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

Last updated: March 4, 2025
Sponsor: Amgen
Overall Status: Completed

Phase

2

Condition

Ulcerative Colitis

Colic

Inflammatory Bowel Disease

Treatment

CCX282-B

Clinical Study ID

NCT00306215
CL004_282
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine whether CCX282-B is effective in treating patients with moderate to severe Crohn's Disease.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • moderate to severe Crohn's Disease

  • CDAI 250-450

  • CRP >7.5

  • signed written informed consent

Exclusion

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 ortotal 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

Total Participants: 436
Treatment Group(s): 1
Primary Treatment: CCX282-B
Phase: 2
Study Start date:
March 01, 2006
Estimated Completion Date:
June 30, 2009

Study Description

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Connect with a study center

  • Bankstown - Lidcombe Hospital

    Bankstown, New South Wales 2200
    Australia

    Site Not Available

  • Royal Brisbane and Womens Hospital

    Herston, Queensland 4029
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park, South Australia 5042
    Australia

    Site Not Available

  • Launceston General Hospital

    Launceston, Tasmania
    Australia

    Site Not Available

  • Box Hill Hospital

    Box Hill, Victoria 3128
    Australia

    Site Not Available

  • St Vincents Hospital

    Fitzroy, Victoria
    Australia

    Site Not Available

  • Bayside Gastroenterology

    Frankston, Victoria
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • The Alfred Hospital

    Prahran, Victoria 3181
    Australia

    Site Not Available

  • Fremantle Hospital

    Fremantle, Western Australia 6160
    Australia

    Site Not Available

  • Universitätsklinik für Innere Medizin

    Innsbruck,
    Austria

    Site Not Available

  • A.ö. Krankenhaus der Elisabethinen Linz

    Linz,
    Austria

    Site Not Available

  • Landesklinikum St. Poelten

    Poelten,
    Austria

    Site Not Available

  • Krankenanstalt Rudolfstiftung

    Wien,
    Austria

    Site Not Available

  • Universitätsklinik für Innere Medizin III

    Wien,
    Austria

    Site Not Available

  • UZ Gent

    Gent,
    Belgium

    Site Not Available

  • UZ Gasthuisberg

    Leuven,
    Belgium

    Site Not Available

  • Unigastro

    Campinas, 13070-040
    Brazil

    Site Not Available

  • Centro Petropolitano de Reumatologia e Fisioterapia

    Centro Petrópolis, 25620-040
    Brazil

    Site Not Available

  • Centro Petropolitano de Reumatologia e Fisioterapia

    Centro Petrópolis, 25620-040
    Brazil

    Site Not Available

  • Hospital das Clínicas de Curitiba UFPR

    Curitiba, 80060-900
    Brazil

    Site Not Available

  • Instituto Goiano de Gastro

    Goiania, 74535-170
    Brazil

    Site Not Available

  • Hospital Geral de Goiânia

    Goiânia, 74043-110
    Brazil

    Site Not Available

  • Hospital Geral de Goiânia

    Goiânia, 74043-110
    Brazil

    Site Not Available

  • Hospital São Lucas PUC-RS

    Porto Alegre, 90610-000
    Brazil

    Site Not Available

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, 90035-003
    Brazil

    Site Not Available

  • Hospital Universitário Clementino Fraga Filho

    Rio de Janeiro, 21941-590
    Brazil

    Site Not Available

  • Santo André Diagnósticos e tratamentoLtda.

    Santo André, 09090-780
    Brazil

    Site Not Available

  • Santo André Diagnósticos e tratamentoLtda.

    Santo André, 09090-780
    Brazil

    Site Not Available

  • Irmandade da Santa Casa de Misericórdia de Santos

    Santos, 11075-900
    Brazil

    Site Not Available

  • Irmandade da Santa Casa de Misericórdia de São Paulo

    Sao Paulo, 01221-020
    Brazil

    Site Not Available

  • Hospital Israelita Albert Einstein

    São Paulo, 05651-901
    Brazil

    Site Not Available

  • Hospital Israelita Albert Einstein

    São Paulo, 05651-901
    Brazil

    Site Not Available

  • Hospital das Clínicas de São Paulo

    São Paulo, 01246-000
    Brazil

    Site Not Available

  • 4 MHAT, 38 "Makedonia" 1000

    Sofia,
    Bulgaria

    Site Not Available

  • Military Medical Academy

    Sofia,
    Bulgaria

    Site Not Available

  • UMHAT "Alexandrovska"

    Sofia,
    Bulgaria

    Site Not Available

  • UMHAT Queen Joanna

    Sofia,
    Bulgaria

    Site Not Available

  • UMHAT" St. Ivan Rilsky"

