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
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