101 completed, 25 terminated, 19 unknown, 18 recruiting. 192 Phase 1, 43 Phase 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 |
|---|---|---|---|---|---|---|
| LMT503 First-in-human SAD, MAD, and FE Study LMT503, Placebo - Inflammatory Bowel Disease, Colitis, Ulcerative | Phase 1 | Not yet recruiting | Lmito Therapeutics Inc. | 72 | 2027-03-01 | 2026-09-01 |
| Safety, Tolerability and PK of ATTO 1091 in Healthy Adult Volunteers and Patients With Ulcerative Colitis ATTO-1091, Placebo - Ulcerative Colitis (UC) | Phase 1 | Not yet recruiting | Attovia Therapeutics Inc | 96 | 2026-12-14 | 2026-09-15 |
| An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates Duvakitug - Ulcerative Colitis, Crohn's Disease | Phase 1 | Not yet recruiting | Sanofi | 25 | 2026-11-03 | 2026-11-06 |
| A Phase I, Randomized, Double-Blind, Placebo-Controlled Study of EQ504 in Single and Multiple Ascending Doses in Healthy Volunteers EQ504, EQ504 Placebo - Ulcerative Colitis | Phase 1 | Not yet recruiting | Equillium | 70 | 2026-10-01 | 2026-10-09 |
| Study of Single and Multiple Ascending Doses of CM551 in Healthy Participants CM551, Placebo - Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) | Phase 1 | Not yet recruiting | Keymed Biosciences Co.Ltd | 48 | 2026-10-01 | 2026-10-28 |
| Phase 1b Clinical Study in Patients With Active Ulcerative Colitis TP317, Matching placebo - Ulcerative Colitis (UC) | Phase 1 | Not yet recruiting | Thetis Pharmaceuticals LLC | 24 | 2026-09-16 | 2026-09-22 |
| A Study to Evaluate the Safety, Tolerability, PK and Preliminary Efficacy of HX15001 Combined With Etrasimod in Moderate-severe Ulcerative Colitis Biological: HX15001 - Colitis, Ulcerative | Phase 1 | Not yet recruiting | Helixon Biotechnology (Suzhou) Co., Ltd | 32 | 2026-09-09 | 2026-08-17 |
| A Study to Investigate the Safety and Tolerability of Multiple Study Interventions in Participants With Moderate to Severe Ulcerative Colitis Aletekitug (GSK1070806) - Colitis, Ulcerative | Phase 1 | Recruiting | GlaxoSmithKline | 8 | 2026-09-03 | 2026-10-28 |
| A Sub Study to Investigate the Safety and Tolerability of Aletekitug in Participants With Moderate To Severe Ulcerative Colitis Aletekitug - Colitis, Ulcerative | Phase 1 | Recruiting | GlaxoSmithKline | 16 | 2026-09-03 | 2026-11-05 |
| A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ONO-6414 Administered Orally in Healthy Adult Participants and Patients With Active Ulcerative Colitis ONO-6414, Placebo - Ulcerative Colitis (UC) | Phase 1 | Recruiting | Ono Pharmaceutical Co., Ltd. | 90 | 2026-08-20 | 2026-09-09 |
| Alpha-0261 Tablets for Moderate-to-Severe Ulcerative Colitis Alpha-0261 - Ulcerative Colitis (UC) | Phase 1 | Not yet recruiting | The First Affiliated Hospital of Anhui Medical University | 10 | 2026-08-03 | 2026-08-04 |
| Xylitol Use for Decolonization of C. Difficile in Patients With IBD Xylitol, Placebo - Inflammatory Bowel Diseases, Clostridioides Difficile Infection | Phase 1 | Not yet recruiting | Brigham and Women's Hospital | 99 | 2026-08-01 | 2026-02-25 |
| Seaweed Extract (Fucoidan) for Gut Inflammation in Ulcerative Colitis Low molecular weight fucoidan and standard care, Placebo and standard of care - Ulcerative Colitis (UC) | Phase 1 / Phase 2 | Enrolling by invitation | Allama Iqbal Medical College | 90 | 2026-08-01 | 2026-08-26 |
| Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study) MGT-006, Vancomycin hydrochloride, Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole - Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate | Phase 1 / Phase 2 | Recruiting | Metagen Therapeutics, Inc. | 54 | 2026-07-09 | 2026-11-03 |
| A Phase Ib/IIa Study of INT-210 Capsules in Participants With Active Ulcerative Colitis INT-210 Capsule - Ulcerative Colitis (UC) | Phase 1 / Phase 2 | Recruiting | Innatus Therapeutics (Shanghai) Co., Ltd. | 24 | 2026-06-11 | 2026-07-09 |
