Clinical trials: Colitis, Ulcerative
Ulcerative Colitis
Korea Post-marketing Surveillance for Xeljanz (Registered) in Ulcerative Colitis Patients
As required for new medications approved by the Ministry of Food and Drug Safety, safety and efficacy information should be provided for a minimum of 90 patients treated in the setting of routine practice during 4 years following…
- Trial name
- NCT04071405
- Testing
- Non-intervention
- Where
- South Korea
- Volunteers
- 110 people
- Sponsor
- Pfizer
Colitis, Ulcerative
A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis
The purpose of this study is to assess the safety and tolerability, efficacy, and biomarker response of BMS-986165 administered orally in participants with moderate to severe ulcerative colitis.
- Trial name
- NCT04613518
- Testing
- BMS-986165
- Where
- 26 sites in United States, Australia and 6 more
- Volunteers
- 38 people
- Sponsor
- Bristol-Myers Squibb
Crohn's Disease, Ulcerative Colitis
A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD)
- Trial name
- NCT03283085
- Testing
- 25 mg Ontamalimab, 75 mg Ontamalimab
- Where
- 419 sites in United States, Argentina and 35 more
- Volunteers
- 557 people
- Sponsor
- Shire
Colitis, Ulcerative
Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis
The purpose of the study was to assess preliminary efficacy, safety, and tolerability of LYS006 in adult patients with mild to moderate ulcerative colitis and to determine if LYS006 has an adequate clinical profile for further…
- Trial name
- NCT04074590
- Testing
- LYS006
- Where
- 9 sites in Bulgaria, Czechia and 4 more
- Volunteers
- 23 people
- Sponsor
- Novartis Pharmaceuticals
Crohn's Disease, Ulcerative Colitis
Comparative Effectiveness of Biologics or Small Molecule Therapies in Inflammatory Bowel Disease (IBD)
The purpose of this study is to assess effectiveness of vedolizumab versus ustekinumab in patients with Crohn's disease and vedolizumab versus tofacitinib in patients with ulcerative colitis, after non-response to anti-tumor…
- Trial name
- COMPARE (NCT04852666)
- Where
- 2 sites in United States
- Volunteers
- 465 people
- Sponsor
- University of North Carolina, Chapel Hill
Ulcerative Colitis
ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis
This Phase IIa study is an 8-week, double-blind, placebo-controlled, randomized study aiming at evaluating the safety and the efficacy of ABX464 given once a day (o.d) at 50 mg in subjects with moderate to severe Active…
- Trial name
- NCT03093259
- Testing
- ABX464
- Where
- 19 sites in Austria, Belgium and 6 more
- Volunteers
- 32 people
- Sponsor
- Abivax S.A.
Colitis, Ulcerative, Crohn Disease
A Study to Observe Vedolizumab and Anti-tumour Necrosis Factors (Anti-TNFs) Outcomes in Real-world Biologic Ulcerative Colitis (UC) and Crohn's Disease (CD) Participants
The purpose of this study is to describe treatment patterns associated with first-line and second line biologic use (vedolizumab or other biologic) and to describe the real-world clinical effectiveness of the use (first-line and…
- Trial name
- EVOLVE-IBERIA (NCT03710486)
- Where
- 26 sites in Portugal, Spain
- Volunteers
- 409 people
- Sponsor
- Takeda
Inflammatory Bowel Diseases
Safety and Tolerability Of Allogeneic Mesenchymal Stromal Cells in Pediatric Inflammatory Bowel Disease
In this trial, investigators will infuse donor bone marrow mesenchymal stromal cells intravenously, as a treatment for pediatric Crohn's disease or ulcerative colitis that has not responded to conventional therapies.
- Trial name
- NCT02150551
- Testing
- Allogeneic bone marrow-derived mesenchymal stromal cells
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Catherine Bollard
Moderate to Severe Ulcerative Colitis
A Study Assessing the Efficacy and Safety of CBP-307 in Subjects With Moderate to Severe Ulcerative Colitis (UC)
This study will evaluate the efficacy and safety of CBP-307 in subjects with moderate to severe ulcerative colitis (UC).
- Trial name
- NCT04700449
- Testing
- Double-Blind 0.2mg CBP-307, Open-label CBP-307, Double-Blind 0.1mg CBP-307
- Where
- 66 sites in United States, China and 2 more
- Volunteers
- 145 people
- Sponsor
- Connect Biopharm LLC
Ulcerative Colitis, Digestive System Diseases
Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis
The purpose of this study is to determine the safety and tolerability of administration of multiple ascending doses of KHK4083 and to select the highest dose tolerated by subjects with moderately active Ulcerative Colitis (UC)…
- Conditions
- Ulcerative Colitis, Digestive System Diseases, Colitis, Ulcerative, Colitis
- Trial name
- NCT02647866
- Testing
- KHK4083
- Where
- 23 sites in United States, Czechia and 5 more
- Volunteers
- 66 people
- Sponsor
- Kyowa Kirin, Inc.
Colitis, Ulcerative, Crohn Disease
A Study to Evaluate Disease Control and Treatment Pattern in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD) in Real Life Practice
The purpose of this study is to characterize the treatment patterns associated with biologics agents use or non-biological therapy in participants with moderate to severe Ulcerative Colitis (UC) and Crohn's Disease (CD).
- Conditions
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
- Trial name
- INTENT (NCT03532932)
- Where
- 36 sites in Belarus, Kazakhstan and 1 more
- Volunteers
- 1,990 people
- Sponsor
- Takeda
Inflammatory Diseases
Study of Efavaleukin Alfa in Healthy Chinese, Japanese, and Caucasian Participants
The primary objective of this study is to evaluate the pharmacokinetics (PK) of efavaleukin alfa after single subcutaneous (SC) administration in healthy Chinese, Japanese, and Caucasian participants.
- Trial name
- NCT04987333
- Testing
- Efavaleukin alfa
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Amgen
Ulcerative Colitis
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
This study was designed to evaluate how the body processes and removes mirikizumab. The study also evaluated safety and disease response in pediatric participants with UC taking mirikizumab.
- Trial name
- SHINE-1 (NCT04004611)
- Testing
- Mirikizumab
- Where
- 37 sites in United States, Canada and 3 more
- Volunteers
- 26 people
- Sponsor
- Eli Lilly and Company
Inflammatory Bowel Diseases, Colitis, Ulcerative
Study of Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes
The purpose of this study is to determine if a relationship exists between Week 6 vedolizumab therapeutic drug monitoring (TDM) and Week 30 Faecal calprotectin (FCP).
- Conditions
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
- Trial name
- VEDO TDM RWE (NCT04567628)
- Testing
- No Intervention
- Where
- Canada
- Volunteers
- 7,873 people
- Sponsor
- Takeda
Ulcerative Colitis
Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis
The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (UC).
- Trial name
- NCT03934216
- Testing
- BMS-986165
- Where
- 107 sites in United States, Australia and 11 more
- Volunteers
- 131 people
- Sponsor
- Bristol-Myers Squibb
Ulcerative Colitis
Phase 2 Dose-finding IMU-838 for Ulcerative Colitis
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the efficacy and safety of IMU-838 for induction and maintenance therapy with an option for open-label treatment…
- Trial name
- CALDOSE-1 (NCT03341962)
- Testing
- IMU-838
- Where
- 131 sites in United States, Albania and 17 more
- Volunteers
- 263 people
- Sponsor
- Immunic AG
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.
Ulcerative Colitis
Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Participants With Ulcerative Colitis (UC)
The principal aim of this study is to evaluate the safety and tolerability of RO7049665 in participants with active ulcerative colitis (UC).
- Trial name
- NCT03943550
- Testing
- RO7049665
- Where
- 6 sites in United States, Georgia and 3 more
- Volunteers
- 45 people
- Sponsor
- Hoffmann-La Roche
Ulcerative Colitis
Efficacy&Safety of ALTB-168 in Patients With Moderate to Severe Active,Anti-TNF Alpha and/or Anti-integrin Refractory UC
To evaluate the efficacy and safety of Neihulizumab (ALTB-168) administered intravenously in patients with moderate to severe active ulcerative colitis who are refractory or intolerant to anti-Tumor Necrosis Factor α and/or…
- Trial name
- TNF (NCT03298022)
- Testing
- ALTB-168
- Where
- 12 sites in United States, Puerto Rico
- Volunteers
- 24 people
- Sponsor
- AltruBio Inc.
Colitis, Ulcerative
A Study of Efficacy and Safety 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 clinical efficacy and safety of combination therapy with guselkumab and golimumab in participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- VEGA (NCT03662542)
- Testing
- Guselkumab Dose 1, Guselkumab Dose 2, Golimumab Dose 1
- Where
- 82 sites in United States, Argentina and 7 more
- Volunteers
- 214 people
- Sponsor
- Janssen Research & Development, LLC