NCT04753697 - Bristol Myers Squibb™

Study Description

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

Condition or Disease:Eosinophilic Esophagitis
Intervention/Treatment: Drug: CC-93538
Other: Placebo
Phase: Phase 3

Detailed Description

N/A

Study Design

Study Type: Interventional
Estimated Enrollment: 399 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Long-term Controlled Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects With Active Eosinophilic Esophagitis.

Actual Study Start Date: February 2021
Estimated Primary Completion Date: November 2023
Estimated Study Completion Date: July 2024

Arms and interventions

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

Outcome Measures

Primary Outcome Measures: 1. Change in DD Clinical Response [ Time Frame: At week 24 ]
The mean change in dysphagia days (DD), evaluated over the prior 14-day period using the modified Daily Symptom Diary (mDSD), from baseline to Week 24
Primary Outcome Measures: 2. Eosinophil Histologic Response (≤ 6/hpf) [ Time Frame: At week 24 ]
The proportion of participants with eosinophilic histologic response defined as a peak esophageal eosinophil count ≤ 6/high-power field (hpf) at Week 24
Secondary Outcome Measures: 1. Proportion of participants with event rescue therapy (Induction and Maintenance Phases) [ Time Frame: Through week 48 ]
The proportion of participants with use of rescue therapy during the study
Secondary Outcome Measures: 2. Pharmacokinetics-Ctrough [ Time Frame: Through week 48 ]
Measurements of trough concentrations of CC-93538 in participants with EoE during the Maintenance Phase
Secondary Outcome Measures: 3. Eosinophil Histologic Response (< 15/hpf) [ Time Frame: At week 24 ]
The proportion of participants with eosinophilic histologic response defined as a peak esophageal eosinophil count < 15/hpf at Week 24
Secondary Outcome Measures: 4. EoE Endoscopic Reference Score (EREFS) [ Time Frame: At week 24 ]
The mean change in the endoscopic features of eosinophilic esophagitis (EoE) as measured by the EoE Endoscopic Reference Score (EREFS) from baseline to Week 24
Secondary Outcome Measures: 5. EoEHSS Grade Score [ Time Frame: At week 24 ]
The mean change in the mean adjusted histology grade score as measured by the EoE histology scoring system (EoEHSS) from baseline to Week 24
Secondary Outcome Measures: 6. EoEHSS Stage Score [ Time Frame: At week 24 ]
The mean change in the mean adjusted histology stage score as measured by the EoE histology scoring system (EoEHSS) from baseline to Week 24
Secondary Outcome Measures: 7. mDSD Composite Score [ Time Frame: At week 24 ]
The mean change in the modified Daily Symptom Diary (mDSD) composite score from baseline to Week 24
Secondary Outcome Measures: 8. DD Clinical Responder Definition [ Time Frame: At week 24 ]
The proportion of participants with a ≥ 50% decrease in dysphagia days (DD) from baseline at Week 24
Secondary Outcome Measures: 9. Kinetics and Onset of Clinical Response_DD [ Time Frame: Through week 24 ]
The mean change in dysphagia days (DD) over time from baseline through Week 24
Secondary Outcome Measures: 10. Kinetics and Onset of Clinical Response_mDSD [ Time Frame: Through week 24 ]
The mean change in the modified Daily Symptom Diary (mDSD) composite score over time from baseline through Week 24
Secondary Outcome Measures: 11. Time to Event _EoE Flare [ Time Frame: Through week 24 ]
The time to event of Eosinophilic Esophagitis (EoE) flare during the Induction Phase
Secondary Outcome Measures: 12. Time to Event_Rescue Therapy [ Time Frame: Through Week 24 ]
The time to event of use of rescue therapy during the Induction Phase
Secondary Outcome Measures: 13. Proportion of Participants with Event-EoE Flare [ Time Frame: Through week 24 ]
The proportion of participants with an EoE flare during the Induction Phase
Secondary Outcome Measures: 14. Proportion of Participants with Event_Rescue Therapy [ Time Frame: Through week 24 ]
The proportion of participants with use of rescue therapy during the Induction Phase
Secondary Outcome Measures: 15. Incidence of Adverse Events (AEs) [ Time Frame: Through week 48 ]
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE except for symptoms associated with an EoE flare requiring an EoE Flare Assessment
Secondary Outcome Measures: 16. Assessment of Immunogenicity through measurement of serum concentrations of anti-drug antibodies to CC-93538 [ Time Frame: Through week 48 ]
Evaluated by the presence of anti-drug antibodies to CC-93538
Secondary Outcome Measures: 17. Pharmacokinetics- Ctrough [ Time Frame: Through week 24 ]
Serum trough concentration Measurements of trough concentrations of CC-93538 in participants with EoE during the Induction Phase
Secondary Outcome Measures: 18. Change in DD Clinical Response [ Time Frame: At week 48 ]
The mean change in dysphagia days (DD), evaluated over the prior 14-day period using the modified Daily Symptom Diary (mDSD), from baseline to Week 48
Secondary Outcome Measures: 19. Eosinophil Histologic Response (≤ 6/hpf) [ Time Frame: At week 48 ]
The proportion of participants with eosinophilic histologic response defined as a peak esophageal eosinophil count ≤ 6/high-power field (hpf) at Week 48
Secondary Outcome Measures: 20. Eosinophil Histologic Response (< 15/hpf) [ Time Frame: At week 48 ]
The proportion of participants with eosinophilic histologic response defined as a peak esophageal eosinophil count < 15/hpf at Week 48
Secondary Outcome Measures: 21. Mean change in EREFS [ Time Frame: At week 48 ]
The mean change in the endoscopic features of eosinophilic esophagitis (EoE) as measured by the EoE Endoscopic Reference Score (EREFS) from baseline to Week 48
Secondary Outcome Measures: 22. EoEHSS Grade Score [ Time Frame: At week 48 ]
The mean change in the mean adjusted histology grade score as measured by the EoE histology scoring system (EoEHSS) from baseline to Week 48
Secondary Outcome Measures: 23. EoEHSS Stage Score [ Time Frame: At week 48 ]
The mean change in the mean adjusted histology stage score as measured by the EoE histology scoring system (EoEHSS) from baseline to Week 48
Secondary Outcome Measures: 24. mDSD Composite Score [ Time Frame: At week 48 ]
The mean change in the modified Daily Symptom Diary (mDSD) composite score from baseline to Week 48
Secondary Outcome Measures: 25. Time to event_EoE Flare (Induction and Maintenance Phase) [ Time Frame: Through week 48 ]
The time to event of EoE flare during the study
Secondary Outcome Measures: 26. Time to event_rescue therapy (Induction and Maintenance Phase) [ Time Frame: Through week 48 ]
The time to event of use of rescue therapy during the study
Secondary Outcome Measures: 27. Proportion of Participants with Event_EoE Flare (Induction and Maintenance Phase) [ Time Frame: Through week 48 ]
The proportion of participants with an EoE flare during the study

