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

October 20, 2025 updated by: Celgene

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Subjects With Eosinophilic Gastroenteritis

The purpose of this study is to evaluate the safety and efficacy of CC-93538 in adult and adolescent participants with eosinophilic gastroenteritis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

  • Japan
      • Akita, Japan, 010-8543
        • Local Institution - 010
      • Hirosaki, Japan, 036-8545
        • Local Institution - 017
      • Hiroshima, Japan, 734-8551
        • Local Institution - 015
      • Kagoshima, Japan, 890-8520
        • Local Institution - 018
      • Kitakyushu, Japan, 802-8561
        • Local Institution - 020
      • Kobe, Japan, 650-0017
        • Local Institution - 004
      • Maebashi, Japan, 371-8511
        • Local Institution - 011
      • Nagaoka, Japan, 940-2085
        • Local Institution - 013
      • Nagasaki, Japan, 852-8501
        • Local Institution - 016
      • Nagoya, Japan, 454-8509
        • Local Institution - 006
      • Nagoya, Japan, 467-8602
        • Local Institution - 021
      • Niigata, Japan, 951-8510
        • Local Institution - 008
      • Osaka, Japan, 545-8586
        • Local Institution - 002
      • Shibukawa, Japan, 377-8577
        • Local Institution - 005
      • Tokyo, Japan, 108-8329
        • Local Institution - 019
      • Yamagata, Japan, 990-9585
        • Local Institution - 003
      • Ōgaki, Japan, 503-8502
        • Local Institution - 012
    • Gifu
      • Gifu, Gifu, Japan, 5011194
        • Local Institution - 024
    • Hyōgo
      • Himeji-shi, Hyōgo, Japan, 670-8560
        • Local Institution - 022
      • Nishinomiya, Hyōgo, Japan, 663-8501
        • Local Institution - 009
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Local Institution - 0025
      • Tsu, Mie-ken, Japan, 514-8507
        • Local Institution - 025
    • Miyagi
      • Sendai, Miyagi, Japan, 982-8502
        • Local Institution - 023
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8603
        • Local Institution - 007
      • Setagaya-ku, Tokyo, Japan, 157-8535
        • Local Institution - 001

Participation Criteria

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

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologic evidence of eosinophilic gastroenteritis (EGE) defined as ≥ 30 eosinophils (eos)/high-power field (hpf) in at least 5 hpf in the stomach and/or ≥ 30 eos/hpf in at least 3 hpf in the duodenum while on stable background therapy for EGE
  • Has weekly symptom scores of ≥ 4/15 for any of Gastric Pain Symptoms domain, Stomach Heaviness Symptom domains, and /or Diarrhea Symptoms domain as assessed by the Izumo Scale with electronic device for the 2 consecutive weeks before Day 1
  • Must agree to maintain a stable diet from the first Screening Visit and throughout the duration of the study, and participants must have maintained a stable diet for at least 4 weeks prior to the first Screening Visit
  • 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:

  • Ascites requiring treatment or symptomatic ascites
  • History of inflammatory bowel disease, achalasia or esophageal surgery
  • Has other causes of gastric and/or duodenal eosinophilia or eosinophilic granulomatosis with polyangiitis (EGPA)

