Clinical trials: Severe Ulcerative Colitis
Acute Severe Ulcerative Colitis
Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis（UPRISE）
This clinical trial aims to evaluate the comparative efficacy and safety of upadacitinib versus infliximab as second-line treatments for acute severe ulcerative colitis, addressing the following key questions: (1) Can…
- Trial name
- NCT07550673
- Testing
- upadacitinib, Infliximab
- Where
- 4 sites in China
- Volunteers
- 226 people
- Sponsor
- Xijing Hospital of Digestive Diseases
Ulcerative Colitis
Efficacy and Safety of LC51-0255 in Subjects With Ulcerative Colitis
This is a Phase 2, multi center, randomized, placebo controlled parallel group study to evaluate the clinical efficacy and safety of LC51 0255 in subjects with moderately to severely active ulcerative colitis
- Trial name
- NCT04096573
- Testing
- LC51-0255
- Sponsor
- LG Chem
Acute Severe Colitis (ASC)
Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis
For acute severe colitis (ASC) patients, corticosteroids (CS) was recommended as the first-line treatment in the guideline, but patients have a great risk of requiring colectomy or turning to second-line treatment.
- Trial name
- NCT02922374
- Testing
- corticosteroids
- Where
- China
- Volunteers
- 117 people
- Sponsor
- Jinling Hospital, China
Exclusive Enteral Nutrition, Ulcerative Colitis
Combined Application of EEN in the Induction of Remission in PUC
The role of exclusive enteral nutrition (EEN) in the induction of remission in pediatric patients with Crohn's disease had been well documented. But the role of EEN in children with Ulcerative Colitis (UC) was not clear.
- Conditions
- Exclusive Enteral Nutrition, Ulcerative Colitis, Children
- Trial name
- NCT04999241
- Testing
- exclusive enteral nutrition, regular food
- Volunteers
- 40 people
- Sponsor
- Children's Hospital of Fudan University
Colitis, Ulcerative
A Study to Evaluate the Safety, Tolerability, PK and Preliminary Efficacy of HX15001 Combined With Etrasimod in Moderate-severe Ulcerative Colitis
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HX15001 injection combined with Etrasimod tablets in participants with moderately to severely active ulcerative…
- Trial name
- NCT07768254
- Testing
- Biological: HX15001
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Helixon Biotechnology (Suzhou) Co., Ltd
Ulcerative Colitis
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to…
- Trial name
- NCT03518086
- Testing
- Mirikizumab
- Where
- 502 sites in United States, Argentina and 33 more
- Volunteers
- 1,281 people
- Sponsor
- Eli Lilly and Company
Colitis, Ulcerative
A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis
MultiStem(r) is a new biological product, manufactured from human stem cells obtained from adult bone marrow or other nonembryonic tissue sources.
- Trial name
- NCT01240915
- Testing
- MultiStem low dose, MultiStem high dose
- Where
- 58 sites in United States, Belgium and 6 more
- Volunteers
- 105 people
- Sponsor
- Pfizer
Ulcerative Colitis
Study of the Efficacy and Safety of AMT-101 in Subjects With Ulcerative Colitis (LOMBARD)
Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis.
- Trial name
- NCT04583358
- Testing
- AMT-101 (oral)
- Where
- 59 sites in United States, Belarus and 12 more
- Volunteers
- 105 people
- Sponsor
- Applied Molecular Transport
Ulcerative Colitis
Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis
To evaluate the real-life effect after 1 year of adalimumab treatment on psychological distress/depression symptoms in moderate-to-severe Ulcerative Colitis (UC) patients.
- Trial name
- UCanADA (NCT02506179)
- Where
- 23 sites in Canada
- Volunteers
- 100 people
- Sponsor
- AbbVie
Major Depressive Disorder, Inflammatory Bowel Diseases
Trial of Mirtazapine for Depression in IBD
This study will test whether it is feasible to conduct a clinical trial of mirtazapine (an antidepressant tablet) in patients who have both depression and inflammatory bowel disease (IBD).
