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

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.

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

Study Overview

• Status: Active, not recruiting
• Conditions: Eosinophilic Esophagitis
• Intervention / Treatment: Drug: CC-93538; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 430
• Phase: Phase 3

Contacts and Locations

• 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 the NCT# and Site #

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1199ABB
    • Local Institution - 697
  • 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
      • Fiona Stanley Hospital
• 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 an der Havel, Germany, 14770
    • Local Institution - 332
  • Frankfurt am Main, Germany, 60313
    • Local Institution - 339
  • Hamburg, Germany, 20249
    • Local Institution - 336
  • Leipzig, Germany, 04103
    • Local Institution - 333
  • Leipzig, Germany, 04129
    • Local Institution - 338
  • Munchen, Germany, 81675
    • Local Institution - 337
  • München, Germany, 80639
    • Local Institution - 340
• 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
  • Tel Aviv, Israel, 64239
    • Local Institution - 278
  • Zerifin, Israel, 70300
    • Local Institution - 279
• Italy
  • Genova, Italy, 16132
    • Local Institution - 257
  • Milano, 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-shi, 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, 457-8511
    • Local Institution - 604
  • Nagoya, Japan, 467-8602
    • Local Institution - 607
  • Niigata-shi, Japan, 951-8510
    • Local Institution - 592
  • Okayama-Shi, Japan, 700-8505
    • Local Institution - 603
  • Osaka, Japan, 545-8586
    • Local Institution - 591
  • Shibukawa, Japan, 377-8577
    • Local Institution - 601
  • Shinjuku-Ku, Japan, 162-8655
    • Local Institution - 602
  • Tokyo, Japan, 108-8329
    • Local Institution - 605
  • Toyoake, Japan, 470-1192
    • Local Institution - 596
  • Yamagata, Japan, 990-9585
    • Local Institution - 590
  • Hyogo
    • Nishinomiya, Hyogo, 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, 00-728
    • Local Institution - 383
  • Warszawa, Poland, 01-192
    • Local Institution - 393
  • Warszawa, Poland, 00-189
    • Local Institution - 387
  • Wroclaw, Poland, 50-556
    • Local Institution - 386
  • Wroclaw, Poland, 51-162
    • Local Institution - 384
  • Wrocław, Poland, 50-381
    • Local Institution - 391
• Portugal
  • Lisboa, Portugal, 1169-045
    • Local Institution - 307
  • Lisboa, 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
  • Cordoba, Spain, 14001
    • Local Institution - 410
  • Madrid, Spain, 28006
    • Local Institution - 409
  • Madrid, Spain, 28046
    • Local Institution - 413
  • Marbella, Spain, 29603
    • Local Institution - 411
  • Sevilla, 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
  • Southampton, United Kingdom, SO16 6YD
    • Local Institution - 226
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211-1320
      • Local Institution - 144
    • Tuscaloosa, Alabama, United States, 35406
      • Local Institution - 158
  • 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
    • Oakland, California, United States, 94609
      • Local Institution - 084
    • 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
    • Denver, Colorado, United States, 80218
      • Local Institution - 092
    • Littleton, Colorado, United States, 80120-5641
      • Local Institution - 170
    • 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, 33032
      • Local Institution - 161
    • Miami, Florida, United States, 33144-2035
      • Local Institution - 138
    • North Miami Beach, Florida, United States, 33162
      • Local Institution - 110
    • Orlando, Florida, United States, 32806-1041
      • Local Institution - 146
    • Orlando, Florida, United States, 32806
      • Local Institution - 088
    • Orlando, Florida, United States, 32825
      • Local Institution - 133
    • 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
