Gastroenterology Studies

A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors (1508131)

This is a multicenter, Phase III, randomized, double-blind, double-dummy, parallel-group study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with infliximab in treating participants with moderate to severe ulcerative colitis (UC) who are naive to tumor necrosis factor (TNF) inhibitors. Participants will be randomized in a 1:1 ratio to receive either etrolizumab 105 (milligrams) by subcutaneous (SC) injection [SC] every 4 weeks [Q4W]) + placebo (intravenous [IV] infusion at Weeks 0, 2, and 6, then every 8 weeks) or infliximab 5 milligrams/kilogram (mg/kg) IV at Weeks 0, 2, and 6, then every 8 weeks) + placebo (SC Q4W). Time on treatment is 54 weeks.

Open-Label Extension and Safety Study for Patients With Crohn’s Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144 (1511175)

This two-part, open-label extension and safety monitoring study will examine the safety and efficacy of continued etrolizumab treatment in patients with moderate to severely active Crohn’s disease who were previously enrolled in the etrolizumab Phase III Study GA29144.

Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis (1607270)

The trial is an open label extension study. Eligible patients from the RPC01-3101 trial diagnosed with moderate to severe ulcerative colitis will be enrolled to receive study medication for up to 5 years or until marketed approval.

Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis (1609306)

The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment in participants with moderately to severely active ulcerative colitis (UC) who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.

A Study to Evaluate the Safety and Efficacy of ABT494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis (1708483)

This study is designed to evaluate the long-term safety and efficacy of ABT-494 in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 (Substudies 1 and 2), who have had loss of response during the maintenance period of Study M14-234 (Substudy 3), or who have successfully completed Study M14-234.

Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn’s Disease (1703395)

The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn’s disease. The study will test GED-0301 compared to placebo for 52 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn’s disease.

Filgotinib in Long-Term Extension Study of Adults With Crohn’s Disease (1708486)

The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study in Crohn’s disease (CD).

Study for Participants with Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies (1511170)

This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies. 

VEST: The UK Vedolizumab Real Life Experience Study in Inflammatory Bowel Disease (1802584)

Vedolizumab has been approved for the treatment of both ulcerative colitis and Crohn’s disease. The aim of this study is to capture the early real life UK experience of vedolizumab including the outcomes of treatment, describing the patient population treated, drug persistence, IBD control PROM, durable remission, tolerance and safety.

Study of Immune Drug Side Effects-SIDEFX. Version 1.0 (1507119)

Our 5ASA and PRED studies are currently investigating the genetic factors underlying ADRs in Gastroenterology (and other diseases), and have already successfully identified genetic variants which increase the risk of a patients suffering from two serious drug reactions. We would now like to explore the immunological mechanisms underlying these reactions by comparing immune cells from patients with genetic risk factors who experienced an ADR with immune cells from other individuals who are tolerant of the same drug. A detailed knowledge of these mechanisms is highly desirable for optimal safe utilisation of drug therapies as well as facilitating the design of safer drugs in the future. This project will be completed within 3 years.

I­-CARE – IBD Cancer and Serious Infections in Europe (1609302)

Inflammatory bowel disease (IBD), encompassing Crohn’s Disease (CD) and ulcerative Colitis (UC), is a chronic, disabling, incurable condition affecting 3 million Europeans. Current therapeutic options are limited immunosuppressant and biologics therapies such as antiTNF therapy in IBD patients are now used both earlier in patient treatment journeys and in a larger proportion of IBD patients. Such treatments can reduce the need for major bowel surgery in many patients whose IBD cannot be brought into remission by less potent medications. However, antiTNF treatments (Adalimumab, Infliximab, Vedolizumab) with or without additional immunosuppressive therapies such Azathiopurine, Mercaptapurine or Methotrexate, place patients at greater risk of developing cancer (particularly lymphoma).

The extent to which this risk exists is not clearly defined because no large scale prospective cohort studies have been conducted. ICARE is a Europeanwide, prospective, longitudinal, observational, multicentre cohort study designed to answer the question of risk of developing cancer or serious infection in IBD patients using immunosuppressive and biologic therapies.