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Ulcerative Colitis clinical trials

View clinical trials related to Ulcerative Colitis.

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NCT ID: NCT06311123 Recruiting - Ulcerative Colitis Clinical Trials

Understanding Ozanimod's MOA Via Mass Cytometry in Ulcerative Colitis

Start date: October 6, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about the mechanism of action of ozanimod in patients with ulcerative colitis (UC). The main questions it aims to answer are: 1. Prospectively assess the effects of ozanimod on the cellular composition of intestinal lamina propria and blood by deep immunophenotyping (CyTOF) of immune cell subsets prior and after the drug's administration. 2. Determine whether changes in cell subsets observed via mass cytometry correlate with with clinical or histologic parameters of disease activity. Colonic biopsies and peripheral blood samples will be collected from patients with UC before and after the onset of ozanimod. Researchers will compare intestinal and peripheral leukocytes before and after the drug's administration.

NCT ID: NCT06269185 Recruiting - Ulcerative Colitis Clinical Trials

Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis

Start date: March 6, 2024
Phase:
Study type: Observational

Anti-TNF (tumor necrosing factor) treatment with infliximab (IFX) and adalimumab (ADA) are established first-line biological therapies used in treatment of patients with ulcerative colitis (UC). There are no head-to-head comparative studies between these two drug but meta-analysis of randomized controlled trials states that IFX might be more effective than ADA for the induction of clinical remission. However, several observational studies conclude that ADA seem to have similar effect as IFX in treating patients with UC but these studies have limitations. The overall aim of this retrospective multicenter observational cohort study is to evaluate if there is a difference in efficacy between infliximab (IFX) and adalimumab (ADA) in treating bio-naive patients with UC in the short and long term during the modern era when therapeutic drug monitoring have been used to optimize anti-TNF treatment.

NCT ID: NCT06231264 Recruiting - Ulcerative Colitis Clinical Trials

Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis

Start date: January 19, 2024
Phase: N/A
Study type: Interventional

The aim of this study was to evaluate the efficacy and safety of transcutaneous electrical acustimulation in patients with mild to moderate ulcerative colitis.

NCT ID: NCT06206811 Recruiting - Ulcerative Colitis Clinical Trials

Phase 1 Study to Investigate OD-07656 in Healthy Adult Participants

Start date: February 12, 2024
Phase: Phase 1
Study type: Interventional

First-in-human study to provide an assessment of the safety, tolerability, pharmacokinetics (PK), including food effects and a drug-drug interaction, and pharmacodynamics (PD) of OD-07656 after administration of ascending single and multiple oral doses to healthy male and female participants in view of treating inflammatory bowel disease (IBD) (including Crohn's disease and ulcerative colitis), Blau syndrome, and spondyloarthritis

NCT ID: NCT06137183 Recruiting - Ulcerative Colitis Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC)

Start date: March 31, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of vixarelimab compared with placebo in participants with moderate to severe UC who have demonstrated inadequate response to, loss of response to, or intolerance to prior conventional or advanced therapy.

NCT ID: NCT06127043 Recruiting - Ulcerative Colitis Clinical Trials

A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA)

Start date: December 4, 2023
Phase: Phase 2
Study type: Interventional

ROSETTA STUDY: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe ulcerative colitis (UC)

NCT ID: NCT06117423 Recruiting - Ulcerative Colitis Clinical Trials

Fluorescence Imaging of Adalimumab-680LT in Inflammatory Bowel Disease

GUIDE
Start date: March 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Crohn's Disease (CD) and Ulcerative Colitis (UC) are chronic inflammatory bowel diseases (IBD). Adalimumab is a human monoclonal antibody against TNF-alpha, a pro-inflammatory cytokine that mediates the inflammatory response in IBD upon binding to the TNF receptors. Primary non-response to adalimumab is high in both CD and UC. Currently, there are no predictors of response to adalimumab and the actual mechanism of action has not yet been elucidated. To gain better understanding of the drug targeting of adalimumab in IBD, the University Medical Center Groningen (UMCG) developed fluorescently labeled adalimumab (adalimumab-680LT). This study aims to assess the safety and the optimal dose of adalimumab-680LT to visualize and potentially quantify the local drug concentration and predict treatment response in IBD patients using in vivo and ex vivo fluorescence molecular imaging (FMI).

