NCT04753697
Recruiting
February 15, 2021
May 3, 2022
Brief summary:
Study CC-93538-EE-001 is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC- 93538 in adult and adolescent participants with eosinophilic esophagitis (EoE). The study will incorporate a 24-week Induction Phase followed by a 24-week Maintenance Phase. Participants will be randomized at the beginning of the study into 3 treatment arms: Placebo for Induction and Maintenance CC-93538 360 mg Subcutaneous (SC) once weekly for Induction followed by 360 mg SC once every other week for Maintenance CC-93538 360 mg SC once weekly for Induction and Maintenance
N/A
Arm | Intervention/treatment |
---|---|
Experimental: Administration of CC-93538 CC-93538 360 mg Subcutaneously (SC) once weekly for 24 weeks followed by CC-93538 360 mg SC once weekly for 24 weeks |
Drug: CC-93538 Subcutaneous |
Experimental: Administration of CC-93538 and Placebo CC-93538 360 mg SC once weekly for 24 weeks followed by CC-93538 360 mg SC once every other week for 24 weeks. During the Maintenance Phase, matching placebo will be administered once every other week on alternate weeks to maintain the blind. |
Drug: CC-93538 Subcutaneous Other: Placebo Subcutaneous |
Placebo Comparator: Administration of Placebo Matching placebo SC once weekly for 24 weeks followed by matching placebo SC once weekly for 24 weeks |
Other: Placebo Subcutaneous |
Inclusion Criteria: Participants must satisfy the following criteria to be enrolled in the study: Male or female patients aged ≥ 12 and ≤ 75 years, with a body weight of > 40 kg. Histologic evidence of eosinophilic esophagitis, defined as a peak count of ≥ 15 eosinophils/high-power field at 2 levels of the esophagus. 3 Participant-reported history of 4 or more Dysphagia Days within 2 consecutive weeks prior to end of screening. 4. Lack of complete response to an adequate trial of proton pump inhibitor (8 weeks). Participants on a proton pump inhibitor must have been on a stable dose for at least 4 weeks prior to first Screening Visit and agree to continue the same dose throughout the study. 5. Participants currently receiving inhaled corticosteroids, leukotriene receptor antagonists, or mast cell stabilizers for indications other than EoE, or medium potency topical corticosteroids for dermatologic conditions, must maintain stable doses for at least 4 weeks prior to the first Screening Visit and throughout the duration of the study. 6. Participants must agree to maintain a stable diet (including any food elimination diet for the treatment of food allergy or eosinophilic esophagitis) and not introduce any changes in their diet from the first Screening Visit to the end of the study. 7. Females of childbearing potential must have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy and agree to practice a highly effective method of contraception until 5 months after the last dose. Exclusion Criteria: The presence of any of the following will exclude a participant from enrollment: Clinical or endoscopic evidence of other diseases that may affect the histologic, endoscopic, and clinical symptom evaluation for this study. Other gastrointestinal disorders such as active Helicobacter pylori infection, esophageal varices, gastritis, colitis, celiac disease, Mendelian disorder associated with eosinophilic esophagitis, liver function impairment, or a known hereditary fructose intolerance. Evidence of a severe endoscopic structural abnormality in the esophagus. Esophageal dilation for symptom relief within 8 weeks prior to first Screening Visit or during the Screening Period, or if esophageal dilation is anticipated within 48 weeks of dosing during the study. Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to the first Screening Visit. Treatment with a high potency topical corticosteroid for dermatologic use, or a systemic corticosteroid within 8 weeks of the first Screening Visit. Treatment with a swallowed topical corticosteroid, leukotriene receptor antagonist, or mast cell stabilizer for EoE, within 4 weeks of the first Screening Visit. Treatment with oral or sublingual immunotherapy within 6 months of the first Screening Visit (any use will be prohibited during the study). Subcutaneous immunotherapy may be allowed if on stable doses for at least 3 months prior to the first Screening Visit and during the study. Actively successful dietary modification adherence (e.g. food elimination diet), resulting in a complete response to EoE. Prior treatment with CC-93538 during a Phase 1 or 2 clinical study. Receipt of a live attenuated vaccine within 4 weeks of the first Screening Visit. Any disease that would affect the conduct of the protocol or interpretation of the study results, or would put a patient at risk by participating in the study (e.g. severe uncontrolled asthma, infection causing eosinophilia, hypereosinophilic syndrome, or cardiovascular condition, or neurologic disorder or psychiatric illness that compromises the Participant's ability to accurately document symptoms of eosinophilic esophagitis). Active or ongoing infections including parasitic/helminthic, hepatitis, tuberculosis, or human immunodeficiency virus. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks of the first Screening Visit. Females who are pregnant or lactating.