Eligibility Criteria

Ages Eligible for Study: 12 to 75 Years (Child, Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: Participants must satisfy the following criteria to be enrolled in the study: 1. Male or female patients aged ≥ 12 and ≤ 75 years, with a body weight of > 40 kg. 2. 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: 1. Clinical or endoscopic evidence of other diseases that may affect the histologic, endoscopic, and clinical symptom evaluation for this study. 2. 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. 3. Evidence of a severe endoscopic structural abnormality in the esophagus. 4. 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. 5. Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to the first Screening Visit. 6. Treatment with a high potency topical corticosteroid for dermatologic use, or a systemic corticosteroid within 8 weeks of the first Screening Visit. 7. Treatment with a swallowed topical corticosteroid, leukotriene receptor antagonist, or mast cell stabilizer for EoE, within 4 weeks of the first Screening Visit. 8. 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. 9. Actively successful dietary modification adherence (e.g. food elimination diet), resulting in a complete response to EoE. 10. Prior treatment with CC-93538 during a Phase 1 or 2 clinical study. 11. Receipt of a live attenuated vaccine within 4 weeks of the first Screening Visit. 12. 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). 13. Active or ongoing infections including parasitic/helminthic, hepatitis, tuberculosis, or human immunodeficiency virus. 14. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks of the first Screening Visit. 15. Females who are pregnant or lactating.

