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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05214768
Other study ID # CC-93538-EG-001
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
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Completed NCT00148603 - Montelukast in the Treatment of Duodenal Eosinophilia N/A
Completed NCT03664960 - An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis Phase 2
Completed NCT00267475 - Data Bank for Eosinophilic Disorders N/A
Completed NCT04856891 - A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis Phase 3
Active, not recruiting NCT03678545 - Dupilumab in Eosinophilic Gastritis Phase 2
Terminated NCT01814059 - Sirolimus for Eosinophil-Associated Gastrointestinal Disorders Phase 1
Recruiting NCT01793168 - Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Completed NCT03496571 - A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis Phase 2
Recruiting NCT02523118 - OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages
Completed NCT05251909 - Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study) Phase 3
Completed NCT05439772 - Examining the Effect of Ondansetron on Bowel Prep Success Phase 4
Completed NCT00266565 - Anti-Interleukin-5 (IL-5) Study for Hypereosinophilic Syndrome Phase 1/Phase 2
Recruiting NCT05199532 - Eosinophilic Gastrointestinal Disorders Registry
Terminated NCT01212016 - Immunopathogenesis of Food Allergy and Eosinophilic Gastrointestinal Disorders N/A
Completed NCT02897271 - Characteristics of Eosinophilic Gastritis, Enteritis, and Colitis in a Multi-Site Cohort

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