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #
United States, Alabama
AES - DRS - Simon Williamson Clinic, PC - Birmingham
Birmingham
United States, Alabama
AES - DRS - Simon Williamson Clinic, PC - Birmingham
Birmingham
United States, Alabama
Gastro Care PC - CAR
Tuscaloosa
United States, Arizona
AES - DRS - Central Phoenix Medical Clinic, LLC
Phoenix
United States, Arizona
AES - DRS - Central Phoenix Medical Clinic, LLC
Phoenix
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale
United States, Arizona
Del Sol Research Management
Tucson
United States, Arizona
MetroHealth Medical Center
Tucson
United States, California
OM Research
Lancaster
United States, California
OM Research
Lancaster
United States, California
Gastrointestinal Biosciences
Los Angeles
United States, California
UCSF Benioff Children's Hospital Oakland
Oakland
United States, California
Palmtree Clinical Research
Palm Springs
United States, California
Alliance Clinical Research, LLC
Poway
United States, California
SDG Clinical Research, Inc.
San Diego
United States, California
SDG Clinical Research, Inc.
San Diego
United States, California
Precision Research Institute, LLC
San Diego
United States, Colorado
Childrens Hospital Colorado
Aurora
United States, Colorado
Peak Gastroenterology Associates
Colorado Springs
United States, Colorado
Rocky Mountain Pediatric Gastroenterology
Denver
United States, Colorado
Western States Clinical Research Inc
Wheat Ridge
United States, Connecticut
Connecticut Clinical Research Foundation
Bristol
United States, Connecticut
Connecticut Clinical Research Foundation
Bristol
United States, Connecticut
University of Connecticut
Farmington
United States, Connecticut
University Of Connecticut
Farmington
United States, Connecticut
Medical Research Center of Connecticut LLC
Hamden
United States, District of Columbia
Children's National Medical Center
Washington
United States, Florida
Gastro Florida
Clearwater
United States, Florida
Nature Coast Clinical Research LLC
Inverness
United States, Florida
Nature Coast Clinical Research LLC
Inverness
United States, Florida
ENCORE Borland-Groover Clinical Research
Jacksonville
United States, Florida
ENCORE Borland-Groover Clinical Research
Jacksonville
United States, Florida
Homestead Associates in Research Inc
Miami
United States, Florida
A Plus Research Inc
Miami
United States, Florida
A Plus Research Inc
Miami
United States, Florida
Med-Care Research
North Miami Beach
United States, Florida
AES - DRS - Synexus Clinical Research US, Inc. - Orlando
Orlando
United States, Florida
Arnold Palmer Hospital For Children
Orlando
United States, Florida
Gastroenterology Consultants of Central Florida - CAR
Orlando
United States, Florida
Advanced Medical Research Center
Port Orange
United States, Florida
US Associates in Research Inc
Sweetwater
United States, Georgia
Emory University
Atlanta
United States, Georgia
Gastroenterology Associates Of Central Georgia LLC
Macon
United States, Georgia
Gastroenterology Associates Of Central Georgia LLC
Macon
United States, Idaho
Grand Teton Research Group PLLC
Idaho Falls
United States, Idaho
Grand Teton Research Group PLLC
Idaho Falls
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago
United States, Illinois
University of Chicago
Chicago
United States, Indiana
Indiana University
Indianapolis
United States, Indiana
Gastroenterology Health Partners PLLC
New Albany
United States, Iowa
Iowa Digestive Disease Center
Clive
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City
United States, Kansas
University of Kansas Medical Center
Kansas City
United States, Kansas
University Of Kansas Medical Center
Kansas City
United States, Kentucky
Tri-State Gastroentrology Associates
Florence
United States, Kentucky
University of Louisville
Louisville
United States, Louisiana
Gastroenterology Associates LLC
Baton Rouge
United States, Louisiana
Gastroenterology Associates LLC
Baton Rouge
United States, Louisiana
Clinical Trials Management LLC
Metairie
United States, Louisiana
Clinical Trials Management LLC
Metairie
United States, Louisiana
Ochsner Children's Health Center
New Orleans
United States, Maryland
Johns Hopkins University
Baltimore
United States, Maryland
Digestive Disease Associates, PA
Catonsville
United States, Maryland
Woodholme Gastroenterology Associates
Glen Burnie
United States, Maryland
Meritus Medical Center
Hagerstown
United States, Massachusetts
Tufts - New England Medical Center
Boston
United States, Massachusetts
Massachusetts General Hospital / Dana-Farber Cancer Institute
Boston
United States, Massachusetts
Boston Children's Hospital
Boston
United States, Massachusetts
Brigham and Women's Hospital
Boston
United States, Massachusetts
Greater Boston Gastroenterology PC
Framingham
United States, Massachusetts
FC Research LLC
South Dartmouth
United States, Massachusetts
FC Research LLC
South Dartmouth
United States, Massachusetts
Baystate Medical Center
Springfield
United States, Massachusetts
UMASS Memorial Hospital
Worcester
United States, Michigan
Troy Gastroenterology
Troy
United States, Michigan
Gastroenterology Associates of Western Michigan PLC
Wyoming
United States, Michigan
Gastroenterology Associates of Western Michigan PLC
Wyoming
United States, Minnesota
Minnesota Gastroenterology
Plymouth
United States, Minnesota
Minnesota Gastroenterology
Plymouth
United States, Minnesota
Mayo Clinic
Rochester
United States, Minnesota
Mayo Clinic
Rochester
United States, Mississippi
GI Associates and Endoscopy Center-GI Clinical Research Department
Flowood
United States, Mississippi
GI Associates and Endoscopy Center-GI Clinical Research Department
Flowood
United States, Missouri
Mid America Gastrointestinal Consultants
Kansas City
United States, Missouri
Washington University Siteman Cancer Center
Saint Louis
United States, Missouri
Washington University Siteman Cancer Center
Saint Louis
United States, Nebraska
University of Nebraska Medical Center
Omaha
United States, Nevada
Advanced Research Institute - Reno
Reno
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon
United States, New Jersey
Atlantic Research Center LLC
Ocean City
United States, New Mexico
New Mexico Clinical Research and Osteoporosis Center
Albuquerque
United States, New York
Long Island Gastrointestinal Research Group LLP
Great Neck
United States, New York
Long Island Gastrointestinal Research Group LLP
Great Neck
United States, New York
NYU Langone Medical Center
New York
United States, New York
NYU Langone Medical Center
New York
United States, New York
Dr. Jeffrey Crespin, MD - New York - CAR
New York
United States, New York
Icahn School of Medicine at Mount Sinai
New York
United States, New York
Rochester Gastroenterology: Devgun Surinder MD
Rochester
United States, New York
Hill Medical Center
Syracuse
United States, New York
Syracuse VA Medical Center
Syracuse
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill
United States, North Carolina
University Of North Carolina At Chapel Hill
Chapel Hill
United States, North Carolina
Clinical Research of Charlotte
Charlotte
United States, North Carolina
Duke University Medical Center
Durham
United States, North Carolina
Duke University Medical Center
Durham
United States, North Carolina
Medication Management LLC
Greensboro
United States, North Carolina
Atlantic Medical Group - Kinston - CAR
Kinston
United States, North Carolina
Atlantic Medical Group - Kinston - CAR
Kinston
United States, Ohio
Dayton Gastroenterology, Inc
Beavercreek
