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Diversity 1

Filgotinib in the Induction and Maintenance of Remission in Adults with Moderately to Severely Active Crohn's Disease

This study is currently recruiting participants.

Primary Objective: The primary objectives of this phase 3, double-blind, randomized, placebo-controlled study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in adults (ages 18-75) who are biologic-naive and biologic-experienced.

Principal Investigator: Ben Griffiths

Study Coordinator: Jonathan Barrett

Trial Website: https://clinicaltrials.gov/ct2/show/NCT02914561

CARMEN CD 306

Efficacy and Safety Study of SHP647 as Induction Therapy in Participants with Moderate to Severe Crohn's Disease

This study is currently recruiting participants.

Primary Objective: The purpose of this phase 3 randomized, double-blind, placebo-controlled, parallel-group study is to evaluate the efficacy and safety of SHP647 in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.

Principal Investigator: Ben Griffiths

Study Coordinator: Jonathan Barrett

Trial Website: https://clinicaltrials.gov/ct2/show/NCT03566823

FIGARO UC 302

Efficacy and Safety Study of SHP647 as Induction Therapy in Participants with Moderate to Severe Ulcerative Colitis

This study is currently recruiting participants.

Primary Objective: The purpose of this phase 3 randomized, double-blind, placebo-controlled, parallel-group study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

Principal Investigator: Ben Griffiths

Study Coordinator: Jonathan Barrett

Trial Website: https://clinicaltrials.gov/ct2/show/NCT03259308

M16-066 Abbvie

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065

This study is currently recruiting participants.

Primary Objective: The purpose of this multicenter, randomized, double-blind, placebo-controlled 52-week maintenance and an open-label extension study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.

Principal Investigator: Ben Griffiths

Study Coordinator: Jonathan Barrett

Trial Website: https://clinicaltrials.gov/ct2/show/NCT03398135

M16-067 Abbvie

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy

This study is currently recruiting participants.

Primary Objective: The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

Principal Investigator: Ben Griffiths

Study Coordinator: Jonathan Barrett

Trial Website: https://clinicaltrials.gov/ct2/show/NCT03398148

Selection 1

Filgotinib in the Induction and Maintenance of Remission in Adults with Moderately to Severely Active Ulcerative Colitis

This study is currently recruiting participants.

Primary Objective: The primary objectives of this combined phase 2b/3, double-blind, randomized, placebo-controlled study are to evaluate the safety and efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced.

Principal Investigator: Ben Griffiths

Study Coordinator: Jonathan Barrett

Trial Website: https://clinicaltrials.gov/ct2/show/NCT02914522

BRII-179 for Chronic Hepatitis B

Brii-179-001: A Study to Evaluate Safety, Tolerability, and Antiviral Activity of BRII-179 (VBI-2601) among Subjects with Chronic Hepatitis B.

This study is currently recruiting participants.

Primary Objective:  The main goal of this study is to assess the safety and tolerability of two dose levels of BRII-179 in people without significant liver damage but with chronic HBV infection. The study will also assess the antiviral activity of BRII-179 (VBI-2601) given by intramuscular injection. To take part in this study, participants must be 18-60 years old and have been on a drug that suppresses replication of the hepatitis B virus e.g. tenofovir or entecavir and have to continue to take this drug throughout the study. If eligible, participation in the study will last up to several months.

Principal Investigator: Dr Nigel Stace

Study Coordinator:  Gizelle Lopez

Trial Website: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12619001210167

Last updated 26 November 2019.