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

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: Completed
• Conditions: Eosinophilic Esophagitis
• Intervention / Treatment: Drug: CC-93538

• Study Type: Interventional
• Enrollment (Actual): 367
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Mar del Plata, Argentina, B7600DHK
    • Local Institution - 695
  • Quilmes, Argentina, B1878DVB
    • Local Institution - 696
• Australia
  • Fitzroy, Australia, 3065
    • Local Institution - 538
  • Western Australia, Australia, 6056
    • Local Institution - 547
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Local Institution - 548
    • Liverpool, New South Wales, Australia, 2170
      • Local Institution - 554
    • Westmead, New South Wales, Australia, 2145
      • Local Institution - 540
  • Queensland
    • Maroorchydore, Queensland, Australia, 4558
      • Local Institution - 546
    • South Brisbane, Queensland, Australia, 4101
      • Local Institution - 550
    • Woolloongabba, Queensland, Australia, 4102
      • Local Institution - 542
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Local Institution - 552
    • Elizabeth Vale, South Australia, Australia, 05112
      • Local Institution - 545
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Local Institution - 553
    • Footscray, Victoria, Australia, 3011
      • Local Institution - 543
    • Melbourne, Victoria, Australia, 3004
      • Local Institution - 539
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Local Institution - 549
• Austria
  • Burgenland, Austria, 7000
    • Local Institution - 437
  • Graz, Austria, 8036
    • Local Institution - 434
  • Linz, Austria, 4010
    • Local Institution - 436
• Belgium
  • Brussels, Belgium, 1090
    • Local Institution - 515
  • Kortrijk, Belgium, 8500
    • Local Institution - 516
  • Leuven, Belgium, 3000
    • Local Institution - 514
  • West-Vlaanderen, Belgium, 8310
    • Local Institution - 512
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Local Institution - 201
    • Edmonton, Alberta, Canada, T5R 1W2
      • Local Institution - 208
    • Edmonton, Alberta, Canada, T6K 4B2
      • Local Institution - 205
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2K5
      • Local Institution - 203
    • Victoria, British Columbia, Canada, V8V3M9
      • Local Institution - 206
  • Ontario
    • Ottawa, Ontario, Canada, K1H 1E4
      • Local Institution - 207
    • Vaughan, Ontario, Canada, L4L 4Y7
      • Local Institution - 200
• Germany
  • Bayern, Germany, 82418
    • Local Institution - 330
  • Brandenburg, Germany, 14770
    • Local Institution - 332
  • Frankfurt am Main, Germany, 60313
    • Local Institution - 339
  • Leipzig, Germany, 04129
    • Local Institution - 338
  • München, Germany, 81675
    • Local Institution - 337
• Israel
  • Haifa, Israel, 3109601
    • Local Institution - 281
  • Holon, Israel, 5822012
    • Local Institution - 283
  • Jerusalem, Israel, 91031
    • Local Institution - 280
  • Jerusalem, Israel, 91120
    • Local Institution - 282
  • Ẕerifin, Israel, 70300
    • Local Institution - 279
  • Tel Aviv
    • Tel Aviv, Tel Aviv, Israel, 64239
      • Local Institution - 278
• Italy
  • Genova, Italy, 16132
    • Local Institution - 257
  • Milan, Italy, 20122
    • Local Institution - 254
  • Padova, Italy, 35128
    • Local Institution - 255
  • Pisa, Italy, 56100
    • Local Institution - 252
  • Rome, Italy, 00161
    • Local Institution - 253
• Japan
  • Akita, Japan, 010-8543
    • Local Institution - 593
  • Isehara City, Kanagawa, Japan, 259-1193
    • Local Institution - 606
  • Kobe, Japan, 650-0017
    • Local Institution - 597
  • Maebashi, Japan, 371-8511
    • Local Institution - 598
  • Nagoya, Japan, 467-8602
    • Local Institution - 607
  • Okayama, Japan, 700-8505
    • Local Institution - 603
  • Shinjuku-Ku, Japan, 162-8655
    • Local Institution - 602
  • Tokyo, Japan, 108-8329
    • Local Institution - 605
  • Yamagata, Japan, 990-9585
    • Local Institution - 590
  • Hyōgo
    • Nishinomiya, Hyōgo, Japan, 663-8501
      • Local Institution - 600
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8603
      • Local Institution - 595
    • Setagaya-ku, Tokyo, Japan, 157-8535
      • Local Institution - 599
• Poland
  • Bydgoszcz, Poland, 85-079
    • Local Institution - 385
  • Częstochowa, Poland, 42-202
    • Local Institution - 389
  • Gdansk, Poland, 80-382
    • Local Institution - 390
  • Katowice, Poland, 40-040
    • Local Institution - 388
  • Lódz, Poland, 90-127
    • Local Institution - 392
  • Warsaw, Poland, 04-501
    • Local Institution - 383
  • Warsaw, Poland, 00-189
    • Local Institution - 387
  • Warsaw, Poland, 01-192
    • Local Institution - 393
  • Wroclaw, Poland, 51-162
    • Local Institution - 384
  • Wroclaw, Poland, 50-088
    • Local Institution - 391
• Portugal
  • Lisbon, Portugal, 1169-045
    • Local Institution - 307
  • Lisbon, Portugal, 1649-035
