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A Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CCX282-B
Sponsored by
ChemoCentryx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring double-blind, placebo-controlled, multicenter, efficacy, safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: moderate to severe Crohn's Disease CDAI 250-450 CRP >7.5 signed written informed consent 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

Sites / Locations

  • Bankstown - Lidcombe Hospital
  • Royal Brisbane and Womens Hospital
  • Royal Adelaide Hospital
  • Flinders Medical Centre
  • Launceston General Hospital
  • Box Hill Hospital
  • St Vincents Hospital
  • Bayside Gastroenterology
  • Royal Melbourne Hospital
  • The Alfred Hospital
  • Fremantle Hospital
  • Universitätsklinik für Innere Medizin
  • A.ö. Krankenhaus der Elisabethinen Linz
  • Landesklinikum St. Poelten
  • Krankenanstalt Rudolfstiftung
  • Universitätsklinik für Innere Medizin III
  • UZ Gent
  • UZ Gasthuisberg
  • Unigastro
  • Centro Petropolitano de Reumatologia e Fisioterapia
  • Hospital das Clínicas de Curitiba UFPR
  • Instituto Goiano de Gastro
  • Hospital Geral de Goiânia
  • Hospital de Clínicas de Porto Alegre
  • Hospital São Lucas PUC-RS
  • Hospital Universitário Clementino Fraga Filho
  • Santo André Diagnósticos e tratamentoLtda.
  • Irmandade da Santa Casa de Misericórdia de Santos
  • Irmandade da Santa Casa de Misericórdia de São Paulo
  • Hospital das Clínicas de São Paulo
  • Hospital Israelita Albert Einstein
  • 4 MHAT, 38 "Makedonia" 1000
  • Military Medical Academy
  • UMHAT "Alexandrovska"
  • UMHAT Queen Joanna
  • UMHAT" St. Ivan Rilsky"
  • V City Hospital
  • UMHAT "St. Marina"
  • Health Science Centre
  • Lair Centre
  • DHC Research
  • Mt. Sinai Hospital
  • Centre Hospitalier--Hotel-Dieu de Levis
  • Hopital Maisonneuve-Rosemont
  • Jewish General Hospital
  • CHAUQ-Hopital St-Sacrement
  • Hepato-Gastroenterologie, Edvarda Benese 1549
  • II.Interni klinika, Endoskopie
  • General University Hospital Prague
  • Medic Kral ltd.
  • Fakultni nemocnice
  • Klinika hepatogastroenterologieIKEM
  • Regional Hospital Pribram
  • Regional Hospital Tabor
  • Private Gastroenterology Centre
  • Medical Department V Århus University Hospital
  • Herlev Hospital Gastroenterologisk department
  • Hvidovre Hospital
  • Medical department S Odense University hospital
  • CHU Amiens - Hôpital Nord
  • Service d'Hépato-Gastroentérologie et de Nutrition Clinique
  • Hopital du Haut-Lévêque
  • Hôpital Charles Nicolle
  • Service de Gastro-Enterologie et Nutrition
  • Charité Campus Mitte, Universitätsmedizin Berlin
  • Medizinische Klinik m.S. Hepatologie, Gastroenterologie, Endokrinologie und Stoffwechsel
  • Fachärztin für Innere Medizin
  • Klinikum der Christian-Albrechts-Universität zu Kiel
  • Universitätsklinikum Magdeburg A.ö.R
  • Gastroenterologische Praxis am Germania-Campus
  • Klinikum der Universität Regensburg
  • Réthy Pál Kórház
  • Fővárosi Önkormányzat Bajcsy-Zsilinszky Kórház
  • Debreceni Egyetem OEC
  • Vaszary Kolos Kórház
  • Petz Aladár Megyei Oktató Kórház
  • BAZ Megyei Kórház
  • Soroka Medical Center
  • Bnai Zion MC
  • Rambam Medical Center,
  • Hadassah Ein-Karem Medical Center
  • Meir Hospital
  • Rabin Medical Center
  • Kaplan Medical Center
  • The Tel-Aviv Sourasky Medical Center
  • Assaf Harofeh Medical Center
  • Ringweg Randenbroek 110
  • Ikazia Ziekenhuis
  • Isala Klinieken Locatie Sophia Afd. Interne Geneeskunde
  • ZOZ MSWiA Oddział Chorób Wewnętrznych
  • 10 Wojskowy Szpital Klinicznym, Oddzial Kliniczny Gasteroenterologii
  • SPZOZ Wojewodzki Szpital
  • Klinika Chorob Wewnetrznych I Gastroenterologii
  • Samodzielny Publiczny Szpital Kliniczny Nr 4
  • SPZOZ Szpital Wojewódzki w Opolu
  • SOPMED Niepubliczny Zakład Opieki Zdrowotnej
  • Klinika Gastroenterologii i Chorób Wewnętrznych Samodzielny Publiczny Szpital Kliniczny nr 1 im. T. Sokołowskiego Pomorskiej Akademii Medycznej ul.Unii Lubelskiej 1
  • Wojskowy Insytutu Medyczny
  • NZOZ Vivamed Zespół Lekarzy Specjalistów ul. Trocka 10A
  • CSK MSWiA, Klinika Gastroenterologii
  • Klinika Gastroenterologii i Hepatologii, Akademii Medycznej
  • Panorama Medi Clinic
  • Louis Leipoldt Gastroenterology Centre, Louis Leipoldt Medical Centre
  • GastroEnterology Unit, Groote Schuur Hospital
  • Quatro Clinical Trial Institute
  • 427 Ontdekkers Road, Florida Park
  • Medicinkliniken, SU/Östra sjukhuset
  • Universitetssjukhuset
  • Medicinmottagningen, Södersjukhuset
  • Sophiahemmet
  • Centre for Gastroenterology Royal Free Hospital
  • Dept of Gastroenterology, John Radcliffe Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