NCT ID: NCT06116331 Recruiting - Ulcerative Colitis Clinical Trials

The Mind-Body IBD Study: Understanding the Mind-body Connection in IBD

Start date: April 1, 2023
Phase:
Study type: Observational

An aspect of IBD care that is often overlooked is mental health treatment. Common mental health problems, such as anxiety and depression are very common in IBD, with a meta-analysis estimating prevalence as high as 25.2% for depression and 32.1% for anxiety. The prevalence of anxiety and depression increases when individuals with active disease are considered, with rates as high as 57.6% for anxiety and 38.9% for depression. Comorbid depression and anxiety in IBD is associated with greater symptom severity, even when statistically controlling for disease activity; more frequent and expensive emergency department visits and inpatient stays, higher costs relating to IBD-related surgery, medication and personal expenditure; noncompliance with medical treatment and finally, increased likelihood of experiencing flares. However, very few studies attempt to unpick the precise mechanism of these bidirectional relationships. Indeed, depression and anxiety may have direct effects on physical health through inflammatory or psychoneuroimmunological pathways. Very few studies investigate the longitudinal brain-gut relationship with regards to objective measures of inflammation. Additionally, the indirect effects of mental health are often overlooked. Depression and anxiety are routinely associated with health behaviours, such as diet, physical activity, sleep, and tobacco/alcohol use.These health behaviours are important factors, given their impact on physical health outcomes. Therefore, a thorough investigation is required to ascertain the precise mechanisms that underpin the bidirectional relationship between depression/anxiety and inflammation/physical health, as this will enable practitioners and researchers to establish non-invasive, behavioural treatment targets for this patient group. AIM The broad aim of this project is to explore whether anxiety/depression has a direct or indirect (via health behaviours) on i) inflammation levels ii) clinical activity and iii) healthcare usage at follow-up, in a population of IBD patients. A secondary aim of the project will be to explore whether changes in disease activity, as measured by self-report measures and faecal calprotectin, explains changes in anxiety and depression symptoms at follow up.

NCT ID: NCT06109441 Recruiting - Ulcerative Colitis Clinical Trials

Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics

Start date: December 4, 2023
Phase: Phase 2
Study type: Interventional

ALTB-268-201 is a Phase 2a, multicenter, single arm, multiple-dose, open-label study evaluating the efficacy and safety of ALTB-268 in subjects with moderately to severely active UC. The study consists of a Screening Phase, an Induction Phase, and a Maintenance Phase. Eligible subjects will be enrolled to receive a SC loading dose of ALTB-268 followed by weekly doses of ALTB-268 for 12 weeks. Primary efficacy endpoint will be evaluated at week 12. Week 12 dosing will occur during the 40 wks Maintenance Phase. During 40 weeklong maintenance phase SC doses of ALTB-268 will be administered every other week. At week 52, all subjects will have an endoscopy performed and efficacy and safety evaluation will take place.

NCT ID: NCT06107179 Recruiting - Ulcerative Colitis Clinical Trials

Monitoring of Pediatric Inflammatory Bowel Diseases Using Multispectral Optoacoustic Tomography

Start date: January 24, 2024
Phase:
Study type: Observational

In this clinical trial, the intestinal wall of pediatric patients with Crohns disease and Ulcerative Colitis will be assessed with multispectral optoacoustic tomography (MSOT) to characterize the optoacoustic signal of the intestinal wall and to monitor disease activity. The goal of this clinical trial is to compare the optoacoustic signal in the intestinal wall of children with inflammatory bowel diseases. The main questions it aims to answer are: - How does the optoacoustic signal in children with inflammatory bowel diseases change over time? - How does the optoacoustic signal in children with inflammatory bowel diseases change when they receive therapy? Participants will be examined with multispectral optoacoustic tomography.