    • Local Institution - 305
  • Porto, Portugal, 4099-001
    • Local Institution - 306
  • Porto, Portugal, 4200-319
    • Local Institution - 308
• Spain
  • Barcelona, Spain, 08036
    • Local Institution - 408
  • Córdoba, Spain, 14001
    • Local Institution - 410
  • Madrid, Spain, 28006
    • Local Institution - 409
  • Madrid, Spain, 28046
    • Local Institution - 413
  • Marbella, Spain, 29603
    • Local Institution - 411
  • Seville, Spain, 41013
    • Local Institution - 412
• Switzerland
  • Lausanne, Switzerland, 1011
    • Local Institution - 357
• United Kingdom
  • Belfast Northern Ireland, United Kingdom, BT9 7AB
    • Local Institution - 228
  • Birmingham, United Kingdom, B15 2SQ
    • Local Institution - 231
  • Cardiff, United Kingdom, CF15 9SS
    • Local Institution - 234
  • Chorley, United Kingdom, PR7 7NA
    • Local Institution - 235
  • Hexam, United Kingdom, NE46 1QJ
    • Local Institution - 233
  • Liverpool, United Kingdom, L22 0LG
    • Local Institution - 236
  • Manchester, United Kingdom, M15 6SX
    • Local Institution - 237
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211-1320
      • Local Institution - 144
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Local Institution - 082
    • Phoenix, Arizona, United States, 85020-4348
      • Local Institution - 147
    • Scottsdale, Arizona, United States, 85259
      • Local Institution - 041
    • Tucson, Arizona, United States, 85715
      • Local Institution - 029
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • Local Institution - 165
  • California
    • Lancaster, California, United States, 93534
      • Local Institution - 075
    • Los Angeles, California, United States, 90067
      • Local Institution - 047
    • San Diego, California, United States, 92103-5639
      • Local Institution - 160
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Local Institution - 068
    • Colorado Springs, Colorado, United States, 80907
      • Local Institution - 067
    • Wheat Ridge, Colorado, United States, 80033
      • Local Institution - 128
  • Connecticut
    • Bristol, Connecticut, United States, 06010
      • Local Institution - 101
    • Farmington, Connecticut, United States, 06030
      • Local Institution - 076
    • Hamden, Connecticut, United States, 06518
      • Local Institution - 156
  • Florida
    • Clearwater, Florida, United States, 33756-3839
      • Local Institution - 099
    • Inverness, Florida, United States, 34452
      • Local Institution - 036
    • Jacksonville, Florida, United States, 32256
      • Local Institution - 042
    • Miami, Florida, United States, 33144-2035
      • Local Institution - 138
    • Orlando, Florida, United States, 32806-1041
      • Local Institution - 146
    • Pinellas Park, Florida, United States, 33781-3228
      • Local Institution - 169
    • Plantation, Florida, United States, 33324-3345
      • Local Institution - 168
    • Port Orange, Florida, United States, 32127
      • Local Institution - 037
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Local Institution - 171
    • Atlanta, Georgia, United States, 30342
      • Local Institution - 054
    • Macon, Georgia, United States, 31201
      • Local Institution - 117
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Local Institution - 024
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Local Institution - 039
    • Gurnee, Illinois, United States, 60031-5711
      • Local Institution - 167
  • Iowa
    • Clive, Iowa, United States, 50325
      • Local Institution - 127
    • Iowa City, Iowa, United States, 52242
      • Local Institution - 094
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Local Institution - 035
  • Kentucky
    • Florence, Kentucky, United States, 41042
      • Local Institution - 046
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Local Institution - 003
    • Metairie, Louisiana, United States, 70006
      • Local Institution - 020
    • Metairie, Louisiana, United States, 70006
      • Local Institution - 044
  • Maryland
    • Columbia, Maryland, United States, 21045
      • Local Institution - 164
    • Glen Burnie, Maryland, United States, 21061
      • Local Institution - 070
    • Hagerstown, Maryland, United States, 21742
      • Local Institution - 012
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Local Institution - 053
    • South Dartmouth, Massachusetts, United States, 02747
      • Local Institution - 083
    • Worcester, Massachusetts, United States, 01655
      • Local Institution - 009
  • Michigan
    • Wyoming, Michigan, United States, 49519
      • Local Institution - 014
  • Minnesota
    • Plymouth, Minnesota, United States, 55446
      • Local Institution - 115
    • Rochester, Minnesota, United States, 55905
      • Local Institution - 049
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Local Institution - 007
    • St Louis, Missouri, United States, 63110
      • Local Institution - 032
