57 completed, 17 unknown, 15 not yet recruiting, 15 recruiting. 130 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 130 | Completed 57, Unknown 17, Not yet recruiting 15, Recruiting 15, Terminated 15, Withdrawn 6, Active not recruiting 3, Enrolling by invitation 2 |
Follow Colitis: new trials by email Literature Review of Colitis trials Research Report on Colitis
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis High dose budesonide rectal foam, Low dose budesonide rectal foam, Matching placebo rectal foam - Ulcerative Colitis | Phase 4 | Not yet recruiting | Bausch Health Americas, Inc. | 100 | 2029-06-01 | 2026-10-06 |
| ASAPP Study - Topical 5-ASA as Prophylaxis for Pouchitis in Ulcerative Colitis Patients After Pelvic Pouch Surgery 5-ASA, Placebo - Ulcerative Colitis (UC), Pouchitis | Phase 4 | Not yet recruiting | University Hospital, Linkoeping | 110 | 2027-04-01 | 2026-08-19 |
| Safety and Efficacy of a STOPping Strategy Versus Classical Maintenance Dose of JAK Inhibitors in Deep Remission Patients With Ulcerative Colitis treatment withdrawal - Ulcerative Colitis in Remission | Phase 4 | Not yet recruiting | Assistance Publique Hopitaux De Marseille | 224 | 2027-01-01 | 2026-07-22 |
| FirST Lines of Biologics in pAtients With ulceRaTivE Colitis: a Randomised Controlled Trial 1: infliximab 2: filgotinib 3: ustekinumab 4: vedolizumab, 1: ustekinumab 2: vedolizumab 3: infliximab 4: filgotinib, 1: vedolizumab 2: infliximab 3: filgotinib 4: ustekinumab - Ulcerative Colitis (UC) | Phase 4 | Not yet recruiting | University Hospital, Clermont-Ferrand | 240 | 2026-12-01 | 2026-10-21 |
| Efficacy of Upadacitinib Re-induction Therapy in Patients With Ulcerative Colitis Who Lost Response to 30 mg Maintenance Dose Upadacitinib - Ulcerative Colitis (UC) | Phase 4 | Not yet recruiting | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | 100 | 2026-11-15 | 2026-07-31 |
| Emerging Indications for Hyperbaric Oxygen Treatment Hyperbaric oxygen treatment (HBOT), 100% Oxygen - Post-COVID-19 Condition, Ulcerative Colitis | Phase 4 | Not yet recruiting | Jay C. Buckey Jr. | 100 | 2026-11-01 | 2026-09-09 |
| Upadacitinib in Patients Hospitalized With Acute Severe Ulcerative Colitis Upadacitinib - UC - Ulcerative Colitis | Phase 4 | Not yet recruiting | University of California, San Francisco | 50 | 2026-10-15 | 2026-09-24 |
| Combination CurQD and Vedolizumab in Ulcerative Colitis CurQD, Placebo, Vedolizumab - Ulcerative Colitis | Phase 4 | Not yet recruiting | Ryan C Ungaro | 160 | 2026-10-01 | 2026-10-05 |
| Use of Fidaxomicin Compared to Vancomycin for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease Vancomycin (POC), Fidaxomicin - Inflammatory Bowel Disease (IBD), Clostridioides Difficile Infection | Phase 4 | Not yet recruiting | Brigham and Women's Hospital | 60 | 2026-09-01 | 2025-11-03 |
| INSIGHT-IBD Pragmatic Study Mirikizumab, Anti-TNF agents, anti-integrin antibodies - Ulcerative Colitis (UC), Crohn Disease (CD) | Phase 4 | Enrolling by invitation | Specialty Networks Research. | 400 | 2026-08-12 | 2026-10-02 |
| A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically Breast Milk Sample Collection, Guselkumab - Psoriasis, Colitis, Ulcerative | Phase 4 | Recruiting | Janssen Research & Development, LLC | 10 | 2026-08-07 | 2026-10-05 |
| Comaprison of Efficacy and Safety Between Etrasimod vs Mesalazine in Chinese Adults With Active UC Etrasimod, mesalazine - Etrasimod, Mesalazine | Phase 4 | Not yet recruiting | Sir Run Run Shaw Hospital | 320 | 2026-07-31 | 2026-08-24 |
| Stopping PPI Therapy in Inactive IBD Continue PPI Therapy, Withdraw PPI Therapy - Ulcerative Colitis (UC), Crohn's Disease | Phase 4 | Recruiting | University of Nottingham | 80 | 2026-07-01 | 2026-07-08 |
| Immunosuppressant Discontinuation in Elderly Patients With Ulcerative Colitis And Long-term Remission Discontinuation of thiopurines. - Ulcerative Colitis (UC) | Phase 4 | Not yet recruiting | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa | 304 | 2026-05-01 | 2026-04-15 |
| Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed Moderate-to-severe Ulcerative Colitis Mirikizumab, Azathioprine (AZA) - Ulcerative Colitis (UC) | Phase 4 | Recruiting | University Hospital Schleswig-Holstein | 300 | 2025-12-05 | 2025-12-16 |
| Interleukin-23 Monoclonal Antibody for Inflammatory Bowel Disease: Efficacy and Safety Interleukin 23 - Crohn's Disease and Ulcerative Colitis | Phase 4 | Recruiting | Sixth Affiliated Hospital, Sun Yat-sen University | 200 | 2025-12-01 | 2026-04-24 |
| De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis Ustekinumab 90 mg SC q8w, Ustekinumab 90 mg SC q12w - Crohn Disease (CD), Ulcerative Colitis (UC) | Phase 4 | Recruiting | McGill University Health Centre/Research Institute of the McGill University Health Centre | 115 | 2025-10-08 | 2025-12-26 |
| MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease PK-model to decide when to dose Vedolizumab and Ustekinumab - Inflammatory Bowel Diseases, Crohn Disease | Phase 4 | Not yet recruiting | Odense University Hospital | 166 | 2025-09-01 | 2025-07-31 |
| Evaluating the Efficacy and Safety of Mirikizumab in Adults Over 60 With Moderate to Severe Crohn's Disease and Ulcerative Colitis Mirikizumab - Crohn Disease (CD), Crohns Disease | Phase 4 | Not yet recruiting | Rubix LS | 150 | 2025-07-16 | 2025-07-10 |
| The Efficacy of Lactobacillous Probiotic and Trace Elements in the Management of Ulcerative Colitis Patients the Patients Will be Recruited From Outpatient Clinic of Inflammatory Bowel Disease (IBD) of the National Hepatology and Tropical Medicine Research Institute NHTMRI, Cairo, Egypt Lactobacillus acidophilus will be assigned for arm 1, trace elements, Control Arm - standard of care - Ulcerative Colitis (UC) | Phase 4 | Recruiting | National Hepatology & Tropical Medicine Research Institute | 132 | 2025-07-02 | 2026-09-16 |
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Colitis, Ulcerative (127) · Crohn Disease (43) · Inflammatory Bowel Diseases (32) · Iron Deficiencies (3) · Arthritis, Psoriatic (2) · Arthritis, Rheumatoid (2) · Breast Feeding (2) · Clostridium Infections (2) · Irritable Bowel Syndrome (2) · Pouchitis (2) · Abdominal Pain (1) · Anemia (1) · Anemia, Iron-Deficiency (1) · Calciphylaxis (1)
Colonic Diseases (130) · Digestive System Diseases (130) · Gastroenteritis (130) · Gastrointestinal Diseases (130) · Intestinal Diseases (130) · Inflammatory Bowel Diseases (95) · Pathological Conditions, Signs and Symptoms (6) · Infections (5) · Immune System Diseases (4) · Metabolic Diseases (4) · Musculoskeletal Diseases (4) · Nutritional and Metabolic Diseases (4) · Signs and Symptoms (4) · Skin and Connective Tissue Diseases (4)
Infliximab (18) · vedolizumab (18) · Mesalamine (16) · golimumab (10) · Adalimumab (6) · Azathioprine (6) · tofacitinib (5) · mirikizumab (4) · Adrenal Cortex Hormones (3) · CT-P13 (3) · Hydrocortisone (3) · Ustekinumab (3) · Fecal Microbiota Transplantation (2) · Injections (2) · Interleukin-23 (2)
Takeda (7) · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives (5) · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa (3) · Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (3) · Merck Sharp & Dohme LLC (3) · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (2) · Asan Medical Center (2) · Bausch Health Americas, Inc. (2) · Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW (2) · Children's Hospital of Fudan University (2) · Geert D'Haens (2) · Guy's and St Thomas' NHS Foundation Trust (2) · Istituto Clinico Humanitas (2) · McMaster University (2) · Post Graduate Institute of Medical Education and Research, Chandigarh (2)
United States (32) · France (14) · Canada (12) · Belgium (11) · Spain (11) · China (10) · Italy (9) · United Kingdom (9) · Netherlands (8) · South Korea (8) · Israel (7) · Germany (6) · Czechia (4) · Denmark (4) · Hungary (4)
Arie Levine, MD (2) · Geert DHaens (2) · Varsha Bhatt (2) · Ying Huang (2) · Andreas M Petersen, MD, ph.d. (1) · Annick Moens, MD, PhD (1) · Anthony Buisson (1) · Axel Dignass, Professor (1) · Batia Weiss, MD (1)
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