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

August 24, 2023 updated by: ChemoCentryx

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

436

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Bankstown, New South Wales, Australia, 2200
        • Bankstown - Lidcombe Hospital
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Womens Hospital
    • South Australia
      • Adelaide, South Australia, Australia
        • Royal Adelaide Hospital
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
    • Tasmania
      • Launceston, Tasmania, Australia
        • Launceston General Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Fitzroy, Victoria, Australia
        • St Vincents Hospital
      • Frankston, Victoria, Australia
        • Bayside Gastroenterology
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
      • Prahran, Victoria, Australia, 3181
        • The Alfred Hospital
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Hospital
  • Austria
      • Innsbruck, Austria
        • Universitätsklinik für Innere Medizin
      • Linz, Austria
        • A.ö. Krankenhaus der Elisabethinen Linz
      • Poelten, Austria
        • Landesklinikum St. Poelten
      • Wien, Austria
        • Krankenanstalt Rudolfstiftung
      • Wien, Austria
        • Universitätsklinik für Innere Medizin III
  • Belgium
      • Gent, Belgium
        • UZ Gent
      • Leuven, Belgium
        • UZ Gasthuisberg
  • Brazil
      • Campinas, Brazil, 13070-040
        • Unigastro
      • Centro Petrópolis, Brazil, 25620-040
        • Centro Petropolitano de Reumatologia e Fisioterapia
      • Curitiba, Brazil, 80060-900
        • Hospital das Clínicas de Curitiba UFPR
      • Goiania, Brazil, 74535-170
        • Instituto Goiano de Gastro
      • Goiânia, Brazil, 74043-110
        • Hospital Geral de Goiânia
      • Porto Alegre, Brazil, 90035-003
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre, Brazil, 90610-000
        • Hospital São Lucas PUC-RS
      • Rio de Janeiro, Brazil, 21941-590
        • Hospital Universitario Clementino Fraga Filho
      • Santo André, Brazil, 09090-780
        • Santo André Diagnósticos e tratamentoLtda.
      • Santos, Brazil, 11075-900
        • Irmandade da Santa Casa de Misericórdia de Santos
      • Sao Paulo, Brazil, 01221-020
        • Irmandade Da Santa Casa De Misericordia De Sao Paulo
      • São Paulo, Brazil, 05651-901
        • Hospital Israelita Albert Einstein
      • São Paulo, Brazil, 01246-000
        • Hospital das Clínicas de São Paulo
  • Bulgaria
      • Sofia, Bulgaria
        • Military Medical Academy
      • Sofia, Bulgaria
        • 4 MHAT, 38 "Makedonia" 1000
      • Sofia, Bulgaria
        • UMHAT "Alexandrovska"
      • Sofia, Bulgaria
        • UMHAT Queen Joanna
      • Sofia, Bulgaria
        • UMHAT" St. Ivan Rilsky"
      • Sofia, Bulgaria
        • V City Hospital
      • Varna, Bulgaria
        • UMHAT "St. Marina"
  • Canada
      • Quebec, Canada
        • CHAUQ-Hopital St-Sacrement
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Health Science Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1H1
        • Lair Centre
    • Ontario
      • Richmond Hill, Ontario, Canada
        • DHC Research
      • Toronto, Ontario, Canada
        • Mt. Sinai Hospital
    • Quebec
      • Levis, Quebec, Canada, G6V 3Z1
        • Centre Hospitalier--Hotel-Dieu de Levis
      • Montreal, Quebec, Canada
        • Jewish General Hospital
      • Montreal, Quebec, Canada
        • Hôpital Maisonneuve-Rosemont
  • Czechia
      • Hradec Kralove, Czechia, 500 12
        • Hepato-Gastroenterologie, Edvarda Benese 1549
      • Olomouc, Czechia, 775 20
        • II.Interni klinika, Endoskopie
      • Prague, Czechia
        • General University Hospital Prague
      • Prague, Czechia
        • Medic Kral ltd.
      • Praha, Czechia, 100 10
        • Fakultní nemocnice
      • Praha, Czechia, 140 21
        • Klinika hepatogastroenterologieIKEM
      • Pribram, Czechia
        • Regional Hospital Pribram
      • Tabor, Czechia
        • Regional Hospital Tabor
      • České Budejovice, Czechia
        • Private Gastroenterology Centre
  • Denmark
      • Arhus C, Denmark, 8000
        • Medical Department V Århus University Hospital
      • Herlev, Denmark, 2730
        • Herlev Hospital Gastroenterologisk department
      • Hvidovre, Denmark
        • Hvidovre Hospital
      • Odense, Denmark, 5000
        • Medical department S Odense University hospital
  • France
      • Amiens, France
        • CHU Amiens - Hopital Nord
      • Nice, France
        • Service d'Hépato-Gastroentérologie et de Nutrition Clinique
      • Pessac, France
        • Hopital Du Haut-Leveque
      • Rouen, France
        • Hopital Charles Nicolle
