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

NCT05214768 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: CC-93538-EG-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 25

Brief Summary

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

Conditions

Eosinophilic Gastroenteritis

Keywords

Eosinophilic Gastroenteritis; CC-93538; Gastrointestinal Diseases; Eosinophilic Gastro-Intestinal Disorder; EGID; Digestive system diseases; Gastroenteritis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Number of Peak Eosinophils (Eos) Count Per High-power Field (Hpf) in Gastrointestinal (GI) Biopsies

  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 Outcomes (26)

• Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16

  Baseline and Week 16

• Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 48

  Baseline and Week 48

• Induction Phase: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 16

  Week 16

• Induction + Maintenance: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 48

  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

  Baseline and Week 48

Study Arms (2)

CC-93538

EXPERIMENTAL

Drug: CC-93538

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CC-93538 DRUG

Specified dose on specified days

Also known as: Cendakimab, BMS-986355

CC-93538

Placebo DRUG

Specified dose on specified days

Placebo

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Celgene: lead

Study Sites (25)

Local Institution - 024

Gifu, Gifu, 5011194, Japan

Location

Local Institution - 022

Himeji-shi, Hyōgo, 670-8560, Japan

Location

Local Institution - 009

Nishinomiya, Hyōgo, 663-8501, Japan

Location

Local Institution - 0025

Tsu, Mie-ken, 514-8507, Japan

Location

Local Institution - 025

Tsu, Mie-ken, 514-8507, Japan

Location

Local Institution - 023

Sendai, Miyagi, 982-8502, Japan

Location

Local Institution - 007

Bunkyo-ku, Tokyo, 113-8603, Japan

Location

Local Institution - 001

Setagaya-ku, Tokyo, 157-8535, Japan

Location

Local Institution - 010

Akita, 010-8543, Japan

Location

Local Institution - 017

Hirosaki, 036-8545, Japan

Location

Local Institution - 015

Hiroshima, 734-8551, Japan

Location

Local Institution - 018

Kagoshima, 890-8520, Japan

Location

Local Institution - 020

Kitakyushu, 802-8561, Japan

Location

Local Institution - 004

Kobe, 650-0017, Japan

Location

Local Institution - 011

Maebashi, 371-8511, Japan

Location

Local Institution - 013

Nagaoka, 940-2085, Japan

Location

Local Institution - 016

Nagasaki, 852-8501, Japan

Location

Local Institution - 006

Nagoya, 454-8509, Japan

Location

Local Institution - 021

Nagoya, 467-8602, Japan

Location

Local Institution - 008

Niigata, 951-8510, Japan

Location

Local Institution - 002

Osaka, 545-8586, Japan

Location

Local Institution - 012

Ōgaki, 503-8502, Japan

Location

Local Institution - 005

Shibukawa, 377-8577, Japan

Location

Local Institution - 019

Tokyo, 108-8329, Japan

Location

Local Institution - 003

Yamagata, 990-9585, Japan

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Eosinophilic enteropathy; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis

Interventions

cendakimab

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 31, 2022
• Study Start: March 4, 2022
• Primary Completion: July 2, 2024
• Study Completion: August 22, 2025
• Last Updated: October 21, 2025
• Results First Posted: September 18, 2025

Record last verified: 2025-10

Locations

JP (25)