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
Verified date | January 2024 |
Source | Celgene |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the safety and efficacy of CC-93538 in adult and adolescent participants with eosinophilic gastroenteritis.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Celgene |
Japan,
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 |
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