      • Toulouse, France
        • Service de Gastro-Enterologie et Nutrition
  • Germany
      • Berlin, Germany
        • Charité Campus Mitte, Universitätsmedizin Berlin
      • Berlin, Germany
        • Medizinische Klinik m.S. Hepatologie, Gastroenterologie, Endokrinologie und Stoffwechsel
      • Hamburg, Germany
        • Fachärztin für Innere Medizin
      • Kiel, Germany
        • Klinikum der Christian-Albrechts-Universität zu Kiel
      • Magdeburg, Germany
        • Universitätsklinikum Magdeburg A.ö.R
      • Münster, Germany
        • Gastroenterologische Praxis am Germania-Campus
      • Regensburg, Germany
        • Klinikum der Universität Regensburg
  • Hungary
      • Bekescsaba, Hungary
        • Réthy Pál Kórház
      • Budapest, Hungary
        • Fővárosi Önkormányzat Bajcsy-Zsilinszky Kórház
      • Debrecen, Hungary
        • Debreceni Egyetem OEC
      • Esztergom, Hungary
        • Vaszary Kolos Kórház
      • Győr, Hungary
        • Petz Aladár Megyei Oktató Kórház
      • Miskolc, Hungary
        • BAZ Megyei Kórház
  • Israel
      • Beer-Sheva, Israel
        • Soroka Medical Center
      • Haifa, Israel, 31048
        • Bnai Zion Mc
      • Haifa, Israel
        • Rambam Medical Center,
      • Jerusalem, Israel, 91120
        • Hadassah Ein-Karem Medical Center
      • Kfar-Saba, Israel
        • Meir Hospital
      • Petach Tikva, Israel, 49100
        • Rabin Medical Center
      • Rechovot, Israel, 76100
        • Kaplan Medical Center
      • Tel Aviv, Israel, 64239
        • The Tel-Aviv Sourasky Medical Center
      • Trzifin, Israel
        • Assaf Harofeh Medical Center
  • Netherlands
      • Amersfoort, Netherlands
        • Ringweg Randenbroek 110
      • Rotterdam, Netherlands, 3083AN
        • Ikazia Ziekenhuis
      • Zwolle, Netherlands, 8025 AB
        • Isala Klinieken Locatie Sophia Afd. Interne Geneeskunde
  • Poland
      • Bialystok, Poland
        • ZOZ MSWiA Oddział Chorób Wewnętrznych
      • Bydgoszcz, Poland
        • 10 Wojskowy Szpital Klinicznym, Oddzial Kliniczny Gasteroenterologii
      • Bydgoszcz, Poland
        • SPZOZ Wojewodzki Szpital
      • Krakow, Poland
        • Klinika Chorob Wewnetrznych I Gastroenterologii
      • Lublin, Poland
        • Samodzielny Publiczny Szpital Kliniczny nr 4
      • Opole, Poland
        • SPZOZ Szpital Wojewódzki w Opolu
      • Sopot, Poland
        • SOPMED Niepubliczny Zakład Opieki Zdrowotnej
      • Szczecin, Poland, 71-252
        • Klinika Gastroenterologii i Chorób Wewnętrznych Samodzielny Publiczny Szpital Kliniczny nr 1 im. T. Sokołowskiego Pomorskiej Akademii Medycznej ul.Unii Lubelskiej 1
      • Warsaw, Poland
        • Wojskowy Insytutu Medyczny
      • Warszawa, Poland, 03-563
        • NZOZ Vivamed Zespół Lekarzy Specjalistów ul. Trocka 10A
      • Warszawa, Poland
        • CSK MSWiA, Klinika Gastroenterologii
      • Wroclaw, Poland
        • Klinika Gastroenterologii i Hepatologii, Akademii Medycznej
  • South Africa
      • Cape Town, South Africa, 7500
        • Panorama Medi Clinic
      • Cape Town, South Africa, 7530
        • Louis Leipoldt Gastroenterology Centre, Louis Leipoldt Medical Centre
      • Cape Town, South Africa, 7925
        • GastroEnterology Unit, Groote Schuur Hospital
      • Cape Town, South Africa
        • Quatro Clinical Trial Institute
      • Johannesburg, South Africa
        • 427 Ontdekkers Road, Florida Park
  • Sweden
      • Göteborg, Sweden
        • Medicinkliniken, SU/Östra sjukhuset
      • Lund, Sweden
        • Universitetssjukhuset
      • Stockholm, Sweden
        • Sophiahemmet
      • Stockholm, Sweden
        • Medicinmottagningen, Södersjukhuset
  • United Kingdom
      • London, United Kingdom, NW3 2PF
        • Centre for Gastroenterology Royal Free Hospital
      • Oxford, United Kingdom
        • Dept of Gastroenterology, John Radcliffe Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Blinded study arm
Drug: CCX282-B
CCX282-B or placebo capsules
Experimental: 2
Blinded study arm
Drug: CCX282-B
CCX282-B or placebo capsules
Experimental: 3
Blinded study arm
Drug: CCX282-B
CCX282-B or placebo capsules
Experimental: 4
Blinded study arm
Drug: CCX282-B
CCX282-B or placebo capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 57

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Day 57

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ChemoCentryx

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

March 21, 2006

First Submitted That Met QC Criteria

March 21, 2006

First Posted (Estimated)

March 23, 2006

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL004_282

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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