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

Sponsor
Celgene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04753697
Collaborator
(none)
399
Enrollment
378
Locations
3
Arms
41.9
Anticipated Duration (Months)
1.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study CC-93538-EE-001 is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC- 93538 in adult and adolescent participants with eosinophilic esophagitis (EoE). The study will incorporate a 24-week Induction Phase followed by a 24-week Maintenance Phase.

Participants will be randomized at the beginning of the study into 3 treatment arms:

  • Placebo for Induction and Maintenance

  • CC-93538 360 mg Subcutaneous (SC) once weekly for Induction followed by 360 mg SC once every other week for Maintenance

  • CC-93538 360 mg SC once weekly for Induction and Maintenance

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
399 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Long-term Controlled Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects With Active Eosinophilic Esophagitis.
Actual Study Start Date :
Feb 22, 2021
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Aug 21, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Administration of CC-93538

CC-93538 360 mg Subcutaneously (SC) once weekly for 24 weeks followed by CC-93538 360 mg SC once weekly for 24 weeks

Drug: CC-93538
Subcutaneous
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

    Outcome Measures

    Primary Outcome Measures

    1. Change in DD Clinical Response [At week 24]

      The mean change in dysphagia days (DD), evaluated over the prior 14-day period using the modified Daily Symptom Diary (mDSD), from baseline to Week 24

    2. Eosinophil Histologic Response (≤ 6/hpf) [At week 24]

      The proportion of participants with eosinophilic histologic response defined as a peak esophageal eosinophil count ≤ 6/high-power field (hpf) at Week 24

    Secondary Outcome Measures

    1. Eosinophil Histologic Response (< 15/hpf) [At week 24]

      The proportion of participants with eosinophilic histologic response defined as a peak esophageal eosinophil count < 15/hpf at Week 24

    2. EoE Endoscopic Reference Score (EREFS) [At week 24]

      The mean change in the endoscopic features of eosinophilic esophagitis (EoE) as measured by the EoE Endoscopic Reference Score (EREFS) from baseline to Week 24

    3. EoEHSS Grade Score [At week 24]

      The mean change in the mean adjusted histology grade score as measured by the EoE histology scoring system (EoEHSS) from baseline to Week 24

    4. EoEHSS Stage Score [At week 24]

      The mean change in the mean adjusted histology stage score as measured by the EoE histology scoring system (EoEHSS) from baseline to Week 24

    5. mDSD Composite Score [At week 24]

      The mean change in the modified Daily Symptom Diary (mDSD) composite score from baseline to Week 24

    6. DD Clinical Responder Definition [At week 24]

      The proportion of participants with a ≥ 50% decrease in dysphagia days (DD) from baseline at Week 24

    7. Kinetics and Onset of Clinical Response_DD [Through week 24]

      The mean change in dysphagia days (DD) over time from baseline through Week 24

    8. Kinetics and Onset of Clinical Response_mDSD [Through week 24]

      The mean change in the modified Daily Symptom Diary (mDSD) composite score over time from baseline through Week 24

    9. Time to Event _EoE Flare [Through week 24]

      The time to event of Eosinophilic Esophagitis (EoE) flare during the Induction Phase

    10. Time to Event_Rescue Therapy [Through Week 24]

      The time to event of use of rescue therapy during the Induction Phase

    11. Proportion of Participants with Event-EoE Flare [Through week 24]

      The proportion of participants with an EoE flare during the Induction Phase

    12. Proportion of Participants with Event_Rescue Therapy [Through week 24]

      The proportion of participants with use of rescue therapy during the Induction Phase

    13. Incidence of Adverse Events (AEs) [Through week 48]

      An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE except for symptoms associated with an EoE flare requiring an EoE Flare Assessment

    14. Assessment of Immunogenicity through measurement of serum concentrations of anti-drug antibodies to CC-93538 [Through week 48]

      Evaluated by the presence of anti-drug antibodies to CC-93538

    15. Pharmacokinetics- Ctrough [Through week 24]

      Serum trough concentration Measurements of trough concentrations of CC-93538 in participants with EoE during the Induction Phase

    16. Change in DD Clinical Response [At week 48]

      The mean change in dysphagia days (DD), evaluated over the prior 14-day period using the modified Daily Symptom Diary (mDSD), from baseline to Week 48

    17. Eosinophil Histologic Response (≤ 6/hpf) [At week 48]

      The proportion of participants with eosinophilic histologic response defined as a peak esophageal eosinophil count ≤ 6/high-power field (hpf) at Week 48

    18. Eosinophil Histologic Response (< 15/hpf) [At week 48]

      The proportion of participants with eosinophilic histologic response defined as a peak esophageal eosinophil count < 15/hpf at Week 48

