Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT04991935 Recruiting August 5, 2021 May 12, 2022

study description
Brief Summary

This study is an open-label, uncontrolled study design to evaluate the longer-term safety profile as well as durability of response of administration of a single dose level of CC-93538. The study will enroll participants who participated in the CC-93538-EE-001 study.

Condition or Disease: Eosinophilic Esophagitis
Intervention/treatment: Drug: CC-93538
Phase: Phase 3
Detailed Description

N/A


study design
Study Type: Interventional
Estimated Enrollment : 259 participants
Intervention Model : Single Group Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
Official Title: Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
Actual Study Start Date: September 2021
Estimated Primary Completion Date: August 2026
Estimated Study Completion Date: August 2026

Arms and interventions
Arm Intervention/treatment
Experimental: Administration of CC-93538
Participants are administered CC-93538 dose subcutaneously once weekly
Drug: CC-93538
CC-93538
outcome measures
Primary Outcome Measures: 1. Incidence of Adverse Events (AEs) [ Time Frame: For a minimum of 28 months ]
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 (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Secondary Outcome Measures: 1. Immunogenicity of CC-93538 assessed through the incidence of anti-drug antibodies [ Time Frame: For a minimum of 28 months ]
This includes neutralizing antibodies when warranted.

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:

Previously participated in prior clinical study CC-93538-EE-001 and either:

completed both the Induction and Maintenance phases; or completed the Induction Phase, however, did not qualify for the Maintenance Phase, including having a severe eosinophilic esophagitis (EoE) flare requiring endoscopic intervention or rescue therapy. Demonstrated compliance with required investigational product dosing during the prior study. Did not permanently discontinue investigational product in the prior study and/or did not experience any clinically significant adverse events related to Investigational Product that would preclude further dosing. Females of childbearing potential must have a negative pregnancy test prior to the first dose of open-label CC-93538 and agree to practice a highly effective method of contraception (as defined in the prior study) until 5 months after the last dose of open-label CC-93538.

Exclusion Criteria:

Clinical or endoscopic evidence of other diseases or conditions that may affect or confound the histologic, endoscopic, or clinical symptom evaluation for this study. Active Helicobacter pylori infection or esophageal varices. Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to open-label extension study (OLE) Day 1. Use of these agents is prohibited during the study. Treatment with oral or sublingual immunotherapy within 6 months of OLE Day 1. Use of these agents is prohibited during the study. Received an investigational product, other than that administered in CC-93538-EE-001, within 5 half-lives prior to OLE Day 1 (includes investigational product received during an interventional trial for COVID-19). Those vaccinated with an investigational COVID-19 vaccine during CC-93538-EE-001 are not eligible, unless allowed following a discussion with the Clinical Trial Physician. Received a live attenuated vaccine within one month prior to OLE Day 1; or anticipates the need for a live attenuated vaccine at any time throughout the course of this study. 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. colitis, celiac disease, Mendelian disorder associated with EoE, severe uncontrolled asthma, infection causing eosinophilia, hypereosinophilic syndrome, or cardiovascular condition, or neurologic or psychiatric illness that could compromise the participant's ability to accurately document symptoms of EoE; newly diagnosed malignancy, lymphoproliferative disease, or clinically significant laboratory abnormality). Active or ongoing infections including parasitic/helminthic infections, viral hepatitis, tuberculosis, or HIV. Has had idiopathic anaphylaxis or major immunologic reaction to an immunoglobulin-G containing agent; or any known hypersensitivity to any ingredient in CC-93538. Females who are pregnant or lactating.


Contacts and Locations
Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations
United States, Alabama AES - DRS - Simon Williamson Clinic, PC - Birmingham Birmingham
United States, Alabama Gastro Care PC - CAR Tuscaloosa
United States, Arizona Phoenix Childrens Hospital Phoenix
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 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 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, 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 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, 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 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 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 Drug Trials America Hartsdale
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 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 Cleveland Clinic Foundation Cleveland
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, Ohio Optimed Research Ltd Columbus
United States, Oregon Velocity Clinical Research - Grants Pass - ERN - PPDS Medford
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, 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 Prisma Health - Upstate Greenville
United States, Tennessee ClinSearch LLC Chattanooga
United States, Tennessee Vanderbilt University Nashville
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 Brooke Army Medical Center Francis Street Medical Center Fort Sam Houston
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 Advanced Research Institute-South Ogden 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
Argentina Investigaciones En Patologias Respiratorias San Miguel de Tucumán
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 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 Local Institution - 597 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 Local Institution - 605 Tokyo
Japan National Center for Child Health and Development Tokyo
Japan Fujita Health University Hospital Toyoake
Japan Local Institution - 596 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 General Hospital Southampton
Sponsors and Collaborators
Celgene
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Responsible Party : Celgene
ClinicalTrials.gov Identifier : NCT04991935     
Other Study ID Numbers : CC-93538-EE-002, 2020-004335-24
First Posted : August 5, 2021
Last Update Posted : May 12, 2022
Last Verified : May 2022
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: Eosinophilic Esophagitis
CC-93538
RPC4046
Adult
Adolescent
Gastrointestinal Diseases
Esophagitis
Gastroenteritis
Eosinophils
Eosinophilia
Esophageal Diseases
Allergic Diseases
Antibody, Monoclonal
Hypersensitivity
Immunologic factors
Physiological Effects of Drugs
Additional relevant MeSH terms :
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis