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

Primary Purpose

Eosinophilic Esophagitis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CC-93538
Placebo
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilic Esophagitis focused on measuring 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

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Administration of CC-93538

Administration of CC-93538 and Placebo

Administration of Placebo

Arm Description

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

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.

Matching placebo SC once weekly for 24 weeks followed by matching placebo SC once weekly for 24 weeks

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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
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
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
mDSD Composite Score
The mean change in the modified Daily Symptom Diary (mDSD) composite score from baseline to Week 24
DD Clinical Responder Definition
The proportion of participants with a ≥ 50% decrease in dysphagia days (DD) from baseline at Week 24
Kinetics and Onset of Clinical Response_DD
The mean change in dysphagia days (DD) over time from baseline 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
Time to Event _EoE Flare
The time to event of Eosinophilic Esophagitis (EoE) flare during the Induction Phase
Time to Event_Rescue Therapy
The time to event of use of rescue therapy during the Induction Phase
Proportion of Participants with Event-EoE Flare
The proportion of participants with an EoE flare during the Induction Phase
Proportion of Participants with Event_Rescue Therapy
The proportion of participants with use of rescue therapy during the Induction Phase
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
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
Pharmacokinetics- Ctrough
Serum trough concentration Measurements of trough concentrations of CC-93538 in participants with EoE during the Induction Phase
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
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
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
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
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
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
mDSD Composite Score
The mean change in the modified Daily Symptom Diary (mDSD) composite score from baseline to Week 48
Time to event_EoE Flare (Induction and Maintenance Phase)
The time to event of EoE flare during the study
Time to event_rescue therapy (Induction and Maintenance Phase)
The time to event of use of rescue therapy during the study
Proportion of Participants with Event_EoE Flare (Induction and Maintenance Phase)
The proportion of participants with an EoE flare during the study
Proportion of participants with event rescue therapy (Induction and Maintenance Phases)
The proportion of participants with use of rescue therapy during the study
Pharmacokinetics-Ctrough
Measurements of trough concentrations of CC-93538 in participants with EoE during the Maintenance Phase

Full Information

First Posted
February 5, 2021
Last Updated
October 3, 2023
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT04753697
Brief Title
A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
December 27, 2023 (Anticipated)
Study Completion Date
October 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
399 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Administration of CC-93538
Arm Type
Experimental
Arm Description
CC-93538 360 mg Subcutaneously (SC) once weekly for 24 weeks followed by CC-93538 360 mg SC once weekly for 24 weeks
Arm Title
Administration of CC-93538 and Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Administration of Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo SC once weekly for 24 weeks followed by matching placebo SC once weekly for 24 weeks
Intervention Type
Drug
Intervention Name(s)
CC-93538
Other Intervention Name(s)
RPC4046
Intervention Description
Subcutaneous
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous
Primary Outcome Measure Information:
Title
Change in DD Clinical Response
Description
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
Time Frame
At week 24
Title
Eosinophil Histologic Response (≤ 6/hpf)
Description
The proportion of participants with eosinophilic histologic response defined as a peak esophageal eosinophil count ≤ 6/high-power field (hpf) at Week 24
Time Frame
At week 24
Secondary Outcome Measure Information:
Title
Eosinophil Histologic Response (< 15/hpf)
Description
The proportion of participants with eosinophilic histologic response defined as a peak esophageal eosinophil count < 15/hpf at Week 24
Time Frame
At week 24
Title
EoE Endoscopic Reference Score (EREFS)
Description
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
Time Frame
At week 24
Title
EoEHSS Grade Score
Description
The mean change in the mean adjusted histology grade score as measured by the EoE histology scoring system (EoEHSS) from baseline to Week 24
Time Frame
At week 24
Title
EoEHSS Stage Score
Description
The mean change in the mean adjusted histology stage score as measured by the EoE histology scoring system (EoEHSS) from baseline to Week 24
Time Frame
At week 24
Title
mDSD Composite Score
Description
The mean change in the modified Daily Symptom Diary (mDSD) composite score from baseline to Week 24
Time Frame
At week 24
Title
DD Clinical Responder Definition
Description
The proportion of participants with a ≥ 50% decrease in dysphagia days (DD) from baseline at Week 24
Time Frame
At week 24
Title
Kinetics and Onset of Clinical Response_DD
Description
The mean change in dysphagia days (DD) over time from baseline through Week 24
Time Frame
Through week 24
Title
Kinetics and Onset of Clinical Response_mDSD
Description
The mean change in the modified Daily Symptom Diary (mDSD) composite score over time from baseline through Week 24
Time Frame
Through week 24
Title
Time to Event _EoE Flare
Description
The time to event of Eosinophilic Esophagitis (EoE) flare during the Induction Phase
Time Frame
Through week 24
Title
Time to Event_Rescue Therapy
Description
The time to event of use of rescue therapy during the Induction Phase
Time Frame
Through Week 24
Title
Proportion of Participants with Event-EoE Flare
Description
The proportion of participants with an EoE flare during the Induction Phase
Time Frame
Through week 24
Title
Proportion of Participants with Event_Rescue Therapy
Description
The proportion of participants with use of rescue therapy during the Induction Phase
Time Frame
Through week 24
Title
Incidence of Adverse Events (AEs)
Description
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
Time Frame
Through week 48
Title
Assessment of Immunogenicity through measurement of serum concentrations of anti-drug antibodies to CC-93538
Description
Evaluated by the presence of anti-drug antibodies to CC-93538
Time Frame
Through week 48
Title
Pharmacokinetics- Ctrough
Description
Serum trough concentration Measurements of trough concentrations of CC-93538 in participants with EoE during the Induction Phase
Time Frame
Through week 24
Title
Change in DD Clinical Response
Description
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
Time Frame
At week 48
Title
Eosinophil Histologic Response (≤ 6/hpf)
Description
The proportion of participants with eosinophilic histologic response defined as a peak esophageal eosinophil count ≤ 6/high-power field (hpf) at Week 48
Time Frame
At week 48
Title
Eosinophil Histologic Response (< 15/hpf)
Description
The proportion of participants with eosinophilic histologic response defined as a peak esophageal eosinophil count < 15/hpf at Week 48
Time Frame
At week 48
Title
Mean change in EREFS
Description
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
Time Frame
At week 48
Title
EoEHSS Grade Score
Description
The mean change in the mean adjusted histology grade score as measured by the EoE histology scoring system (EoEHSS) from baseline to Week 48
Time Frame
At week 48
Title
EoEHSS Stage Score
Description
The mean change in the mean adjusted histology stage score as measured by the EoE histology scoring system (EoEHSS) from baseline to Week 48
Time Frame
At week 48
Title
mDSD Composite Score
Description
The mean change in the modified Daily Symptom Diary (mDSD) composite score from baseline to Week 48
Time Frame
At week 48
Title
Time to event_EoE Flare (Induction and Maintenance Phase)
Description
The time to event of EoE flare during the study
Time Frame
Through week 48
Title
Time to event_rescue therapy (Induction and Maintenance Phase)
Description
The time to event of use of rescue therapy during the study
Time Frame
Through week 48
Title
Proportion of Participants with Event_EoE Flare (Induction and Maintenance Phase)
Description
The proportion of participants with an EoE flare during the study
Time Frame
Through week 48
Title
Proportion of participants with event rescue therapy (Induction and Maintenance Phases)
Description
The proportion of participants with use of rescue therapy during the study
Time Frame
Through week 48
Title
Pharmacokinetics-Ctrough
Description
Measurements of trough concentrations of CC-93538 in participants with EoE during the Maintenance Phase
Time Frame
Through week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must satisfy the following criteria to be enrolled in the study: Male or female patients aged ≥ 12 and ≤ 75 years, with a body weight of > 40 kg. 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: Clinical or endoscopic evidence of other diseases that may affect the histologic, endoscopic, and clinical symptom evaluation for this study. 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. Evidence of a severe endoscopic structural abnormality in the esophagus. 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. Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to the first Screening Visit. Treatment with a high potency topical corticosteroid for dermatologic use, or a systemic corticosteroid within 8 weeks of the first Screening Visit. Treatment with a swallowed topical corticosteroid, leukotriene receptor antagonist, or mast cell stabilizer for EoE, within 4 weeks of the first Screening Visit. 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. Actively successful dietary modification adherence (e.g. food elimination diet), resulting in a complete response to EoE. Prior treatment with CC-93538 during a Phase 1 or 2 clinical study. Receipt of a live attenuated vaccine within 4 weeks of the first Screening Visit. 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). Active or ongoing infections including parasitic/helminthic, hepatitis, tuberculosis, or human immunodeficiency virus. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks of the first Screening Visit. Females who are pregnant or lactating.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 144
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211-1320
Country
United States
Facility Name
Local Institution - 158
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35406
Country
United States
Facility Name
Local Institution - 082
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Local Institution - 147
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020-4348
Country
United States
Facility Name
Local Institution - 041
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Local Institution - 029
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Local Institution - 165
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Local Institution - 075
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Local Institution - 047
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Facility Name
Local Institution - 084
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Local Institution - 160
City
San Diego
State/Province
California
ZIP/Postal Code
92103-5639
Country
United States
Facility Name
Local Institution - 068
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Local Institution - 067
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Local Institution - 092
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Local Institution - 170
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120-5641
Country
United States
Facility Name
Local Institution - 128
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Local Institution - 101
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
Local Institution - 076
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Local Institution - 156
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Local Institution - 099
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Local Institution - 036
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Local Institution - 042
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Local Institution - 161
City
Miami
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Facility Name
Local Institution - 138
City
Miami
State/Province
Florida
ZIP/Postal Code
33144-2035
Country
United States
Facility Name
Local Institution - 110
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Local Institution - 146
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806-1041
Country
United States
Facility Name
Local Institution - 088
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Local Institution - 133
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Facility Name
Local Institution - 169
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781-3228
Country
United States
Facility Name
Local Institution - 168
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324-3345
Country
United States
Facility Name
Local Institution - 037
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Local Institution - 140
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172-2741
Country
United States
Facility Name
Local Institution - 043
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Local Institution - 171
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Local Institution - 054
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Local Institution - 117
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Local Institution - 024
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Local Institution - 039
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Local Institution - 167
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031-5711
Country
United States
Facility Name
Local Institution - 118
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Local Institution - 127
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Local Institution - 094
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Local Institution - 035
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Local Institution - 046
City
Florence
State/Province
Kentucky
ZIP/Postal Code
41042
Country
United States
Facility Name
Local Institution - 019
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Local Institution - 003
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Local Institution - 020
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Local Institution - 044
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Local Institution - 109
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Local Institution - 065
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Facility Name
Local Institution - 164
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
Local Institution - 070
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Local Institution - 012
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
Facility Name
Local Institution - 053
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02110
Country
United States
Facility Name
Local Institution - 097
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Local Institution - 017
City
Framingham
State/Province
Massachusetts
ZIP/Postal Code
01702
Country
United States
Facility Name
Local Institution - 083
City
South Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Local Institution - 081
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Local Institution - 009
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Local Institution - 098
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Local Institution - 014
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Local Institution - 115
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Local Institution - 049
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Local Institution - 034
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Local Institution - 007
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Local Institution - 032
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1010
Country
United States
Facility Name
Local Institution - 038
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-6805
Country
United States
Facility Name
Local Institution - 015
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Local Institution - 139
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106-4725
Country
United States
Facility Name
Local Institution - 028
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Local Institution - 051
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Local Institution - 154
City
New York
State/Province
New York
ZIP/Postal Code
10017-2009
Country
United States
Facility Name
Local Institution - 011
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Local Institution - 116
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210-2306
Country
United States
Facility Name
Local Institution - 142
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Local Institution - 016
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Local Institution - 045
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Local Institution - 106
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Local Institution - 131
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405-6950
Country
United States
Facility Name
Local Institution - 126
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501-3851
Country
United States
Facility Name
Dayton Gastroenterology, Inc
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45440-3237
Country
United States
Facility Name
Local Institution - 006
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Local Institution - 001
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Local Institution - 052
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Local Institution - 072
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Local Institution - 145
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212-3119
Country
United States
Facility Name
Local Institution - 059
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Local Institution - 166
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112-5550
Country
United States
Facility Name
Local Institution - 120
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Local Institution - 025
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Local Institution - 155
City
Pottsville
State/Province
Pennsylvania
ZIP/Postal Code
17901-3636
Country
United States
Facility Name
Local Institution - 066
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Local Institution - 143
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621-2062
Country
United States
Facility Name
Local Institution - 057
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Local Institution - 114
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Local Institution - 095
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Local Institution - 105
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Local Institution - 148
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234-7858
Country
United States
Facility Name
Local Institution - 112
City
Houston
State/Province
Texas
ZIP/Postal Code
77079-2211
Country
United States
Facility Name
Local Institution - 079
City
Rockwell
State/Province
Texas
ZIP/Postal Code
75032
Country
United States
Facility Name
Local Institution - 008
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Local Institution - 077
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Local Institution - 104
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Local Institution - 157
City
Draper
State/Province
Utah
ZIP/Postal Code
84020-5645
Country
United States
Facility Name
Local Institution - 125
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403-3323
Country
United States
Facility Name
Local Institution - 074
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Local Institution - 027
City
Leesburg
State/Province
Virginia
ZIP/Postal Code
20176
Country
United States
Facility Name
Local Institution - 013
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
Local Institution - 064
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Local Institution - 137
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Local Institution - 023
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Local Institution - 085
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Local Institution - 060
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Local Institution - 121
City
Casper
State/Province
Wyoming
ZIP/Postal Code
10456
Country
United States
Facility Name
Local Institution - 697
City
Buenos Aires
ZIP/Postal Code
C1199ABB
Country
Argentina
Facility Name
Local Institution - 695
City
Mar Del Plata
ZIP/Postal Code
B7600DHK
Country
Argentina
Facility Name
Local Institution - 696
City
Quilmes
ZIP/Postal Code
B1878DVB
Country
Argentina
Facility Name
Local Institution - 548
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Local Institution - 554
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Local Institution - 540
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Local Institution - 546
City
Maroorchydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
Local Institution - 550
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Local Institution - 542
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Local Institution - 552
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Local Institution - 545
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
05112
Country
Australia
Facility Name
Local Institution - 553
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Local Institution - 543
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Local Institution - 539
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Local Institution - 549
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Local Institution - 538
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Facility Name
Local Institution - 547
City
Western Australia
ZIP/Postal Code
6056
Country
Australia
Facility Name
Local Institution - 437
City
Burgenland
ZIP/Postal Code
7000
Country
Austria
Facility Name
Local Institution - 434
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Local Institution - 436
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Local Institution - 515
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Local Institution - 516
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Local Institution - 514
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution - 512
City
West-Vlaanderen
ZIP/Postal Code
8310
Country
Belgium
Facility Name
Local Institution - 201
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Local Institution - 208
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5R 1W2
Country
Canada
Facility Name
Local Institution - 205
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6K 4B2
Country
Canada
Facility Name
Local Institution - 203
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Local Institution - 206
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V3M9
Country
Canada
Facility Name
Local Institution - 207
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1E4
Country
Canada
Facility Name
Local Institution - 200
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
Local Institution - 330
City
Bayern
ZIP/Postal Code
82418
Country
Germany
Facility Name
Local Institution - 332
City
Brandenburg an der Havel
ZIP/Postal Code
14770
Country
Germany
Facility Name
Local Institution - 339
City
Frankfurt am Main
ZIP/Postal Code
60313
Country
Germany
Facility Name
Local Institution - 336
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
Local Institution - 333
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Local Institution - 338
City
Leipzig
ZIP/Postal Code
04129
Country
Germany
Facility Name
Local Institution - 337
City
Munchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Local Institution - 340
City
München
ZIP/Postal Code
80639
Country
Germany
Facility Name
Local Institution - 281
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Local Institution - 283
City
Holon
ZIP/Postal Code
5822012
Country
Israel
Facility Name
Local Institution - 280
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Local Institution - 282
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Local Institution - 278
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Local Institution - 279
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Local Institution - 257
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Local Institution - 254
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Local Institution - 255
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution - 252
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
Local Institution - 253
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Local Institution - 600
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Local Institution - 595
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Local Institution - 599
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
157-8535
Country
Japan
Facility Name
Local Institution - 593
City
Akita-shi
ZIP/Postal Code
010-8543
Country
Japan
Facility Name
Local Institution - 606
City
Isehara City, Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Local Institution - 597
City
Kobe
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Local Institution - 598
City
Maebashi
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Local Institution - 604
City
Nagoya
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
Local Institution - 607
City
Nagoya
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Local Institution - 592
City
Niigata-shi
ZIP/Postal Code
951-8510
Country
Japan
Facility Name
Local Institution - 603
City
Okayama-Shi
ZIP/Postal Code
700-8505
Country
Japan
Facility Name
Local Institution - 591
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Local Institution - 601
City
Shibukawa
ZIP/Postal Code
377-8577
Country
Japan
Facility Name
Local Institution - 602
City
Shinjuku-Ku
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Local Institution - 605
City
Tokyo
ZIP/Postal Code
108-8329
Country
Japan
Facility Name
Local Institution - 590
City
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Facility Name
Local Institution - 385
City
Bydgoszcz
ZIP/Postal Code
85-079
Country
Poland
Facility Name
Local Institution - 389
City
Częstochowa
ZIP/Postal Code
42-202
Country
Poland
Facility Name
Local Institution - 390
City
Gdansk
ZIP/Postal Code
80-382
Country
Poland
Facility Name
Local Institution - 388
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
Local Institution - 392
City
Lódz
ZIP/Postal Code
90-127
Country
Poland
Facility Name
Local Institution - 383
City
Warsaw
ZIP/Postal Code
00-728
Country
Poland
Facility Name
Local Institution - 387
City
Warszawa
ZIP/Postal Code
00-635
Country
Poland
Facility Name
Local Institution - 393
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Local Institution - 386
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Local Institution - 391
City
Wrocław
ZIP/Postal Code
50-381
Country
Poland
Facility Name
Local Institution - 307
City
Lisboa
ZIP/Postal Code
1169-045
Country
Portugal
Facility Name
Local Institution - 305
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Local Institution - 306
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Local Institution - 308
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Local Institution - 408
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution - 410
City
Cordoba
ZIP/Postal Code
14001
Country
Spain
Facility Name
Local Institution - 409
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Local Institution - 413
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Local Institution - 411
City
Marbella
ZIP/Postal Code
29603
Country
Spain
Facility Name
Local Institution - 412
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Local Institution - 357
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Local Institution - 228
City
Belfast Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Local Institution - 231
City
Birmingham
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Facility Name
Local Institution - 234
City
Cardiff
ZIP/Postal Code
CF15 9SS
Country
United Kingdom
Facility Name
Local Institution - 235
City
Chorley
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
Facility Name
Local Institution - 233
City
Hexam
ZIP/Postal Code
NE46 1QJ
Country
United Kingdom
Facility Name
Local Institution - 236
City
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
Facility Name
Local Institution - 237
City
Manchester
ZIP/Postal Code
M15 6SX
Country
United Kingdom
Facility Name
Local Institution - 226
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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