    19. Mean change in EREFS [At week 48]

      The mean change in the endoscopic features of eosinophilic esophagitis (EoE) as measured by the EoE Endoscopic Reference Score (EREFS) from baseline to Week 48

    20. EoEHSS Grade Score [At week 48]

      The mean change in the mean adjusted histology grade score as measured by the EoE histology scoring system (EoEHSS) from baseline to Week 48

    21. EoEHSS Stage Score [At week 48]

      The mean change in the mean adjusted histology stage score as measured by the EoE histology scoring system (EoEHSS) from baseline to Week 48

    22. mDSD Composite Score [At week 48]

      The mean change in the modified Daily Symptom Diary (mDSD) composite score from baseline to Week 48

    23. Time to event_EoE Flare (Induction and Maintenance Phase) [Through week 48]

      The time to event of EoE flare during the study

    24. Time to event_rescue therapy (Induction and Maintenance Phase) [Through week 48]

      The time to event of use of rescue therapy during the study

    25. Proportion of Participants with Event_EoE Flare (Induction and Maintenance Phase) [Through week 48]

      The proportion of participants with an EoE flare during the study

    26. Proportion of participants with event rescue therapy (Induction and Maintenance Phases) [Through week 48]

      The proportion of participants with use of rescue therapy during the study

    27. Pharmacokinetics-Ctrough [Through week 48]

      Measurements of trough concentrations of CC-93538 in participants with EoE during the Maintenance Phase

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    1. 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.

    2. 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.

    3. 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.

    4. Females of childbearing potential must have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy and agree to practice a highly effective method of contraception until 5 months after the last dose.

    Exclusion Criteria:
    The presence of any of the following will exclude a participant from enrollment:

    1. Clinical or endoscopic evidence of other diseases that may affect the histologic, endoscopic, and clinical symptom evaluation for this study.

    2. Other gastrointestinal disorders such as active Helicobacter pylori infection, esophageal varices, gastritis, colitis, celiac disease, Mendelian disorder associated with eosinophilic esophagitis, liver function impairment, or a known hereditary fructose intolerance.

    3. Evidence of a severe endoscopic structural abnormality in the esophagus.

    4. Esophageal dilation for symptom relief within 8 weeks prior to first Screening Visit or during the Screening Period, or if esophageal dilation is anticipated within 48 weeks of dosing during the study.

    5. Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to the first Screening Visit.

    6. Treatment with a high potency topical corticosteroid for dermatologic use, or a systemic corticosteroid within 8 weeks of the first Screening Visit.

    7. Treatment with a swallowed topical corticosteroid, leukotriene receptor antagonist, or mast cell stabilizer for EoE, within 4 weeks of the first Screening Visit.

    8. Treatment with oral or sublingual immunotherapy within 6 months of the first Screening Visit (any use will be prohibited during the study). Subcutaneous immunotherapy may be allowed if on stable doses for at least 3 months prior to the first Screening Visit and during the study.

    9. Actively successful dietary modification adherence (e.g. food elimination diet), resulting in a complete response to EoE.

    10. Prior treatment with CC-93538 during a Phase 1 or 2 clinical study.

    11. Receipt of a live attenuated vaccine within 4 weeks of the first Screening Visit.

    12. Any disease that would affect the conduct of the protocol or interpretation of the study results, or would put a patient at risk by participating in the study (e.g. severe uncontrolled asthma, infection causing eosinophilia, hypereosinophilic syndrome, or cardiovascular condition, or neurologic disorder or psychiatric illness that compromises the Participant's ability to accurately document symptoms of eosinophilic esophagitis).

    13. Active or ongoing infections including parasitic/helminthic, hepatitis, tuberculosis, or human immunodeficiency virus.

    14. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks of the first Screening Visit.

    15. Females who are pregnant or lactating.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AES - DRS - Simon Williamson Clinic, PC - Birmingham Birmingham Alabama United States 35211-1320
    2 AES - DRS - Simon Williamson Clinic, PC - Birmingham Birmingham Alabama United States 35211-1320
    3 Gastro Care PC - CAR Tuscaloosa Alabama United States 35406
    4 Local Institution - 158 Tuscaloosa Alabama United States 35406
    5 AES - DRS - Central Phoenix Medical Clinic, LLC Phoenix Arizona United States 85020-4348
    6 AES - DRS - Central Phoenix Medical Clinic, LLC Phoenix Arizona United States 85020-4348
    7 Mayo Clinic Scottsdale Scottsdale Arizona United States 85259
    8 Mayo Clinic Scottsdale Scottsdale Arizona United States 85259
    9 Del Sol Research Management Tucson Arizona United States 85715
    10 Del Sol Research Management Tucson Arizona United States 85715
    11 MetroHealth Medical Center Tucson Arizona United States 85723-0001
    12 OM Research Lancaster California United States 93534
    13 OM Research Lancaster California United States 93534
    14 Gastrointestinal Biosciences Los Angeles California United States 90067
    15 UCSF Benioff Children's Hospital Oakland Oakland California United States 94609
    16 Palmtree Clinical Research Palm Springs California United States 92262
    17 Palmtree Clinical Research Palm Springs California United States 92262
    18 Alliance Clinical Research, LLC Poway California United States 92064-2021
    19 SDG Clinical Research, Inc. San Diego California United States 92103-5639
    20 SDG Clinical Research, Inc. San Diego California United States 92103-5639
    21 Precision Research Institute, LLC San Diego California United States 92114
    22 Childrens Hospital Colorado Aurora Colorado United States 80045
    23 Peak Gastroenterology Associates Colorado Springs Colorado United States 80907
    24 Peak Gastroenterology Associates Colorado Springs Colorado United States 80907
    25 Rocky Mountain Pediatric Gastroenterology Denver Colorado United States 80218
    26 Rocky Mountain Pediatric Gastroenterology Denver Colorado United States 80218
    27 Western States Clinical Research Inc Wheat Ridge Colorado United States 80033
    28 Western States Clinical Research Inc Wheat Ridge Colorado United States 80033
    29 Connecticut Clinical Research Foundation Bristol Connecticut United States 06010
    30 Connecticut Clinical Research Foundation Bristol Connecticut United States 06010
    31 University of Connecticut Farmington Connecticut United States 06030
    32 University Of Connecticut Farmington Connecticut United States 06030
    33 Medical Research Center of Connecticut LLC Hamden Connecticut United States 06518
    34 Medical Research Center of Connecticut LLC Hamden Connecticut United States 06518
    35 Children's National Medical Center Washington District of Columbia United States 20010
    36 Gastro Florida Clearwater Florida United States 33756-3839
    37 Gastro Florida Clearwater Florida United States 33756-3839
    38 Nature Coast Clinical Research LLC Inverness Florida United States 34452
    39 Nature Coast Clinical Research LLC Inverness Florida United States 34452
    40 ENCORE Borland-Groover Clinical Research Jacksonville Florida United States 32256
    41 ENCORE Borland-Groover Clinical Research Jacksonville Florida United States 32256
    42 Homestead Associates in Research Inc Miami Florida United States 33032
    43 A Plus Research Inc Miami Florida United States 33144-2035
    44 A Plus Research Inc Miami Florida United States 33144-2035
    45 Med-Care Research North Miami Beach Florida United States 33162
    46 Med-Care Research North Miami Beach Florida United States 33162
    47 AES - DRS - Synexus Clinical Research US, Inc. - Orlando Orlando Florida United States 32806-1041
    48 AES - DRS - Synexus Clinical Research US, Inc. - Orlando Orlando Florida United States 32806-1041
    49 Arnold Palmer Hospital For Children Orlando Florida United States 32806
    50 Arnold Palmer Hospital For Children Orlando Florida United States 32806
    51 Gastroenterology Consultants of Central Florida - CAR Orlando Florida United States 32825
    52 Gastroenterology Consultants of Central Florida - CAR Orlando Florida United States 32825
    53 Advanced Medical Research Center Port Orange Florida United States 32127
    54 US Associates in Research Inc Sweetwater Florida United States 33172-2741
    55 Emory University Atlanta Georgia United States 30322
    56 Gastroenterology Associates Of Central Georgia LLC Macon Georgia United States 31201
    57 Gastroenterology Associates Of Central Georgia LLC Macon Georgia United States 31201
    58 Grand Teton Research Group PLLC Idaho Falls Idaho United States 83404
    59 Grand Teton Research Group PLLC Idaho Falls Idaho United States 83404
    60 Northwestern University Feinberg School of Medicine Chicago Illinois United States 60611
    61 Northwestern University Feinberg School Of Medicine Chicago Illinois United States 60611
    62 University of Chicago Chicago Illinois United States 60637
    63 Indiana University Indianapolis Indiana United States 46202
    64 Gastroenterology Health Partners PLLC New Albany Indiana United States 47150
    65 Gastroenterology Health Partners PLLC New Albany Indiana United States 47150
    66 Iowa Digestive Disease Center Clive Iowa United States 50325
    67 Iowa Digestive Disease Center Clive Iowa United States 50325
    68 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    69 University Of Iowa Hospitals And Clinics Iowa City Iowa United States 52242
    70 University of Kansas Medical Center Kansas City Kansas United States 66160
    71 University Of Kansas Medical Center Kansas City Kansas United States 66160
    72 Tri-State Gastroentrology Associates Florence Kentucky United States 41042
    73 Tri-State Gastroentrology Associates Florence Kentucky United States 41042
    74 University of Louisville Louisville Kentucky United States 40202
    75 University Of Louisville Louisville Kentucky United States 40202
    76 Gastroenterology Associates LLC Baton Rouge Louisiana United States 70809
    77 Gastroenterology Associates LLC Baton Rouge Louisiana United States 70809
    78 Clinical Trials Management LLC Metairie Louisiana United States 70006
    79 Clinical Trials Management LLC Metairie Louisiana United States 70006
    80 Clinical Trials Management LLC Metairie Louisiana United States 70006
    81 Ochsner Children's Health Center New Orleans Louisiana United States 70121
    82 Ochsner Children's Health Center New Orleans Louisiana United States 70121
    83 Johns Hopkins University Baltimore Maryland United States 21224
    84 Digestive Disease Associates, PA Catonsville Maryland United States 21228
    85 Woodholme Gastroenterology Associates Glen Burnie Maryland United States 21061
    86 Woodholme Gastroenterology Associates Glen Burnie Maryland United States 21061
    87 Meritus Medical Center Hagerstown Maryland United States 21742
    88 Meritus Medical Center Hagerstown Maryland United States 21742
    89 Boston Specialists Boston Massachusetts United States 02111
    90 Tufts - New England Medical Center Boston Massachusetts United States 02111
    91 Massachusetts General Hospital / Dana-Farber Cancer Institute Boston Massachusetts United States 02114
    92 Massachusetts General Hospital / Dana-Farber Cancer Institute Boston Massachusetts United States 02114
    93 Boston Children's Hospital Boston Massachusetts United States 02115
    94 Boston Children's Hospital Boston Massachusetts United States 02115
    95 Brigham and Women's Hospital Boston Massachusetts United States 02115
    96 Greater Boston Gastroenterology PC Framingham Massachusetts United States 01702
    97 FC Research LLC South Dartmouth Massachusetts United States 02747
    98 FC Research LLC South Dartmouth Massachusetts United States 02747
    99 Baystate Medical Center Springfield Massachusetts United States 01199
    100 UMASS Memorial Hospital Worcester Massachusetts United States 01655
    101 Clinical Research Institute of Michigan Troy Michigan United States 48098
    102 Troy Gastroenterology Troy Michigan United States 48098
    103 Gastroenterology Associates of Western Michigan PLC Wyoming Michigan United States 49519
    104 Gastroenterology Associates of Western Michigan PLC Wyoming Michigan United States 49519
    105 Minnesota Gastroenterology Plymouth Minnesota United States 55446
    106 Minnesota Gastroenterology Plymouth Minnesota United States 55446
    107 Mayo Clinic Rochester Minnesota United States 55905
    108 Mayo Clinic Rochester Minnesota United States 55905
    109 GI Associates and Endoscopy Center-GI Clinical Research Department Flowood Mississippi United States 39232
    110 GI Associates and Endoscopy Center-GI Clinical Research Department Flowood Mississippi United States 39232
    111 Mid America Gastrointestinal Consultants Kansas City Missouri United States 64111
    112 Mid America Gastrointestinal Consultants Kansas City Missouri United States 64111
    113 Washington University Siteman Cancer Center Saint Louis Missouri United States 63110-1010
    114 Washington University Siteman Cancer Center Saint Louis Missouri United States 63110-1010
    115 University of Nebraska Medical Center Omaha Nebraska United States 68198-6805
    116 University Of Nebraska Medical Center Omaha Nebraska United States 68198-6805
    117 Advanced Research Institute - Reno Reno Nevada United States 89511-2060
    118 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    119 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    120 Atlantic Research Center LLC Ocean City New Jersey United States 07712
    121 New Mexico Clinical Research and Osteoporosis Center Albuquerque New Mexico United States 87106-4725
    122 New Mexico Clinical Research and Osteoporosis Center Albuquerque New Mexico United States 87106-4725
    123 Long Island Gastrointestinal Research Group LLP Great Neck New York United States 11023
    124 Long Island Gastrointestinal Research Group LLP Great Neck New York United States 11023
    125 NYU Langone Medical Center New York New York United States 10016
    126 NYU Langone Medical Center New York New York United States 10016
    127 Dr. Jeffrey Crespin, MD - New York - CAR New York New York United States 10017-2009
    128 Icahn School of Medicine at Mount Sinai New York New York United States 10029
    129 Columbia Presbyterian Medical Center New York New York United States 10032-3725
    130 Rochester Gastroenterology: Devgun Surinder MD Rochester New York United States 14625
    131 Hill Medical Center Syracuse New York United States 13210
    132 Syracuse VA Medical Center Syracuse New York United States 13210
    133 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599
    134 University Of North Carolina At Chapel Hill Chapel Hill North Carolina United States 27599
    135 Clinical Research of Charlotte Charlotte North Carolina United States 28277
    136 Clinical Research of Charlotte Charlotte North Carolina United States 28277
    137 Duke University Medical Center Durham North Carolina United States 27705
    138 Duke University Medical Center Durham North Carolina United States 27705
    139 Medication Management LLC Greensboro North Carolina United States 27405-6950
    140 Medication Management LLC Greensboro North Carolina United States 27405-6950
    141 Atlantic Medical Group - Kinston - CAR Kinston North Carolina United States 28501-3851
    142 Atlantic Medical Group - Kinston - CAR Kinston North Carolina United States 28501-3851
    143 Dayton Gastroenterology, Inc Beavercreek Ohio United States 45440-3237
    144 Dayton Gastroenterology, Inc Beavercreek Ohio United States 45440-3237
    145 Consultants for Clinical Research Cincinnati Ohio United States 45219
    146 GCGA Physicians, LLC dba/Gastro Health Research Cincinnati Ohio United States 45219
    147 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
    148 Cincinnati Children'S Hospital Medical Center Cincinnati Ohio United States 45229
    149 University of Cincinnati Medical Center Cincinnati Ohio United States 45267
    150 University Of Cincinnati Medical Center Cincinnati Ohio United States 45267
    151 The Cleveland Clinic Foundation Cleveland Ohio United States 44195
    152 AES - DRS - Synexus Clinical Research US, Inc. - Columbus Columbus Ohio United States 43212-3119
    153 Optimed Research Ltd Columbus Ohio United States 43235
    154 Optimed Research Ltd Columbus Ohio United States 43235
    155 Penn State Health Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
    156 Penn State Health Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
    157 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104-978
    158 University of Pennsylvania - Perelman Center for Advanced Medicine Philadelphia Pennsylvania United States 19104
    159 University of Pennsylvania - Perelman Center for Advanced Medicine Philadelphia Pennsylvania United States 19104
    160 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
    161 Glenn S Freed, DO - CAR Pottsville Pennsylvania United States 17901-3636
    162 Glenn S Freed, DO - CAR Pottsville Pennsylvania United States 17901-3636
    163 University Gastroenterology Providence Rhode Island United States 02905
    164 AES - DRS - Synexus Clinical Research US, Inc. - Anderson Anderson South Carolina United States 29621-2062
    165 AES - DRS - Synexus Clinical Research US, Inc. - Anderson Anderson South Carolina United States 29621-2062
    166 Prisma Health - Upstate Greenville South Carolina United States 29615
    167 Prisma Health - Upstate Greenville South Carolina United States 29615
    168 ClinSearch LLC Chattanooga Tennessee United States 37421
    169 ClinSearch LLC Chattanooga Tennessee United States 37421
    170 Vanderbilt University Nashville Tennessee United States 37212
    171 Vanderbilt University Nashville Tennessee United States 37212
    172 Texas Digestive Disease Consultants Dallas Cedar Park Texas United States 78613
    173 Texas Digestive Disease Consultants Dallas Cedar Park Texas United States 78613
    174 AES - DRS - Synexus Clinical Research US, Inc. - Dallas Dallas Texas United States 75234-7858
    175 Childrens Medical Center Dallas Texas United States 75235
    176 Childrens Medical Center Dallas Texas United States 75235
    177 Cook Childrens Medical Center Fort Worth Texas United States 76104