Blinded study arm

Blinded study arm

Blinded study arm

Blinded study arm

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 21, 2006
Last Updated
August 24, 2023
Sponsor
ChemoCentryx
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1. Study Identification

Unique Protocol Identification Number
NCT00306215
Brief Title
A Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ChemoCentryx

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
double-blind, placebo-controlled, multicenter, efficacy, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
436 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Blinded study arm
Arm Title
2
Arm Type
Experimental
Arm Description
Blinded study arm
Arm Title
3
Arm Type
Experimental
Arm Description
Blinded study arm
Arm Title
4
Arm Type
Experimental
Arm Description
Blinded study arm
Intervention Type
Drug
Intervention Name(s)
CCX282-B
Intervention Description
CCX282-B or placebo capsules
Primary Outcome Measure Information:
Title
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
Time Frame
Day 57
Secondary Outcome Measure Information:
Title
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
Time Frame
Day 57

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: moderate to severe Crohn's Disease CDAI 250-450 CRP >7.5 signed written informed consent 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Bankstown - Lidcombe Hospital
City
Bankstown
State/Province
New South Wales
ZIP/Postal Code
2200
Country
Australia
Facility Name
Royal Brisbane and Womens Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Launceston General Hospital
City
Launceston
State/Province
Tasmania
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
St Vincents Hospital
City
Fitzroy
State/Province
Victoria
Country
Australia
Facility Name
Bayside Gastroenterology
City
Frankston
State/Province
Victoria
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
The Alfred Hospital
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Fremantle Hospital
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Universitätsklinik für Innere Medizin
City
Innsbruck
Country
Austria
Facility Name
A.ö. Krankenhaus der Elisabethinen Linz
City
Linz
Country
Austria
Facility Name
Landesklinikum St. Poelten
City
Poelten
Country
Austria
Facility Name
Krankenanstalt Rudolfstiftung
City
Wien
Country
Austria
Facility Name
Universitätsklinik für Innere Medizin III
City
Wien
Country
Austria
Facility Name
UZ Gent
City
Gent
Country
Belgium
Facility Name
UZ Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
Unigastro
City
Campinas
ZIP/Postal Code
13070-040
Country
Brazil
Facility Name
Centro Petropolitano de Reumatologia e Fisioterapia
City
Centro Petrópolis
ZIP/Postal Code
25620-040
Country
Brazil
Facility Name
Hospital das Clínicas de Curitiba UFPR
City
Curitiba
ZIP/Postal Code
80060-900
Country
Brazil
Facility Name
Instituto Goiano de Gastro
City
Goiania
ZIP/Postal Code
74535-170
Country
Brazil
Facility Name
Hospital Geral de Goiânia
City
Goiânia
ZIP/Postal Code
74043-110
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Hospital São Lucas PUC-RS
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Hospital Universitário Clementino Fraga Filho
City
Rio de Janeiro
ZIP/Postal Code
21941-590
Country
Brazil
Facility Name
Santo André Diagnósticos e tratamentoLtda.
City
Santo André
ZIP/Postal Code
09090-780
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericórdia de Santos
City
Santos
ZIP/Postal Code
11075-900
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericórdia de São Paulo
City
Sao Paulo
ZIP/Postal Code
01221-020
