Condition category
Digestive System
Date applied
13/09/2005
Date assigned
21/12/2005
Last edited
22/02/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daan Hommes

ORCID ID

Contact details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 5666545
d.w.hommes@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CL003_282_b

Study information

Scientific title

Acronym

CCX

Study hypothesis

The purpose of this research study is to investigate the effects of an investigational medication, called CCX282-B, on safety and on some of the symptoms of Crohn’s Disease in patients who are experiencing an active flare-up of moderate to severe Crohn’s Disease

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Crohn's Disease

Intervention

An investigational medication, called CCX282-B (capsules), compared to placebo

Intervention type

Drug

Phase

Not Specified

Drug names

CCX282-B

Primary outcome measures

The primary immunologic and clinical activity objective of this study is to provide pilot information regarding the immunologic and clinical activity of daily oral doses of CCX282-B in the treatment of moderate to severe Crohn’s Disease, based on changes in the Crohn’s Disease Activity Index (CDAI).

Secondary outcome measures

Secondary immunologic and clinical activity objectives include evaluation of the effect of CCX282-B on the Inflammatory Bowel Disease Questionnaire (IBDQ) instrument, C-reactive protein (CRP), the endoscopic appearance and biopsy of the colon and terminal ileum, and markers of leukocyte subsets and activation status.

Overall trial start date

01/08/2004

Overall trial end date

01/02/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of moderate to severe Crohn's Disease in small intestine; disease must be active at the time of study entry
2. Use of adequate and approved methods of birth control throughout the study period
3.
Willing and able to sign an informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70

Participant exclusion criteria

1. Pregnant or breastfeeding
2. Infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV; the virus that causes AIDS)
3. Abuse of alcohol or of illegal drugs

Recruitment start date

01/08/2004

Recruitment end date

01/02/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

ChemoCentryx (USA)

Sponsor details

850 Maude Avenue
Mountain View
CA 94043
United States of America
+1 650 210 2924
pbekker@chemocentryx.com

Sponsor type

Industry

Website

http://www.chemocentryx.com/

Funders

Funder type

Industry

Funder name

ChemoCentryx

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes