Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis

March 29, 2024 updated by: Celgene

A Phase 3, Multicenter, Multinational, Open-Label Extension Study to Evaluate the Long-Term Safety of CC-93538 in Adult and Adolescent Subjects With Eosinophilic Esophagitis

This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538. The study will enroll participants who participated in the CC-93538-EE-001 or CC-93538-DDI-001 studies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

259

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

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

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1199ABB
        • Withdrawn
        • Local Institution - 697
      • BuenosAires, Argentina, C1125ABE
        • Withdrawn
        • Local Institution - 694
      • Mar Del Plata, Argentina, B7600DHK
        • Completed
        • Local Institution - 695
      • Quilmes, Argentina, B1878DVB
        • Completed
        • Local Institution - 696
      • San Miguel de Tucumán, Argentina, T4000IAR
        • Withdrawn
        • Local Institution - 698
  • Australia
      • Fitzroy, Australia, 3065
        • Recruiting
        • Local Institution - 538
        • Contact:
          • Site 538
      • Western Australia, Australia, 6056
        • Recruiting
        • St John of God Midland Hospital
        • Contact:
          • Ajay Sharma, Site 547
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Recruiting
        • Concord Repatriation General Hospital
        • Contact:
          • Lisa Sze Ein Shim, Site 548
      • Liverpool, New South Wales, Australia, 2170
        • Recruiting
        • Liverpool Hospital
        • Contact:
          • Watson Ng, Site 554
          • Phone Number: +61287384085
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • The Childrens Hospital at Westmead
        • Contact:
          • Shoma Dutt, Site 540
          • Phone Number: 0298453999
    • Queensland
      • Maroorchydore, Queensland, Australia, 4558
        • Recruiting
        • Coastal Digestive Health
        • Contact:
          • Hansjoerg Seltenreich, Site 546
      • North Mackay, Queensland, Australia, 4740
        • Withdrawn
        • Local Institution - 551
      • South Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Local Institution - 550
        • Contact:
          • Site 550
      • Woolloongabba, Queensland, Australia, 4102
        • Recruiting
        • Local Institution - 542
        • Contact:
          • Site 542
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Local Institution - 552
        • Contact:
          • Site 552
      • Elizabeth Vale, South Australia, Australia, 05112
        • Recruiting
        • Local Institution - 545
        • Contact:
          • Site 545
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Local Institution - 553
        • Contact:
          • Site 553
      • Footscray, Victoria, Australia, 3011
        • Completed
        • Local Institution - 543
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital
        • Contact:
          • Varan Perananthan, Site 539
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • Fiona Stanley Hospital
        • Contact:
          • Abhey Singh, Site 549
  • Austria
      • Burgenland, Austria, 7000
        • Completed
        • Local Institution - 437
      • Graz, Austria, 8036
        • Recruiting
        • Local Institution - 434
        • Contact:
          • Site 434
      • Linz, Austria, 4010
        • Recruiting
        • Hospital of Barmherzige Schwestern Linz
        • Contact:
          • Peter Piringer, Site 436
      • Vienna, Austria, 1090
        • Withdrawn
        • Local Institution - 435
  • Belgium
      • Brussels, Belgium, 1090
        • Completed
        • Local Institution - 515
      • Kortrijk, Belgium, 8500
        • Recruiting
        • Local Institution - 516
        • Contact:
          • Site 516
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Contact:
          • Tim Vanuytsel, Site 514
      • West-Vlaanderen, Belgium, 8310
        • Recruiting
        • AZ Sint-Lucas Brugge
        • Contact:
          • Joris Arts, Site 512
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Recruiting
        • University of Calgary
        • Contact:
          • Christopher Ma, Site 201
      • Edmonton, Alberta, Canada, T6K 4B2
        • Recruiting
        • South Edmonton Gastroenterology
        • Contact:
          • Jesse Siffledeen, Site 205
          • Phone Number: 7806191972
      • Edmonton, Alberta, Canada, T6G2V2
        • Withdrawn
        • Local Institution - 202
      • Edmonton, Alberta, Canada, T5R 1W2
        • Recruiting
        • GIRI Gastroenterology and Internal Medicine Research Institute
        • Contact:
          • Allen Lim, Site 208
          • Phone Number: 17809301915
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Recruiting
        • GI Research Institute
        • Contact:
          • Hin Hin Ko, Site 203
          • Phone Number: 6046886332x238
      • Victoria, British Columbia, Canada, V8V3M9
        • Recruiting
        • Percuro Clinical Research Ltd
        • Contact:
          • Ranjit Singh, Site 206
    • Ontario
      • Ottawa, Ontario, Canada, K1H 1E4
        • Recruiting
        • Local Institution - 207
        • Contact:
          • Site 207
      • Toronto, Ontario, Canada, M5T 2S8
        • Withdrawn
        • Local Institution - 204
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Recruiting
        • Toronto Digestive Disease Associates Inc
        • Contact:
          • Michael Gould, Site 200
          • Phone Number: 4166500017
  • Germany
      • Bayern, Germany, 82418
        • Recruiting
        • Klinikum Garmisch-Partenkirchen GmbH
        • Contact:
          • Hans-Dieter Allescher, Site 330
      • Brandenburg an der Havel, Germany, 14770
        • Recruiting
        • Local Institution - 332
        • Contact:
          • Site 332
      • Frankfurt am Main, Germany, 60313
        • Recruiting
        • Local Institution - 339
        • Contact:
          • Site 339
      • Hamburg, Germany, 20249
        • Withdrawn
        • Local Institution - 336
      • Leipzig, Germany, 04129
        • Completed
        • Local Institution - 338
      • Leipzig, Germany, 04103
        • Withdrawn
        • Local Institution - 333
      • Mainz, Germany, 55122
        • Withdrawn
        • Local Institution - 334
      • Munchen, Germany, 81675
        • Recruiting
        • Klinikum Rechts der Isar der Technischen Universitaet Muenchen
        • Contact:
          • Simon Weidlich, Site 337
      • München, Germany, 80639
        • Withdrawn
        • Local Institution - 340
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Local Institution - 281
        • Contact:
          • Site 281
      • Holon, Israel, 5822012
        • Recruiting
        • Local Institution - 283
        • Contact:
          • Site 283
      • Jerusalem, Israel, 91120
        • Recruiting
        • Local Institution - 282
        • Contact:
          • Site 282
      • Jerusalem, Israel, 91031
        • Not yet recruiting
        • Local Institution - 280
        • Contact:
          • Site 280
      • Zerifin, Israel, 70300
        • Recruiting
        • Local Institution - 279
        • Contact:
          • Site 279
    • Tel Aviv
      • Tel-Aviv, Tel Aviv, Israel, 64239
        • Completed
        • Local Institution - 278
  • Italy
      • Genova, Italy, 16132
        • Completed
        • Local Institution - 257
      • Milano, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
        • Contact:
          • Maurizio Vecchi, Site 254
          • Phone Number: +39 02-55033418
      • Napoli, Italy, 80131
        • Withdrawn
        • Local Institution - 256
      • Padova, Italy, 35128
        • Recruiting
        • Local Institution - 255
        • Contact:
          • Site 255
      • Pisa, Italy, 56100
        • Recruiting
        • Local Institution - 252
        • Contact:
          • Site 252
      • Rome, Italy, 00161
        • Recruiting
        • Azienda Policlinico Umberto I
        • Contact:
          • Salvatore Oliva, Site 253
  • Japan
      • Akita-shi, Japan, 010-8543
        • Recruiting
        • Akita University Hospital
        • Contact:
          • Katsunori Iijima, Site 593
      • Isehara City, Kanagawa, Japan, 259-1193
        • Recruiting
        • Local Institution - 606
        • Contact:
          • Site 606
      • Kobe, Japan, 650-0017
        • Recruiting
        • Kobe University Hospital
        • Contact:
          • Yuzo Kodama, Site 597
      • Maebashi, Japan, 371-8511
        • Recruiting
        • Local Institution - 598
        • Contact:
          • Site 598
      • Nagoya, Japan, 457-8511
        • Withdrawn
        • Local Institution - 604
      • Nagoya, Japan, 467-8602
        • Recruiting
        • Local Institution - 607
        • Contact:
          • Site 607
      • Niigata-shi, Japan, 951-8510
        • Withdrawn
        • Local Institution - 592
      • Okayama-Shi, Japan, 700-8505
        • Recruiting
        • Local Institution - 603
        • Contact:
          • Site 603
      • Osaka, Japan, 545-8586
        • Withdrawn
        • Local Institution - 591
      • Shibukawa, Japan, 377-8577
        • Withdrawn
        • Local Institution - 601
      • Shinjuku-Ku, Japan, 162-8655
        • Recruiting
        • Center Hospital of the National Center for Global Health and Medicine
        • Contact:
          • Junichi Akiyama, Site 602
      • Tokyo, Japan, 108-8329
        • Recruiting
        • International University of Health and Werfare Mita Hospital
        • Contact:
          • Mikinori Kataoka, Site 605
      • Toyoake, Japan, 470-1192
        • Withdrawn
        • Local Institution - 596
      • Yamagata, Japan, 990-9585
        • Recruiting
        • Yamagata University Hospital
        • Contact:
          • Yasuhiko Abe, Site 590
    • Hyogo
      • Nishinomiya, Hyogo, Japan, 663-8501
        • Recruiting
        • Local Institution - 600
        • Contact:
          • Site 600
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8603
        • Recruiting
        • Nippon Medical School Hospital
        • Contact:
          • Katsuhiko Iwakiri, Site 595
      • Setagaya-ku, Tokyo, Japan, 157-8535
        • Recruiting
        • Local Institution - 599
        • Contact:
          • Site 599
  • Poland
      • Bydgoszcz, Poland, 85-079
        • Completed
        • Local Institution - 385
      • Częstochowa, Poland, 42-202
        • Completed
        • Local Institution - 389
      • Gdansk, Poland, 80-382
        • Recruiting
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
        • Contact:
          • Marek Cesarz, Site 390
      • Katowice, Poland, 40-040
        • Recruiting
        • Local Institution - 388
        • Contact:
          • Site 388
      • Lódz, Poland, 90-127
        • Completed
        • Local Institution - 392
      • Szczecin, Poland, 71-270
        • Withdrawn
        • Local Institution - 382
      • Warsaw, Poland, 04-501
        • Recruiting
        • WIP Warsaw IBD Point
        • Contact:
          • Jaroslaw Kierkus, Site 383
      • Warszawa, Poland, 00-635
        • Recruiting
        • Local Institution - 387
        • Contact:
          • Site 387
      • Warszawa, Poland, 01-192
        • Recruiting
        • Local Institution - 393
        • Contact:
          • Site 393
      • Wroclaw, Poland, 50-556
        • Withdrawn
        • Local Institution - 386
      • Wroclaw, Poland, 51-162
        • Completed
        • Local Institution - 384
      • Wroclaw, Poland, 50-088
        • Recruiting
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
        • Contact:
          • Anna Sidorowicz-Bialynicka, Site 391
  • Portugal
      • Lisboa, Portugal, 1169-045
        • Recruiting
        • Local Institution - 307
        • Contact:
          • Site 307
      • Lisboa, Portugal, 1649-035
        • Recruiting
        • Centro Hospitalar Lisboa Norte EPE Hospital de Santa Maria
        • Contact:
          • Celia Costa, Site 305
      • Porto, Portugal, 4200-319
        • Recruiting
        • Centro Hospitalar de São João, E.P.E.
        • Contact:
          • Eunice Trindade, Site 308
      • Porto, Portugal, 4099-001
        • Not yet recruiting
        • Local Institution - 306
        • Contact:
          • Site 306
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Local Institution - 408
        • Contact:
          • Site 408
      • Cordoba, Spain, 14001
        • Recruiting
        • Local Institution - 410
        • Contact:
          • Site 410
      • Madrid, Spain, 28006
        • Recruiting
        • Local Institution - 409
        • Contact:
          • Site 409
      • Madrid, Spain, 28046
        • Recruiting
        • Local Institution - 413
        • Contact:
          • Site 413
      • Marbella, Spain, 29603
        • Completed
        • Local Institution - 411
      • Sevilla, Spain, 41013
        • Recruiting
        • Local Institution - 412
        • Contact:
          • Site 412
  • Switzerland
      • Lausanne, Switzerland, 1011
        • Recruiting
        • Chuv Bh-04
        • Contact:
          • Alain Schoepfer, Site 357
      • Liestal, Switzerland, 4410
        • Withdrawn
        • Local Institution - 356
  • United Kingdom
      • Belfast Northern Ireland, United Kingdom, BT9 7AB
        • Recruiting
        • Belfast Health and Social Care Trust
        • Contact:
          • Inder Mainie, Site 228
      • Birmingham, United Kingdom, B15 2SQ
        • Completed
        • Local Institution - 231
      • Cambridge, United Kingdom, CB2 2 QQ
        • Withdrawn
        • Local Institution - 229
      • Cardiff, United Kingdom, CF15 9SS
        • Completed
        • Local Institution - 234
      • Chorley, United Kingdom, PR7 7NA
        • Completed
        • Local Institution - 235
      • Hardwick, United Kingdom, TS19 8PE
        • Withdrawn
        • Local Institution - 232
      • Hexam, United Kingdom, NE46 1QJ
        • Completed
        • Local Institution - 233
      • Liverpool, United Kingdom, L22 0LG
        • Completed
        • Local Institution - 236
      • Manchester, United Kingdom, M15 6SX
        • Recruiting
        • Local Institution - 237
        • Contact:
          • Site 237
      • Manchester, United Kingdom, M13 9WL
        • Withdrawn
        • Local Institution - 230
      • Southampton, United Kingdom, SO16 6YD
        • Withdrawn
        • Local Institution - 226
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211-1320
        • Completed
        • Local Institution - 144
      • Tuscaloosa, Alabama, United States, 35406
        • Withdrawn
        • Gastro Care PC - CAR
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Phoenix Childrens Hospital
        • Contact:
          • Shauna Schroeder, Site 082
          • Phone Number: 602-933-0940
      • Phoenix, Arizona, United States, 85020-4348
        • Completed