| To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of LYNC-101 for Injection in Healthy Adult Participants LYNC-101, LYNC-101 Placebo - UC - Ulcerative Colitis | Phase 1 | Enrolling by invitation | LyncBio Therapeutics Co., Ltd. | 50 | 2026-05-28 | 2026-08-27 |
| A Phase I Study to Evaluate the Safety/Tolerability of BDHK-2009 Tablets in Healthy Adult BDHK-2009 Tablets, Placebo - Ulcerative Colitis (UC), Ulcerative Colitis (Disorder) | Phase 1 | Recruiting | Benethera (Shaoxing) Biotechnology Co., Ltd. | 68 | 2026-05-18 | 2026-06-08 |
| BCMA-CD19 cCAR T for the Treatment of Refractory Inflammatory Bowel Disease (IBD) ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T - Inflammatory Bowel Diseases (IBD) | Phase 1 / Phase 2 | Not yet recruiting | iCell Gene Therapeutics | 18 | 2026-04-07 | 2026-04-22 |
| Safety and Efficiency of the Universal CNK-UT009 in Difficult-to-treat Inflammatory Bowel Disease Patients injection of CNK-UT009 - Inflamatory Bowel Disease, Crohn Disease (CD) | Phase 1 | Not yet recruiting | Second Affiliated Hospital, Zhejiang University, School of Medicine | 40 | 2026-04-01 | 2026-02-18 |
| A Study of MB-001 in Moderately to Severely Active Ulcerative Colitis MB-001, Matching placebo to MB-001 - Ulcerative Colitis (UC) | Phase 1 / Phase 2 | Recruiting | Mage Biologics | 100 | 2026-04-01 | 2026-10-20 |
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Colitis, Ulcerative (184) · Inflammatory Bowel Diseases (51) · Crohn Disease (47) · Arthritis, Rheumatoid (4) · Autoimmune Diseases (4) · Arthritis, Psoriatic (3) · Carcinoma, Non-Small-Cell Lung (3) · Lupus Erythematosus, Systemic (3) · Multiple Sclerosis (3) · Psoriasis (3) · Urogenital Neoplasms (3) · Arthritis, Juvenile (2) · Clostridium Infections (2) · Diarrhea (2)
Colonic Diseases (192) · Digestive System Diseases (192) · Gastroenteritis (192) · Intestinal Diseases (192) · Gastrointestinal Diseases (190) · Inflammatory Bowel Diseases (134) · Immune System Diseases (10) · Skin and Connective Tissue Diseases (9) · Skin Diseases (8) · Infections (6) · Pathological Conditions, Signs and Symptoms (6) · Arthritis (5) · Connective Tissue Diseases (5) · Joint Diseases (5)
Fecal Microbiota Transplantation (16) · Mesalamine (9) · Infliximab (4) · CT-P13 (3) · Vancomycin (3) · vedolizumab (3) · Adalimumab (2) · Cholecalciferol (2) · Disulfides (2) · GSK1070806 (2) · Immunoglobulin G (2) · LDP-02 (2) · Metronidazole (2) · Microbiota (2) · NX-13 (2)
GlaxoSmithKline (8) · Stanford University (5) · University Medical Center Groningen (4) · Amgen (3) · Brigham and Women's Hospital (3) · Bristol-Myers Squibb (3) · Janssen Research & Development, LLC (3) · M.D. Anderson Cancer Center (3) · Meir Medical Center (3) · National Institute of Allergy and Infectious Diseases (NIAID) (3) · Tillotts Pharma AG (3) · Bridge Biotherapeutics, Inc. (2) · Fondazione Policlinico Universitario Agostino Gemelli IRCCS (2) · Genentech, Inc. (2) · Gilead Sciences (2)
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Yinghong Wang (3) · Bittoo Kanwar, MD (2) · Fred Konikoff, professor (2) · Simon Lichtiger, MD (2) · Ali Keshavarzian, M.D. (1)
PMID 19408340, PMID 19714757, PMID 21317177, PMID 23059643, PMID 23542823, PMID 23648372, PMID 24557009, PMID 25162366, PMID 25185797, PMID 25647155, PMID 26595549, PMID 26802087, PMID 26822613, PMID 26893546, PMID 28349233, PMID 28778448, PMID 28827258, PMID 31272391, PMID 31784432, PMID 31792136, PMID 32161949, PMID 32306792, PMID 32325480, PMID 32763240, PMID 33188747, PMID 33571293, PMID 33676969, PMID 34606847, PMID 34880013, PMID 34969665, PMID 35014040, PMID 35262901, PMID 35365713, PMID 35428657, PMID 35470301, PMID 36732049, PMID 37004656, PMID 37302449, PMID 37952114, PMID 38365502, PMID 38580386, PMID 39707077, PMID 39758967, PMID 39787364, PMID 40236400, PMID 40933007, PMID 41242336, PMID 41895287, PMID 42735684
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