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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00306215




Registration number
NCT00306215
Ethics application status
Date submitted
21/03/2006
Date registered
23/03/2006
Date last updated
25/08/2023

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease
Scientific title
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
Secondary ID [1] 0 0
CL004_282
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CCX282-B

Experimental: 1 - Blinded study arm

Experimental: 2 - Blinded study arm

Experimental: 3 - Blinded study arm

Experimental: 4 - Blinded study arm


Treatment: Drugs: CCX282-B
CCX282-B or placebo capsules
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of subjects achieving a clinical response (defined as a decrease from baseline in Crohn's Disease Activity Index [CDAI] score of at least 70) on Day 57
Timepoint [1] 0 0
Day 57
Secondary outcome [1] 0 0
Percentage of subjects achieving clinical remission (defined as a Crohn's Disease Activity Index [CDAI] score less than or equal to 150) on Day 57
Timepoint [1] 0 0
Day 57

Eligibility
Key inclusion criteria
Key

* moderate to severe Crohn's Disease
* CDAI 250-450
* CRP >7.5
* signed written informed consent

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* > 100 cm of small bowel resected
* ileostomy, colostomy or rectal pouch
* diagnosis of ulcerative colitis or indeterminate colitis
* evidence of short bowel syndrome requiring enteral or parenteral supplementation or total parenteral nutrition
* hepatitis B, C or HIV infection
* history of infection requiring IV antibiotics
* serious or GI infection in the previous 12 weeks

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2009
Sample size
Target
Accrual to date
Final
436
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Bankstown - Lidcombe Hospital - Bankstown
Recruitment hospital [2] 0 0
Royal Brisbane and Womens Hospital - Herston
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [5] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [6] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [7] 0 0
St Vincents Hospital - Fitzroy
Recruitment hospital [8] 0 0
Bayside Gastroenterology - Frankston
Recruitment hospital [9] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [10] 0 0
The Alfred Hospital - Prahran
Recruitment hospital [11] 0 0
Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
- Launceston
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
- Fitzroy
Recruitment postcode(s) [8] 0 0
- Frankston
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment postcode(s) [10] 0 0
3181 - Prahran
Recruitment postcode(s) [11] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Innsbruck
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Austria
State/province [2] 0 0
Linz
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Austria
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Poelten
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Austria
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Wien
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Belgium
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Gent
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Belgium
State/province [6] 0 0
Leuven
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Brazil
State/province [7] 0 0
Campinas
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Brazil
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Centro Petrópolis
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Brazil
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Curitiba
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Brazil
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Goiania
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Goiânia
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Porto Alegre
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Rio de Janeiro
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Santo André
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Santos
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Sao Paulo
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Brazil
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São Paulo
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Bulgaria
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Sofia
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Varna
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Alberta
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British Columbia
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Ontario
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Quebec
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Czechia
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Hradec Kralove
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Czechia
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Olomouc
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Prague
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Praha
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Czechia
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Pribram
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Tabor
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Arhus C
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Herlev
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Hvidovre
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Bekescsaba
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Budapest
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Debrecen
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Esztergom
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Gyor
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Miskolc
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Beer-Sheva
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Kfar-Saba
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Petach Tikva
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Rechovot
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Zwolle
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Bialystok
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Cape Town
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Johannesburg
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Sweden
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Göteborg
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Sweden
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Lund
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Sweden
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Stockholm
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United Kingdom
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London
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United Kingdom
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Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ChemoCentryx
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00306215