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

Sponsor

Celgene (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05214768

Collaborator

(none)

Enrollment

Locations

Arms

53.5

Anticipated Duration (Months)

22.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Eosinophilic Gastroenteritis	Drug: CC-93538 Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 4, 2022

Anticipated Primary Completion Date :

Sep 20, 2023

Anticipated Study Completion Date :

Aug 19, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CC-93538	Drug: CC-93538 Specified dose on specified days Other Names: Cendakimab
Placebo Comparator: Placebo	Drug: Placebo Specified dose on specified days

Arm

Intervention/Treatment

Experimental: CC-93538

Drug: CC-93538

Specified dose on specified days

Other Names:

Cendakimab

Placebo Comparator: Placebo

Drug: Placebo

Specified dose on specified days

Outcome Measures

Primary Outcome Measures

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

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 [Up to 48 weeks]
For participants who use concomitant treatment only
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
Pharmacokinetics: Trough concentrations of CC-93538 [Up to 48 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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