulisokibart, PRA023), IL-23 inhibitors, JAK inhibitor combination strategies, and novel oral agents. UC trials are entirely separate from Crohn's disease trials — endoscopic, histologic, and clinical confirmation of UC (not Crohn's or IBD unclassified) is required.

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Data from ClinicalTrials.gov · Updated in real time · Educational use only

Frequently Asked Questions

What clinical trials are available for ulcerative colitis?▾
Ulcerative colitis has a very active trial pipeline, particularly for moderate-to-severe disease that has not responded to standard therapies. Biologic-naive induction trials test new first-line advanced therapies — these trials often enroll patients who have failed 5-ASAs or corticosteroids but have not yet tried a biologic or JAK inhibitor. Biologic-experienced trials enroll patients who have had an inadequate response to, or intolerance of, one or more prior advanced therapies (anti-TNF, vedolizumab, ustekinumab, JAK inhibitors). The most exciting current development areas include: TL1A inhibitors (tulisokibart from Prometheus/Merck and PRA023/mepolizumab from Pfizer) — a novel mechanism showing strong early results; next-generation IL-23 inhibitors (risankizumab, mirikizumab, guselkumab); pan-JAK and selective JAK inhibitor combinations; oral S1P modulators; and microbiome-targeted therapies. Maintenance and long-term extension trials are also enrolling. Remission induction followed by step-down or de-escalation trials are exploring whether patients in deep remission can safely reduce therapy.
How is ulcerative colitis different from Crohn's disease for trial purposes?▾
Ulcerative colitis and Crohn's disease are both forms of inflammatory bowel disease (IBD), but they are distinct diagnoses with different clinical behavior, pathology, and regulatory approvals — and they are not interchangeable in clinical trials. UC is limited to the colon and rectum, causes continuous mucosal inflammation beginning in the rectum, and is characterized by bloody diarrhea as the predominant symptom. Crohn's disease can affect any segment of the GI tract from mouth to anus, causes patchy, transmural inflammation, and may present with fistulas, strictures, or perianal disease. Drug approvals often differ: some biologics are approved for both (infliximab, adalimumab, vedolizumab, ustekinumab), while others are approved only for one (golimumab and tofacitinib for UC only; certolizumab for Crohn's only). From a trial perspective, UC trials use UC-specific disease activity scores (Mayo Score, UCEIS) while Crohn's trials use the CDAI (Crohn's Disease Activity Index) and endoscopic scoring (SES-CD). Patients cannot enroll in a UC trial with a diagnosis of Crohn's disease or IBD-unclassified, and vice versa. If your IBD diagnosis is uncertain, clarification with gastroenterology (including possible repeat endoscopy and biopsy review) is important before trial screening.
Does prior biologic use affect UC trial eligibility?▾
Yes — prior biologic and advanced therapy history is the primary stratification variable in almost all UC trials. Biologic-naive patients (who have never received an anti-TNF, vedolizumab, ustekinumab, JAK inhibitor, or S1P modulator) have access to the broadest range of trials, including first-line induction studies. Anti-TNF-naive but conventional therapy-experienced patients (who have used mesalamine and/or azathioprine but not a biologic) are a commonly enrolled subgroup. Biologic-experienced patients — defined as those with prior inadequate response, loss of response, or intolerance to one or more advanced therapies — may be specifically targeted by trials testing second-line or later-line agents. Prior anti-TNF failure is particularly important: many trials test agents in patients who have specifically failed an anti-TNF agent (infliximab, adalimumab), as this represents an unmet need. The number and type of prior advanced therapies (anti-TNF, vedolizumab, JAK inhibitor) all affect eligibility — some trials require failure of two prior advanced therapies, others only one. Maintaining a clear record of all prior biologics, including dates, doses, reason for discontinuation, and response level, is essential for trial screening.
What disease activity scores are used in UC clinical trials?▾
UC trials use standardized scoring systems to objectively measure disease activity and confirm eligibility. The Mayo Score (0–12 points) is the most widely used and combines four components: stool frequency (0–3), rectal bleeding (0–3), physician global assessment (0–3), and endoscopic findings (0–3, called the endoscopic Mayo subscore or EMS). Most trials require a total Mayo Score ≥6 with an endoscopic subscore ≥2 (moderate-severe mucosal disease) for enrollment — this confirms objectively active disease. The Modified Mayo Score (0–9) excludes the physician global assessment component and is used in some newer trials. The Ulcerative Colitis Endoscopic Index of Severity (UCEIS, 0–8) provides a more granular endoscopic assessment and is increasingly required in addition to or instead of the endoscopic Mayo subscore. Endoscopy (colonoscopy or flexible sigmoidoscopy) is almost universally required within a defined window (typically 12–18 months, or performed at screening) to confirm active mucosal inflammation and rule out other diagnoses. Fecal calprotectin and C-reactive protein (CRP) are commonly used as supplementary biomarkers for eligibility and monitoring. Histology (biopsy) is required to confirm UC and exclude Crohn's in most trials.

Related Conditions

Crohn's DiseaseRheumatoid ArthritisLupus

Data source: All clinical trial information is sourced from ClinicalTrials.gov, the official U.S. registry maintained by the National Library of Medicine. Tidera Health is an independent educational platform and is not affiliated with ClinicalTrials.gov or the National Library of Medicine. Always verify trial details directly with the research coordinator or your physician.