        • Local Institution - 147
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic Scottsdale
        • Contact:
          • Jennifer Horsley-Silva, Site 041
      • Tucson, Arizona, United States, 85715
        • Recruiting
        • Del Sol Research Management
        • Contact:
          • Bassel Kisso, Site 029
          • Phone Number: 520-318-1236
      • Tucson, Arizona, United States, 85723-0001
        • Withdrawn
        • MetroHealth Medical Center
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Recruiting
        • Arkansas Gastroenterology, P.A.
        • Contact:
          • Scott Wofford, Site 165
    • California
      • Lancaster, California, United States, 93534
        • Recruiting
        • OM Research
        • Contact:
          • Jatinder Pruthi, Site 075
          • Phone Number: 661-388-2239
      • Los Angeles, California, United States, 90067
        • Recruiting
        • GastroIntestinal BioSciences
        • Contact:
          • Nicholas Karyotakis, Site 047
          • Phone Number: 310-766-2079
      • Oakland, California, United States, 94609
        • Withdrawn
        • UCSF Benioff Children's Hospital Oakland
      • Palm Springs, California, United States, 92262
        • Withdrawn
        • Palmtree Clinical Research
      • Poway, California, United States, 92064-2021
        • Withdrawn
        • Alliance Clinical Research, LLC
      • San Diego, California, United States, 92103-5639
        • Recruiting
        • SDG Clinical Research, Inc.
        • Contact:
          • Sajiv Chandradas, Site 160
      • San Diego, California, United States, 92114
        • Withdrawn
        • Precision Research Institute, LLC
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Childrens Hospital Colorado
        • Contact:
          • Nathalie Nguyen, Site 068
          • Phone Number: 720-777-6669
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Peak Gastroenterology Associates
        • Contact:
          • Bhaktasharan Patel, Site 067
          • Phone Number: 719-310-6719
      • Denver, Colorado, United States, 80218
        • Withdrawn
        • Rocky Mountain Pediatric Gastroenterology
      • Littleton, Colorado, United States, 80120-5641
        • Withdrawn
        • Local Institution - 170
      • Wheat Ridge, Colorado, United States, 80033
        • Recruiting
        • Western States Clinical Research Inc
        • Contact:
          • Jeffrey Rumbyrt, Site 128
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Recruiting
        • Connecticut Clinical Research Foundation
        • Contact:
          • Salam Zakko, Site 101
          • Phone Number: 860-585-9848
      • Farmington, Connecticut, United States, 06030
        • Recruiting
        • University of Connecticut
        • Contact:
          • Houman Rezaizadeh, Site 076
          • Phone Number: 860-679-7889
      • Hamden, Connecticut, United States, 06518
        • Recruiting
        • Medical Research Center of Connecticut LLC
        • Contact:
          • Paul Feuerstadt, Site 156
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Withdrawn
        • Children's National Medical Center
    • Florida
      • Clearwater, Florida, United States, 33756-3839
        • Recruiting
        • Gastro Florida
        • Contact:
          • Michael Weiss, Site 099
          • Phone Number: 239-275-8882
      • Inverness, Florida, United States, 34452
        • Recruiting
        • Nature Coast Clinical Research LLC
        • Contact:
          • Siddharth Mathur, Site 036
          • Phone Number: 352-341-2100
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Encore Borland-Groover Clinical Research
        • Contact:
          • Michael Ibach, Site 042
          • Phone Number: 904-680-0871
      • Miami, Florida, United States, 33032
        • Withdrawn
        • Homestead Associates In Research Inc
      • Miami, Florida, United States, 33144-2035
        • Recruiting
        • A Plus Research Inc
        • Contact:
          • Carlos Ramos, Site 138
          • Phone Number: 523-618-9362
      • North Miami Beach, Florida, United States, 33162
        • Withdrawn
        • Med-Care Research
      • Orlando, Florida, United States, 32806
        • Withdrawn
        • Arnold Palmer Hospital for Children
      • Orlando, Florida, United States, 32825
        • Withdrawn
        • Gastroenterology Consultants of Central Florida - CAR
      • Orlando, Florida, United States, 32806-1041
        • Completed
        • Local Institution - 146
      • Pinellas Park, Florida, United States, 33781-3228
        • Completed
        • Local Institution - 169
      • Plantation, Florida, United States, 33324-3345
        • Recruiting
        • Asthma, Allergy Care Center of Florida
        • Contact:
          • Shahnaz Fatteh, Site 168
          • Phone Number: 954-723-0334
      • Port Orange, Florida, United States, 32127
        • Recruiting
        • Advanced Medical Research Center
        • Contact:
          • Ammar Hemaidan, Site 037
      • Sweetwater, Florida, United States, 33172-2741
        • Withdrawn
        • US Associates in Research Inc
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Children's Center for Digestive Healthcare
        • Contact:
          • Jeffrey Lewis, Site 054
          • Phone Number: 404-503-2279
      • Atlanta, Georgia, United States, 30328
        • Recruiting
        • AES - DRS - Synexus Clinical Research US, Inc. - Atlanta
        • Contact:
          • Muhammad Munir, Site 171
      • Atlanta, Georgia, United States, 30322
        • Withdrawn
        • Emory University School of Medicine
      • Macon, Georgia, United States, 31201
        • Recruiting
        • Gastroenterology Associates Of Central Georgia LLC
        • Contact:
          • Shahriar Sedghi, Site 117
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Recruiting
        • Grand Teton Research Group PLLC
        • Contact:
          • Larry Evans, Site 024
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University Feinberg School of Medicine
        • Contact:
          • Ikuo Hirano, Site 039
      • Chicago, Illinois, United States, 60637
        • Withdrawn
        • University of Chicago
      • Chicago, Illinois, United States, 60611
        • Withdrawn
        • Ann and Robert H Lurie Childrens Hospital of Chicago
      • Gurnee, Illinois, United States, 60031-5711
        • Recruiting
        • Illinois Gastroenterology Group- Gurnee (GI Allian
        • Contact:
          • Jonathan Rosenberg, Site 167
          • Phone Number: 847-244-2960
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Withdrawn
        • Indiana University (IU) Health Physicians - IU Health Neuroscience Center
      • New Albany, Indiana, United States, 47150
        • Withdrawn
        • Gastroenterology Health Partners PLLC
    • Iowa
      • Clive, Iowa, United States, 50325
        • Recruiting
        • Iowa Digestive Disease Center
        • Contact:
          • Rajalakshmi Iyer, Site 127
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals and Clinics
        • Contact:
          • Rami El Abiad, Site 094
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
          • Reza Hejazi, Site 035
          • Phone Number: 915-545-3901
    • Kentucky
      • Florence, Kentucky, United States, 41042
        • Completed
        • Local Institution - 046
      • Louisville, Kentucky, United States, 40202
        • Withdrawn
        • University of Louisville
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Recruiting
        • Gastroenterology Associates LLC
        • Contact:
          • Satyaprasad Alapati, Site 003
          • Phone Number: 22592711907850
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • Clinical Trials Management LLC
        • Contact:
          • David Dulitz, Site 020
          • Phone Number: 504-455-1310
      • New Orleans, Louisiana, United States, 70121
        • Withdrawn
        • Ochsner Children's Health Center
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Withdrawn
        • Johns Hopkins University
      • Catonsville, Maryland, United States, 21228
        • Withdrawn
        • Digestive Disease Associates, PA
      • Columbia, Maryland, United States, 21045
        • Completed
        • Local Institution - 164
      • Glen Burnie, Maryland, United States, 21061
        • Recruiting
        • Woodholme Gastroenterology Associates
        • Contact:
          • Kenolisa Onwueme, Site 070
      • Hagerstown, Maryland, United States, 21742
        • Completed
        • Local Institution - 012
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Withdrawn
        • Boston Children's Hospital
      • Boston, Massachusetts, United States, 02115
        • Withdrawn
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02110
        • Recruiting
        • Boston Specialists
        • Contact:
          • John Leung, Site 053
          • Phone Number: 617-636-2379
      • Boston, Massachusetts, United States, 02114
        • Withdrawn
        • Massachusetts General Hospital / Dana-Farber Cancer Institute
      • Framingham, Massachusetts, United States, 01702
        • Withdrawn
        • Greater Boston Gastroenterology PC
      • South Dartmouth, Massachusetts, United States, 02747
        • Recruiting
        • FC Research LLC
        • Contact:
          • Paul Sepe, Site 083
      • Springfield, Massachusetts, United States, 01199
        • Withdrawn
        • Baystate Medical Center
      • Worcester, Massachusetts, United States, 01655
        • Completed
        • Local Institution - 009
    • Michigan
      • Troy, Michigan, United States, 48098
        • Withdrawn
        • Clinical Research Institute of Michigan
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • Gastroenterology Associates of Western Michigan PLC
        • Contact:
          • Allan Coates, Site 014
          • Phone Number: 616-328-5344
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Recruiting
        • Minnesota Gastroenterology
        • Contact:
