A Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease
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
1 other identifier
interventional
436
16 countries
101
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2006
Typical duration for phase_2
101 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 21, 2006
CompletedFirst Posted
Study publicly available on registry
March 23, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedMarch 6, 2025
March 1, 2025
2.4 years
March 21, 2006
March 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Day 57
Secondary Outcomes (1)
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
Day 57
Study Arms (4)
1
EXPERIMENTALBlinded study arm
2
EXPERIMENTALBlinded study arm
3
EXPERIMENTALBlinded study arm
4
EXPERIMENTALBlinded study arm
Interventions
Eligibility Criteria
You may qualify if:
- moderate to severe Crohn's Disease
- CDAI 250-450
- CRP \>7.5
- signed written informed consent
You may not qualify if:
- \> 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (112)
Bankstown - Lidcombe Hospital
Bankstown, New South Wales, 2200, Australia
Royal Brisbane and Womens Hospital
Herston, Queensland, 4029, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Launceston General Hospital
Launceston, Tasmania, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
St Vincents Hospital
Fitzroy, Victoria, Australia
Bayside Gastroenterology
Frankston, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
The Alfred Hospital
Prahran, Victoria, 3181, Australia
Fremantle Hospital
Fremantle, Western Australia, 6160, Australia
Universitätsklinik für Innere Medizin
Innsbruck, Austria
A.ö. Krankenhaus der Elisabethinen Linz
Linz, Austria
Landesklinikum St. Poelten
Pölten, Austria
Krankenanstalt Rudolfstiftung
Vienna, Austria
Universitätsklinik für Innere Medizin III
Vienna, Austria
UZ Gent
Ghent, Belgium
UZ Gasthuisberg
Leuven, Belgium
Unigastro
Campinas, 13070-040, Brazil
Centro Petropolitano de Reumatologia e Fisioterapia
Centro Petrópolis, 25620-040, Brazil
Hospital das Clínicas de Curitiba UFPR
Curitiba, 80060-900, Brazil
Hospital Geral de Goiânia
Goiânia, 74043-110, Brazil
Instituto Goiano de Gastro
Goiânia, 74535-170, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, 90035-003, Brazil
Hospital São Lucas PUC-RS
Porto Alegre, 90610-000, Brazil
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, 21941-590, Brazil
Santo André Diagnósticos e tratamentoLtda.
Santo André, 09090-780, Brazil
Irmandade da Santa Casa de Misericórdia de Santos
Santos, 11075-900, Brazil
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, 01221-020, Brazil
Hospital das Clínicas de São Paulo
São Paulo, 01246-000, Brazil
Hospital Israelita Albert Einstein
São Paulo, 05651-901, Brazil
4 MHAT, 38 "Makedonia" 1000
Sofia, Bulgaria
Military Medical Academy
Sofia, Bulgaria
UMHAT "Alexandrovska"
Sofia, Bulgaria
UMHAT Queen Joanna
Sofia, Bulgaria
UMHAT" St. Ivan Rilsky"
Sofia, Bulgaria
V City Hospital
Sofia, Bulgaria
UMHAT "St. Marina"
Varna, Bulgaria
Health Science Centre
Calgary, Alberta, T2N 4N1, Canada
Lair Centre
Vancouver, British Columbia, V5Z 1H1, Canada
DHC Research
Richmond Hill, Ontario, Canada
Mt. Sinai Hospital
Toronto, Ontario, Canada
Centre Hospitalier--Hotel-Dieu de Levis
Lévis, Quebec, G6V 3Z1, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
CHAUQ-Hopital St-Sacrement
Québec, Quebec, Canada
Private Gastroenterology Centre
České Budejovice, Czechia
Hepato-Gastroenterologie, Edvarda Benese 1549
Hradec Králové, 500 12, Czechia
II.Interni klinika, Endoskopie
Olomouc, 775 20, Czechia
Fakultni nemocnice
Prague, 100 10, Czechia
Klinika hepatogastroenterologieIKEM
Prague, 140 21, Czechia
General University Hospital Prague
Prague, Czechia
Medic Kral ltd.
