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Completed

NCT Number: NCT00306215

A Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease

The purpose of this study is to determine whether CCX282-B is effective in treating patients with moderate to severe Crohn's Disease.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bankstown - Lidcombe Hospital, Bankstown, New South Wales, Australia

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About this study

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • moderate to severe Crohn's Disease
  • CDAI 250-450
  • CRP >7.5
  • signed written informed consent

Key Exclusion Criteria:

  • > 100 cm of small bowel resected
  • ileostomy, colostomy or rectal pouch
  • diagnosis of ulcerative colitis or indeterminate colitis
  • evidence of short bowel syndrome requiring enteral or parenteral supplementation or total parenteral nutrition
  • hepatitis B, C or HIV infection
  • history of infection requiring IV antibiotics
  • serious or GI infection in the previous 12 weeks

Treatment and study plan

CCX282-B

Drug

CCX282-B or placebo capsules

Primary outcomes

  1. Percentage of subjects achieving a clinical response (defined as a decrease from baseline in Crohn's Disease Activity Index [CDAI] score of at least 70) on Day 57

    Time frame: Day 57

Secondary outcomes

  1. Percentage of subjects achieving clinical remission (defined as a Crohn's Disease Activity Index [CDAI] score less than or equal to 150) on Day 57

    Time frame: Day 57

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Multinational, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Mar 23, 2006
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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