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Vercirnon Induction Study in Crohn's Disease (SHIELD-4)

NCT01536418Phase 3

Key facts

Status: Terminated
Start: Nov 2011
Primary completion: Oct 2013
Countries: 31
Sponsor: GSK
Modality: Small Molecules

Drugs: vercirnon
Conditions: Crohn's disease

Overview

Phase 3, randomised, double-blind trial of vercirnon in Crohn's disease (2 arms), sponsored by GSK. Primary endpoint: Percentage of Participants Achieving Clinical Response at 12 weeks. Started Nov 2011; status: terminated.

Design

2 arms

Study design: RandomizedDouble-blind

Vercirnon 500mg QD
500 mg once daily for 12 weeks
Vercirnon 500mg BID
500 mg twice daily for 12 weeks

Who it enrols

Adults with moderately-to-severely active Crohn's disease (CDAI 220-450) and elevated CRP or calprotectin who have failed corticosteroids or immunosuppressants.

Endpoints

Primary

Percentage of Participants Achieving Clinical Response12 weeks

Secondary

Percentage of Participants Achieving Clinical Remission12 weeks
Percentage of Participants With a Clinical Response at Week 8 and at Both Week 8 and Week 1212 weeks
Change From Baseline in C-reactive Protein Concentration12 weeks
Change From Baseline in Faecal Calprotectin12 weeks
Pharmacokinetics of GSK1605786A12 weeks

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