Clinical trial

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

Name

CL004_282

Description

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

Trial arms

Trial start

2006-03-01

Estimated PCD

2008-08-01

Trial end

2009-06-01

Status

Completed

Phase

Early phase I

Treatment

CCX282-B

CCX282-B or placebo capsules

Arms:

1, 2, 3, 4

Size

436

Primary endpoint

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

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 436, 'type': 'ACTUAL'}}

Updated at

2023-08-25

1 organization

1 product

1 indication

Organization

ChemoCentryx

Product

CCX282-B

Indication

Crohn's disease