Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Participants With Eosinophilic Gastroenteritis
Lead Sponsor:
Celgene
Conditions:
Eosinophilic Gastroenteritis
Eligibility:
All Genders
12-75 years
Phase:
PHASE3
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
- 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
- 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
Key Trial Info
Start Date :
March 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05214768
Start Date
March 4 2022
End Date
August 22 2025
Last Update
October 21 2025
Active Locations (25)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution - 024
Gifu, Gifu, Japan, 5011194
2
Local Institution - 022
Himeji-shi, Hyōgo, Japan, 670-8560
3
Local Institution - 009
Nishinomiya, Hyōgo, Japan, 663-8501
4
Local Institution - 0025
Tsu, Mie-ken, Japan, 514-8507