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Home › Conditions › Ulcerative Colitis

Ulcerative Colitis

Part of Inflammatory Bowel Disease

33 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Ulcerative Colitis

188 trials tracked for Ulcerative Colitis: 76 in phase 3 or 4 and 46 with published results. The most-cited published study has 730 citations.

188Trials tracked
76Phase 3 & 4
0Recruiting
46With published results
Phase distribution
Phase 4 13 Phase 3 63 Phase 2 64 Phase 1 10 Other / NA 38
  1. Phase 3 An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis Completed · 730 cited
  2. Phase 3 Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis Completed · 320 cited
  3. Phase 3 Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis Completed · 223 cited
  4. Phase 3 An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease Completed · 195 cited
  5. Phase 4 Predicting Response to Standardized Pediatric Colitis Therapy Completed · 167 cited
  6. Phase 3 Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Ulcerative Colitis (AEGIS-1) Completed · 133 cited
Show 44 more trials
  1. Phase 3 Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis Completed · 121 cited
  2. Phase 3 A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis Completed · 121 cited
  3. Phase 3 A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis Completed · 120 cited
  4. Phase 3 A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis Completed · 120 cited
  5. Phase 3 Phase III Study of MLN0002 (300 mg) in the Treatment of Ulcerative Colitis Completed · 102 cited
  6. Phase 3 A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors Completed · 94 cited
  7. Phase 3 A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors Completed · 93 cited
  8. Phase 3 A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors Completed · 90 cited
  9. Phase 3 A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors Completed · 90 cited
  10. Phase 3 A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors Completed · 90 cited
  11. Phase 3 Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis Completed · 80 cited
  12. Phase 3 A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis. Completed · 78 cited
  13. Phase 3 Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA) Completed · 77 cited
  14. Phase 3 CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC) Completed · 63 cited
  15. Phase 3 Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD) Completed · 61 cited
  16. Phase 3 A Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting Completed · 44 cited
  17. Phase 3 Effect of Probiotic Supplementation on the Immune System in Patients With Ulcerative Colitis in Amman, Jordan Completed · 43 cited
  18. Phase 3 A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis Completed · 41 cited
  19. Phase 4 Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032) Completed · 39 cited
  20. Phase 3 Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis Completed · 33 cited
  21. Phase 4 Preference for a Prefilled Syringe or Smartject™ Device for Delivering Golimumab in Participants Suffering From Moderate-to-severe Ulcerative Colitis (MK-8259-027) Completed · 32 cited
  22. Phase 3 An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1) Completed · 26 cited
  23. Phase 3 The Efficacy and Safety of Cobitolimod (Kappaproct®) in Chronic Active Treatment Refractory Ulcerative Colitis Patients Completed · 26 cited
  24. Phase 4 Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis Completed · 25 cited
  25. Phase 4 Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease With Ferrous Sulphate Completed · 24 cited
  26. Phase 4 Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels Completed · 23 cited
  27. Phase 3 Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis Completed · 22 cited
  28. Phase 3 An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis Completed · 22 cited
  29. Phase 3 An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis Completed · 18 cited
  30. Phase 4 Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022). Completed · 15 cited
  31. Phase 3 A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease Completed · 13 cited
  32. Phase 4 Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease Completed · 11 cited
  33. Phase 3 Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission Completed · 7 cited
  34. Phase 3 Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis Completed · 7 cited
  35. Phase 3 Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis Completed · 5 cited
  36. Phase 3 Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis Completed · 5 cited
  37. Phase 3 Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis Completed · 5 cited
  38. Phase 3 A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis Completed · 3 cited
  39. Phase 4 Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab Completed · 2 cited
  40. Phase 3 BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis Completed
  41. Phase 4 A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease Completed
  42. Phase 4 Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis Completed
  43. Phase 4 Strategies in Maintenance for Patients Receiving Long-term Therapy (S.I.M.P.L.E.) With MMX (Multi-Matrix System) Mesalamine for Ulcerative Colitis (UC) Completed
  44. Phase 4 Dose Escalation and Remission (DEAR) Completed

Showing the 50 most-cited and recently-updated of 188 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found Updated — new results For clinicians

Ulcerative Colitis: what the trials found

Several therapies have demonstrated efficacy in achieving clinical outcomes for ulcerative colitis. RPC1063 showed clinical response rates ranging from 77.0% to 92.9% and endoscopic improvement between 41.4% and 72.0% 1. Vedolizumab has shown significant results across multiple trials, including a durable clinical response at week 52 of up to 72.2% 19 and clinical remission rates reaching 46.2% in some cohorts 19. In another trial, Vedolizumab showed clinical remission rates of 33.3% to 44.4% at week 14 2, while a different study reported clinical response rates for UC patients increasing over time (up to 73.5% by week 46) 14.

Mesalamine and its formulations have established roles in management; MMX mesalamine showed significantly higher complete remission rates (47.8%) compared to a comparator (26.0%) at month 12 16, with associated mucosal healing of 76.4% 16. Another study on mesalamine demonstrated clinical remission in 57% of subjects, with 73% achieving endoscopic remission 20.

Golimumab was evaluated in several trials; one study showed a 24.9% partial Mayo score response at week 54 6, and another established a correlation between serum soluble ST2 levels and endoscopic activity of disease at week 6 (p=0.0074) 11. Regarding supportive care, iron supplementation with ferrous sulphate resulted in significant differences in the proportion of patients experiencing intolerance to oral iron compared to a control (p<0.05), though it did not significantly change stool calprotectin levels 9.

Specific delivery methods and adjuncts were also evaluated. A study on Golimumab showed high preference for prefilled syringe or Smartject™ devices among patients 7. Additionally, Shingrix was studied regarding cell-mediated immunity, showing no significant difference in changes to cell-mediated immunity (p=0.16) 13.

Recent results — preliminary, needs further review

  • ABBV-668 showed a 33.3% clinical response rate and 16.7% endoscopic improvement in a Phase 2 study 4.

For the clinician treating this condition

  • Vedolizumab demonstrates consistent efficacy for achieving both clinical remission and mucosal healing across multiple trials [18, 19].
  • MMX mesalamine is associated with significantly higher rates of complete remission and mucosal healing at 12 months compared to standard alternatives 16.
  • Serum soluble ST2 levels may correlate with endoscopic activity of the disease at week 6 11.
  • Iron supplementation (ferrous sulphate) can address iron deficiency but is associated with a significant rate of oral iron intolerance 9.

