Condition category
Digestive System
Date applied
21/01/2008
Date assigned
30/05/2008
Last edited
16/06/2014
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 Satish Keshav

ORCID ID

Contact details

Dept of Gastroenterology
Level 5
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Satish.Keshav@ndm.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00306215

Protocol/serial number

CL004_282

Study information

Scientific title

Acronym

CCX282-B

Study hypothesis

To 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

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

Study design

Multinational double-blind placebo-controlled parallel-group study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Moderate to severe Crohn's disease

Intervention

An 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 type

Drug

Phase

Not Applicable

Drug names

CCX282-B

Primary outcome measures

1. CDAI 70-point response at day 57
2. Relapse rate during the maintenance period
3. Safety and tolerability of CCX282-B

Secondary outcome measures

1. CDAI 100-point response and CDAI remission rate
2. Change in C-reactive protein from baseline

Overall trial start date

13/03/2006

Overall trial end date

31/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

423

Participant exclusion criteria

1. 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

Recruitment start date

13/03/2006

Recruitment end date

31/03/2009

Locations

Countries of recruitment

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

Trial participating centre

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

Sponsor information

Organisation

ChemoCentryx, Inc. (USA)

Sponsor details

850 Maude Avenue
Mountain View
CA
94043
United States of America
+1 650 210 2900
pbekker@chemocentryx.com

Sponsor type

Industry

Website

http://www.chemocentryx.com

Funders

Funder type

Industry

Funder name

ChemoCentryx, Inc. (USA)

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23527300

Publication citations

  1. Results

    Keshav S, Vaňásek T, Niv Y, Petryka R, Howaldt S, Bafutto M, Rácz I, Hetzel D, Nielsen OH, Vermeire S, Reinisch W, Karlén P, Schreiber S, Schall TJ, Bekker P, , A randomized controlled trial of the efficacy and safety of CCX282-B, an orally-administered blocker of chemokine receptor CCR9, for patients with Crohn's disease., PLoS ONE, 2013, 8, 3, e60094, doi: 10.1371/journal.pone.0060094.

Additional files

Editorial Notes