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

Eosinophilic Gastroenteritis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05214768
• Other study ID #: CC-93538-EG-001
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 4, 2022
• Est. completion date: November 19, 2026

Study information

• Verified date: January 2024
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: November 19, 2026
• Est. primary completion date: December 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Enteritis
• Eosinophilia
• Eosinophilic Esophagitis
• Eosinophilic Gastroenteritis
• Gastritis
• Gastroenteritis

Intervention

Drug:
• CC-93538
Specified dose on specified days
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
Japan	Local Institution - 010	Akita-shi
Japan	Local Institution - 007	Bunkyo-ku	Tokyo
Japan	Local Institution - 024	Gifu City	Gifu
Japan	Local Institution - 022	Himeji-shi	Hyogo
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-shi
Japan	Local Institution - 009	Nishinomiya	Hyogo
Japan	Local Institution - 012	Ogaki
Japan	Local Institution - 002	Osaka
Japan	Local Institution - 023	Sendai	Miyagi
Japan	Local Institution - 001	Setagaya-ku	Tokyo
Japan	Local Institution - 005	Shibukawa
Japan	Local Institution - 019	Tokyo
Japan	Local Institution - 0025	Tsu	MIE
Japan	Local Institution - 025	Tsu	MIE
Japan	Local Institution - 003	Yamagata

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in mean number of peak eosinophils (eos) per high-power field (hpf) in gastrointestinal (GI) biopsies from baseline to Week 16		At Week 16
Secondary	Incidence of clinical response: eosinophilic gastroenteritis (EGE) related symptoms with changes from baseline in the five domain scores of the Izumo Scale from baseline		Up to 48 weeks
Secondary	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		Up to 48 weeks
Secondary	Incidence of histologic response composite: proportion of participants with a > 75% reduction of peak gastric and/or duodenal eos count from baseline		Up to 48 weeks
Secondary	Incidence of adverse events (AEs)		Up to 48 weeks
Secondary	Incidence of serious adverse events		Up to 48 weeks
Secondary	Number of participants with clinical laboratory abnormalities		Up to 48 weeks
Secondary	Number of participants with electrocardiogram abnormalities		Up to 48 weeks
Secondary	Number of participants with vital sign abnormalities		Up to 48 weeks
Secondary	Number of participants with physical examination abnormalities		Up to 48 weeks
Secondary	Number of participants with the presence of anti-drug antibodies, including neutralizing antibodies		Up to 48 weeks
Secondary	Eosinophil histologic response: changes in mean number of peak eos per hpf in GI biopsies		Up to 48 weeks
Secondary	Eosinophil histologic response: percent changes in mean number of peak eos per hpf in GI biopsies from baseline		Up to 48 weeks
Secondary	Clinical response: eosinophilic gastrointestinal disorder (EGID) Severity Score		Up to 48 weeks
Secondary	Time to event: the time to event of EGE flare		Up to 48 weeks
Secondary	Time to event: the time to event of use of rescue therapy		Up to 48 weeks
Secondary	Time to event: The time until concomitant corticosteroid use to zero	For participants who use concomitant treatment only	Up to 48 weeks
Secondary	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	Up to 48 weeks
Secondary	Pharmacokinetics: Trough concentrations of CC-93538		Up to 48 weeks

External Links

•   BMS Clinical Trial Information