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Colitis clinical trials

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NCT ID: NCT03768219 Terminated - Ulcerative Colitis Clinical Trials

Study to Evaluate APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis

Start date: March 18, 2019
Phase: Phase 1
Study type: Interventional

Phase 1 study in 2 stages with 2 expansion cohorts. The first stage is a single ascending dose (SAD) study of APVO210 in healthy volunteers. The second stage is a multiple ascending dose (MAD) study of APVO210 in healthy volunteers. Two expansion cohorts evaluate multiple doses of APVO210 in psoriasis patients and ulcerative colitis patients.

NCT ID: NCT03759041 Terminated - Ulcerative Colitis Clinical Trials

A Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis

ECO-RESET
Start date: December 19, 2018
Phase: Phase 2
Study type: Interventional

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER-287 in Adults with Active Mild-to-Moderate Ulcerative Colitis

NCT ID: NCT03758443 Terminated - Clinical trials for Ulcerative Colitis (UC)

Efficacy & Safety of TD-1473 in Ulcerative Colitis

RHEA
Start date: March 11, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.

NCT ID: NCT03756454 Terminated - Clinical trials for Clostridia Difficile Colitis

Comparing the Effectiveness of IV Bezlotoxumab Versus Placebo in Decreasing Morbidity and Mortality in Patients With Fulminant C. Diff Requiring Surgery.

Start date: August 19, 2019
Phase: Phase 4
Study type: Interventional

A new medication, Bezlotoxumab, has been approved for treatment of recurrent Clostridium difficile diarrhea by the U.S. Food and Drug Administration. The way this new medication works, is by binding the toxin produced by C. difficile bacteria and preventing damage to the large bowel. The toxin, and not the bacteria, is responsible for the damage, resulting in the clinical symptoms seen in patients. Sometimes, the infection can make a patient severely ill with organ failure and death. If severe enough, the infection requires surgery to remove the large bowel and allow the patient a better chance at recovery. Even with surgery and removal of the bowel, patients can continue to be severely ill and have a very high rate of mortality. The toxin that injures the large bowel has been shown to obtain access to systemic circulation because of the injury to the bowel. At this time, the investigators continue antibiotics and supportive care to help patients recover post-operatively, as the investigators do not have other interventions in this critical population. Bezlotoxumab is known to bind this toxin and stop it from causing further injury in the bowel; it has the potential to bind the systemic toxin to prevent further damage throughout the body. This study is proposing that this new medication, Bezlotoxumab, can be added to the current standard of care for severe infection that requires surgery, and result in a decrease of the complications associated with this disease process. In this study, some patients will receive the medication after surgery; others will receive extra fluid. The investigators will not know who received which in order to decrease any bias in the results. All participants will receive similar post-operative care and be monitored closely. When enough patients are enrolled in the study, the results will be evaluated.

NCT ID: NCT03724929 Terminated - Ulcerative Colitis Clinical Trials

Value of Pharmacokinetic Assays in the Prediction of Therapeutic Response in Ulcerative Colitis

PREDIRESPUC
Start date: March 4, 2019
Phase: N/A
Study type: Interventional

Vedolizumab (VDZ) is a monoclonal antibody that binds to the heterodimer α4β7 integrin and which has shown its efficacy in Ulcerative Colitis (UC) by inducing and maintaining clinical response/remission. The French marketing authorization was obtained for Ulcerative Colitis in patients in failure with anti-Tumor Necrosis Factor (anti-TNF) agents. In the pivotal study, correlation between drug levels and clinical response during induction and maintenance therapy were reported. Moreover, in 3.7% of cases, anti-vedolizumab antibodies were reported during the time-course and 1% had samples that were persistently positive. Up to now, data on the pharmacologic VDZ parameters are scarce and the relationships as well as the predictive value of the measurement of VDZ concentrations and VDZ monoclonal antibodies (mAbs) during the induction and maintenance phases remains unknown. It could be of paramount interest to early identify UC patients under VDZ who will be responders to VDZ induction and to identify those who will achieve clinical remission under maintenance therapy with VDZ.

NCT ID: NCT03656627 Terminated - Clinical trials for Rheumatoid Arthritis

Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease

Start date: June 27, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to explore the safety, tolerability and activity of Nivolumab, a PD-1 inhibitor, in cohorts of patients with autoimmune disease. Two cohorts of patients will be enrolled, based on autoimmune disease type. Patients will be screened within 28 days prior to the start of dosing. Eligible patients will be enrolled in either of the two cohorts. Patients will receive treatment every two weeks, in an outpatient setting. One cycle is a 28-day period, with Nivolumab given on days 1 and 15 of a 28-day cycle. Subjects will be permitted to continue treatment beyond initial RECIST 1.1.

NCT ID: NCT03650413 Terminated - Ulcerative Colitis Clinical Trials

An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease

Start date: January 14, 2019
Phase: Phase 2
Study type: Interventional

This study will evaluate the long-term safety and tolerability of UTTR1147A in participants with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD), enrolling up to 320 participants from the parent studies: Phase Ib Study GA29469 (NCT02749630) and Phase II Study GA39925 (NCT03558152).

NCT ID: NCT03616821 Terminated - Ulcerative Colitis Clinical Trials

Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis

Expedition
Start date: August 7, 2018
Phase: Phase 2
Study type: Interventional

The present study (D5272C00001/Legacy #3151-201-008) aims to evaluate the efficacy and safety of brazikumab in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal appearance as observed on endoscopy

NCT ID: NCT03604536 Terminated - Ulcerative Colitis Clinical Trials

Individualization Treatment Through a Self-managed Web-based Solution in Ulcerative Colitis

Start date: December 2, 2019
Phase:
Study type: Observational

This study investigates the effect of individualized monotherapy with Mesalazine (Pentasa Sachet ®) on time to remission in patients with mild to moderate UC in an eHealth setting.

NCT ID: NCT03587519 Terminated - Ulcerative Colitis Clinical Trials

Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery

SLIRPS
Start date: November 6, 2018
Phase: N/A
Study type: Interventional

In patients with ulcerative or indeterminate colitis who undergo ileal pouch anal anastomosis and diverting loop ileostomy (IPAA) surgery* a short interval to loop ileostomy reversal will result in differences in complications and quality of life compared to a long interval to loop ileostomy reversal.