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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	12 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05214768
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Celgene
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Bristol-Myers Squibb
Principal Investigator Affiliation	Bristol-Myers Squibb
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Active, not recruiting
Countries	Japan
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Eosinophilic Gastroenteritis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: CC-93538

Placebo Comparator: Placebo

Interventions

Drug: - CC-93538

Specified dose on specified days

Drug: - Placebo

Specified dose on specified days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Local Institution - 024, Gifu City, Gifu, Japan

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Local Institution - 024

Gifu City, Gifu, 5011194

Local Institution - 022, Himeji-shi, Hyogo, Japan

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Local Institution - 022

Himeji-shi, Hyogo, 670-8560

Local Institution - 009, Nishinomiya, Hyogo, Japan

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Local Institution - 009

Nishinomiya, Hyogo, 663-8501

Local Institution - 0025, Tsu, MIE, Japan

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Local Institution - 0025

Tsu, MIE, 514-8507

Local Institution - 025, Tsu, MIE, Japan

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Local Institution - 025

Tsu, MIE, 514-8507

Local Institution - 023, Sendai, Miyagi, Japan

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Local Institution - 023

Sendai, Miyagi, 982-8502

Local Institution - 007, Bunkyo-ku, Tokyo, Japan

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Local Institution - 007

Bunkyo-ku, Tokyo, 113-8603

Local Institution - 001, Setagaya-ku, Tokyo, Japan

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Local Institution - 001

Setagaya-ku, Tokyo, 157-8535

Local Institution - 010, Akita-shi, Japan

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Local Institution - 010

Akita-shi, , 010-8543

Local Institution - 017, Hirosaki, Japan

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Local Institution - 017

Hirosaki, , 036-8545

Local Institution - 015, Hiroshima, Japan

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Local Institution - 015

Hiroshima, , 734-8551

Local Institution - 018, Kagoshima, Japan

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Local Institution - 018

Kagoshima, , 890-8520

Local Institution - 020, Kitakyushu, Japan

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Local Institution - 020

Kitakyushu, , 802-8561

Local Institution - 004, Kobe, Japan

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Local Institution - 004

Kobe, , 650-0017

Local Institution - 011, Maebashi, Japan

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Local Institution - 011

Maebashi, , 371-8511

Local Institution - 013, Nagaoka, Japan

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Local Institution - 013

Nagaoka, , 940-2085

Local Institution - 016, Nagasaki, Japan

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Local Institution - 016

Nagasaki, , 852-8501

Local Institution - 006, Nagoya, Japan

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Local Institution - 006

Nagoya, , 454-8509

Local Institution - 021, Nagoya, Japan

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Local Institution - 021

Nagoya, , 467-8602

Local Institution - 008, Niigata-shi, Japan

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Local Institution - 008

Niigata-shi, , 951-8510

Local Institution - 012, Ogaki, Japan

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Local Institution - 012

Ogaki, , 503-8502

Local Institution - 002, Osaka, Japan

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Local Institution - 002

Osaka, , 545-8586

Local Institution - 005, Shibukawa, Japan

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Local Institution - 005

Shibukawa, , 377-8577

Local Institution - 019, Tokyo, Japan

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Local Institution - 019

Tokyo, , 108-8329

Local Institution - 003, Yamagata, Japan

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Local Institution - 003

Yamagata, , 990-9585

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