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Local Institution - 038
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Local Institution - 015
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106-4725
      • Local Institution - 139
  • New York
    • Great Neck, New York, United States, 11023
      • Local Institution - 028
    • New York, New York, United States, 10016-4744
      • Local Institution - 051
    • Syracuse, New York, United States, 13210-2306
      • Local Institution - 116
    • Syracuse, New York, United States, 13210
      • Local Institution - 142
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Local Institution - 016
    • Durham, North Carolina, United States, 27705
      • Local Institution - 106
    • Greensboro, North Carolina, United States, 27405
      • Local Institution - 131
  • Ohio
    • Beavercreek, Ohio, United States, 45440-3237
      • Local Institution - 130
    • Cincinnati, Ohio, United States, 45219
      • Local Institution - 006
    • Cincinnati, Ohio, United States, 45229
      • Local Institution - 001
    • Cincinnati, Ohio, United States, 45267
      • Local Institution - 052
    • Columbus, Ohio, United States, 43235
      • Local Institution - 059
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112-5550
      • Local Institution - 166
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Local Institution - 120
    • Philadelphia, Pennsylvania, United States, 19104
      • Local Institution - 025
    • Pottsville, Pennsylvania, United States, 17901-3636
      • Local Institution - 155
  • South Carolina
    • Anderson, South Carolina, United States, 29621-2062
      • Local Institution - 143
    • Greenville, South Carolina, United States, 29615
      • Local Institution - 057
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Local Institution - 114
    • Nashville, Tennessee, United States, 37212
      • Local Institution - 095
  • Texas
    • Cedar Park, Texas, United States, 78613
      • Local Institution - 105
    • Dallas, Texas, United States, 75234-7858
      • Local Institution - 148
    • Houston, Texas, United States, 77079-2211
      • Local Institution - 112
    • San Antonio, Texas, United States, 78229
      • Local Institution - 008
    • Southlake, Texas, United States, 76092
      • Local Institution - 077
    • Tyler, Texas, United States, 75701
      • Local Institution - 104
  • Utah
    • Ogden, Utah, United States, 84403-3323
      • Local Institution - 125
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Local Institution - 013
    • Richmond, Virginia, United States, 23249
      • Local Institution - 064
  • Washington
    • Spokane, Washington, United States, 99218
      • Local Institution - 137
    • Vancouver, Washington, United States, 98664
      • Local Institution - 023

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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
Number of Participants With Treatment Emergent Adverse Events (TEAE)	An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization.	From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)
Number of Participants With Clinically Significant Maximum Post Baseline Shifts in Laboratory Parameters	Blood samples were collected to assess clinical significant shifts in laboratory parameters. "Normal to High" means at baseline the value is Normal and maximum post baseline value is High.	From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)
Number of Participants With Clinically Meaningful Mean Changes in Vital Signs and Physical Parameters	SBP (Systolic blood Pressure) and DBP (Diastolic Blood Pressure) measured in mmHg and Heart rates measured in beats per minute.	From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Incidence of Treatment Emergent Anti-CEN Antibodies	Blood samples were collected to assess Anti-CEN antibodies. Post-Baseline ADA Positive define as 1) at least 1 positive post-baseline given baseline is negative or missing; or 2) at least 1 positive post-baseline with titer >= 4-fold baseline titer given positive baseline.	From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2022
• Primary Completion (Actual): August 14, 2025
• Study Completion (Actual): August 14, 2025

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 6, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Adolescent; Hypersensitivity; Gastroenteritis; Gastrointestinal Diseases; Adult; Esophagitis; Cendakimab; Eosinophilic Esophagitis; CC-93538; RPC4046; Eosinophils; Eosinophilia; Esophageal Diseases; Allergic Diseases; Antibody, Monoclonal; Immunologic factors; Physiological Effects of Drugs
• Additional Relevant MeSH Terms: Immune System Diseases; Digestive System Diseases; Hypersensitivity, Immediate; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Gastrointestinal Diseases; Hypersensitivity; Gastroenteritis; Esophagitis; Eosinophilic Esophagitis; Eosinophilia; Esophageal Diseases; cendakimab
• 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