An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn*s Disease (CCX114644)

Phase 3

Withdrawn

• Conditions: Crohn's disease; 10017969

• Registration Number: NL-OMON36684
• Lead Sponsor: GlaxoSmithKline

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• Status: Withdrawn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: 30

Inclusion Criteria

* Completion of the placebo-controlled induction study, CCX114151, without achieving clinical response or remission or completion of maintenance study CCX114157, withdrawal from maintenance study CCX114157 due to worsening of Crohn*s disease.
* 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 suspected small bowel stricture
* Enterocutaneous, abdominal or pelvic fistulae with abscesses or fistulae likely to require surgery during the study period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Adverse effects.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Clinical response or remission, change in CDAI, IBDQ score, safety, quality of<br /><br>life, healthcare related resource utilisation.</p><br>