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

Phase 2

Completed

• Conditions: Crohn's Disease
• Interventions: Drug: CCX282-B

• Registration Number: NCT00306215
• Lead Sponsor: Amgen

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-21
• Study First Submitted QC: 2006-03-21
• Study First Posted: 2006-03-23
• Primary Completion: 2008-08
• Study Completion: 2009-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 436

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	CCX282-B	Blinded study arm
4	CCX282-B	Blinded study arm
1	CCX282-B	Blinded study arm
2	CCX282-B	Blinded study arm

Primary Outcome Measures

Name	Time	Method
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	Day 57

Secondary Outcome Measures

Name	Time	Method
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	Day 57

Trial Locations

Locations (112)

Bankstown - Lidcombe Hospital; 🇦🇺 Bankstown, New South Wales, Australia

Royal Brisbane and Womens Hospital; 🇦🇺 Herston, Queensland, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

Flinders Medical Centre; 🇦🇺 Bedford Park, South Australia, Australia

Launceston General Hospital; 🇦🇺 Launceston, Tasmania, Australia

Box Hill Hospital; 🇦🇺 Box Hill, Victoria, Australia

St Vincents Hospital; 🇦🇺 Fitzroy, Victoria, Australia

Bayside Gastroenterology; 🇦🇺 Frankston, Victoria, Australia

Royal Melbourne Hospital; 🇦🇺 Parkville, Victoria, Australia

The Alfred Hospital; 🇦🇺 Prahran, Victoria, Australia

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