Pilot, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety and Clinical Activity of CCX282-B in Patients with Moderate to Severe Crohn’s Disease

ISRCTN	ISRCTN58248439
DOI	https://doi.org/10.1186/ISRCTN58248439
ClinicalTrials.gov number	NCT00102921
Secondary identifying numbers	CL003_282_b

Submission date: 13/09/2005
Registration date: 21/12/2005
Last edited: 11/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Daan Hommes
Scientific

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 5666545
Email	d.w.hommes@amc.uva.nl

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Pilot, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety and Clinical Activity of CCX282-B in Patients with Moderate to Severe Crohn’s Disease
Study acronym	CCX
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Crohn's Disease
Intervention	An investigational medication, called CCX282-B (capsules), compared to placebo
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	CCX282-B
Primary outcome measure	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 study start date	01/08/2004
Completion date	01/02/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	70
Key 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
Key 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
Date of first enrolment	01/08/2004
Date of final enrolment	01/02/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

Meibergdreef 9

Amsterdam
1105 AZ
Netherlands

Sponsor information

ChemoCentryx (USA)
Industry

850 Maude Avenue
Mountain View
CA 94043
United States of America

Phone	+1 650 210 2924
Email	pbekker@chemocentryx.com
Website	http://www.chemocentryx.com/
"ROR"	https://ror.org/04gp12571

Funders

Funder type

Industry

ChemoCentryx

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

11/01/2021: The NCT code has been added.