United States, Ohio
Consultants for Clinical Research
Cincinnati
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
United States, Ohio
Cincinnati Children'S Hospital Medical Center
Cincinnati
United States, Ohio
University of Cincinnati Medical Center
Cincinnati
United States, Ohio
The Cleveland Clinic Foundation
Cleveland
United States, Ohio
AES - DRS - Synexus Clinical Research US, Inc. - Columbus
Columbus
United States, Ohio
Optimed Research Ltd
Columbus
United States, Pennsylvania
Penn State Health Milton S. Hershey Medical Center
Hershey
United States, Pennsylvania
Penn State Health Milton S. Hershey Medical Center
Hershey
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia
United States, Pennsylvania
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia
United States, Pennsylvania
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia
United States, Pennsylvania
Thomas Jefferson University
Philadelphia
United States, Pennsylvania
Glenn S Freed, DO - CAR
Pottsville
United States, Pennsylvania
Glenn S Freed, DO - CAR
Pottsville
United States, Rhode Island
University Gastroenterology
Providence
United States, South Carolina
AES - DRS - Synexus Clinical Research US, Inc. - Anderson
Anderson
United States, South Carolina
AES - DRS - Synexus Clinical Research US, Inc. - Anderson
Anderson
United States, South Carolina
Prisma Health - Upstate
Greenville
United States, Tennessee
ClinSearch LLC
Chattanooga
United States, Tennessee
Vanderbilt University
Nashville
United States, Tennessee
Vanderbilt University
Nashville
United States, Texas
Texas Digestive Disease Consultants Dallas
Cedar Park
United States, Texas
Texas Digestive Disease Consultants Dallas
Cedar Park
United States, Texas
AES - DRS - Synexus Clinical Research US, Inc. - Dallas
Dallas
United States, Texas
Childrens Medical Center
Dallas
United States, Texas
Cook Childrens Medical Center
Fort Worth
United States, Texas
Houston Endoscopy and Research Center
Houston
United States, Texas
Houston Endoscopy and Research Center
Houston
United States, Texas
Digestive Health Associates of Texas (DHAT)
Rockwell
United States, Texas
Southern Star Research Institute LLC
San Antonio
United States, Texas
Texas Digestive Disease Consultants - Southlake
Southlake
United States, Texas
Texas Digestive Disease Consultants - Southlake
Southlake
United States, Texas
Tyler Research Institute, LLC
Tyler
United States, Texas
Tyler Research Institute, LLC
Tyler
United States, Utah
Intermountain Clinical Research
Draper
United States, Utah
Ogden Clinic Gastrenterology - CAR
Ogden
United States, Utah
Ogden Clinic Gastrenterology - CAR
Ogden
United States, Utah
University of Utah Primary Children's Medical Center
Salt Lake City
United States, Utah
University of Utah School of Medicine
Salt Lake City
United States, Vermont
University of Vermont Medical Center Gastro
Burlington
United States, Virginia
Emeritas Research Group
Leesburg
United States, Virginia
Blue Ridge Medical Research
Lynchburg
United States, Virginia
McGuire Veterans Affairs Medical Center
Richmond
United States, Virginia
Carilion Clinic
Roanoke
United States, Washington
Velocity Clinical Research - Spokane - ERN - PPDS
Spokane
United States, Washington
Vancouver Clinic Inc PS
Vancouver
United States, Wisconsin
University of Wisconsin
Madison
United States, Wisconsin
Aurora Saint Lukes Medical Center
Milwaukee
United States, Wisconsin
Medical College of Wisconsin
Milwaukee
United States, Wyoming
Gastroenterology Associates, PC - Casper - CAR
Casper
Argentina
Hospital Italiano de Buenos Aires
Buenos Aires
Argentina
Local Institution - 697
Buenos Aires
Argentina
Gedyt
BuenosAires
Argentina
Centro de Investigaciones Medica Mar del Plata
Mar Del Plata
Argentina
Instituto CER S.A.
Quilmes
Australia, New South Wales
Concord Repatriation General Hospital
Concord
Australia, New South Wales
Liverpool Hospital
Liverpool
Australia, New South Wales
The Childrens Hospital at Westmead
Westmead
Australia, Queensland
Coastal Digestive Health
Maroorchydore
Australia, Queensland
Local Institution - 546
Maroorchydore
Australia, Queensland
Coral Sea Clinical Research Institute
North Mackay
Australia, Queensland
Mater Adult Hospital
South Brisbane
Australia, Queensland
Princess Alexandra Hospital
Woolloongabba
Australia, South Australia
Royal Adelaide Hospital
Adelaide
Australia, South Australia
Lyell McEwin Hospital
Elizabeth Vale
Australia, Victoria
Local Institution - 553
Clayton
Australia, Victoria
Monash Health, Monash Medical Centre
Clayton
Australia, Victoria
Footscray Hospital
Footscray
Australia, Victoria
Local Institution - 543
Footscray
Australia, Victoria
The Alfred Hospital
Melbourne
Australia, Western Australia
Fiona Stanley Hospital
Murdoch
Australia, Western Australia
Local Institution - 549
Murdoch
Australia
St Vincents Hospital Melbourne
Fitzroy
Australia
St John of God Midland Hospital
Western Australia
Austria
Krankenhaus der Barmherzigen Brüder Eisenstadt
Burgenland
Austria
LKH-Universitätsklinikum Klinikum Graz
Graz
Austria
Local Institution - 434
Graz
Austria
Hospital of Barmherzige Schwestern Linz
Linz
Austria
Local Institution - 436
Linz
Austria
Medizinische Universitat Wien
Vienna
Belgium
UZ Brussel
Brussels
Belgium
AZ Groeninge
Kortrijk
Belgium
UZ Leuven
Leuven
Belgium
AZ Sint-Lucas Brugge
West-Vlaanderen
Canada, Alberta
Local Institution - 201
Calgary
Canada, Alberta
University of Calgary
Calgary
Canada, Alberta
University of Alberta
Edmonton
Canada, Alberta
South Edmonton Gastroenterology
Edmonton
Canada, British Columbia
GI Research Institute
Vancouver
Canada, British Columbia
PerCuro Clinical Research LTD
Victoria
Canada, Ontario
Local Institution - 207
Ottawa
Canada, Ontario
Ottawa Allergy Research Corporation
Ottawa
Canada, Ontario
Local Institution - 204
Toronto
Canada, Ontario
Toronto Western Hospital
Toronto
Canada, Ontario
Toronto Digestive Disease Associates Inc
Vaughan
Germany
Local Institution - 332
Brandenburg an der Havel
Germany
Staedisches Klinikum Brandenburg
Brandenburg an der Havel
Germany
AES - DRS - Synexus Frankfurt Research Centre
Frankfurt am Main
Germany
Klinikum Garmisch-Partenkirchen Gmbh
Garmisch-Partenkirchen
Germany
Local Institution - 330
Garmisch-Partenkirchen
Germany
Facharztzentrum Eppendorf
Hamburg
Germany
Universitatsklinikum Leipzig
Leipzig
Germany
EUGASTRO GmbH
Leipzig
Germany
Local Institution - 338
Leipzig
Germany
Klinikum rechts der Isar der Technischen Universitaet Muenchen
Munchen
Germany
Praxis Prof. Herbert Kellner
München
Israel
Local Institution - 281
Haifa
Israel
Rambam Medical Center
Haifa
Israel
Edith Wolfson Medical Center
Holon
Israel
Shaare Zedek Medical Center
Jerusalem
Israel
Hadassah Medical Center
Jerusalem
Israel
Local Institution - 282
Jerusalem
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv
Israel
Local Institution - 279
Zerifin
Israel
Shamir Medical Center - Assaf Harofeh
Zerifin
Italy
Ospedale Policlinico San Martino
Genova
Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milano
Italy
Local Institution - 254
Milano
Italy
AOU dell'Università degli Studi della Campania Luigi Vanvitelli
Napoli
Italy