    • Sweetwater, Florida, United States, 33172-2741
      • Local Institution - 140
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Local Institution - 043
    • 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
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Local Institution - 118
  • 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
    • Louisville, Kentucky, United States, 40202
      • Local Institution - 019
  • 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
    • Baltimore, Maryland, United States, 21224
      • Local Institution - 109
    • Catonsville, Maryland, United States, 21228
      • Local Institution - 065
    • 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, 02110
      • Local Institution - 053
    • Boston, Massachusetts, United States, 02114
      • Local Institution - 097
    • Framingham, Massachusetts, United States, 01702
      • Local Institution - 017
    • South Dartmouth, Massachusetts, United States, 02747
      • Local Institution - 083
    • Springfield, Massachusetts, United States, 01199
      • Local Institution - 081
    • Worcester, Massachusetts, United States, 01655
      • Local Institution - 009
  • Michigan
    • Troy, Michigan, United States, 48098
      • Local Institution - 098
    • 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
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Local Institution - 034
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Local Institution - 007
    • Saint Louis, Missouri, United States, 63110-1010
      • Local Institution - 032
  • Nebraska
    • Omaha, Nebraska, United States, 68198-6805
      • 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
      • Local Institution - 051
    • New York, New York, United States, 10017-2009
      • Local Institution - 154
    • New York, New York, United States, 10029
      • Local Institution - 011
    • 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
    • Charlotte, North Carolina, United States, 28277
      • Local Institution - 045
    • Durham, North Carolina, United States, 27705
      • Local Institution - 106
    • Greensboro, North Carolina, United States, 27405-6950
      • Local Institution - 131
    • Kinston, North Carolina, United States, 28501-3851
      • Local Institution - 126
  • Ohio
    • Beavercreek, Ohio, United States, 45440-3237
      • Dayton Gastroenterology, Inc
    • Cincinnati, Ohio, United States, 45219
      • Local Institution - 006
    • Cincinnati, Ohio, United States, 45229
      • Local Institution - 001
    • Cincinnati, Ohio, United States, 45267
      • Local Institution - 052
    • Cleveland, Ohio, United States, 44195
      • Local Institution - 072
    • Columbus, Ohio, United States, 43212-3119
      • Local Institution - 145
    • 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
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Local Institution - 066
  • 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
    • Rockwell, Texas, United States, 75032
      • Local Institution - 079
    • 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
    • Draper, Utah, United States, 84020-5645
      • Local Institution - 157
    • Ogden, Utah, United States, 84403-3323
      • Local Institution - 125
    • Salt Lake City, Utah, United States, 84132
      • Local Institution - 074
  • Virginia
    • Leesburg, Virginia, United States, 20176
      • Local Institution - 027
    • Lynchburg, Virginia, United States, 24502
      • Local Institution - 013
    • Richmond, Virginia, United States, 23249
      • Local Institution - 064
    • Roanoke, Virginia, United States, 24013
      • Local Institution - 134
  • Washington
    • Spokane, Washington, United States, 99204
      • Local Institution - 137
    • Vancouver, Washington, United States, 98664
      • Local Institution - 023
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Local Institution - 085
    • Milwaukee, Wisconsin, United States, 53226
      • Local Institution - 060
  • Wyoming
    • Casper, Wyoming, United States, 10456
      • Local Institution - 121

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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; Other Names: RPC4046
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 Names: RPC4046; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in DD Clinical Response	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	At week 24
Eosinophil Histologic Response (≤ 6/hpf)	The proportion of participants with eosinophilic histologic response defined as a peak esophageal eosinophil count ≤ 6/high-power field (hpf) at Week 24	At week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eosinophil Histologic Response (< 15/hpf)	The proportion of participants with eosinophilic histologic response defined as a peak esophageal eosinophil count < 15/hpf at Week 24	At week 24
EoE Endoscopic Reference Score (EREFS)	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	At week 24
EoEHSS Grade Score	The mean change in the mean adjusted histology grade score as measured by the EoE histology scoring system (EoEHSS) from baseline to Week 24	At week 24
EoEHSS Stage Score	The mean change in the mean adjusted histology stage score as measured by the EoE histology scoring system (EoEHSS) from baseline to Week 24	At week 24
mDSD Composite Score	The mean change in the modified Daily Symptom Diary (mDSD) composite score from baseline to Week 24	At week 24
DD Clinical Responder Definition	The proportion of participants with a ≥ 50% decrease in dysphagia days (DD) from baseline at Week 24	At week 24
Kinetics and Onset of Clinical Response_DD	The mean change in dysphagia days (DD) over time from baseline through Week 24	Through week 24
Kinetics and Onset of Clinical Response_mDSD	The mean change in the modified Daily Symptom Diary (mDSD) composite score over time from baseline through Week 24	Through week 24
Time to Event _EoE Flare	The time to event of Eosinophilic Esophagitis (EoE) flare during the Induction Phase	Through week 24
Time to Event_Rescue Therapy	The time to event of use of rescue therapy during the Induction Phase	Through Week 24
Proportion of Participants with Event-EoE Flare	The proportion of participants with an EoE flare during the Induction Phase	Through week 24
Proportion of Participants with Event_Rescue Therapy	The proportion of participants with use of rescue therapy during the Induction Phase	Through week 24
Incidence of Adverse Events (AEs)	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	Through week 48
Assessment of Immunogenicity through measurement of serum concentrations of anti-drug antibodies to CC-93538	Evaluated by the presence of anti-drug antibodies to CC-93538	Through week 48
Pharmacokinetics- Ctrough	Serum trough concentration Measurements of trough concentrations of CC-93538 in participants with EoE during the Induction Phase	Through week 24
Change in DD Clinical Response	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	At week 48
Eosinophil Histologic Response (≤ 6/hpf)	The proportion of participants with eosinophilic histologic response defined as a peak esophageal eosinophil count ≤ 6/high-power field (hpf) at Week 48	At week 48
Eosinophil Histologic Response (< 15/hpf)	The proportion of participants with eosinophilic histologic response defined as a peak esophageal eosinophil count < 15/hpf at Week 48	At week 48
Mean change in EREFS	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	At week 48
EoEHSS Grade Score	The mean change in the mean adjusted histology grade score as measured by the EoE histology scoring system (EoEHSS) from baseline to Week 48	At week 48
EoEHSS Stage Score	The mean change in the mean adjusted histology stage score as measured by the EoE histology scoring system (EoEHSS) from baseline to Week 48	At week 48
mDSD Composite Score	The mean change in the modified Daily Symptom Diary (mDSD) composite score from baseline to Week 48	At week 48
Time to event_EoE Flare (Induction and Maintenance Phase)	The time to event of EoE flare during the study	Through week 48
Time to event_rescue therapy (Induction and Maintenance Phase)	The time to event of use of rescue therapy during the study	Through week 48
Proportion of Participants with Event_EoE Flare (Induction and Maintenance Phase)	The proportion of participants with an EoE flare during the study	Through week 48
Proportion of participants with event rescue therapy (Induction and Maintenance Phases)	The proportion of participants with use of rescue therapy during the study	Through week 48
Pharmacokinetics-Ctrough	Measurements of trough concentrations of CC-93538 in participants with EoE during the Maintenance Phase	Through week 48

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): February 22, 2021
• Primary Completion (Actual): January 11, 2024
• Study Completion (Estimated): October 2, 2024

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 11, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Adolescent; Hypersensitivity; Gastroenteritis; Gastrointestinal Diseases; Adult; Esophagitis; Eosinophilic Esophagitis; CC-93538; RPC4046; Eosinophils; Eosinophilia; Esophageal Diseases; Allergic Diseases; Antibody, Monoclonal; Immunologic factors; Physiological Effects of Drugs; cendakimab
• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Hypersensitivity; Esophageal Diseases; Leukocyte Disorders; Eosinophilia; Eosinophilic Esophagitis; Esophagitis
• Other Study ID Numbers: CC-93538-EE-001; U1111-1263-4351 (Registry Identifier: WHO); 2020-004336-16 (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