A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Participants With Eosinophilic Gastroenteritis
NCT ID: NCT05214768
Last Updated: 2025-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
48 participants
INTERVENTIONAL
2022-03-04
2025-08-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CC-93538
CC-93538
Specified dose on specified days
Placebo
Placebo
Specified dose on specified days
Interventions
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CC-93538
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* History of inflammatory bowel disease, achalasia or esophageal surgery
* Has other causes of gastric and/or duodenal eosinophilia or eosinophilic granulomatosis with polyangiitis (EGPA)
12 Years
75 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 024
Gifu, Gifu, Japan
Local Institution - 022
Himeji-shi, Hyōgo, Japan
Local Institution - 009
Nishinomiya, Hyōgo, Japan
Local Institution - 0025
Tsu, Mie-ken, Japan
Local Institution - 025
Tsu, Mie-ken, Japan
Local Institution - 023
Sendai, Miyagi, Japan
Local Institution - 007
Bunkyo-ku, Tokyo, Japan
Local Institution - 001
Setagaya-ku, Tokyo, Japan
Local Institution - 010
Akita, , Japan
Local Institution - 017
Hirosaki, , Japan
Local Institution - 015
Hiroshima, , Japan
Local Institution - 018
Kagoshima, , Japan
Local Institution - 020
Kitakyushu, , Japan
Local Institution - 004
Kobe, , Japan
Local Institution - 011
Maebashi, , Japan
Local Institution - 013
Nagaoka, , Japan
Local Institution - 016
Nagasaki, , Japan
Local Institution - 006
Nagoya, , Japan
Local Institution - 021
Nagoya, , Japan
Local Institution - 008
Niigata, , Japan
Local Institution - 002
Osaka, , Japan
Local Institution - 012
Ōgaki, , Japan
Local Institution - 005
Shibukawa, , Japan
Local Institution - 019
Tokyo, , Japan
Local Institution - 003
Yamagata, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CC-93538-EG-001
Identifier Type: -
Identifier Source: org_study_id
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