21 recruiting. 21 Phase 3, 6 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 21 | Recruiting 21 |
| Phase 2 | 6 | Recruiting 6 |
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 |
|---|---|---|---|---|---|---|
| Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis Ponesimod, Placebo - Ulcerative Colitis (UC) | Phase 3 | Recruiting | Vanda Pharmaceuticals | 150 | 2026-09-01 | 2026-08-18 |
| Vedolizumab for the Prevention of ICI Related Diarrhea or Colitis in Patients With Cancer Vedolizumab, Placebo - IrAE, Immune-related Adverse Event | Phase 2 / Phase 3 | Recruiting | AHS Cancer Control Alberta | 36 | 2026-08-13 | 2026-08-27 |
| Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease MODIFI-IBD Trial) Modafinil, Placebo - Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Chronic Fatigue | Phase 2 / Phase 3 | Recruiting | Radboud University Medical Center | 60 | 2026-08-03 | 2026-09-14 |
| A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis JNJ-78934804, Guselkumab - Colitis, Ulcerative | Phase 3 | Recruiting | Janssen Research & Development, LLC | 644 | 2026-05-23 | 2026-11-03 |
| A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis Duvakitug, Placebo - Ulcerative Colitis | Phase 3 | Recruiting | Sanofi | 751 | 2026-01-16 | 2026-10-16 |
| A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD) Vedolizumab SC, No Intervention - Ulcerative Colitis, Crohn's Disease | Phase 3 | Recruiting | Takeda | 70 | 2025-10-27 | 2026-10-09 |
| An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis Duvakitug, Placebo - Ulcerative Colitis | Phase 3 | Recruiting | Sanofi | 980 | 2025-10-08 | 2026-10-23 |
| A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis Filgotinib - Ulcerative Colitis | Phase 3 | Recruiting | Alfasigma S.p.A. | 80 | 2025-09-29 | 2026-10-20 |
| A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis Risankizumab - Ulcerative Colitis | Phase 3 | Recruiting | AbbVie | 120 | 2025-07-28 | 2026-10-27 |
| Evaluate the Efficacy and Safety of Probiotic 6600 as an Adjuvant Therapy for Colitis Probiotics 6600, Placebo - Colitis, IBD (Inflammatory Bowel Disease) | Phase 2 / Phase 3 | Recruiting | Changhai Hospital | 120 | 2025-07-01 | 2025-07-02 |
| Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study Mirikizumab, Tirzepatide, Placebo - Ulcerative Colitis, Obesity or Overweight | Phase 3 | Recruiting | Eli Lilly and Company | 350 | 2025-06-26 | 2026-11-04 |
| Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis Upadacitinib Oral Product - Colitis, Ulcerative | Phase 3 | Recruiting | McMaster University | 134 | 2025-04-16 | 2025-06-22 |
| A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease Vedolizumab IV, Vedolizumab SC - Ulcerative Colitis, Crohn's Disease | Phase 3 | Recruiting | Takeda | 70 | 2025-01-22 | 2026-08-03 |
| Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011) Tulisokibart, Placebo to tulisokibart - Crohn Disease, Colitis, Ulcerative | Phase 3 | Recruiting | Merck Sharp & Dohme LLC | 1380 | 2024-11-25 | 2026-11-03 |
| A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants Guselkumab - Crohns Disease, Colitis, Ulcerative | Phase 3 | Recruiting | Janssen Research & Development, LLC | 196 | 2024-10-29 | 2026-11-03 |
| Efficacy and Safety of Oral Controlled-Ileocolonic-Release Nicotinamide (CICR-NAM) in Patients With Mild to Moderately Active Ulcerative Colitis Low-Dose CICR-NAM, High-Dose CICR-NAM, 0 g/d CICR-NAM (blinded) - Ulcerative Colitis, Unspecified | Phase 2 / Phase 3 | Recruiting | University Hospital Schleswig-Holstein | 459 | 2024-09-12 | 2026-10-22 |
| Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis Infliximab, Methylprednisolone, Prednisolone - Colitis | Phase 3 | Recruiting | Odense University Hospital | 195 | 2023-08-22 | 2023-08-24 |
| A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD) Vedolizumab IV, No Intervention - Ulcerative Colitis, Crohn's Disease | Phase 3 | Recruiting | Takeda | 240 | 2023-05-16 | 2026-05-07 |
| A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis Ozanimod - Colitis, Ulcerative | Phase 2 / Phase 3 | Recruiting | Bristol-Myers Squibb | 120 | 2022-05-30 | 2026-10-20 |
| A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON) Mirikizumab - Ulcerative Colitis, Ulcerative Colitis Chronic | Phase 3 | Recruiting | Eli Lilly and Company | 150 | 2021-05-26 | 2026-10-07 |
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Colitis, Ulcerative (18) · Crohn Disease (6) · Inflammatory Bowel Diseases (3) · Arthritis, Juvenile (1) · Arthritis, Psoriatic (1) · Diarrhea (1) · Fatigue (1) · Obesity (1) · Overweight (1) · Pediatric Crohn's disease (1) · Pediatric ulcerative colitis (1)
Colonic Diseases (21) · Digestive System Diseases (21) · Gastroenteritis (21) · Gastrointestinal Diseases (21) · Intestinal Diseases (21) · Inflammatory Bowel Diseases (16) · Pathological Conditions, Signs and Symptoms (3) · Signs and Symptoms (3) · Arthritis (1) · Autoimmune Diseases (1) · Body Weight (1) · Bone Diseases (1) · Connective Tissue Diseases (1) · Immune System Diseases (1)
vedolizumab (4) · guselkumab (2) · mirikizumab (2) · Fecal Microbiota Transplantation (1) · GLPG0634 (1) · Infliximab (1) · Mesalamine (1) · Methylprednisolone (1) · Modafinil (1) · Prednisolone (1) · Prednisone (1) · Tirzepatide (1) · ozanimod (1) · ponesimod (1) · risankizumab (1)
Takeda (3) · Eli Lilly and Company (2) · Janssen Research & Development, LLC (2) · Sanofi (2) · AHS Cancer Control Alberta (1) · AbbVie (1) · Alfasigma S.p.A. (1) · Bristol-Myers Squibb (1) · Changhai Hospital (1) · Guangzhou First People's Hospital (1) · McMaster University (1) · Merck Sharp & Dohme LLC (1) · Odense University Hospital (1) · Radboud University Medical Center (1) · University Hospital Schleswig-Holstein (1)
Poland (13) · United States (13) · Belgium (11) · Italy (11) · Spain (11) · United Kingdom (11) · Canada (10) · Germany (10) · Japan (10) · China (8) · France (8) · Netherlands (8) · South Korea (8) · Israel (7) · Australia (6)
Christina H. Ruhlmann, PhD (1) · Marjolijn Duijvestein, PhD, MD (1) · Stefan Schreiber, Prof. Dr. Dr. hc. (1) · Yuqiang Nie, MD (1)
2023 (5), 2025 (2)