A phase II, 20-week, multi-centre, randomised, double-blind, placebo-controlled, parallel group proof of concept study to investigate the efficacy and safety of GSK1605786 for treatment of patients with active Ulcerative Colitis (CCX115393)

Phase 2

Withdrawn

• Conditions: ulcerative colitis; 10017969

• Registration Number: NL-OMON35581
• Lead Sponsor: GlaxoSmithKline BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

* Male and female patients 18 years or above with a history of UC for at least 3 months who remain symptomatic despite receiving oral aminosalicylate (with or without topical aminosalicylate) at a dose of >2.4mg/day mesalazine/mesalamine or equivalent for at least 2 weeks.
* At screening: active ulcerative colitis with spread at least 15 cm from the anal verge and MAYO score of 5-10 inclusive.
* Safe contraception for women of childbearing potential.

Exclusion Criteria

* Breastfeeding, pregnancy.
* Known coeliac disease, those who follow a gluten-free diet to manage symptoms of suspected coeliac disease and subjects with a positive screening test for celiac disease.
* Known or suspicion of CD, indeterminate colitis, microscopic colitis, ischaemic colitis or radiation-induced colitis.
* Imminent need for surgery for UC.
* Bowel surgery in the past that might interfere with MAYO score.
* Use of prohibited medications (see protocol for details).
* Usual exclusion criteria for biologicals.
* QTc *450 msec (480 msec for those with Bundle Branch Block)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Ordinal response (remission, response, or no response) to treatment as assessed<br /><br>by the MAYO score at week 12.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Adverse events, remission, response, endoscopic remission, time to<br /><br>withdrawal/rescue medication, quality of life (IBDQ questionnaire), biomarkers,<br /><br>PK, receptor occupancy, TECK/CCL25 and CCR9 expression.</p><br>