Azienda Ospedaliera di Padova
Padova
Italy
Azienda Ospedaliera Universitaria Pisana
Pisa
Italy
Local Institution - 252
Pisa
Italy
Azienda Policlinico Umberto I
Rome
Italy
Local Institution - 253
Rome
Japan
Akita University Hospital
Akita-shi
Japan
Nippon Medical School Hospital
Bunkyo-ku
Japan
Tokai University Hospital
Isehara City, Kanagawa
Japan
Kobe University Hospital
Kobe
Japan
Gunma University Hospital
Maebashi
Japan
Daido Clinic
Nagoya
Japan
Nagoya City University Hospital
Nagoya
Japan
Niigata University Medical and Dental Hospital
Niigata-shi
Japan
Hyogo College of Medicine Hospital
Nishinomiya
Japan
Kawasaki Medical School Hospital
Okayama-Shi
Japan
Local Institution - 603
Okayama-Shi
Japan
Osaka City University Hospital
Osaka
Japan
Gunma Children's Medical Center
Shibukawa
Japan
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-Ku
Japan
International University of Health and Werfare Mita Hospital
Tokyo
Japan
National Center for Child Health and Development
Tokyo
Japan
Fujita Health University Hospital
Toyoake
Japan
Local Institution - 590
Yamagata
Japan
Yamagata University Hospital
Yamagata
Poland
Vitamed Galaj i Cichomski sp.j.
Bydgoszcz
Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie
Czestochowa
Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk
Poland
Local Institution - 390
Gdansk
Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice
Poland
AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi
Lódz
Poland
TWOJA PRZYCHODNIA Medical Centre of Szczecin LLC
Szczecin
Poland
WIP Warsaw IBD Point
Warsaw
Poland
Centrum Zdrowia MDM
Warszawa
Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warszawa
Poland
Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
Wroclaw
Poland
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
Wroclaw
Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wrocław
Portugal
Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos
Lisboa
Portugal
Centro Hospitalar Lisboa Central- Hospital Dona Estefânia
Lisboa
Portugal
Centro Hospitalar do Porto - Hospital de Santo António
Porto
Portugal
Centro Hospitalar de São João, E.P.E.
Porto
Spain
Hospital Clinic de Barcelona
Barcelona
Spain
Local Institution - 408
Barcelona
Spain
Hospital Universitario Reina Sofia
Cordoba
Spain
Local Institution - 410
Cordoba
Spain
Hospital La Princesa
Madrid
Spain
Hospital Universitario La Paz
Madrid
Spain
Local Institution - 413
Madrid
Spain
Hospital Costa del Sol
Marbella
Spain
Local Institution - 411
Marbella
Spain
Hospital Virgen del Rocio
Sevilla
Switzerland
Chuv Bh-04
Lausanne
United Kingdom
Belfast Health and Social Care Trust
Belfast Northern Ireland
United Kingdom
AES - DRS - Synexus Midlands Clinical Research Centre
Birmingham
United Kingdom
Addenbrooke's Hospital
Cambridge
United Kingdom
AES - DRS - Synexus Wales Clinical Research Centre
Cardiff
United Kingdom
AES - DRS - NW Consortium Lancashire
Chorley
United Kingdom
AES - DRS - Synexus North Teesside Clinical Research Centre
Hardwick
United Kingdom
AES - DRS - Synexus Hexham Clinical Research Centre
Hexam
United Kingdom
AES - DRS - NW Consortium Merseyside
Liverpool
United Kingdom
Royal Manchester Children's Hospital
Manchester
United Kingdom
AES - DRS - NW Consortium Manchester
Manchester
United Kingdom
Southampton University Hospitals NHS Trust
Southampton
Celgene
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb