Clinical trial NCT05214768: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Eosinophilic Gastroenteritis
Keywords: Eosinophilic Gastroenteritis
CC-93538
Gastrointestinal Diseases
Eosinophilic Gastro-Intestinal Disorder
EGID
Digestive system diseases
Gastroenteritis
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2022-01-31
Enrollment: 48
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes in mean number of peak eosinophils (eos) per high-power field (hpf) in gastrointestinal (GI) biopsies from baseline to Week 16
timeFrame: At Week 16
Secondary outcomes:
measure: Incidence of clinical response: eosinophilic gastroenteritis (EGE) related symptoms with changes from baseline in the five domain scores of the Izumo Scale from baseline
timeFrame: Up to 48 weeks
measure: 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
timeFrame: Up to 48 weeks
measure: Incidence of histologic response composite: proportion of participants with a > 75% reduction of peak gastric and/or duodenal eos count from baseline
timeFrame: Up to 48 weeks
measure: Incidence of adverse events (AEs)
timeFrame: Up to 48 weeks
measure: Incidence of serious adverse events
timeFrame: Up to 48 weeks
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 48 weeks
measure: Number of participants with electrocardiogram abnormalities
timeFrame: Up to 48 weeks
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 48 weeks
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 48 weeks
measure: Number of participants with the presence of anti-drug antibodies, including neutralizing antibodies
timeFrame: Up to 48 weeks
measure: Eosinophil histologic response: changes in mean number of peak eos per hpf in GI biopsies
timeFrame: Up to 48 weeks
measure: Eosinophil histologic response: percent changes in mean number of peak eos per hpf in GI biopsies from baseline
timeFrame: Up to 48 weeks
measure: Clinical response: eosinophilic gastrointestinal disorder (EGID) Severity Score
timeFrame: Up to 48 weeks
measure: Time to event: the time to event of EGE flare
timeFrame: Up to 48 weeks
measure: Time to event: the time to event of use of rescue therapy
timeFrame: Up to 48 weeks
measure: Time to event: The time until concomitant corticosteroid use to zero
timeFrame: Up to 48 weeks
measure: Proportion of participants with event: The proportion of participants for whom the dose of concomitant steroids is reduced to zero
timeFrame: Up to 48 weeks
measure: Pharmacokinetics: Trough concentrations of CC-93538
timeFrame: Up to 48 weeks
Other outcomes:
Locations:
city: Gifu City
country: Japan
facility: Local Institution - 024
state: Gifu
city: Himeji-shi
country: Japan
facility: Local Institution - 022
state: Hyogo
city: Nishinomiya
country: Japan
facility: Local Institution - 009
state: Hyogo
city: Tsu
country: Japan
facility: Local Institution - 0025
state: MIE
city: Tsu
country: Japan
facility: Local Institution - 025
state: MIE
city: Sendai
country: Japan
facility: Local Institution - 023
state: Miyagi
city: Bunkyo-ku
country: Japan
facility: Local Institution - 007
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Local Institution - 001
state: Tokyo
city: Akita-shi
country: Japan
facility: Local Institution - 010
city: Hirosaki
country: Japan
facility: Local Institution - 017
city: Hiroshima
country: Japan
facility: Local Institution - 015
city: Kagoshima
country: Japan
facility: Local Institution - 018
city: Kitakyushu
country: Japan
facility: Local Institution - 020
city: Kobe
country: Japan
facility: Local Institution - 004
city: Maebashi
country: Japan
facility: Local Institution - 011
city: Nagaoka
country: Japan
facility: Local Institution - 013
city: Nagasaki
country: Japan
facility: Local Institution - 016
city: Nagoya
country: Japan
facility: Local Institution - 006
city: Nagoya
country: Japan
facility: Local Institution - 021
city: Niigata-shi
country: Japan
facility: Local Institution - 008
city: Ogaki
country: Japan
facility: Local Institution - 012
city: Osaka
country: Japan
facility: Local Institution - 002
city: Shibukawa
country: Japan
facility: Local Institution - 005
city: Tokyo
country: Japan
facility: Local Institution - 019
city: Yamagata
country: Japan
facility: Local Institution - 003
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: