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

Primary Purpose

Eosinophilic Gastroenteritis

Status
Recruiting
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
CC-93538
Placebo
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilic Gastroenteritis focused on measuring Eosinophilic Gastroenteritis, CC-93538, Gastrointestinal Diseases, Eosinophilic Gastro-Intestinal Disorder, EGID, Digestive system diseases, Gastroenteritis

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution - 024Recruiting
  • Local Institution - 022Recruiting
  • Local Institution - 009Recruiting
  • Local Institution - 0025Recruiting
  • Local Institution - 025
  • Local Institution - 023Recruiting
  • Local Institution - 007Recruiting
  • Local Institution - 001Recruiting
  • Local Institution - 010Recruiting
  • Local Institution - 017Recruiting
  • Local Institution - 015Recruiting
  • Local Institution - 018Recruiting
  • Local Institution - 020Recruiting
  • Local Institution - 004Recruiting
  • Local Institution - 011Recruiting
  • Local Institution - 013Recruiting
  • Local Institution - 016Recruiting
  • Local Institution - 006Recruiting
  • Local Institution - 014
  • Local Institution - 021Recruiting
  • Local Institution - 008Recruiting
  • Local Institution - 012Recruiting
  • Local Institution - 002Recruiting
  • Local Institution - 005Recruiting
  • Local Institution - 019Recruiting
  • Local Institution - 003Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CC-93538

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Changes in mean number of peak eosinophils (eos) per high-power field (hpf) in gastrointestinal (GI) biopsies from baseline to Week 16

Secondary Outcome Measures

Incidence of clinical response: eosinophilic gastroenteritis (EGE) related symptoms with changes from baseline in the five domain scores of the Izumo Scale from baseline
Incidence of clinical response composite: proportion of participants who achieve < 4/15 in each of three Symptoms of Interest scores of the Izumo Scale from baseline
Incidence of histologic response composite: proportion of participants with a > 75% reduction of peak gastric and/or duodenal eos count from baseline
Incidence of adverse events (AEs)
Incidence of serious adverse events
Number of participants with clinical laboratory abnormalities
Number of participants with electrocardiogram abnormalities
Number of participants with vital sign abnormalities
Number of participants with physical examination abnormalities
Number of participants with the presence of anti-drug antibodies, including neutralizing antibodies
Eosinophil histologic response: changes in mean number of peak eos per hpf in GI biopsies
Eosinophil histologic response: percent changes in mean number of peak eos per hpf in GI biopsies from baseline
Clinical response: eosinophilic gastrointestinal disorder (EGID) Severity Score
Time to event: the time to event of EGE flare
Time to event: the time to event of use of rescue therapy
Time to event: The time until concomitant corticosteroid use to zero
For participants who use concomitant treatment only
Proportion of participants with event: The proportion of participants for whom the dose of concomitant steroids is reduced to zero
For participants who use concomitant treatment only
Pharmacokinetics: Trough concentrations of CC-93538

Full Information

First Posted
January 12, 2022
Last Updated
September 7, 2023
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT05214768
Brief Title
A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Participants With Eosinophilic Gastroenteritis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 4, 2022 (Actual)
Primary Completion Date
December 18, 2023 (Anticipated)
Study Completion Date
November 19, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Gastroenteritis
Keywords
Eosinophilic Gastroenteritis, CC-93538, Gastrointestinal Diseases, Eosinophilic Gastro-Intestinal Disorder, EGID, Digestive system diseases, Gastroenteritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CC-93538
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CC-93538
Other Intervention Name(s)
Cendakimab, BMS-986355
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Changes in mean number of peak eosinophils (eos) per high-power field (hpf) in gastrointestinal (GI) biopsies from baseline to Week 16
Time Frame
At Week 16
Secondary Outcome Measure Information:
Title
Incidence of clinical response: eosinophilic gastroenteritis (EGE) related symptoms with changes from baseline in the five domain scores of the Izumo Scale from baseline
Time Frame
Up to 48 weeks
Title
Incidence of clinical response composite: proportion of participants who achieve < 4/15 in each of three Symptoms of Interest scores of the Izumo Scale from baseline
Time Frame
Up to 48 weeks
Title
Incidence of histologic response composite: proportion of participants with a > 75% reduction of peak gastric and/or duodenal eos count from baseline
Time Frame
Up to 48 weeks
Title
Incidence of adverse events (AEs)
Time Frame
Up to 48 weeks
Title
Incidence of serious adverse events
Time Frame
Up to 48 weeks
Title
Number of participants with clinical laboratory abnormalities
Time Frame
Up to 48 weeks
Title
Number of participants with electrocardiogram abnormalities
Time Frame
Up to 48 weeks
Title
Number of participants with vital sign abnormalities
Time Frame
Up to 48 weeks
Title
Number of participants with physical examination abnormalities
Time Frame
Up to 48 weeks
Title
Number of participants with the presence of anti-drug antibodies, including neutralizing antibodies
Time Frame
Up to 48 weeks
Title
Eosinophil histologic response: changes in mean number of peak eos per hpf in GI biopsies
Time Frame
Up to 48 weeks
Title
Eosinophil histologic response: percent changes in mean number of peak eos per hpf in GI biopsies from baseline
Time Frame
Up to 48 weeks
Title
Clinical response: eosinophilic gastrointestinal disorder (EGID) Severity Score
Time Frame
Up to 48 weeks
Title
Time to event: the time to event of EGE flare
Time Frame
Up to 48 weeks
Title
Time to event: the time to event of use of rescue therapy
Time Frame
Up to 48 weeks
Title
Time to event: The time until concomitant corticosteroid use to zero
Description
For participants who use concomitant treatment only
Time Frame
Up to 48 weeks
Title
Proportion of participants with event: The proportion of participants for whom the dose of concomitant steroids is reduced to zero
Description
For participants who use concomitant treatment only
Time Frame
Up to 48 weeks
Title
Pharmacokinetics: Trough concentrations of CC-93538
Time Frame
Up to 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 024
City
Gifu City
State/Province
Gifu
ZIP/Postal Code
5011194
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 024
Facility Name
Local Institution - 022
City
Himeji-shi
State/Province
Hyogo
ZIP/Postal Code
670-8560
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 022
Facility Name
Local Institution - 009
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 009
Facility Name
Local Institution - 0025
City
Tsu
State/Province
MIE
ZIP/Postal Code
514-8507
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0025
Facility Name
Local Institution - 025
City
Tsu
State/Province
MIE
ZIP/Postal Code
514-8507
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 025
Facility Name
Local Institution - 023
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
982-8502
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 023
Facility Name
Local Institution - 007
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 007
Facility Name
Local Institution - 001
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
157-8535
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 001
Facility Name
Local Institution - 010
City
Akita-shi
ZIP/Postal Code
010-8543
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 010
Facility Name
Local Institution - 017
City
Hirosaki
ZIP/Postal Code
036-8545
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 017
Facility Name
Local Institution - 015
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 015
Facility Name
Local Institution - 018
City
Kagoshima
ZIP/Postal Code
890-8544
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 018
Facility Name
Local Institution - 020
City
Kitakyushu
ZIP/Postal Code
802-8561
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 020
Facility Name
Local Institution - 004
City
Kobe
ZIP/Postal Code
650-0017
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 004
Facility Name
Local Institution - 011
City
Maebashi
ZIP/Postal Code
371-8511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 011
Facility Name
Local Institution - 013
City
Nagaoka
ZIP/Postal Code
940-2085
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 013
Facility Name
Local Institution - 016
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 016
Facility Name
Local Institution - 006
City
Nagoya
ZIP/Postal Code
454-8509
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 006
Facility Name
Local Institution - 014
City
Nagoya
ZIP/Postal Code
457-8511
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Local Institution - 021
City
Nagoya
ZIP/Postal Code
467-8602
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 021
Facility Name
Local Institution - 008
City
Niigata-shi
ZIP/Postal Code
951-8510
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 008
Facility Name
Local Institution - 012
City
Ogaki
ZIP/Postal Code
503-8502
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 012
Facility Name
Local Institution - 002
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 002
Facility Name
Local Institution - 005
City
Shibukawa
ZIP/Postal Code
377-8577
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 005
Facility Name
Local Institution - 019
City
Tokyo
ZIP/Postal Code
108-8329
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 019
Facility Name
Local Institution - 003
City
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 003

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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