          • Benjamin Mitlyng, Site 115
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Diana Snyder, Site 049
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Withdrawn
        • GI Associates and Endoscopy Center-GI Clinical Research Department
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Mid America Gastrointestinal Consultants
        • Contact:
          • Hillary Bownik, Site 007
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University Siteman Cancer Center
        • Contact:
          • Prakash Gyawali, Site 032
          • Phone Number: 314-747-3969
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University Of Nebraska Medical Center
        • Contact:
          • Alexander Hewlett, Site 038
    • Nevada
      • Reno, Nevada, United States, 89511-2060
        • Withdrawn
        • Advanced Research Institute - Reno
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center
        • Contact:
          • Michael Curley, Site 015
          • Phone Number: 603-650-5261
    • New Jersey
      • Ocean City, New Jersey, United States, 07712
        • Withdrawn
        • Atlantic Research Center LLC
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106-4725
        • Recruiting
        • New Mexico Clinical Research and Osteoporosis Center
        • Contact:
          • Lance Rudolph, Site 139
          • Phone Number: 505-855-5505
    • New York
      • Great Neck, New York, United States, 11023
        • Recruiting
        • Long Island Gastrointestinal Research Group LLP
        • Contact:
          • Michael Goldstein, Site 028
          • Phone Number: 516-482-5976
      • Hartsdale, New York, United States, 10530
        • Withdrawn
        • Drug Trials America
      • New York, New York, United States, 10029
        • Withdrawn
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10075
        • Withdrawn
        • Lenox Hill Hospital
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Medical Center
        • Contact:
          • Rita Knotts, Site 051
          • Phone Number: 888-888-8888
      • New York, New York, United States, 10017-2009
        • Withdrawn
        • Dr. Jeffrey Crespin, MD - New York - CAR
      • New York, New York, United States, 10032-3725
        • Withdrawn
        • Columbia Presbyterian Medical Center
      • Rochester, New York, United States, 14625-2664
        • Withdrawn
        • Rochester Gastroenterology: Devgun Surinder MD
      • Syracuse, New York, United States, 13210
        • Recruiting
        • Syracuse VA Medical Center
        • Contact:
          • Uma Murthy, Site 142
      • Syracuse, New York, United States, 13210-2306
        • Recruiting
        • Hill Medical Center
        • Contact:
          • Uma Murthy, Site 116
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina at Chapel Hill
        • Contact:
          • Evan Dellon, Site 016
      • Charlotte, North Carolina, United States, 28277
        • Withdrawn
        • Clinical Research of Charlotte
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University Medical Center
        • Contact:
          • David Leiman, Site 106
          • Phone Number: 919-668-7924
      • Greensboro, North Carolina, United States, 27405
        • Completed
        • Local Institution - 131
      • Kinston, North Carolina, United States, 28501-3851
        • Withdrawn
        • Atlantic Medical Group - Kinston - CAR
    • Ohio
      • Beavercreek, Ohio, United States, 45440-3237
        • Recruiting
        • Dayton Gastroenterology, Inc
        • Contact:
          • Ilyas Ikramuddin, Site 130
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
          • Juan Abonia, Site 001
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati Medical Center
        • Contact:
          • Vidhya Kunnathur, Site 052
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • GCGA Physicians, LLC dba/Gastro Health Research
        • Contact:
          • Pradeep Bekal, Site 006
          • Phone Number: 513-872-4549
      • Cleveland, Ohio, United States, 44195
        • Withdrawn
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44195
        • Withdrawn
        • The Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43235
        • Recruiting
        • Optimed Research Ltd
        • Contact:
          • Donald McNeil, Site 059
          • Phone Number: 614-505-3030
      • Columbus, Ohio, United States, 43212-3119
        • Withdrawn
        • AES - DRS - Synexus Clinical Research US, Inc. - Columbus
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112-5550
        • Completed
        • Local Institution - 166
    • Oregon
      • Medford, Oregon, United States, 97504-9741
        • Withdrawn
        • Velocity Clinical Research - Grants Pass - ERN - PPDS
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Health Milton S. Hershey Medical Center
        • Contact:
          • Kofi Clarke, Site 120
          • Phone Number: 717-531-0630
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania - Perelman Center for Advanced Medicine
