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

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

Official Title
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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

Conditions
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Eosinophilic Gastroenteritis

Intervention / Treatment
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* Drug: CC-93538
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CC-93538<br> | Drug: CC-93538<br>* Specified dose on specified days<br>* Other names: BMS-986355;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 
| 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 | 
| Incidence of adverse events (AEs) |  | Up to 48 weeks | 
| Incidence of serious adverse events |  | Up to 48 weeks | 
| Number of participants with clinical laboratory abnormalities |  | Up to 48 weeks | 
| Number of participants with electrocardiogram abnormalities |  | Up to 48 weeks | 
| Number of participants with vital sign abnormalities |  | Up to 48 weeks | 
| Number of participants with physical examination abnormalities |  | Up to 48 weeks | 
| Number of participants with the presence of anti-drug antibodies, including neutralizing antibodies |  | Up to 48 weeks | 
| Eosinophil histologic response: changes in mean number of peak eos per hpf in GI biopsies |  | 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 | 
| Time to event: the time to event of EGE flare |  | Up to 48 weeks | 
| Time to event: the time to event of use of rescue therapy |  | Up to 48 weeks | 
| Time to event: The time until concomitant corticosteroid use to zero | For participants who use concomitant treatment only | Up to 48 weeks | 
| 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 | 
| Pharmacokinetics: Trough concentrations of CC-93538 |  | Up to 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eosinophilic Gastroenteritis, CC-93538, Gastrointestinal Diseases, Eosinophilic Gastro-Intestinal Disorder, EGID, Digestive system diseases, Gastroenteritis