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

Celgene

Status and phase

Completed

Phase 3

Conditions

Eosinophilic Gastroenteritis

Treatments

Drug: Placebo

Drug: CC-93538

Study type

Interventional

Funder types

Industry

Identifiers

CC-93538-EG-001

Details and patient eligibility

About

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

Enrollment

48 patients

Sex

All

Ages

12 to 75 years old

Volunteers

No 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