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

ISRCTN ISRCTN61635363
DOI https://doi.org/10.1186/ISRCTN61635363
ClinicalTrials.gov number NCT00306215
Secondary identifying numbers CL004_282
Submission date
21/01/2008
Registration date
30/05/2008
Last edited
16/06/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Satish Keshav
Scientific

Dept of Gastroenterology, Level 5
John Radcliffe Hospital
Headley Way, Headington
Oxford
OX3 9DU
United Kingdom

Satish.Keshav@ndm.ox.ac.uk

Study information

Study designMultinational double-blind placebo-controlled parallel-group study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronymCCX282-B
Study objectivesTo determine whether CCX282-B is effective in inducing and then maintaining treatment response (based on Clinical Disease Activity Index [CDAI] changes from baseline) in patients with Crohn’s disease.

Please note that this trial was preceded by another trial registered on the ISRCTN - see http://www.controlled-trials.com/ISRCTN58248439.
Ethics approval(s)Ethics approval has been received in all countries in which this trial is ongoing. Lead centre ethics approval received from West Glasgow Ethics Committee 1 on 02/05/2006, ref: 06/S0703/42
Health condition(s) or problem(s) studiedModerate to severe Crohn's disease
InterventionAn investigational medication, CCX282-B administered orally via capsule versus placebo for 12 weeks:
1. CCX282-B 250 mg four times a day (qd)
2. CCX282-B 500 mg qd
3. CCX282-B 250 mg twice a day (b.i.d)
4. Placebo

Four-week active phase CCX282-B 250 mg, b.i.d. and 36-week maintenance phase 250 mg CCX282-B b.i.d. or placebo, four-week safety monitoring.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)CCX282-B
Primary outcome measure1. CDAI 70-point response at day 57
2. Relapse rate during the maintenance period
3. Safety and tolerability of CCX282-B
Secondary outcome measures1. CDAI 100-point response and CDAI remission rate
2. Change in C-reactive protein from baseline
Overall study start date13/03/2006
Completion date31/03/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants423
Key inclusion criteria1. Male or female subjects, at least 18 years old
2. Active, moderate to severe Crohn’s disease
3. CDAI between 250 and 450
4. Fasting serum C-reactive proterin (CRP) concentration above 7.5 mg/L
5. If on therapy for Crohn’s disease, must have been on a stable treatment regimen for at least four weeks
6. If a female of childbearing potential, or if a male whose partner is a woman of childbearing potential, the subject must agree to use adequate contraception during the study
7. The subject must be willing and able to give written informed consent and comply with the requirements of the study protocol
8. No more than 100 cm small bowel resection
9. If taking oral antibiotics chronically, must have continuous use for at least four weeks prior to randomisation and at stable doses for at least two weeks prior to randomisation
Key exclusion criteria1. If female, the subject is pregnant or breastfeeding
2. Use of cyclosporin, tacrolimus, sirolimus, or mycophenolate mofetil and/or greater than 20 mg prednisone or a prednisone-equivalent, parenteral glucocorticoids or corticotrophin, or any experimental treatment for Crohn's disease within four weeks prior to study entry
3. Tumour necrotising factor (TNF) inhibitor or natalizumab use during 12 weeks prior to study entry
4. History or presence of any medical or psychiatric condition or disease, or laboratory abnormality that may place the subject at unacceptable risk for study participation and completion
5. Bowel surgery within 12 weeks prior to randomisation and/or planned or likely to require bowel surgery during the study
6. Presence of symptomatic obstructive stricture
7. Active tuberculosis, hepatitis B, C and/or human immunodeficiency virus (HIV) infection
8. History of any form of cancer within five years prior to study entry except for localised tumours that have been resected successfully
9. History of infection requiring intravenous antibiotics, a serious infection within 12 weeks of randomisation
10. Ulcerative or indeterminate colitis
Date of first enrolment13/03/2006
Date of final enrolment31/03/2009

Locations

Countries of recruitment

  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Czech Republic
  • Denmark
  • England
  • France
  • Germany
  • Hungary
  • Israel
  • Netherlands
  • Poland
  • South Africa
  • Sweden
  • United Kingdom

Study participating centre

Dept of Gastroenterology, Level 5
Oxford
OX3 9DU
United Kingdom

Sponsor information

ChemoCentryx, Inc. (USA)
Industry

850 Maude Avenue
Mountain View, CA
94043
United States of America

+1 650 210 2900
pbekker@chemocentryx.com
http://www.chemocentryx.com
ROR logo https://ror.org/04gp12571

Funders

Funder type

Industry

ChemoCentryx, Inc. (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2013 Yes No
BMC - Part of Springer Nature Springer Nature