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Home › Conditions › Ulcerative Colitis

Ulcerative Colitis

Part of Inflammatory Bowel Disease

42 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 737 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 · 737 cited
  2. Phase 3 Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis Completed · 326 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 · 200 cited
  5. Phase 4 Predicting Response to Standardized Pediatric Colitis Therapy Completed · 168 cited
  6. Phase 3 Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Ulcerative Colitis (AEGIS-1) Completed · 134 cited
Show 44 more trials
  1. Phase 3 Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis Completed · 125 cited
  2. Phase 3 A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis Completed · 124 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 · 124 cited
  4. Phase 3 A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis Completed · 124 cited
  5. Phase 3 Phase III Study of MLN0002 (300 mg) in the Treatment of Ulcerative Colitis Completed · 103 cited
  6. 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 · 96 cited
  7. 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 · 95 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 · 92 cited
  9. 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 · 92 cited
  10. 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 · 91 cited
  11. Phase 3 Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis Completed · 82 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 · 68 cited
  15. Phase 3 Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD) Completed · 62 cited
  16. 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 · 44 cited
  17. 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
  18. Phase 3 Effect of Probiotic Supplementation on the Immune System in Patients With Ulcerative Colitis in Amman, Jordan Completed · 43 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 4 Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis Completed · 28 cited
  23. Phase 3 An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1) Completed · 27 cited
  24. Phase 3 The Efficacy and Safety of Cobitolimod (Kappaproct®) in Chronic Active Treatment Refractory Ulcerative Colitis Patients Completed · 26 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 · 23 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 · 20 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 · 6 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 4 Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab Completed · 4 cited
  39. Phase 3 A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis Completed · 3 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.
ILC3-to-ILC1 transition is strongly supported in Crohn's Disease but evidence for UC plasticity is limited
Neurology Sys. Review
ILC3-to-ILC1 transition is strongly supported in Crohn's Disease but evidence for UC plasticity is limited Immune Cell Changes May Offer New Paths for Crohn's Disease
This narrative review explores the role of innate lymphoid cell (ILC) plasticity in Crohn's disease and ulcerative colitis. The authors find…
New research explores how specific immune cells change in Crohn's disease, potentially leading to more precise treatments for inflammatory b…
Frontiers Sep 9, 2026
Extracellular vesicle-based therapies show potential for tissue repair and barrier restoration in inflammatory bowel disease
Gastroenterology Sys. Review
Extracellular vesicle-based therapies show potential for tissue repair and barrier restoration in inflammatory bowel disease Extracellular Vesicles Show Potential for Inflammatory Bowel Disease
This narrative review explores the therapeutic potential of various extracellular vesicle-based therapies for ulcerative colitis and Crohn's…
New research explores how tiny particles called extracellular vesicles might help repair tissue and manage symptoms in Crohn's disease and u…
Frontiers Sep 8, 2026
Vunakizumab may induce severe ulcerative colitis and hepatic enzyme elevation in patients with psoriatic arthritis
Allergy & Immunology Sys. Review
Vunakizumab may induce severe ulcerative colitis and hepatic enzyme elevation in patients with psoriatic arthritis Vunakizumab Linked to Severe Ulcerative Colitis in Single Case
This case report and literature review describes a single case of severe ulcerative colitis and hepatic enzyme elevation following vunakizum…
A single case report shows a patient developed severe ulcerative colitis and high liver enzymes after receiving vunakizumab injections.
Frontiers Sep 4, 2026
mTOR-glycolytic axis activation drives inflammatory loops and mucosal barrier dysfunction in ulcerative colitis
Allergy & Immunology Sys. Review
mTOR-glycolytic axis activation drives inflammatory loops and mucosal barrier dysfunction in ulcerative colitis New research identifies a metabolic hub driving ulcerative colitis inflammation
This systematic review synthesizes the role of the mTOR-glycolytic axis as a central hub in ulcerative colitis. The review identifies how th…
A specific metabolic pathway called the mTOR-glycolytic axis may be a key driver of inflammation and tissue damage in people with ulcerative…
Frontiers Sep 2, 2026
Enteral nutrition shows greater clinical effectiveness than low residue diet in ulcerative colitis
Nutrition & Obesity Medicine Meta-analysis
Enteral nutrition shows greater clinical effectiveness than low residue diet in ulcerative colitis Enteral nutrition shows more effectiveness than low residue diets
This network meta-analysis of 1,039 adults with ulcerative colitis found enteral nutrition associated with greater clinical effectiveness th…
New data suggests that enteral nutrition may be more effective than a low residue diet for managing ulcerative colitis symptoms.
Frontiers Aug 29, 2026
Matrine and oxymatrine reduce histopathological scores and pro-inflammatory cytokines in ulcerative colitis animal models
Drug Pipeline Meta-analysis
Matrine and oxymatrine reduce histopathological scores and pro-inflammatory cytokines in ulcerative colitis animal models Matrine and oxymatrine show promise against ulcerative colitis symptoms
This meta-analysis of 13 preclinical studies evaluated matrine and oxymatrine monotherapy for ulcerative colitis. The analysis found signifi…
New research in animal models shows that matrine and oxymatrine may reduce inflammation and improve tissue health in cases of ulcerative col…
Frontiers Aug 24, 2026
Mapping Global Research Trends and Clinical Hotspots in Ulcerative Colitis and Depression
Rheumatology Meta-analysis
Mapping Global Research Trends and Clinical Hotspots in Ulcerative Colitis and Depression Ulcerative Colitis and Depression Research Surges
A comprehensive bibliometric analysis identifies key research trends and multidisciplinary approaches for managing patients with ulcerative …
Research on ulcerative colitis and depression is booming, with a focus on drug safety and quality of life.
Frontiers Aug 5, 2026
Crohn disease and ulcerative colitis causally raise ankylosing spondylitis risk
Rheumatology Meta-analysis
Crohn disease and ulcerative colitis causally raise ankylosing spondylitis risk Crohn's disease and ulcerative colitis linked to joint inflammation
This Mendelian randomization meta-analysis found positive causal relationships between Crohn disease and ulcerative colitis and ankylosing s…
People with Crohn's disease or ulcerative colitis face a higher risk of developing ankylosing spondylitis, a form of inflammatory joint dise…
NEJM Aug 3, 2026
Acceptance and Commitment Therapy reduces anxiety, depression, and stress in patients with inflammatory bowel disease
Psychiatry Meta-analysis
Acceptance and Commitment Therapy reduces anxiety, depression, and stress in patients with inflammatory bowel disease Acceptance and Commitment Therapy reduces anxiety for inflammatory bowel disease
This meta-analysis of 459 patients with Crohn's disease or ulcerative colitis found that Acceptance and Commitment Therapy (ACT) significant…
A new review shows that Acceptance and Commitment Therapy can significantly lower anxiety, stress, and depression for people with Crohn's or…
Aug 1, 2026
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

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