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

Amgen436 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

436

Conditions

Crohn's Disease

Interventions

CCX282-BDRUG

CCX282-B or placebo capsules

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (112)

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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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

...and 102 more locations