Combined Phase 2b/3. Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis

25th April 2017 - ongoing

Status: In Recruitment

Specialism: Lower GI, Inflammatory Bowel Disease (IBD).

Team: Dr Sunil SamuelDr Gordon Moran.

The overall objective of the study is to evaluate the effect of treatment with filgotinib on the induction and maintenance of remission in subjects with moderately to severely active Ulcerative Colitis (UC). Subjects who are biologic-naïve and biologic-experienced will be enrolled in Cohorts A and B respectively. Treatment assignments will be randomized within each Cohort.

Janus kinases (JAKs) are intracellular cytoplasmic tyrosine kinases (TYKs) that transduce cytokine signaling from membrane receptors through signal transducer and activator of transcription (STAT) to the nucleus of cells. JAK inhibitors block the signaling of various cytokines, growth factors, and hormones, including the pro-inflammatory cytokine interleukin (IL)-6. Four different types of JAKs are known, JAK1, JAK2, JAK3, and TYK2 which interact with different sets of membrane receptors. Inhibition of JAKs is a promising therapeutic option for a range of inflammatory conditions including rheumatoid arthritis (RA) and CD.

Filgotinib (GS-6034, formerly known as GLPG0634) is a potent and selective inhibitor of JAK1. The compound has shown good preliminary efficacy in RA and CD patients in Phase 2 studies.

In humans, filgotinib is metabolized to form one major active metabolite, GS—829845. Though the

potency of this metabolite is lower than the parent molecule, the overall exposure and peak plasma concentration in humans is higher than seen in all tested animal species. As a consequence, dedicated pharmacology and toxicology studies have been performed with GS-829845. Results from pharmacodynamics (PD) testing in healthy volunteers suggest that the clinical activity of filgotinib could result from the combination of the parent molecule and the metabolite.

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Dr Sunil Samuel
dr-gordon-moran Dr Gordon Moran Dr Moran did his undergraduate medical training at University of Malta Medical School and was awarded an MD in 1999. He completed his basic postgraduate training at St. Luke's Hospital in Malta and gained membership of the Royal College of Physicians of…
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