Country
Brazil
Facility Name
Hospital das Clínicas de São Paulo
City
São Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Hospital Israelita Albert Einstein
City
São Paulo
ZIP/Postal Code
05651-901
Country
Brazil
Facility Name
4 MHAT, 38 "Makedonia" 1000
City
Sofia
Country
Bulgaria
Facility Name
Military Medical Academy
City
Sofia
Country
Bulgaria
Facility Name
UMHAT "Alexandrovska"
City
Sofia
Country
Bulgaria
Facility Name
UMHAT Queen Joanna
City
Sofia
Country
Bulgaria
Facility Name
UMHAT" St. Ivan Rilsky"
City
Sofia
Country
Bulgaria
Facility Name
V City Hospital
City
Sofia
Country
Bulgaria
Facility Name
UMHAT "St. Marina"
City
Varna
Country
Bulgaria
Facility Name
Health Science Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
Lair Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1H1
Country
Canada
Facility Name
DHC Research
City
Richmond Hill
State/Province
Ontario
Country
Canada
Facility Name
Mt. Sinai Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Centre Hospitalier--Hotel-Dieu de Levis
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
CHAUQ-Hopital St-Sacrement
City
Quebec
Country
Canada
Facility Name
Hepato-Gastroenterologie, Edvarda Benese 1549
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
II.Interni klinika, Endoskopie
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
General University Hospital Prague
City
Prague
Country
Czechia
Facility Name
Medic Kral ltd.
City
Prague
Country
Czechia
Facility Name
Fakultni nemocnice
City
Praha
ZIP/Postal Code
100 10
Country
Czechia
Facility Name
Klinika hepatogastroenterologieIKEM
City
Praha
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
Regional Hospital Pribram
City
Pribram
Country
Czechia
Facility Name
Regional Hospital Tabor
City
Tabor
Country
Czechia
Facility Name
Private Gastroenterology Centre
City
České Budejovice
Country
Czechia
Facility Name
Medical Department V Århus University Hospital
City
Arhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Herlev Hospital Gastroenterologisk department
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Hvidovre Hospital
City
Hvidovre
Country
Denmark
Facility Name
Medical department S Odense University hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
CHU Amiens - Hôpital Nord
City
Amiens
Country
France
Facility Name
Service d'Hépato-Gastroentérologie et de Nutrition Clinique
City
Nice
Country
France
Facility Name
Hopital du Haut-Lévêque
City
Pessac
Country
France
Facility Name
Hôpital Charles Nicolle
City
Rouen
Country
France
Facility Name
Service de Gastro-Enterologie et Nutrition
City
Toulouse
Country
France
Facility Name
Charité Campus Mitte, Universitätsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
Medizinische Klinik m.S. Hepatologie, Gastroenterologie, Endokrinologie und Stoffwechsel
City
Berlin
Country
Germany
Facility Name
Fachärztin für Innere Medizin
City
Hamburg
Country
Germany
Facility Name
Klinikum der Christian-Albrechts-Universität zu Kiel
City
Kiel
Country
Germany
Facility Name
Universitätsklinikum Magdeburg A.ö.R
City
Magdeburg
Country
Germany
Facility Name
Gastroenterologische Praxis am Germania-Campus
City
Münster
Country
Germany
Facility Name
Klinikum der Universität Regensburg
City
Regensburg
Country
Germany
Facility Name
Réthy Pál Kórház
City
Bekescsaba
Country
Hungary
Facility Name
Fővárosi Önkormányzat Bajcsy-Zsilinszky Kórház
City
Budapest
Country
Hungary
Facility Name
Debreceni Egyetem OEC
City
Debrecen
Country
Hungary
Facility Name
Vaszary Kolos Kórház
City
Esztergom
Country
Hungary
Facility Name
Petz Aladár Megyei Oktató Kórház
City
Győr
Country
Hungary