    178 Houston Endoscopy and Research Center Houston Texas United States 77079
    179 Houston Endoscopy and Research Center Houston Texas United States 77079
    180 Digestive Health Associates of Texas (DHAT) Rockwell Texas United States 75032
    181 Southern Star Research Institute LLC San Antonio Texas United States 78229
    182 Southern Star Research Institute LLC San Antonio Texas United States 78229
    183 Texas Digestive Disease Consultants - Southlake Southlake Texas United States 76092
    184 Texas Digestive Disease Consultants - Southlake Southlake Texas United States 76092
    185 Tyler Research Institute, LLC Tyler Texas United States 75701
    186 Tyler Research Institute, LLC Tyler Texas United States 75701
    187 Intermountain Clinical Research Draper Utah United States 84020-5645
    188 Intermountain Clinical Research Draper Utah United States 84020-5645
    189 Ogden Clinic Gastrenterology - CAR Ogden Utah United States 84403-3323
    190 Ogden Clinic Gastrenterology - CAR Ogden Utah United States 84403-3323
    191 University of Utah Primary Children's Medical Center Salt Lake City Utah United States 84132
    192 University of Utah School of Medicine Salt Lake City Utah United States 84132
    193 University of Vermont Medical Center Gastro Burlington Vermont United States 05401
    194 University of Vermont Medical Center Gastro Burlington Vermont United States 05401
    195 Emeritas Research Group Leesburg Virginia United States 20176
    196 Blue Ridge Medical Research Lynchburg Virginia United States 24502
    197 Blue Ridge Medical Research Lynchburg Virginia United States 24502
    198 McGuire Veterans Affairs Medical Center Richmond Virginia United States 23249
    199 McGuire Veterans Affairs Medical Center Richmond Virginia United States 23249
    200 Carilion Clinic Roanoke Virginia United States 24013
    201 Velocity Clinical Research - Spokane - ERN - PPDS Spokane Washington United States 99204
    202 Velocity Clinical Research - Spokane - ERN - PPDS Spokane Washington United States 99204
    203 Vancouver Clinic Inc PS Vancouver Washington United States 98664
    204 Vancouver Clinic Inc PS Vancouver Washington United States 98664
    205 University of Wisconsin Madison Wisconsin United States 53792
    206 Aurora Saint Lukes Medical Center Milwaukee Wisconsin United States 53215
    207 Aurora Saint Lukes Medical Center Milwaukee Wisconsin United States 53215
    208 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    209 Gastroenterology Associates, PC - Casper - CAR Casper Wyoming United States 10456
    210 Hospital Italiano de Buenos Aires Buenos Aires Argentina C1199ABB
    211 Local Institution - 697 Buenos Aires Argentina C1199ABB
    212 Gedyt BuenosAires Argentina C1125ABE
    213 Centro de Investigaciones Medica Mar del Plata Mar Del Plata Argentina B7600DHK
    214 Instituto CER S.A. Quilmes Argentina B1878DVB
    215 Concord Repatriation General Hospital Concord New South Wales Australia 2139
    216 Local Institution - 548 Concord New South Wales Australia 2139
    217 Liverpool Hospital Liverpool New South Wales Australia 2170
    218 Local Institution - 554 Liverpool New South Wales Australia 2170
    219 The Childrens Hospital at Westmead Westmead New South Wales Australia 2145
    220 Coastal Digestive Health Maroorchydore Queensland Australia 4558
    221 Local Institution - 546 Maroorchydore Queensland Australia 4558
    222 Coral Sea Clinical Research Institute North Mackay Queensland Australia 4740
    223 Local Institution - 550 South Brisbane Queensland Australia 4101
    224 Mater Adult Hospital South Brisbane Queensland Australia 4101
    225 Princess Alexandra Hospital Woolloongabba Queensland Australia 4102
    226 Local Institution - 552 Adelaide South Australia Australia 5000
    227 Royal Adelaide Hospital Adelaide South Australia Australia 5000
    228 Local Institution - 545 Elizabeth Vale South Australia Australia 5112
    229 Lyell McEwin Hospital Elizabeth Vale South Australia Australia 5112
    230 Local Institution - 553 Clayton Victoria Australia 3168
    231 Monash Health, Monash Medical Centre Clayton Victoria Australia 3168
    232 Footscray Hospital Footscray Victoria Australia 3011
    233 Local Institution - 543 Footscray Victoria Australia 3011
    234 Local Institution - 539 Melbourne Victoria Australia 3004
    235 The Alfred Hospital Melbourne Victoria Australia 3004
    236 Fiona Stanley Hospital Murdoch Western Australia Australia 6150
    237 Local Institution - 549 Murdoch Western Australia Australia 6150
    238 St Vincents Hospital Melbourne Fitzroy Australia 3065
    239 Local Institution - 547 Western Australia Australia 6056
    240 St John of God Midland Hospital Western Australia Australia 6056
    241 Krankenhaus der Barmherzigen Brüder Eisenstadt Burgenland Austria 7000
    242 LKH-Universitätsklinikum Klinikum Graz Graz Austria 8036
    243 Local Institution - 434 Graz Austria 8036
    244 Hospital of Barmherzige Schwestern Linz Linz Austria 4010
    245 Local Institution - 436 Linz Austria 4010
    246 Local Institution - 435 Vienna Austria 1090
    247 Medizinische Universitat Wien Vienna Austria 1090
    248 Local Institution - 515 Brussels Belgium 1090
    249 UZ Brussel Brussels Belgium 1090
    250 AZ Groeninge Kortrijk Belgium 8500
    251 Local Institution - 516 Kortrijk Belgium 8500
    252 Local Institution - 514 Leuven Belgium 3000
    253 UZ Leuven Leuven Belgium 3000
    254 AZ Sint-Lucas Brugge West-Vlaanderen Belgium 8310
    255 Local Institution - 201 Calgary Alberta Canada T2N 2T9
    256 University of Calgary Calgary Alberta Canada T2N 2T9
    257 University of Alberta Edmonton Alberta Canada T6G2V2
    258 Local Institution - 205 Edmonton Alberta Canada T6L 6K3
    259 South Edmonton Gastroenterology Edmonton Alberta Canada T6L 6K3
    260 GI Research Institute Vancouver British Columbia Canada V6Z 2K5
    261 PerCuro Clinical Research LTD Victoria British Columbia Canada V8V3M9
    262 Local Institution - 207 Ottawa Ontario Canada K1H 1E4
    263 Ottawa Allergy Research Corporation Ottawa Ontario Canada K1Y 4G2
    264 Local Institution - 204 Toronto Ontario Canada M5T 2S8
    265 Toronto Western Hospital Toronto Ontario Canada M5T 2S8
    266 Local Institution - 200 Vaughan Ontario Canada L4L 4Y7
    267 Toronto Digestive Disease Associates Inc Vaughan Ontario Canada L4L 4Y7
    268 Local Institution - 332 Brandenburg an der Havel Germany 14770
    269 Staedisches Klinikum Brandenburg Brandenburg an der Havel Germany 14770
    270 AES - DRS - Synexus Frankfurt Research Centre Frankfurt am Main Germany 60313
    271 Local Institution - 339 Frankfurt am Main Germany 60313
    272 Klinikum Garmisch-Partenkirchen Gmbh Garmisch-Partenkirchen Germany 82467
    273 Local Institution - 330 Garmisch-Partenkirchen Germany 82467
    274 Facharztzentrum Eppendorf Hamburg Germany 20249
    275 Universitatsklinikum Leipzig Leipzig Germany 04103
    276 EUGASTRO GmbH Leipzig Germany 4103
    277 Local Institution - 338 Leipzig Germany 4103
    278 Klinikum rechts der Isar der Technischen Universitaet Muenchen Munchen Germany 81675
    279 Praxis Prof. Herbert Kellner München Germany 80639
    280 Local Institution - 281 Haifa Israel 35254
    281 Rambam Medical Center Haifa Israel 35254
    282 Edith Wolfson Medical Center Holon Israel 5822012
    283 Local Institution - 283 Holon Israel 5822012
    284 Shaare Zedek Medical Center Jerusalem Israel 91031
    285 Hadassah Medical Center Jerusalem Israel 91120
    286 Local Institution - 282 Jerusalem Israel 91120
    287 Tel Aviv Sourasky Medical Center Tel Aviv Israel 64239
    288 Local Institution - 279 Zerifin Israel 70300
    289 Shamir Medical Center - Assaf Harofeh Zerifin Israel 70300
    290 Ospedale Policlinico San Martino Genova Italy 16132
    291 Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milano Italy 20122
    292 Local Institution - 254 Milano Italy 20122
    293 AOU dell'Università degli Studi della Campania Luigi Vanvitelli Napoli Italy 80131
    294 Local Institution - 256 Napoli Italy 80131
    295 Azienda Ospedaliera di Padova Padova Italy 35128
    296 Azienda Ospedaliera Universitaria Pisana Pisa Italy 56100
    297 Local Institution - 252 Pisa Italy 56100
    298 Azienda Policlinico Umberto I Rome Italy 00161
    299 Local Institution - 253 Rome Italy 00161
    300 Local Institution - 595 Bunkyo-ku Tokyo Japan 113-8603
    301 Akita University Hospital Akita-shi Japan 010-8543
    302 Local Institution - 593 Akita-shi Japan 010-8543
    303 Nippon Medical School Hospital Bunkyo-ku Japan 113-8602
    304 Tokai University Hospital Isehara City, Kanagawa Japan 259-1193
    305 Kobe University Hospital Kobe Japan 650-0017
    306 Local Institution - 597 Kobe Japan 650-0017
    307 Gunma University Hospital Maebashi Japan 371-8511
    308 Local Institution - 598 Maebashi Japan 371-8511
    309 Daido Clinic Nagoya Japan 457-8511
    310 Local Institution - 604 Nagoya Japan 457-8511
    311 Local Institution - 607 Nagoya Japan 467-8602
    312 Nagoya City University Hospital Nagoya Japan 467-8602
    313 Local Institution - 592 Niigata-shi Japan 951-8510
    314 Niigata University Medical and Dental Hospital Niigata-shi Japan 951-8510
    315 Hyogo College of Medicine Hospital Nishinomiya Japan 663-8501
    316 Local Institution - 600 Nishinomiya Japan 663-8501
    317 Kawasaki Medical School Hospital Okayama-Shi Japan 700-8505
    318 Local Institution - 603 Okayama-Shi Japan 700-8505
    319 Local Institution - 591 Osaka Japan 545-8586
    320 Osaka City University Hospital Osaka Japan 545-8586
    321 Gunma Children's Medical Center Shibukawa Japan 377-8577
    322 Center Hospital of the National Center for Global Health and Medicine Shinjuku-Ku Japan 162-8655
    323 Local Institution - 602 Shinjuku-Ku Japan 162-8655
    324 International University of Health and Werfare Mita Hospital Tokyo Japan 108-8329
    325 Local Institution - 599 Tokyo Japan 157-8535
    326 National Center for Child Health and Development Tokyo Japan 157-8535
    327 Fujita Health University Hospital Toyoake Japan 470-1192
    328 Local Institution - 590 Yamagata Japan 990-9585
    329 Yamagata University Hospital Yamagata Japan 990-9585
    330 Local Institution - 385 Bydgoszcz Poland 85-079
    331 Vitamed Galaj i Cichomski sp.j. Bydgoszcz Poland 85-079
    332 AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie Czestochowa Poland 42-202
    333 Local Institution - 389 Czestochowa Poland 42-202
    334 AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku Gdansk Poland 80-382
    335 Local Institution - 390 Gdansk Poland 80-382
    336 AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach Katowice Poland 40-040
    337 Local Institution - 388 Katowice Poland 40-040
    338 AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi Lódz Poland 90-127
    339 TWOJA PRZYCHODNIA Medical Centre of Szczecin LLC Szczecin Poland 71-270
    340 Local Institution - 383 Warsaw Poland 00-728
    341 WIP Warsaw IBD Point Warsaw Poland 00-728
    342 Centrum Zdrowia MDM Warszawa Poland 00-635
    343 Local Institution - 387 Warszawa Poland 00-635
    344 AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie Warszawa Poland 01-192
    345 Local Institution - 393 Warszawa Poland 01-192
    346 Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego Wroclaw Poland 50-556
    347 Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska Wroclaw Poland 51-162
    348 AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu Wrocław Poland 50-381
    349 Local Institution - 391 Wrocław Poland 50-381
    350 Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos Lisboa Portugal 1069-639
    351 Centro Hospitalar Lisboa Central- Hospital Dona Estefânia Lisboa Portugal 1169-045
    352 Local Institution - 305 Lisboa Portugal 1649-035
    353 Centro Hospitalar do Porto - Hospital de Santo António Porto Portugal 4099 - 001
    354 Centro Hospitalar de São João, E.P.E. Porto Portugal 4200-319
    355 Local Institution - 308 Porto Portugal 4200-319
    356 Hospital Clinic de Barcelona Barcelona Spain 08036
    357 Local Institution - 408 Barcelona Spain 08036
    358 Hospital Universitario Reina Sofia Cordoba Spain 14001
    359 Local Institution - 410 Cordoba Spain 14001
    360 Hospital La Princesa Madrid Spain 28006
    361 Local Institution - 409 Madrid Spain 28006
    362 Hospital Universitario La Paz Madrid Spain 28046
    363 Local Institution - 413 Madrid Spain 28046
    364 Hospital Costa del Sol Marbella Spain 29603
    365 Local Institution - 411 Marbella Spain 29603
    366 Hospital Virgen del Rocio Sevilla Spain 41013
    367 Chuv Bh-04 Lausanne Switzerland 1011
    368 Belfast Health and Social Care Trust Belfast Northern Ireland United Kingdom BT9 7AB
    369 AES - DRS - Synexus Midlands Clinical Research Centre Birmingham United Kingdom B15 2SQ
    370 Addenbrooke's Hospital Cambridge United Kingdom CB2 2QQ
    371 AES - DRS - Synexus Wales Clinical Research Centre Cardiff United Kingdom CF15 9SS
    372 AES - DRS - NW Consortium Lancashire Chorley United Kingdom PR7 7NA
    373 AES - DRS - Synexus North Teesside Clinical Research Centre Hardwick United Kingdom TS19 8PE
    374 AES - DRS - Synexus Hexham Clinical Research Centre Hexam United Kingdom NE46 1QJ
    375 AES - DRS - NW Consortium Merseyside Liverpool United Kingdom L22 0LG
    376 Royal Manchester Children's Hospital Manchester United Kingdom M13 9WL
    377 AES - DRS - NW Consortium Manchester Manchester United Kingdom M15 6SX
    378 Southampton University Hospitals NHS Trust Southampton United Kingdom SO16 6YD

    Sponsors and Collaborators

    • Celgene

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Celgene
    ClinicalTrials.gov Identifier:
    NCT04753697
    Other Study ID Numbers:
    • CC-93538-EE-001
    • U1111-1263-4351
    • 2020-004336-16
    First Posted:
    Feb 15, 2021
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Celgene
    Eosinophilic Esophagitis
    CC-93538
    RPC4046
    Adult
    Adolescent
    Gastrointestinal Diseases
    Esophagitis
    Gastroenteritis
    Eosinophils
    Eosinophilia
    Esophageal Diseases
    Allergic Diseases
    Antibody, Monoclonal
    Hypersensitivity
    Immunologic factors
    Physiological Effects of Drugs
    cendakimab
    Additional relevant MeSH terms:
    Esophagitis
    Eosinophilic Esophagitis

    Study Results

    No Results Posted as of Aug 22, 2022