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 (NCT) | NCT00102921 |
| Protocol serial number | CL003_282_b |
| Sponsor | ChemoCentryx (USA) |
| Funder | ChemoCentryx |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 5666545 |
|---|---|
| d.w.hommes@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | CCX282-B |
| Primary outcome measure(s) |
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). |
| Key secondary outcome measure(s) |
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. |
| Completion date | 01/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
1105 AZ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
11/01/2021: The NCT code has been added.