    Sofia,
    Bulgaria

    Site Not Available

  • V City Hospital

    Sofia,
    Bulgaria

    Site Not Available

  • UMHAT "St. Marina"

    Varna,
    Bulgaria

    Site Not Available

  • Health Science Centre

    Calgary, Alberta T2N 4N1
    Canada

    Site Not Available

  • Lair Centre

    Vancouver, British Columbia V5Z 1H1
    Canada

    Site Not Available

  • DHC Research

    Richmond Hill, Ontario
    Canada

    Site Not Available

  • Mt. Sinai Hospital

    Toronto, Ontario
    Canada

    Site Not Available

  • Centre Hospitalier--Hotel-Dieu de Levis

    Levis, Quebec G6V 3Z1
    Canada

    Site Not Available

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec
    Canada

    Site Not Available

  • Jewish General Hospital

    Montreal, Quebec
    Canada

    Site Not Available

  • CHAUQ-Hopital St-Sacrement

    Quebec,
    Canada

    Site Not Available

  • Hepato-Gastroenterologie, Edvarda Benese 1549

    Hradec Kralove, 500 12
    Czech Republic

    Site Not Available

  • II.Interni klinika, Endoskopie

    Olomouc, 775 20
    Czech Republic

    Site Not Available

  • General University Hospital Prague

    Prague,
    Czech Republic

    Site Not Available

  • Medic Kral ltd.

    Prague,
    Czech Republic

    Site Not Available

  • Fakultni nemocnice

    Praha, 100 10
    Czech Republic

    Site Not Available

  • Klinika hepatogastroenterologieIKEM

    Praha, 140 21
    Czech Republic

    Site Not Available

  • Regional Hospital Pribram

    Pribram,
    Czech Republic

    Site Not Available

  • Regional Hospital Tabor

    Tabor,
    Czech Republic

    Site Not Available

  • Private Gastroenterology Centre

    České Budejovice,
    Czech Republic

    Site Not Available

  • Private Gastroenterology Centre

    České Budejovice,
    Czech Republic

    Site Not Available

  • Hepato-Gastroenterologie, Edvarda Benese 1549

    Hradec Kralove, 500 12
    Czechia

    Site Not Available

  • II.Interni klinika, Endoskopie

    Olomouc, 775 20
    Czechia

    Site Not Available

  • General University Hospital Prague

    Prague,
    Czechia

    Site Not Available

  • Medic Kral ltd.

    Prague,
    Czechia

    Site Not Available

  • Fakultni nemocnice

    Praha, 100 10
    Czechia

    Site Not Available

  • Klinika hepatogastroenterologieIKEM

    Praha, 140 21
    Czechia

    Site Not Available

  • Regional Hospital Pribram

    Pribram,
    Czechia

    Site Not Available

  • Regional Hospital Tabor

    Tabor,
    Czechia

    Site Not Available

  • Private Gastroenterology Centre

    České Budejovice,
    Czechia

    Site Not Available

  • Medical Department V Århus University Hospital

    Arhus C, 8000
    Denmark

    Site Not Available

  • Herlev Hospital Gastroenterologisk department

    Herlev, 2730
    Denmark

    Site Not Available

  • Hvidovre Hospital

    Hvidovre,
    Denmark

    Site Not Available

  • Medical department S Odense University hospital

    Odense, 5000
    Denmark

    Site Not Available

  • CHU Amiens - Hôpital Nord

    Amiens,
    France

    Site Not Available

  • Service d'Hépato-Gastroentérologie et de Nutrition Clinique

    Nice,
    France

    Site Not Available

  • Hopital du Haut-Lévêque

    Pessac,
    France

    Site Not Available

  • Hôpital Charles Nicolle

    Rouen,
    France

    Site Not Available

  • Service de Gastro-Enterologie et Nutrition

    Toulouse,
    France

    Site Not Available

  • Charité Campus Mitte, Universitätsmedizin Berlin

    Berlin,
    Germany

    Site Not Available

  • Medizinische Klinik m.S. Hepatologie, Gastroenterologie, Endokrinologie und Stoffwechsel