        • Contact:
          • Gary Falk, Site 025
      • Philadelphia, Pennsylvania, United States, 19107
        • Withdrawn
        • Thomas Jefferson University - Clinical Research Institute
      • Philadelphia, Pennsylvania, United States, 19104
        • Withdrawn
        • The Children's Hospital of Philadelphia (CHOP)
      • Pottsville, Pennsylvania, United States, 17901-3636
        • Recruiting
        • Glenn S Freed, DO - CAR
        • Contact:
          • Glenn Freed, Site 155
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Withdrawn
        • University Gastroenterology
    • South Carolina
      • Anderson, South Carolina, United States, 29621-2062
        • Completed
        • Local Institution - 143
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • Prisma Health - Upstate
        • Contact:
          • Jonathan Markowitz, Site 057
          • Phone Number: 864-454-5125
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Completed
        • Local Institution - 114
      • Nashville, Tennessee, United States, 37212
        • Recruiting
        • Vanderbilt University
        • Contact:
          • Michael Vaezi, Site 095
    • Texas
      • Cedar Park, Texas, United States, 78613
        • Recruiting
        • Texas Digestive Disease Consultants Dallas
        • Contact:
          • Dustin Kiker, Site 105
          • Phone Number: 512-341-0900
      • Dallas, Texas, United States, 75235
        • Withdrawn
        • Childrens Medical Center
      • Dallas, Texas, United States, 75234-7858
        • Completed
        • Local Institution - 148
      • Fort Sam Houston, Texas, United States, 78235-8200
        • Withdrawn
        • Brooke Army Medical Center Francis Street Medical Center
      • Fort Worth, Texas, United States, 76104
        • Withdrawn
        • Cook Childrens Medical Center
      • Houston, Texas, United States, 77079-2211
        • Recruiting
        • Houston Endoscopy and Research Center
        • Contact:
          • Vikram Jayanty, Site 112
          • Phone Number: 713-932-9200
      • Rockwell, Texas, United States, 75032
        • Withdrawn
        • Digestive Health Associates of Texas (DHAT)
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Southern Star Research Institute LLC
        • Contact:
          • Jeff Bullock, Site 008
          • Phone Number: 210-581-2812
      • Southlake, Texas, United States, 76092
        • Recruiting
        • Texas Digestive Disease Consultants - Southlake
        • Contact:
          • Timothy Ritter, Site 077
      • Tyler, Texas, United States, 75701
        • Recruiting
        • Tyler Research Institute, LLC
        • Contact:
          • George DuVall, Site 104
          • Phone Number: 903-597-2314
    • Utah
      • Draper, Utah, United States, 84020-5645
        • Withdrawn
        • Intermountain Clinical Research
      • Ogden, Utah, United States, 84403-3323
        • Recruiting
        • Ogden Clinic Gastrenterology - CAR
        • Contact:
          • Chad Gonzales, Site 125
      • Ogden, Utah, United States, 84405
        • Withdrawn
        • Advanced Research Institute-South Ogden
      • Salt Lake City, Utah, United States, 84132
        • Withdrawn
        • University of Utah Primary Children's Medical Center
      • Salt Lake City, Utah, United States, 84132
        • Withdrawn
        • University of Utah School of Medicine
      • Sandy, Utah, United States, 84092-4350
        • Withdrawn
        • Granite Peaks Gastroenterology
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Withdrawn
        • University of Vermont Medical Center Gastro
    • Virginia
      • Leesburg, Virginia, United States, 20176
        • Withdrawn
        • Emeritas Research Group
      • Lynchburg, Virginia, United States, 24502
        • Recruiting
        • Blue Ridge Medical Research
        • Contact:
          • Larry Clark, Site 013
          • Phone Number: 434-455-8675
      • Richmond, Virginia, United States, 23249
        • Recruiting
        • McGuire Veterans Affairs Medical Center
        • Contact:
          • Joseph Spataro, Site 064
          • Phone Number: 804-675-5021
      • Roanoke, Virginia, United States, 24013
        • Withdrawn
        • Carilion Clinic
    • Washington
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Velocity Clinical Research - Spokane - ERN - PPDS
        • Contact:
          • Sarah Smiley, Site 137
      • Vancouver, Washington, United States, 98664
        • Recruiting
        • Vancouver Clinic Inc PS
        • Contact:
          • Jason Etzel, Site 023
          • Phone Number: 360-397-3168
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Withdrawn
        • University of Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Withdrawn
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Withdrawn
        • Aurora Saint Lukes Medical Center
    • Wyoming
      • Casper, Wyoming, United States, 10456
        • Withdrawn
        • Gastroenterology Associates, PC - Casper - CAR