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

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

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Specified dose on specified days
Experimental: CC-93538
Drug: CC-93538
Specified dose on specified days
Other Names:
  • BMS-986355
  • Cendakimab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Number of Peak Eosinophils (Eos) Count Per High-power Field (Hpf) in Gastrointestinal (GI) Biopsies
Time Frame: Baseline and Week 16
Blood samples were collected to assess eosinophils count. Baseline data are defined as last measurement collected on or prior the date of first dose for Induction Phase.
Baseline and Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16
Time Frame: Baseline and Week 16
The Izumo Scale questionnaire assesses the comprehensive 5 different GI symptom domains during the past week and consists with 15 weekly questions (3 questions per 1 domain): Heartburn Symptoms domain(Questions1 through3), Gastric Pain Symptoms domain(Questions4 through6), Stomach Heaviness Symptoms domain(Questions7 through9), Constipation Symptoms domain (Question 10 through12), Diarrhea Symptoms domain (Questions13 through15). Each question is scored on a 6-point Likert scale of "0 = No trouble at all" to "5 = Can't stand it," and the score for each question within a domain is added to determine domain specific scores scaled from 0 to 15, with higher values indicating greater symptom severity.
Baseline and Week 16
Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 48
Time Frame: Baseline and Week 48
The Izumo Scale questionnaire assesses the comprehensive 5 different GI symptom domains during the past week and consists with 15 weekly questions (3 questions per 1 domain): Heartburn Symptoms domain(Questions1 through3), Gastric Pain Symptoms domain(Questions4 through6), Stomach Heaviness Symptoms domain(Questions7 through9), Constipation Symptoms domain (Question 10 through12), Diarrhea Symptoms domain (Questions13 through15). Each question is scored on a 6-point Likert scale of "0 = No trouble at all" to "5 = Can't stand it," and the score for each question within a domain is added to determine domain specific scores scaled from 0 to 15, with higher values indicating greater symptom severity. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
Baseline and Week 48
Induction Phase: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 16
Time Frame: Week 16
Clinical response defined as percentage of participants who achieve <4/15 in each of three Symptoms of Interest (Gastric Pain Symptoms domain, Stomach Heaviness Symptoms domain, and Diarrhea Symptoms domain) scores of Izumo Scale from baseline. Histologic response defined as a > 75% reduction of peak gastric and/or duodenal eos count from baseline. Izumo Scale tests 5 different GI symptom domains during past week and consists with 15 weekly questions (3 questions per 1 domain): Heartburn Symptoms domain(Ques1 through3), Gastric Pain Symptoms domain(Questions4 through6), Stomach Heaviness Symptoms domain(Ques7 through9), Constipation Symptoms domain (Question 10 through12), Diarrhea Symptoms domain (Ques13 through15). Each question is scored on a 6-point Likert scale of "0 = No trouble at all" to "5 = Can't stand it," and score for each question within a domain added to determine domain specific scores scaled from 0 to 15, with higher values indicating greater symptom severity.
Week 16
Induction + Maintenance: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 48
Time Frame: Baseline and week 48
Clinical response defined as percentage of participants who achieve <4/15 in each of three Symptoms of Interest (Gastric Pain Symptoms domain, Stomach Heaviness Symptoms domain, and Diarrhea Symptoms domain) scores of Izumo Scale from baseline. Histologic response defined as a > 75% reduction of peak gastric and/or duodenal eos count from baseline. Izumo Scale tests 5 different GI symptom domains during past week and consists with 15 weekly questions (3 questions per 1 domain): Heartburn Symptoms domain(Ques1 through3), Gastric Pain Symptoms domain(Questions4 through6), Stomach Heaviness Symptoms domain(Ques7 through9), Constipation Symptoms domain (Question 10 through12), Diarrhea Symptoms domain (Ques13 through15). Each question is scored on a 6-point Likert scale of "0 = No trouble at all" to "5 = Can't stand it," and score for each question within a domain added to determine domain specific scores scaled from 0 to 15, with higher values indicating greater symptom severity.
Baseline and week 48
Induction + Maintenance: Change From Baseline in Mean Number of Peak Eosinophils (Eos) Count Per High-power Field (Hpf) in Gastrointestinal (GI) Biopsies at Week 48
Time Frame: Baseline and Week 48
Blood samples were collected to assess eosinophils count. Baseline data are defined as last measurement collected on or prior the date of first dose for Induction Phase. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm
Baseline and Week 48