- Trial name
- MDIBD (NCT06309472)
- Testing
- Mirtazapine
- Where
- 4 sites in United Kingdom
- Volunteers
- 76 people
- Sponsor
- King's College London
Colitis Ulcerative
A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis
This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe UC.
- Trial name
- SPECIFI-UC (NCT06867094)
- Testing
- SAR441566
- Where
- 117 sites in United States, Argentina and 22 more
- Volunteers
- 170 people
- Sponsor
- Sanofi
Ulcerative Colitis
Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC)
To describe the effectiveness, treatment patterns, quality of life, and safety of participants with moderately or severely active UC treated with filgotinib in a real-world setting.
- Trial name
- GALOCEAN (NCT05817942)
- Testing
- Filgotinib
- Where
- 81 sites in Austria, Belgium and 8 more
- Volunteers
- 509 people
- Sponsor
- Alfasigma S.p.A.
Inflammatory Bowel Diseases
Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib
Patients with ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD), have been shown to be at increased risk of developing certain infections, such as shingles from the Herpes Zoster (HZ) virus, as a result of their…
- Trial name
- NCT03591770
- Testing
- SHINGRIX
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Boston Medical Center
Ulcerative Colitis
A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis
To determine the dose or doses of PF-00547659 that will be the most effective to improve or halt the disease symptoms in patients with moderate to severe ulcerative colitis.
- Trial name
- TURANDOT (NCT01620255)
- Testing
- PF-00547659 SC Injection
- Where
- 190 sites in United States, Australia and 19 more
- Volunteers
- 357 people
- Sponsor
- Shire
Colitis, Ulcerative
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial…
- Trial name
- DUET-UC (NCT05242484)
- Testing
- Guselkumab, Golimumab, JNJ-78934804
- Where
- 403 sites in United States, Argentina and 35 more
- Volunteers
- 577 people
- Sponsor
- Janssen Research & Development, LLC
Ulcerative Colitis
Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®
This is a multi-center, randomized, parallel arm, double-blind study with approximately 750 participants with moderately to severely active Colitis Ulcerosa randomized to receive either PB016 or Entyvio®
- Trial name
- UCESIVE (NCT05771155)
- Testing
- Intravenous (IV) infusions
- Where
- Georgia
- Volunteers
- 750 people
- Sponsor
- Polpharma Biologics S.A.
Ulcerative Colitis
A Study of AK101 in Subjects With Moderately to Severely Active Ulcerative Colitis
This is a Phase Ib clinical study to evaluate the safety, tolerance, pharmacokinetics and efficacy of AK101 in subjects with moderately to severely active ulcerative colitis.
- Trial name
- NCT06281704
- Testing
- AK101 IV, AK101 SC, AK101 IV/AK101 SC
- Where
- 12 sites in China
- Volunteers
- 34 people
- Sponsor
- Akeso
Crohn's Disease, Ulcerative Colitis
A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)
Crohn's Disease and Ulcerative Colitis are two types of inflammatory bowel disease (IBD), which is a serious, long-term condition in the gut (intestine) that can cause pain and swelling (inflammation) in the bowel.
- Trial name
- NCT06764615
- Testing
- Zasocitinib
- Where
- 16 sites in United States, China and 6 more
- Volunteers
- 192 people
- Sponsor
- Takeda
Colitis, Ulcerative
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
This Phase III, randomized, double-blind, parallel-grouped, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab in maintenance of remission in participants with moderately to severely…
- Trial name
- LAUREL (NCT02165215)
- Testing
- Etrolizumab
- Where
- 104 sites in United States, Brazil and 13 more
- Volunteers
- 359 people
- Sponsor
- Hoffmann-La Roche
Moderately to Severely Active Ulcerative Colitis
A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active…
- Trial name
- Ametrine-1 (NCT06589986)
- Testing
- Afimkibart
- Where
- 184 sites in United States, Argentina and 28 more
- Volunteers
- 400 people
- Sponsor
- Hoffmann-La Roche