Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Country [2] 0 0
Austria
State/province [2] 0 0
Linz
Country [3] 0 0
Austria
State/province [3] 0 0
Poelten
Country [4] 0 0
Austria
State/province [4] 0 0
Wien
Country [5] 0 0
Belgium
State/province [5] 0 0
Gent
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Brazil
State/province [7] 0 0
Campinas
Country [8] 0 0
Brazil
State/province [8] 0 0
Centro Petrópolis
Country [9] 0 0
Brazil
State/province [9] 0 0
Curitiba
Country [10] 0 0
Brazil
State/province [10] 0 0
Goiania
Country [11] 0 0
Brazil
State/province [11] 0 0
Goiânia
Country [12] 0 0
Brazil
State/province [12] 0 0
Porto Alegre
Country [13] 0 0
Brazil
State/province [13] 0 0
Rio de Janeiro
Country [14] 0 0
Brazil
State/province [14] 0 0
Santo André
Country [15] 0 0
Brazil
State/province [15] 0 0
Santos
Country [16] 0 0
Brazil
State/province [16] 0 0
Sao Paulo
Country [17] 0 0
Brazil
State/province [17] 0 0
São Paulo
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Sofia
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Varna
Country [20] 0 0
Canada
State/province [20] 0 0
Alberta
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Czechia
State/province [24] 0 0
Hradec Kralove
Country [25] 0 0
Czechia
State/province [25] 0 0
Olomouc
Country [26] 0 0
Czechia
State/province [26] 0 0
Prague
Country [27] 0 0
Czechia
State/province [27] 0 0
Praha
Country [28] 0 0
Czechia
State/province [28] 0 0
Pribram
Country [29] 0 0
Czechia
State/province [29] 0 0
Tabor
Country [30] 0 0
Czechia
State/province [30] 0 0
Ceské Budejovice
Country [31] 0 0
Denmark
State/province [31] 0 0
Arhus C
Country [32] 0 0
Denmark
State/province [32] 0 0
Herlev
Country [33] 0 0
Denmark
State/province [33] 0 0
Hvidovre
Country [34] 0 0
Denmark
State/province [34] 0 0
Odense
Country [35] 0 0
France
State/province [35] 0 0
Amiens
Country [36] 0 0
France
State/province [36] 0 0
Nice
Country [37] 0 0
France
State/province [37] 0 0
Pessac
Country [38] 0 0
France
State/province [38] 0 0
Rouen
Country [39] 0 0
France
State/province [39] 0 0
Toulouse
Country [40] 0 0
Germany
State/province [40] 0 0
Berlin
Country [41] 0 0
Germany
State/province [41] 0 0
Hamburg
Country [42] 0 0
Germany
State/province [42] 0 0
Kiel
Country [43] 0 0
Germany
State/province [43] 0 0
Magdeburg
Country [44] 0 0
Germany
State/province [44] 0 0
Münster
Country [45] 0 0
Germany
State/province [45] 0 0
Regensburg
Country [46] 0 0
Hungary
State/province [46] 0 0
Bekescsaba
Country [47] 0 0
Hungary
State/province [47] 0 0
Budapest
Country [48] 0 0
Hungary
State/province [48] 0 0
Debrecen
Country [49] 0 0
Hungary
State/province [49] 0 0
Esztergom
Country [50] 0 0
Hungary
State/province [50] 0 0
Gyor
Country [51] 0 0
Hungary
State/province [51] 0 0
Miskolc
Country [52] 0 0
Israel
State/province [52] 0 0
Beer-Sheva
Country [53] 0 0
Israel
State/province [53] 0 0
Haifa
Country [54] 0 0
Israel
State/province [54] 0 0
Jerusalem
Country [55] 0 0
Israel
State/province [55] 0 0
Kfar-Saba
Country [56] 0 0
Israel
State/province [56] 0 0
Petach Tikva
Country [57] 0 0
Israel
State/province [57] 0 0
Rechovot
Country [58] 0 0
Israel
State/province [58] 0 0
Tel Aviv
Country [59] 0 0
Israel
State/province [59] 0 0
Trzifin
Country [60] 0 0
Netherlands
State/province [60] 0 0
Amersfoort
Country [61] 0 0
Netherlands
State/province [61] 0 0
Rotterdam
Country [62] 0 0
Netherlands
State/province [62] 0 0
Zwolle
Country [63] 0 0
Poland
State/province [63] 0 0
Bialystok
Country [64] 0 0
Poland
State/province [64] 0 0
Bydgoszcz
Country [65] 0 0
Poland
State/province [65] 0 0
Krakow
Country [66] 0 0
Poland
State/province [66] 0 0
Lublin
Country [67] 0 0
Poland
State/province [67] 0 0
Opole
Country [68] 0 0
Poland
State/province [68] 0 0
Sopot
Country [69] 0 0
Poland
State/province [69] 0 0
Szczecin
Country [70] 0 0
Poland
State/province [70] 0 0
Warsaw
Country [71] 0 0
Poland
State/province [71] 0 0
Warszawa
Country [72] 0 0
Poland
State/province [72] 0 0
Wroclaw
Country [73] 0 0
South Africa
State/province [73] 0 0
Cape Town
Country [74] 0 0
South Africa
State/province [74] 0 0
Johannesburg
Country [75] 0 0
Sweden
State/province [75] 0 0
Göteborg
Country [76] 0 0
Sweden
State/province [76] 0 0
Lund
Country [77] 0 0
Sweden
State/province [77] 0 0
Stockholm
Country [78] 0 0
United Kingdom
State/province [78] 0 0
London
Country [79] 0 0
United Kingdom
State/province [79] 0 0
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