Crohn's DiseasePhase 2NCT00306215
A Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease
A Phase 2 study testing CCX282-B in people with Crohn's Disease, run by Amgen at 112 sites in 17 countries.
Trial summary
The purpose of this study is to determine whether CCX282-B is effective in treating patients with moderate to severe Crohn's Disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- CCX282-B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 436 participants
- Where
- 112 sitesin 17 countries
- Study dates
- Mar 2006to Jun 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- moderate to severe Crohn's Disease
- CDAI 250-450
- CRP >7.5
- signed written informed consent
Who cannot join
- > 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
Trial locations and contacts
112 sites in 17 countries.
112 sites in 17 countries
Brazil13 sites
Unigastro
Campinas, 13070-040
Centro Petropolitano de Reumatologia e Fisioterapia
Centro Petrópolis, 25620-040
Hospital das Clínicas de Curitiba UFPR
Curitiba, 80060-900
Hospital Geral de Goiânia
Goiânia, 74043-110
Instituto Goiano de Gastro
Goiânia, 74535-170
Hospital de Clínicas de Porto Alegre
Porto Alegre, 90035-003
Hospital São Lucas PUC-RS
Porto Alegre, 90610-000
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, 21941-590
Santo André Diagnósticos e tratamentoLtda.
Santo André, 09090-780
Irmandade da Santa Casa de Misericórdia de Santos
Santos, 11075-900
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, 01221-020
Hospital das Clínicas de São Paulo
São Paulo, 01246-000
Hospital Israelita Albert Einstein
São Paulo, 05651-901
Poland12 sites
ZOZ MSWiA Oddział Chorób Wewnętrznych
Bialystok
10 Wojskowy Szpital Klinicznym, Oddzial Kliniczny Gasteroenterologii
Bydgoszcz
SPZOZ Wojewodzki Szpital
Bydgoszcz
Klinika Chorob Wewnetrznych I Gastroenterologii
Krakow
Samodzielny Publiczny Szpital Kliniczny Nr 4
Lublin
SPZOZ Szpital Wojewódzki w Opolu
Opole
SOPMED Niepubliczny Zakład Opieki Zdrowotnej
Sopot
Klinika Gastroenterologii i Chorób Wewnętrznych Samodzielny Publiczny Szpital Kliniczny nr 1 im. T. Sokołowskiego Pomorskiej Akademii Medycznej ul.Unii Lubelskiej 1
Szczecin, 71-252
NZOZ Vivamed Zespół Lekarzy Specjalistów ul. Trocka 10A
Warsaw, 03-563
CSK MSWiA, Klinika Gastroenterologii
Warsaw
Wojskowy Insytutu Medyczny
Warsaw
Klinika Gastroenterologii i Hepatologii, Akademii Medycznej
Wroclaw
Australia11 sites
Royal Adelaide Hospital
Adelaide, South Australia
Bankstown - Lidcombe Hospital
Bankstown, New South Wales, 2200
Flinders Medical Centre
Bedford Park, South Australia, 5042
Box Hill Hospital
Box Hill, Victoria, 3128
St Vincents Hospital
Fitzroy, Victoria
Bayside Gastroenterology
Frankston, Victoria
Fremantle Hospital
Fremantle, Western Australia, 6160
Royal Brisbane and Womens Hospital
Herston, Queensland, 4029
Launceston General Hospital
Launceston, Tasmania
Royal Melbourne Hospital
Parkville, Victoria, 3050
The Alfred Hospital
Prahran, Victoria, 3181
Czechia9 sites
Private Gastroenterology Centre
České Budejovice
Hepato-Gastroenterologie, Edvarda Benese 1549
Hradec Králové, 500 12
II.Interni klinika, Endoskopie
Olomouc, 775 20
Fakultni nemocnice
Prague, 100 10
Klinika hepatogastroenterologieIKEM
Prague, 140 21
General University Hospital Prague
Prague
Medic Kral ltd.
