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New drug shows promise for rare stomach disorder in japanese study

NCT ID NCT05214768

Disease control Sponsor: Celgene Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 15, 2026 · Updated 3 times

Summary

This study tested a drug called CC-93538 (Cendakimab) in 48 Japanese adults and adolescents with eosinophilic gastroenteritis, a condition where certain white blood cells build up in the digestive tract causing pain and other symptoms. The trial was randomized and placebo-controlled, meaning some participants got the drug and others got a dummy treatment. The main goal was to see if the drug could reduce the number of these cells in gut biopsies and improve symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CC-93538 (Cendakimab)
What this could lead to
If successful, this could provide a new treatment option to control eosinophilic gastroenteritis, reducing inflammation and symptoms.
What could go wrong
This is a completed Phase 3 trial with only 48 participants, all Japanese. Results may not apply to other populations, and the drug may not show significant benefit over placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

48 people

The number who actually took part.

Started

Mar 2022

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Digestive System Diseases digestive system disorder Eosinophilic enteropathy eosinophilic gastroenteritis gastroenteritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Eosinophilic gastroenteritis

Contacts and locations

Locations

  • Local Institution - 001

    Setagaya-ku, Tokyo, 157-8535, Japan

  • Local Institution - 002

    Osaka, Osaka, 545-8586, Japan

  • Local Institution - 0025

    Tsu, Mie-ken, 514-8507, Japan

  • Local Institution - 003

    Yamagata, 990-9585, Japan

  • Local Institution - 004

    Kobe, 650-0017, Japan

  • Local Institution - 005

    Shibukawa, 377-8577, Japan

  • Local Institution - 006

    Nagoya, 454-8509, Japan

  • Local Institution - 007

    Bunkyo-ku, Tokyo, 113-8603, Japan

  • Local Institution - 008

    Niigata, 951-8510, Japan

  • Local Institution - 009

    Nishinomiya, Hyōgo, 663-8501, Japan

  • Local Institution - 010

    Akita, 010-8543, Japan

  • Local Institution - 011

    Maebashi, 371-8511, Japan

  • Local Institution - 012

    Ōgaki, 503-8502, Japan

  • Local Institution - 013

    Nagaoka, 940-2085, Japan

  • Local Institution - 015

    Hiroshima, 734-8551, Japan

  • Local Institution - 016

    Nagasaki, Nagasaki, 852-8501, Japan

  • Local Institution - 017

    Hirosaki, 036-8545, Japan

  • Local Institution - 018

    Kagoshima, Kagoshima-ken, 890-8520, Japan

  • Local Institution - 019

    Tokyo, 108-8329, Japan

  • Local Institution - 020

    Kitakyushu, 802-8561, Japan

  • Local Institution - 021

    Nagoya, 467-8602, Japan

  • Local Institution - 022

    Himeji-shi, Hyōgo, 670-8560, Japan

  • Local Institution - 023

    Sendai, Miyagi, 982-8502, Japan

  • Local Institution - 024

    Gifu, Gifu, 5011194, Japan

  • Local Institution - 025

    Tsu, Mie-ken, 514-8507, Japan

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