A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Participants With Eosinophilic Gastroenteritis
- Conditions
- Eosinophilic Gastroenteritis
- Interventions
- Drug: Placebo
- Registration Number
- NCT05214768
- Lead Sponsor
- Celgene
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 48
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - CC-93538 CC-93538 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Number of participants with physical examination abnormalities Up to 48 weeks Time to event: the time to event of EGE flare Up to 48 weeks Proportion of participants with event: The proportion of participants for whom the dose of concomitant steroids is reduced to zero Up to 48 weeks For participants who use concomitant treatment only
Incidence of adverse events (AEs) Up to 48 weeks Incidence of serious adverse events Up to 48 weeks 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 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 Number of participants with vital sign abnormalities Up to 48 weeks Time to event: The time until concomitant corticosteroid use to zero Up to 48 weeks For participants who use concomitant treatment only
Number of participants with clinical laboratory abnormalities Up to 48 weeks Number of participants with the presence of anti-drug antibodies, including neutralizing antibodies Up to 48 weeks 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 Eosinophil histologic response: percent changes in mean number of peak eos per hpf in GI biopsies from baseline Up to 48 weeks Clinical response: eosinophilic gastrointestinal disorder (EGID) Severity Score Up to 48 weeks Number of participants with electrocardiogram abnormalities Up to 48 weeks Eosinophil histologic response: changes in mean number of peak eos per hpf in GI biopsies Up to 48 weeks Time to event: the time to event of use of rescue therapy Up to 48 weeks Pharmacokinetics: Trough concentrations of CC-93538 Up to 48 weeks
Trial Locations
- Locations (25)
Local Institution - 002
🇯🇵Osaka, Japan
Local Institution - 022
🇯🇵Himeji-shi, Hyogo, Japan
Local Institution - 009
🇯🇵Nishinomiya, Hyogo, Japan
Local Institution - 0025
🇯🇵Tsu, MIE, Japan
Local Institution - 007
🇯🇵Bunkyo-ku, Tokyo, Japan
Local Institution - 001
🇯🇵Setagaya-ku, Tokyo, Japan
Local Institution - 010
🇯🇵Akita-shi, Japan
Local Institution - 015
🇯🇵Hiroshima, Japan
Local Institution - 018
🇯🇵Kagoshima, Japan
Local Institution - 017
🇯🇵Hirosaki, Japan
Local Institution - 020
🇯🇵Kitakyushu, Japan
Local Institution - 011
🇯🇵Maebashi, Japan
Local Institution - 016
🇯🇵Nagasaki, Japan
Local Institution - 006
🇯🇵Nagoya, Japan
Local Institution - 008
🇯🇵Niigata-shi, Japan
Local Institution - 021
🇯🇵Nagoya, Japan
Local Institution - 005
🇯🇵Shibukawa, Japan
Local Institution - 019
🇯🇵Tokyo, Japan
Local Institution - 003
🇯🇵Yamagata, Japan
Local Institution - 023
🇯🇵Sendai, Miyagi, Japan
Local Institution - 025
🇯🇵Tsu, MIE, Japan
Local Institution - 013
🇯🇵Nagaoka, Japan
Local Institution - 012
🇯🇵Ogaki, Japan
Local Institution - 024
🇯🇵Gifu City, Gifu, Japan
Local Institution - 004
🇯🇵Kobe, Japan