Prague
Regional Hospital Pribram
Příbram
Regional Hospital Tabor
Tábor
Israel9 sites
Soroka Medical Center
Beersheba
Bnai Zion MC
Haifa, 31048
Rambam Medical Center,
Haifa
Hadassah Ein-Karem Medical Center
Jerusalem, 91120
Meir Hospital
Kfar Saba
Rabin Medical Center
Petah Tikva, 49100
Kaplan Medical Center
Rehovot, 76100
The Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
Assaf Harofeh Medical Center
Trzifin
Canada8 sites
Health Science Centre
Calgary, Alberta, T2N 4N1
Centre Hospitalier--Hotel-Dieu de Levis
Lévis, Quebec, G6V 3Z1
Hopital Maisonneuve-Rosemont
Montreal, Quebec
Jewish General Hospital
Montreal, Quebec
CHAUQ-Hopital St-Sacrement
Québec, Quebec
DHC Research
Richmond Hill, Ontario
Mt. Sinai Hospital
Toronto, Ontario
Lair Centre
Vancouver, British Columbia, V5Z 1H1
Bulgaria7 sites
4 MHAT, 38 "Makedonia" 1000
Sofia
Military Medical Academy
Sofia
UMHAT "Alexandrovska"
Sofia
UMHAT Queen Joanna
Sofia
UMHAT" St. Ivan Rilsky"
Sofia
V City Hospital
Sofia
UMHAT "St. Marina"
Varna
Germany7 sites
Charité Campus Mitte, Universitätsmedizin Berlin
Berlin
Medizinische Klinik m.S. Hepatologie, Gastroenterologie, Endokrinologie und Stoffwechsel
Berlin
Fachärztin für Innere Medizin
Hamburg
Klinikum der Christian-Albrechts-Universität zu Kiel
Kiel
Universitätsklinikum Magdeburg A.ö.R
Magdeburg
Gastroenterologische Praxis am Germania-Campus
Münster
Klinikum der Universität Regensburg
Regensburg
Hungary6 sites
Réthy Pál Kórház
Békéscsaba
Fővárosi Önkormányzat Bajcsy-Zsilinszky Kórház
Budapest
Debreceni Egyetem OEC
Debrecen
Vaszary Kolos Kórház
Esztergom
Petz Aladár Megyei Oktató Kórház
Győr
BAZ Megyei Kórház
Miskolc
Austria5 sites
Universitätsklinik für Innere Medizin
Innsbruck
A.ö. Krankenhaus der Elisabethinen Linz
Linz
Landesklinikum St. Poelten
Pölten
Krankenanstalt Rudolfstiftung
Vienna
Universitätsklinik für Innere Medizin III
Vienna
France5 sites
CHU Amiens - Hôpital Nord
Amiens
Service d'Hépato-Gastroentérologie et de Nutrition Clinique
Nice
Hopital du Haut-Lévêque
Pessac
Hôpital Charles Nicolle
Rouen
Service de Gastro-Enterologie et Nutrition
Toulouse
South Africa5 sites
Panorama Medi Clinic
Cape Town, 7500
Louis Leipoldt Gastroenterology Centre, Louis Leipoldt Medical Centre
Cape Town, 7530
GastroEnterology Unit, Groote Schuur Hospital
Cape Town, 7925
Quatro Clinical Trial Institute
Cape Town
427 Ontdekkers Road, Florida Park
Johannesburg
Denmark4 sites
Medical Department V Århus University Hospital
Arhus C, 8000
Herlev Hospital Gastroenterologisk department
Herlev, 2730
Hvidovre Hospital
Hvidovre
Medical department S Odense University hospital
Odense, 5000
Sweden4 sites
Medicinkliniken, SU/Östra sjukhuset
Gothenburg
Universitetssjukhuset
Lund
Medicinmottagningen, Södersjukhuset
Stockholm
Sophiahemmet
Stockholm
Netherlands3 sites
Ringweg Randenbroek 110
Amersfoort
Ikazia Ziekenhuis
Rotterdam, 3083AN
Isala Klinieken Locatie Sophia Afd. Interne Geneeskunde
Zwolle, 8025 AB
United Kingdom2 sites
Centre for Gastroenterology Royal Free Hospital
London, NW3 2PF
Dept of Gastroenterology, John Radcliffe Hospital
Oxford
About this study
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
The purpose of this study is to determine whether CCX282-B is effective in treating patients with moderate to severe Crohn's Disease.
Read the detailed description
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
- Conditions
- Crohn's Disease
- Being tested
- CCX282-B
- Keywords
- double-blind, placebo-controlled, multicenter, efficacy, safety
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCX282-BDrug
CCX282-B or placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Blinded study arm Receives: Drug: CCX282-B |
| 2 | Experimental | Blinded study arm Receives: Drug: CCX282-B |
| 3 | Experimental | Blinded study arm Receives: Drug: CCX282-B |
| 4 | Experimental | Blinded study arm Receives: Drug: CCX282-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionAug 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 436 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306215
- Sponsor's protocol ID
- CL004_282
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2006
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23527300
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00306215
- Acronym / sponsor ID
- CL004_282
- Conditions
- Crohn's Disease
- Keywords
- double-blind, placebo-controlled, multicenter, efficacy, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 436 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 23 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether CCX282-B is effective in treating patients with moderate to severe Crohn's Disease.
Detailed description
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CCX282-BBlinded study arm |
| 2 | Experimental | Drug: CCX282-BBlinded study arm |
| 3 | Experimental | Drug: CCX282-BBlinded study arm |
| 4 | Experimental | Drug: CCX282-BBlinded study arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- moderate to severe Crohn's Disease
- CDAI 250-450
- CRP >7.5
- signed written informed consent
Key exclusion criteria (7 listed)
- > 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCX282-BCCX282-B or placebo capsules | Drug | 1, 2, 3, 4 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Derived from this study: PubMed 23527300Keshav 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
112 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CCX282-B in people with Crohn's Disease, run by Amgen at 112 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 112 sites in Brazil, Poland, Australia, Czechia, Israel and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00306215, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.