    Berlin,
    Germany

    Site Not Available

  • Fachärztin für Innere Medizin

    Hamburg,
    Germany

    Site Not Available

  • Klinikum der Christian-Albrechts-Universität zu Kiel

    Kiel,
    Germany

    Site Not Available

  • Universitätsklinikum Magdeburg A.ö.R

    Magdeburg,
    Germany

    Site Not Available

  • Gastroenterologische Praxis am Germania-Campus

    Münster,
    Germany

    Site Not Available

  • Gastroenterologische Praxis am Germania-Campus

    Münster,
    Germany

    Site Not Available

  • Klinikum der Universität Regensburg

    Regensburg,
    Germany

    Site Not Available

  • Réthy Pál Kórház

    Bekescsaba,
    Hungary

    Site Not Available

  • Fővárosi Önkormányzat Bajcsy-Zsilinszky Kórház

    Budapest,
    Hungary

    Site Not Available

  • Debreceni Egyetem OEC

    Debrecen,
    Hungary

    Site Not Available

  • Vaszary Kolos Kórház

    Esztergom,
    Hungary

    Site Not Available

  • Petz Aladár Megyei Oktató Kórház

    Győr,
    Hungary

    Site Not Available

  • Petz Aladár Megyei Oktató Kórház

    Győr,
    Hungary

    Site Not Available

  • BAZ Megyei Kórház

    Miskolc,
    Hungary

    Site Not Available

  • Soroka Medical Center

    Beer-Sheva,
    Israel

    Site Not Available

  • Bnai Zion MC

    Haifa, 31048
    Israel

    Site Not Available

  • Rambam Medical Center,

    Haifa,
    Israel

    Site Not Available

  • Hadassah Ein-Karem Medical Center

    Jerusalem, 91120
    Israel

    Site Not Available

  • Meir Hospital

    Kfar-Saba,
    Israel

    Site Not Available

  • Rabin Medical Center

    Petach Tikva, 49100
    Israel

    Site Not Available

  • Kaplan Medical Center

    Rechovot, 76100
    Israel

    Site Not Available

  • The Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Assaf Harofeh Medical Center

    Trzifin,
    Israel

    Site Not Available

  • Ringweg Randenbroek 110

    Amersfoort,
    Netherlands

    Site Not Available

  • Ikazia Ziekenhuis

    Rotterdam, 3083AN
    Netherlands

    Site Not Available

  • Isala Klinieken Locatie Sophia Afd. Interne Geneeskunde

    Zwolle, 8025 AB
    Netherlands

    Site Not Available

  • ZOZ MSWiA Oddział Chorób Wewnętrznych

    Bialystok,
    Poland

    Site Not Available

  • 10 Wojskowy Szpital Klinicznym, Oddzial Kliniczny Gasteroenterologii

    Bydgoszcz,
    Poland

    Site Not Available

  • SPZOZ Wojewodzki Szpital

    Bydgoszcz,
    Poland

    Site Not Available

  • Klinika Chorob Wewnetrznych I Gastroenterologii

    Krakow,
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny Nr 4

    Lublin,
    Poland

    Site Not Available

  • SPZOZ Szpital Wojewódzki w Opolu

    Opole,
    Poland

    Site Not Available

  • SOPMED Niepubliczny Zakład Opieki Zdrowotnej

    Sopot,
    Poland

    Site Not Available

  • Klinika Gastroenterologii i Chorób Wewnętrznych Samodzielny Publiczny Szpital Kliniczny nr 1 im. T. Sokołowskiego Pomorskiej Akademii Medycznej ul.Unii Lubelskiej 1

    Szczecin, 71-252
    Poland

    Site Not Available

  • Wojskowy Insytutu Medyczny

    Warsaw,
    Poland

    Site Not Available

  • CSK MSWiA, Klinika Gastroenterologii

    Warszawa,
    Poland

    Site Not Available

  • NZOZ Vivamed Zespół Lekarzy Specjalistów ul. Trocka 10A

    Warszawa, 03-563
    Poland

    Site Not Available

  • Klinika Gastroenterologii i Hepatologii, Akademii Medycznej

    Wroclaw,
    Poland

    Site Not Available

  • GastroEnterology Unit, Groote Schuur Hospital

    Cape Town, 7925
    South Africa

    Site Not Available

  • Louis Leipoldt Gastroenterology Centre, Louis Leipoldt Medical Centre

    Cape Town, 7530
    South Africa

    Site Not Available

  • Panorama Medi Clinic

    Cape Town, 7500
    South Africa

    Site Not Available

  • Quatro Clinical Trial Institute

    Cape Town,
    South Africa

    Site Not Available

  • 427 Ontdekkers Road, Florida Park

    Johannesburg,
    South Africa

    Site Not Available

  • Medicinkliniken, SU/Östra sjukhuset

    Göteborg,
    Sweden

    Site Not Available

  • Medicinkliniken, SU/Östra sjukhuset

    Göteborg,
    Sweden

    Site Not Available

  • Universitetssjukhuset

    Lund,
    Sweden

    Site Not Available

  • Medicinmottagningen, Södersjukhuset

    Stockholm,
    Sweden

    Site Not Available

  • Sophiahemmet

    Stockholm,
    Sweden

    Site Not Available

  • Centre for Gastroenterology Royal Free Hospital

    London, NW3 2PF
    United Kingdom

    Site Not Available

  • Dept of Gastroenterology, John Radcliffe Hospital

    Oxford,
    United Kingdom

    Site Not Available

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