Contacts and Locations

Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@bms.com

Locations

United States, Alabama
AES - DRS - Simon Williamson Clinic, PC - Birmingham
Birmingham

United States, Arizona
AES - DRS - Central Phoenix Medical Clinic, LLC
Phoenix

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
Gastrointestinal Biosciences
Los Angeles

United States, California
UCSF Benioff Children's Hospital Oakland
Oakland

United States, California
Alliance Clinical Research, LLC
Poway

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
University of Connecticut
Farmington

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
ENCORE Borland-Groover Clinical Research
Jacksonville

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, 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, Illinois
Summit Digestive and Liver Disease Specialists - Chicago - CAR
Oakbrook Terrace

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, Kentucky
Tri-State Gastroentrology Associates
Florence

United States, Kentucky
University of Louisville
Louisville

United States, Louisiana
Gastroenterology Associates LLC
Baton Rouge

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
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
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, Minnesota
Minnesota Gastroenterology
Plymouth

United States, Minnesota
Mayo Clinic
Rochester

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, 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
NYU Langone Medical Center
New York

United States, New York
Icahn School of Medicine at Mount Sinai
New York

United States, New York
Hill Medical Center
Syracuse

United States, New York
Syracuse VA Medical Center
Syracuse

United States, North Carolina
Asheville Gastroenterology Associates, P.A.
Asheville

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
Medication Management LLC
Greensboro

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
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
Children's Hospital of Philadelphia
Philadelphia

United States, Pennsylvania
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia

United States, Pennsylvania
Thomas Jefferson University
Philadelphia

United States, Rhode Island
University Gastroenterology
Providence

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, Texas
Texas Digestive Disease Consultants Dallas
Dallas

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
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
Tyler Research Institute, LLC
Tyler

United States, Utah
Intermountain Clinical Research
Draper

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
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
The Childrens Hospital at Westmead
Westmead

Australia, Queensland
Coastal Digestive Health
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
Monash Health, Monash Medical Centre
Clayton

Australia, Victoria
Footscray Hospital
Footscray

Australia, Victoria
The Alfred Hospital
Melbourne

Australia, Western Australia
Fiona Stanley Hospital
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
Hospital of Barmherzige Schwestern Linz
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
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
Ottawa Allergy Research Corporation
Ottawa

Canada, Ontario
Toronto Western Hospital
Toronto

Canada, Ontario
Toronto Digestive Disease Associates Inc
Vaughan

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
Facharztzentrum Eppendorf
Hamburg

Germany
Universitatsklinikum Leipzig
Leipzig

Germany
EUGASTRO GmbH
Leipzig

Germany
Gastroenterologische Gemeinschaftspraxis Mainz
Mainz

Germany
Klinikum rechts der Isar der Technischen Universitaet Muenchen
Munchen

Germany
Praxis Prof. Herbert Kellner
München

Israel
Rambam Medical Center
Haifa

Israel
Edith Wolfson Medical Center
Holon

Israel
Shaare Zedek Medical Center
Jerusalem

Israel
Hadassah Medical Center
Jerusalem

Israel
Tel Aviv Sourasky Medical Center
Tel Aviv

Israel
Shamir Medical Center - Assaf Harofeh
Zerifin

Italy
Ospedale Policlinico San Martino
Genova

Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
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
Azienda Policlinico Umberto I
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
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
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
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
AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw

Poland
Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
Wroclaw

Poland
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
Wroclaw

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
Hospital Universitario Reina Sofia
Cordoba

Spain
Hospital La Princesa
Madrid

Spain
Hospital Universitario La Paz
Madrid

Spain
Hospital Costa del Sol
Marbella

Spain
Hospital Virgen del Rocio
Sevilla

Switzerland
Chuv Bh-04
Lausanne

Switzerland
Kantonsspital Liestal
Liestal

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

Sponsors and Collaborators

Celgene

Investigators

Study Director: Cristian Rodriguez, MD Bristol-Myers Squibb

More Information

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04753697 History of Changes
Other Study ID Numbers: CC-93538-EE-001, U1111-1263-4351, 2020-004336-16
First Posted: February 15, 2021 Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: October 2021
Individual Participant
Data (IPD) Sharing
Statement:
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene: Physiological Effects of Drugs
Immunologic factors
Hypersensitivity
Antibody, Monoclonal
Allergic Diseases
Esophageal Diseases
Eosinophilia
Eosinophils Gastroenteritis
Esophagitis
Gastrointestinal Diseases
Adolescent
Adult
RPC4046
CC-93538
Eosinophilic Esophagitis
Additional relevant MeSH terms: Eosinophilic Esophagitis Esophagitis

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Condition Categories

Clinical Trials of Interest

A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis

Study Description

Detailed Description

Study Design

Arms and interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Criteria

Contacts and Locations

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Locations

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Clinical Trials of Interest

A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis

Study Description

Detailed Description

Study Design

Arms and interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Criteria

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Contacts

Locations

Sponsors and Collaborators

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Individual Participant Data (IPD) Sharing Statement:

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Individual Participant
Data (IPD) Sharing
Statement: