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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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Belgium
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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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Brazil
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Goiânia
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Brazil
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Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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Santo André
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Brazil
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Santos
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Brazil
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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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Bulgaria
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Varna
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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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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Czechia
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Prague
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Czechia
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Praha
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Czechia
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Pribram
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Czechia
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Tabor
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Czechia
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Ceské Budejovice
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Denmark
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Arhus C
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Denmark
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Herlev
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Denmark
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Hvidovre
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Denmark
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Odense
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France
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Amiens
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France
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Nice
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France
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Pessac
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France
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Rouen
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France
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Toulouse
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Germany
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Berlin
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Germany
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Hamburg
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Germany
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Kiel
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Germany
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Magdeburg
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Germany
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Münster
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Germany
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Regensburg
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Hungary
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Bekescsaba
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Esztergom
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Hungary
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Gyor
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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
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Israel
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Jerusalem
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Israel
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Kfar-Saba
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Israel
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Petach Tikva
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Israel
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Rechovot
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Israel
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Tel Aviv
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Israel
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Trzifin
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Netherlands
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Amersfoort
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Netherlands
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Rotterdam
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Netherlands
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Zwolle
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Poland
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Bialystok
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Poland
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Bydgoszcz
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Poland
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Krakow
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Poland
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Lublin
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Poland
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Opole
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Poland
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Sopot
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Poland
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Szczecin
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Poland
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Warsaw
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Poland
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Warszawa
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Poland
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Wroclaw
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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
The purpose of this study is to determine whether CCX282-B is effective in treating patients
with moderate to severe Crohn's Disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00306215
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00306215