Prague, Czechia
Regional Hospital Pribram
Příbram, Czechia
Regional Hospital Tabor
Tábor, Czechia
Medical Department V Århus University Hospital
Arhus C, 8000, Denmark
Herlev Hospital Gastroenterologisk department
Herlev, 2730, Denmark
Hvidovre Hospital
Hvidovre, Denmark
Medical department S Odense University hospital
Odense, 5000, Denmark
CHU Amiens - Hôpital Nord
Amiens, France
Service d'Hépato-Gastroentérologie et de Nutrition Clinique
Nice, France
Hopital du Haut-Lévêque
Pessac, France
Hôpital Charles Nicolle
Rouen, France
Service de Gastro-Enterologie et Nutrition
Toulouse, France
Charité Campus Mitte, Universitätsmedizin Berlin
Berlin, Germany
Medizinische Klinik m.S. Hepatologie, Gastroenterologie, Endokrinologie und Stoffwechsel
Berlin, Germany
Fachärztin für Innere Medizin
Hamburg, Germany
Klinikum der Christian-Albrechts-Universität zu Kiel
Kiel, Germany
Universitätsklinikum Magdeburg A.ö.R
Magdeburg, Germany
Gastroenterologische Praxis am Germania-Campus
Münster, Germany
Klinikum der Universität Regensburg
Regensburg, Germany
Réthy Pál Kórház
Békéscsaba, Hungary
Fővárosi Önkormányzat Bajcsy-Zsilinszky Kórház
Budapest, Hungary
Debreceni Egyetem OEC
Debrecen, Hungary
Vaszary Kolos Kórház
Esztergom, Hungary
Petz Aladár Megyei Oktató Kórház
Győr, Hungary
BAZ Megyei Kórház
Miskolc, Hungary
Soroka Medical Center
Beersheba, Israel
Bnai Zion MC
Haifa, 31048, Israel
Rambam Medical Center,
Haifa, Israel
Hadassah Ein-Karem Medical Center
Jerusalem, 91120, Israel
Meir Hospital
Kfar Saba, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Kaplan Medical Center
Rehovot, 76100, Israel
The Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Assaf Harofeh Medical Center
Trzifin, Israel
Ringweg Randenbroek 110
Amersfoort, Netherlands
Ikazia Ziekenhuis
Rotterdam, 3083AN, Netherlands
Isala Klinieken Locatie Sophia Afd. Interne Geneeskunde
Zwolle, 8025 AB, Netherlands
ZOZ MSWiA Oddział Chorób Wewnętrznych
Bialystok, Poland
10 Wojskowy Szpital Klinicznym, Oddzial Kliniczny Gasteroenterologii
Bydgoszcz, Poland
SPZOZ Wojewodzki Szpital
Bydgoszcz, Poland
Klinika Chorob Wewnetrznych I Gastroenterologii
Krakow, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 4
Lublin, Poland
SPZOZ Szpital Wojewódzki w Opolu
Opole, Poland
SOPMED Niepubliczny Zakład Opieki Zdrowotnej
Sopot, Poland
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
NZOZ Vivamed Zespół Lekarzy Specjalistów ul. Trocka 10A
Warsaw, 03-563, Poland
CSK MSWiA, Klinika Gastroenterologii
Warsaw, Poland
Wojskowy Insytutu Medyczny
Warsaw, Poland
Klinika Gastroenterologii i Hepatologii, Akademii Medycznej
Wroclaw, Poland
Panorama Medi Clinic
Cape Town, 7500, South Africa
Louis Leipoldt Gastroenterology Centre, Louis Leipoldt Medical Centre
Cape Town, 7530, South Africa
GastroEnterology Unit, Groote Schuur Hospital
Cape Town, 7925, South Africa
Quatro Clinical Trial Institute
Cape Town, South Africa
427 Ontdekkers Road, Florida Park
Johannesburg, South Africa
Medicinkliniken, SU/Östra sjukhuset
Gothenburg, Sweden
Universitetssjukhuset
Lund, Sweden
Medicinmottagningen, Södersjukhuset
Stockholm, Sweden
Sophiahemmet
Stockholm, Sweden
Centre for Gastroenterology Royal Free Hospital
London, NW3 2PF, United Kingdom
Dept of Gastroenterology, John Radcliffe Hospital
Oxford, United Kingdom
Related Publications (1)
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.
PMID: 23527300DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2006
First Posted
March 23, 2006
Study Start
March 1, 2006
Primary Completion
August 1, 2008
Study Completion
June 1, 2009
Last Updated
March 6, 2025
Record last verified: 2025-03