Participation Criteria

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

Eligibility Criteria

Ages Eligible for Study

12 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

    1. Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Induction Phase and has completed Week 24 of the Induction Phase; OR
    2. Subject completed the Induction Phase and does not qualify for entry to the Maintenance Phase for reasons other than a severe EoE flare; OR
    3. Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Maintenance Phase and completed Week 48 of the Maintenance Phase; OR
    4. Subject completed Week 48 of the Maintenance Phase
  • OR Subject must have participated in Study CC-93538-DDI-001 and completed assessments through the end of treatment visit
  • Demonstrated ≥ 80% and ≤ 120% overall compliance with required investigational product dosing during the prior studies.
  • Did not permanently discontinue investigational product in the prior studies and/or did not experience any clinically significant adverse events related to Investigational Product that would preclude further dosing in the opinion of the Investigator.
  • 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 the CC-93538-EE-001 or CC-93538-DDI-001 studies, 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 the CC-93538-EE-001 or CC-93538-DDI-001 studies are not eligible to participate, 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 parasitic/helminthic infection or a suspected parasitic/helminthic infections or chronic infection (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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Administration of CC-93538
Participants are administered CC-93538 dose subcutaneously once weekly
Drug: CC-93538
CC-93538
Other Names:
  • BMS-986355
  • cendakimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
For a minimum of 28 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
For a minimum of 28 months

Collaborators and Investigators

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

Sponsor

Celgene

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

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

Helpful Links

Study record dates

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

Study Major Dates

Study Start (Actual)

September 14, 2021

Primary Completion (Estimated)

June 9, 2026

Study Completion (Estimated)

September 29, 2026

Study Registration Dates

First Submitted

July 28, 2021

First Submitted That Met QC Criteria

July 28, 2021

First Posted (Actual)

August 5, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-93538-EE-002
  • 2020-004335-24 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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/

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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

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