Induction Phase: Percent Changes in Mean Number of Peak Eos Per Hpf in GI Biopsies From Baseline
Time Frame: Baseline and Week 16
Blood samples were collected to assess eosinophils count. Baseline data are defined as last measurement collected on or prior the date of first dose for Induction Phase.
Baseline and Week 16
Induction + Maintenance: Percent Changes in Mean Number of Peak Eos Per Hpf in GI Biopsies From Baseline
Time Frame: Baseline and Week 48
Blood samples were collected to assess eosinophils count. Baseline data are defined as last measurement collected on or prior the date of first dose for Induction Phase. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
Baseline and Week 48
Induction Phase: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction)
Time Frame: Week 16
Histologic response defined as a > 75% reduction of peak gastric and/or duodenal eos count from baseline.
Week 16
Induction + Maintenance: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction)
Time Frame: Week 48
Histologic response defined as a > 75% reduction of peak gastric and/or duodenal eos count from baseline. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
Week 48
Induction Phase: Percentage of Participants Who Achieve <4/15 in Each of Three Symptoms of Interest Scores Using the Izumo Scale
Time Frame: Week 16
The Izumo Scale questionnaire assesses the comprehensive 5 different GI symptom domains during the past week and consists with 15 weekly questions (3 questions per 1 domain): Heartburn Symptoms domain(Questions1 through3), Gastric Pain Symptoms domain(Questions4 through6), Stomach Heaviness Symptoms domain(Questions7 through9), Constipation Symptoms domain (Question 10 through12), Diarrhea Symptoms domain (Questions13 through15). Each question is scored on a 6-point Likert scale of "0 = No trouble at all" to "5 = Can't stand it," and the score for each question within a domain is added to determine domain specific scores scaled from 0 to 15, with higher values indicating greater symptom severity. Gastric Pain Symptoms domain, Stomach Heaviness Symptoms domain, and Diarrhea Symptoms domain are Symptoms of Interest.
Week 16
Induction + Maintenance: Percentage of Participants Who Achieve <4/15 in Each of Three Symptoms of Interest Scores Using the Izumo Scale
Time Frame: Baseline and Week 48
The Izumo Scale questionnaire assesses the comprehensive 5 different GI symptom domains during the past week and consists with 15 weekly questions (3 questions per 1 domain): Heartburn Symptoms domain(Questions1 through3), Gastric Pain Symptoms domain(Questions4 through6), Stomach Heaviness Symptoms domain(Questions7 through9), Constipation Symptoms domain (Question 10 through12), Diarrhea Symptoms domain (Questions13 through15). Each question is scored on a scale of "0 = No trouble at all" to "5 = Can't stand it," and one symptom domain is scored from 0 to 15, with higher values indicating greater symptom severity. Gastric Pain Symptoms domain, Stomach Heaviness Symptoms domain, and Diarrhea Symptoms domain are Symptoms of Interest. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm. Only participants from ages 12 -19 years old at specified timepoint are included in the analysis.
Baseline and Week 48
Induction Phase: Changes in Total Score of Eosinophilic Gastrointestinal Disorder (EGID) Severity Score From Baseline to Weeks 16 in Adolescent (12 to 19 Years)
Time Frame: Baseline and Week 16
The EGID Severity Score for participants from 12 to 19 years old assesses 6 different symptoms (vomiting, dysphagia, anorexia, abdominal pain, diarrhea, bloody stool), 2 clinical laboratory tests (albumin, eos ratio of peripheral blood cells) and general condition, including height and weight. The score ranges from 0 to 100 and the higher the score, the greater the severity. A score of ≥ 40 is considered as severe, a score of 15 to 39 as moderate and ≤ 14 score as mild.
Baseline and Week 16
Induction Phase: Changes in Total Score of EGID Severity Score From Baseline to Weeks 16 in Adults (>= 20 Years)
Time Frame: Baseline and Week 16
The EGID Severity Scores are assessed by the investigator. The EGID Severity Score for participants ≥ 20 years old assess the intensity and the frequency of 6 different symptoms (vomiting, dysphagia, anorexia, abdominal pain, diarrhea, bloody stool), 2 clinical laboratory tests (albumin, eos ratio of peripheral blood cells) and 2 medical history items (history of surgery and use of systemic corticosteroid or immunosuppressives). The score ranges from 0 to 82 and the higher the score, the greater the severity. A score of ≥ 40 is considered as severe, a score of 15 to 39 as moderate and a score of ≤ 14 score as mild.
Baseline and Week 16
Induction+ Maintenance: Changes in Total Score of EGID Severity Score From Baseline to Weeks 48 in Adolescent (12 to 19 Years)
Time Frame: Baseline and Week 48
