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.

Official 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

Conditions

Crohn’s Disease

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

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

Study Start

March 2006; Expected completion: September 2008

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

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

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

Total Enrolment

423

Contact Details

Bankstown – Lidcombe Hospital, Bankstown, New South Wales, 2200, Australia; Recruiting

• Diane Redmond: 61 (2) 9722 7757; Diane.Redmond@swsahs.nsw.gov.au

Royal Brisbane and Womens Hospital, Herston, Queensland, 4029, Australia; Recruiting

• Karen Cooley: 61 (7) 3636 4273; karen_cooley@health.qld.gov.au
• Rebecca Cooley: 61 (7) 3636 2674; akcooley@tpg.com.au

Flinders Medical Centre, Bedford Park, South Australia, 5042, Australia; Recruiting

• Peta Leach: 61 (8) 8204 3942; peta.leach@fmc.sa.gov.au
• Helen Lewis: 61 (8) 8204 4885; helen.lewis@fmc.sa.gov.au

Royal Adelaide Hospital, Adelaide, South Australia, Australia; Recruiting

• Lee-Anne Faraguna: +61 (0) 8 8222 5827; lfaragun@mail.rah.sa.gov.au

Launceston General Hospital, Launceston, Tasmania, Australia; Recruiting

• Liz Mayne: 61 (3) 6348 8700; Elizabeth.Mayne@dhhs.tas.gov.au

Box Hill Hospital, Box Hill, Victoria, 3128, Australia; Recruiting

• Anne McFarlane: 61 (3) 9895 0347; anne.mcfarlane@med.monash.edu.au
• Lai Wan Reid: Laiwan.Reid@med.monash.edu.au

Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia; Recruiting

• Cathy Pizzey: 61 (0) 3 9342 7798; cathy.pizzey@mh.org.au

The Alfred Hospital, Prahran, Victoria, 3181, Australia; Recruiting

• Graham M. Ramalingam: +61 (3) 9207 1070; M.Ramalingam@alfred.org.au
• Vathy Nagalingam: +61 (3) 9276 2223

Bayside Gastroenterology, Frankston, Victoria, Australia; Recruiting

• Rita Coffey: (03)9784 7979; rcoffey@phcn.vic.gov.au

St Vincents Hospital, Fitzroy, Victoria, Australia; Recruiting

• Angela Gibbs: +61 (0) 3 9288 3592; angela.gibbs@svhm.org.au

Fremantle Hospital, Fremantle, Western Australia, 6160, Australia; Recruiting

• Jill Philpott: 61 (8) 9431 2698; Jillian.Philpott@health.wa.gov.au