A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohnâ¤*s Disease

Phase 3

• Conditions: 10017969; Crohn's disease

• Registration Number: NL-OMON36415
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

• Subjects achieving clinical response (CDAI decrease >= 100points) and/or remission (CDAI <150) upon completion of treatment in Study CCX114151.
• Safe contraception for women of childbearing potential.
• Any medications being currently received for Crohn*s disease must remain stable throughout the study period with the exception of tapering of corticosteroids.
• Subjects on corticosteroids at entry must be willing to undergo corticosteroid dose tapering

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>Proportion of subjects in clinical remission (CDAI score <150 points) at both<br /><br>Weeks 28 and 52 of the 52-week treatment period.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>E.g. CDAI score <150 points in patients not taking corticosteroids at both<br /><br>Weeks 28 and 52, clinical remission in week 52, change from baseline in CDAI at<br /><br>various time points, IBDQ score, safety, quality of life, healthcare related<br /><br>resource utilisation.</p><br>