Facility Name
BAZ Megyei Kórház
City
Miskolc
Country
Hungary
Facility Name
Soroka Medical Center
City
Beer-Sheva
Country
Israel
Facility Name
Bnai Zion MC
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Rambam Medical Center,
City
Haifa
Country
Israel
Facility Name
Hadassah Ein-Karem Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Meir Hospital
City
Kfar-Saba
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Kaplan Medical Center
City
Rechovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
The Tel-Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Trzifin
Country
Israel
Facility Name
Ringweg Randenbroek 110
City
Amersfoort
Country
Netherlands
Facility Name
Ikazia Ziekenhuis
City
Rotterdam
ZIP/Postal Code
3083AN
Country
Netherlands
Facility Name
Isala Klinieken Locatie Sophia Afd. Interne Geneeskunde
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
ZOZ MSWiA Oddział Chorób Wewnętrznych
City
Bialystok
Country
Poland
Facility Name
10 Wojskowy Szpital Klinicznym, Oddzial Kliniczny Gasteroenterologii
City
Bydgoszcz
Country
Poland
Facility Name
SPZOZ Wojewodzki Szpital
City
Bydgoszcz
Country
Poland
Facility Name
Klinika Chorob Wewnetrznych I Gastroenterologii
City
Krakow
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 4
City
Lublin
Country
Poland
Facility Name
SPZOZ Szpital Wojewódzki w Opolu
City
Opole
Country
Poland
Facility Name
SOPMED Niepubliczny Zakład Opieki Zdrowotnej
City
Sopot
Country
Poland
Facility Name
Klinika Gastroenterologii i Chorób Wewnętrznych Samodzielny Publiczny Szpital Kliniczny nr 1 im. T. Sokołowskiego Pomorskiej Akademii Medycznej ul.Unii Lubelskiej 1
City
Szczecin
ZIP/Postal Code
71-252
Country
Poland
Facility Name
Wojskowy Insytutu Medyczny
City
Warsaw
Country
Poland
Facility Name
NZOZ Vivamed Zespół Lekarzy Specjalistów ul. Trocka 10A
City
Warszawa
ZIP/Postal Code
03-563
Country
Poland
Facility Name
CSK MSWiA, Klinika Gastroenterologii
City
Warszawa
Country
Poland
Facility Name
Klinika Gastroenterologii i Hepatologii, Akademii Medycznej
City
Wroclaw
Country
Poland
Facility Name
Panorama Medi Clinic
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Louis Leipoldt Gastroenterology Centre, Louis Leipoldt Medical Centre
City
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
GastroEnterology Unit, Groote Schuur Hospital
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Quatro Clinical Trial Institute
City
Cape Town
Country
South Africa
Facility Name
427 Ontdekkers Road, Florida Park
City
Johannesburg
Country
South Africa
Facility Name
Medicinkliniken, SU/Östra sjukhuset
City
Göteborg
Country
Sweden
Facility Name
Universitetssjukhuset
City
Lund
Country
Sweden
Facility Name
Medicinmottagningen, Södersjukhuset
City
Stockholm
Country
Sweden
Facility Name
Sophiahemmet
City
Stockholm
Country
Sweden
Facility Name
Centre for Gastroenterology Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2PF
Country
United Kingdom
Facility Name
Dept of Gastroenterology, John Radcliffe Hospital
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23527300
Citation
Keshav S, Vanasek T, Niv Y, Petryka R, Howaldt S, Bafutto M, Racz I, Hetzel D, Nielsen OH, Vermeire S, Reinisch W, Karlen P, Schreiber S, Schall TJ, Bekker P; Prospective Randomized Oral-Therapy Evaluation in Crohn's Disease Trial-1 PROTECT-1 Study Group. 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. Epub 2013 Mar 20.
Results Reference
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Learn more about this trial

A Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease

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