AI synthesis of 12 cited trials, updated Jun 21, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Combined TCM and conventional medicine therapies show higher overall effectiveness than monotherapy in ulcerative colitis
Drug Pipeline Meta-analysis
Combined TCM and conventional medicine therapies show higher overall effectiveness than monotherapy in ulcerative colitis Combined therapies show higher effectiveness for ulcerative colitis patients
This systematic review and network meta-analysis of 46 RCTs involving 3,763 patients found that combining Traditional Chinese Medicine (TCM)…
Combining traditional Chinese medicine with standard care may improve overall results for people living with ulcerative colitis.
Frontiers Jun 30, 2026
Bidirectional associations exist between obstructive lung diseases and inflammatory bowel disease across 30 observational studies
Allergy & Immunology Meta-analysis
Bidirectional associations exist between obstructive lung diseases and inflammatory bowel disease across 30 observational studies Lung Disease and Inflammatory Bowel Disease Show Linked Risks
This meta-analysis of 30 observational studies identifies bidirectional associations between obstructive lung diseases (COPD, asthma, bronch…
Research shows a link between inflammatory bowel disease and several lung conditions, including asthma and COPD, suggesting these issues oft…
Frontiers Jun 30, 2026
Plant-derived exosome-like nanoparticles mitigate weight loss and improve colon length in ulcerative colitis models
Gastroenterology Meta-analysis
Plant-derived exosome-like nanoparticles mitigate weight loss and improve colon length in ulcerative colitis models Plant Nanoparticles Show Potential to Treat Ulcerative Colitis
This meta-analysis of 25 preclinical studies involving 304 animal subjects indicates that plant-derived exosome-like nanoparticles (PELNs) m…
New research on plant-derived nanoparticles shows promise for treating ulcerative colitis symptoms and improving gut health in animal models…
Frontiers Jun 24, 2026
Epigallocatechin-3-gallate shows positive therapeutic effects on various digestive system diseases in animal models
Oncology Meta-analysis
Epigallocatechin-3-gallate shows positive therapeutic effects on various digestive system diseases in animal models Green tea compound shows potential for several digestive diseases
This meta-analysis of 63 preclinical studies involving 738 animals indicates that Epigallocatechin-3-gallate (EGCG) has a positive therapeut…
A review of animal studies suggests a green tea compound could help treat various cancers and digestive conditions.
Frontiers Jun 11, 2026
Mucus-barrier regulatory programs in Crohn's disease and ulcerative colitis involve ER stress and microbial sensing
Allergy & Immunology Meta-analysis
Mucus-barrier regulatory programs in Crohn's disease and ulcerative colitis involve ER stress and microbial sensing New findings show how mucus barriers fail in Crohn's and Ulcerative Colitis
This meta-analysis of transcriptomic datasets and an Agr2-/- mouse model identifies consensus mucus-barrier regulatory programs in active IB…
Researchers found that specific genes control the protective mucus layer in the gut. These same pathways are disrupted in people with IBD.
Frontiers Jun 9, 2026
IBD-related neuroimaging shows brain alterations in emotional networks with distinguishable phenotypes for Crohn's and ulcerative colitis
Neurology Sys. Review
IBD-related neuroimaging shows brain alterations in emotional networks with distinguishable phenotypes for Crohn's and ulcerative colitis Brain scans show different emotional patterns in Crohn's and ulcerative colitis
This bibliometric analysis and systematic scoping review examines 175 articles on IBD-related neuroimaging literature from Web of Science an…
A review of 175 articles found that brain activity in Crohn's and ulcerative colitis affects emotion centers differently. This suggests dist…
Frontiers Jun 4, 2026
Mediterranean diet shows no significant advantage over control diets for inducing remission in inflammatory bowel disease patients
Nutrition & Obesity Medicine Meta-analysis
Mediterranean diet shows no significant advantage over control diets for inducing remission in inflammatory bowel disease patients Mediterranean diet helps some patients with inflammatory bowel disease reach remission better than control diets
This systematic review and meta-analysis evaluated the Mediterranean diet versus control diets in patients with inflammatory bowel disease. …
A review of studies found that a Mediterranean diet helped about 62% of patients reach remission. This approach worked well for both Crohn's…
Jun 1, 2026
Meta-analysis of GWAS data identifies genetic risk factors for inflammatory bowel disease in 125,992 individuals
Genetics & Precision Medicine Meta-analysis
Meta-analysis of GWAS data identifies genetic risk factors for inflammatory bowel disease in 125,992 individuals Genetic map reveals new targets for inflammatory bowel disease
This meta-analysis review synthesizes genome-wide association study data from 125,992 individuals with IBD and more than 1.2 million control…
A massive genetic study found 619 new signals linked to Crohn's and ulcerative colitis, offering fresh clues for future treatments.
medRxiv May 18, 2026
Meta-analysis associates childhood antibiotic use with increased inflammatory bowel disease risk
Infectious Disease Meta-analysis
Meta-analysis associates childhood antibiotic use with increased inflammatory bowel disease risk Early antibiotics may raise your risk of developing inflammatory bowel disease later in life
This meta-analysis of 8 studies involving 2783 cases examines the association between antibiotic use in children aged 1 to 17 years and the …
New research shows that taking antibiotics during childhood could increase the chance of developing inflammatory bowel disease later in life
May 4, 2026
Extended Risankizumab Benefits Initial Nonresponders in Ulcerative Colitis
Drug Pipeline RCT
Extended Risankizumab Benefits Initial Nonresponders in Ulcerative Colitis Over half of ulcerative colitis patients found relief with longer treatment
Over 50% of patients with ulcerative colitis who did not respond to initial risankizumab achieved clinical response with 12 more weeks of ex…
More than half of patients with ulcerative colitis who did not respond to initial treatment found clinical response with extended risankizum…
May 1, 2026
Narrative review discusses NF-kB inhibition for inflammatory bowel diseases and related conditions
Gastroenterology Sys. Review
Narrative review discusses NF-kB inhibition for inflammatory bowel diseases and related conditions Blocking NF-κB May Ease Gut Inflammation in IBD
This narrative review explores the role of NF-kB pathway inhibition in treating inflammatory conditions.
A review finds that blocking a key inflammatory pathway could help treat Crohn's, colitis, and celiac disease.
Frontiers May 1, 2026
Meta-analysis shows reduced oral microbial Shannon diversity in Crohn's disease versus controls
Gastroenterology Meta-analysis
Meta-analysis shows reduced oral microbial Shannon diversity in Crohn's disease versus controls Oral bacteria shifts could reveal Crohn's disease risk
This meta-analysis reviews data from multiple cohorts involving 1,136 IBD patients and 759 controls.
A new study links distinct mouth bacteria changes to higher gut inflammation levels in Crohn's disease patients.
medRxiv Apr 29, 2026

Questions about Ulcerative Colitis

How does the gut bacteria diversity in ulcerative colitis compare to healthy controls?

Ulcerative colitis patients consistently show reduced gut bacterial diversity (lower Shannon index) and altered composition compared to healthy controls, with depletion of beneficial butyrate-producing bacteria and increases in certain pro-inflammatory groups.

Full answer →
Is there a link between NF-kB pathway inhibition and treating ulcerative colitis?

Yes, inhibiting the NF-κB pathway is a key treatment strategy for ulcerative colitis, as it reduces inflammation and may prevent cancer progression.

Full answer →
Are there specific biomarkers that can accurately diagnose ulcerative colitis in a new patient?

Yes, three biomarkers (ARHGEF3, S100A8, RHOU) show high diagnostic accuracy for ulcerative colitis, and bile acid ratios are also promising noninvasive markers.

Full answer →
Can enteral nutrition therapy help achieve remission in patients with ulcerative colitis?

Enteral nutrition therapy may help achieve remission in ulcerative colitis, with studies showing clinical remission rates around 60% and benefits in acute severe cases, but evidence is stronger for Crohn's disease.

Full answer →

All Ulcerative Colitis Articles