Clinical trials: Severe Ulcerative Colitis
Crohn Disease, Ulcerative Colitis
Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis
This is a Phase 1b, open-label, dose-escalation, signal-finding, multi-center study. The study will evaluate the safety, tolerability, pharmacokinetics and short-term efficacy of MDGN-002 in adults with moderate to severe, active…
- Trial name
- NCT03169894
- Testing
- MDGN-002
- Where
- 13 sites in United States
- Volunteers
- 8 people
- Sponsor
- Avalo Therapeutics, Inc.
Colitis, Ulcerative
Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis
The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical…
- Trial name
- NCT01294410
- Testing
- Anti-IP-10 Antibody
- Where
- 75 sites in United States, Australia and 12 more
- Volunteers
- 305 people
- Sponsor
- Bristol-Myers Squibb
Ulcerative Colitis, Ultrasound Therapy; Complications
Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol.
Introduction Acute severe ulcerative colitis (ASUC) occurs in 15-25 % of all ulcerative colitis (UC) patients. Initial treatment with intravenous corticosteroids fails in 30-50 % of patients, for whom the next line of treatment…
- Trial name
- SUCCES (NCT03942861)
- Testing
- Solu-Medrol
- Where
- Denmark
- Volunteers
- 50 people
- Sponsor
- Copenhagen University Hospital at Herlev
Ulcerative Colitis
ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis…
- Trial name
- NCT05507216
- Testing
- ABX464
- Where
- 262 sites in United States, Argentina and 25 more
- Volunteers
- 636 people
- Sponsor
- Abivax S.A.
Ulcerative Colitis
Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)
Chronic intestinal hypoxia and accompanying mucosal inflammation is a hallmark of ulcerative colitis (UC). Hyperbaric oxygen therapy (HBOT) involves breathing 100% oxygen under increased atmospheric pressure to increase tissue…
- Trial name
- HBOT-UC (NCT05987852)
- Testing
- Hyperbaric Oxygen Therapy
- Where
- 13 sites in United States
- Volunteers
- 126 people
- Sponsor
- Northwestern University
Moderate-to-severe Inflammatory Bowel Disease
A Study to Evaluate the Safety of SHR-7590 in Chinese Healthy Participants and in Patients With Moderate-to-severe Inflammatory Bowel Disease
This Phase I first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-7590 via subcutaneous or intravenous administration in Chinese healthy participants and patients with…
- Trial name
- NCT07758101
- Testing
- SHR-7590
- Where
- China
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
Colitis, Ulcerative
Safety, Efficacy, and Tolerability Study of PF-06480605 in Subjects With Moderate to Severe Ulcerative Colitis.
The purpose of this study is to evaluate the safety, tolerability, and efficacy of PF-06480605 in subjects with moderate to severe ulcerative colitis.
- Trial name
- NCT02840721
- Testing
- PF-06480605
- Where
- 28 sites in United States, Belgium and 4 more
- Volunteers
- 50 people
- Sponsor
- Telavant, Inc.
Ulcerative Colitis
Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio
The study has been designed as a randomised, parallel-group, double-blind, 2 arm study of the comparative efficacy, safety and immunogenicity of AVT16 and Entyvio in male and female subjects with moderate to severe active…
- Trial name
- NCT06570772
- Testing
- AVT16, Vedolizumab
- Where
- 100 sites in Argentina, Bulgaria and 9 more
- Volunteers
- 301 people
- Sponsor
- Alvotech Swiss AG
Inflammatory Bowel Diseases, Crohn Disease
Real Life Remote Monitoring of Mild, Moderate and Severe Infectious Complications in IBD by Patient Reported Assessment
Inflammatory bowel disease (IBD) is a chronic relapsing immune mediated inflammatory disease (IMID) of the gastrointestinal tract. Like all IMIDs (e.g.
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, IBD
- Trial name
- NCT04151420
- Testing
- Remote monitoring tool (infections questionnaire) validation
- Where
- 2 sites in Netherlands
- Volunteers
- 584 people
- Sponsor
- Maastricht University Medical Center
Ulcerative Colitis
Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis
A phase 2b study to evaluate the long-term efficacy and safety study of ABX464 50mg as maintenance therapy in patients with moderate to severe Ulcerative Colitis.
- Trial name
- NCT04023396
- Testing
- ABX464
- Where
- 120 sites in Austria, Belarus and 14 more
- Volunteers
- 217 people
- Sponsor
- Abivax S.A.
Ulcerative Colitis
Open-label Extension Study of Brazikumab in Ulcerative Colitis
The purpose of this OLE Study D5272C00002 (Legacy #3151-202-008) is to permit participants who previously enrolled in the double-blind Study D5272C00001 (Legacy #3151-201-008) to receive brazikumab, allowing for long-term…
- Trial name
- Expedition (NCT04277546)
- Testing
- Brazikumab Maintenance Dose, Brazikumab Induction Dose
- Where
- 36 sites in United States, Czechia and 9 more
- Volunteers
- 57 people
- Sponsor
- AstraZeneca
Colitis, Ulcerative
Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis
This study aims to examine patients with acute severe UC who are refractory to intravenous corticosteroids and determine whether a strategy of using upadacitinib first followed by infliximab in upadacitinib non-responders is…
- Trial name
- RESCUE UC (NCT06660693)
- Testing
- Upadacitinib Oral Product
- Where
- Canada
- Volunteers
- 134 people
- Sponsor
- McMaster University
Crohn Disease, Ulcerative Colitis
SAVES-IBD: Safety & Efficacy of Aspirin vs. Standard of Care for VTE Prophylaxis After IBD Surgery
Aim to determine if aspirin 81 mg orally twice daily is effective and safe as an extended VTE chemoprophylaxis agent after major abdominal surgery for IBD patients.
- Conditions
- Crohn Disease, Ulcerative Colitis, Venous Thromboembolism
- Trial name
- SAVES-IBD (NCT05104229)
- Testing
- Aspirin 81Mg Ec Tab, Standard of Care
- Where
- United States
- Sponsor
- Stefan Holubar MD MS FACS, FASCRS
Ulcerative Colitis
Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis
The primary objective of this study is to evaluate the long-term safety and tolerability of efavaleukin alfa in participants with moderate to severe ulcerative colitis (UC).
- Trial name
- NCT05672199
- Testing
- Efavaleukin alfa
- Where
- 25 sites in United States, Argentina and 11 more
- Volunteers
- 25 people
- Sponsor
- Amgen
Ulcerative Colitis
Gastrointestinal Motility in Severe Ulcerative Colitis Obtained by Motilis-3D-transit
The purpose of this study is to describe gastrointestinal (GI) motility in patients suffering from severe Ulcerative Colitis (UC) and to compare these results with similar results obtained in remission.
- Trial name
- NCT01745029
- Testing
- Motilis-3D-transit
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- University of Aarhus
Ulcerative Colitis
Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Ulcerative Colitis
The purpose of this study is to assess the clinical benefit and tolerability of adalimumab, a fully human monoclonal antibody to tumor necrosis factor α (TNF- α), in patients with ulcerative colitis (UC) naive to treatment with…
- Trial name
- NCT01494857
- Testing
- Adalimumab
- Where
- 3 sites in Israel
- Volunteers
- 200 people
- Sponsor
- Clalit Health Services
Ulcerative Colitis
A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis
This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study that will enroll approximately 368 subjects aged 18 to 75 years old with Moderately to Severely Active Ulcerative Colitis.
- Trial name
- NCT05181137
- Testing
- SHR0302
- Where
- 113 sites in United States, China and 3 more
- Volunteers
- 368 people
- Sponsor
- Reistone Biopharma Company Limited
Colitis, Ulcerative
A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- PURSUIT 2 (NCT03596645)
- Testing
- Golimumab, Infliximab
- Where
- 58 sites in United States, Belgium and 9 more
- Volunteers
- 84 people
- Sponsor
- Janssen Research & Development, LLC
Ulcerative Colitis
Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis
The role of steroids in the treatment of ulcerative Colitis (UC) is well established, and recommended by professional societies.
- Trial name
- NCT01941589
- Testing
- oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone, corticosteroids only
- Where
- 10 sites in China, France and 5 more
- Volunteers
- 149 people
- Sponsor
- Sheba Medical Center
Ulcerative Colitis
Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis
The primary objective of this study is to evaluate the effect of abrilumab on induction of remission in adults with moderate to severe ulcerative colitis after 8 weeks of treatment as assessed by a total Mayo Score ≤ 2 points…
- Trial name
- NCT01694485
- Testing
- Abrilumab
- Where
- 123 sites in United States, Australia and 18 more
- Volunteers
- 359 people
- Sponsor
- Amgen