The EGID Severity Score for participants from 12 to 19 years old assesses 6 different symptoms (vomiting, dysphagia, anorexia, abdominal pain, diarrhea, bloody stool), 2 clinical laboratory tests (albumin, eos ratio of peripheral blood cells) and general condition, including height and weight. The score ranges from 0 to 100 and the higher the score, the greater the severity. A score of ≥ 40 is considered as severe, a score of 15 to 39 as moderate and ≤ 14 score as mild. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
Baseline and Week 48
Induction + Maintenance: Changes in Total Score of EGID Severity Score From Baseline to Weeks 48 in Adults (>= 20 Years)
Time Frame: Baseline and Week 48
The EGID Severity Scores are assessed by the investigator. The EGID Severity Score for participants ≥ 20 years old assess the intensity and the frequency of 6 different symptoms (vomiting, dysphagia, anorexia, abdominal pain, diarrhea, bloody stool), 2 clinical laboratory tests (albumin, eos ratio of peripheral blood cells) and 2 medical history items (history of surgery and use of systemic corticosteroid or immunosuppressives). The score ranges from 0 to 82 and the higher the score, the greater the severity. A score of ≥ 40 is considered as severe, a score of 15 to 39 as moderate and a score of ≤ 14 score as mild. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
Baseline and Week 48
Induction Phase: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy
Time Frame: Through Week 16
Any worsening of EGE symptoms during study participation will be documented as an EGE flare. Worsening of EGE symptoms is defined as continuous worsening of symptoms for 2 consecutive visits (4 weeks apart) compared to baseline, measured by the weekly Izumo Scale score (≥ 4 weeks of no change from baseline or ≥ 4 weeks of worsening from baseline).
Through Week 16
Induction + Maintenance: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy
Time Frame: Through Week 48
Any worsening of EGE symptoms during study participation will be documented as an EGE flare. Worsening of EGE symptoms is defined as continuous worsening of symptoms for 2 consecutive visits (4 weeks apart) compared to baseline, measured by the weekly Izumo Scale score (≥ 4 weeks of no change from baseline or ≥ 4 weeks of worsening from baseline). Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
Through Week 48
Maintenance Phase: Time to Reduce to Zero Concomitant Corticosteroid Use
Time Frame: From Week 16 through Week 48
Participants who use concomitant corticosteroid at baseline and entered Maintenance Phase
From Week 16 through Week 48
Percentage of Participants for Whom the Dose of Concomitant Steroids is Reduced to Zero
Time Frame: Week 24, 32, 40 and 48
Participants who use concomitant corticosteroid at baseline and entered Maintenance period were included in the analysis.
Week 24, 32, 40 and 48
Induction and Maintenance: Number of Participants With Treatment-Emergent Adverse Events
Time Frame: From Day 1 untill Week 48
A treatment emergent adverse event (TEAE) is any AE that emerges during treatment or Safety Follow-up Period having been absent pre-treatment or worsens in severity relative to the pretreatment state. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
From Day 1 untill Week 48
Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Vital Signs Measurements
Time Frame: From Day 1 untill Week 48
Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
From Day 1 untill Week 48
Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Physical Examinations Parameters
Time Frame: From Day 1 untill Week 48
Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
From Day 1 untill Week 48
Induction and Maintenance: Number of Participants With Mean Changes Over Time That Were of Clinically Concern in Hematology Parameters, Serum Chemistry Parameters, and Urinalysis Parameters
Time Frame: From Day 1 untill Week 48
Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
From Day 1 untill Week 48
Induction and Maintenance: Number of Participants With Anti-Drug-Antibody
Time Frame: From Day 1 till Week 48
Blood samples were collected to assess Anti-Drug-Antibody. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
From Day 1 till Week 48
Induction Phase: CC-93538 Trough Concentration at Week 16
Time Frame: Week 16
Blood samples were collected to assess CC-93538 trough concentrations.
Week 16
Maintenance Phase: CC-93538 Trough Concentration at Week 48
Time Frame: Week 48
Blood samples were collected to assess CC-93538 trough concentrations. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.
Week 48

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celgene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

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

Helpful Links

Study record dates

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

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 2, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 22, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CC-93538-EG-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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

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