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CC-93538

Phase 3

Eosinophilic Esophagitis | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Apr 6, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment797
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04991935Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic EsophagitisPHASE3 COMPLETED 367Aug 9, 2022Aug 14, 2025Apr 6, 2026167 United States, Argentina +13
NCT04753697A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic EsophagitisPHASE3 COMPLETED 430Feb 22, 2021Aug 29, 2024Mar 13, 2025212 United States, Argentina +13
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Study Endpoints
Primary Endpoints
Number of Participants With Treatment Emergent Adverse Events (TEAE)
From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization.

Number of Participants With Clinically Significant Maximum Post Baseline Shifts in Laboratory Parameters
From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)

Blood samples were collected to assess clinical significant shifts in laboratory parameters. "Normal to High" means at baseline the value is Normal and maximum post baseline value is High.

Number of Participants With Clinically Meaningful Mean Changes in Vital Signs and Physical Parameters
From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)

SBP (Systolic blood Pressure) and DBP (Diastolic Blood Pressure) measured in mmHg and Heart rates measured in beats per minute.

Change From Baseline in Mean Dysphagia Days (DD) at Week 24
Baseline (Day 1) and Week 24

Dysphagia Days (DD) was assessed using a modified daily symptom diary (mDSD). The DD was evaluated over the prior 14-day period using the mDSD, which includes 6 primary questions. These questions assess solid food consumption that day (Q1), experience with trouble swallowing (Q2), food going down slowly (Q3), food getting stuck in the throat or chest (Q4), actions taken by participants to obtain relief (Q5), and any pain associated with swallowing (Q6). The number of DD was normalized by calculating the number of diary days with a "yes" to any or all of Q2, Q3, and Q4 in the 14-day period prior to a visit, dividing by the number of measurable diary days in the 14-day period, and then multiplying by the length of the period (14). A measurable diary day for DD is defined as a diary day for which Questions 2 to 4 are answered. Mean DD ranges from 0 to 14 for the 14-day period.

Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 24
Week 24

Blood samples were collected to assess esophageal eosinophil count.

Secondary Endpoints
Number of Participants With Incidence of Treatment Emergent Anti-CEN Antibodies
From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)
Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 48
Week 48
Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 24
Week 24
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Administration of CC-93538EXPERIMENTALParticipants are administered CC-93538 dose subcutaneously once weekly
Administration of CC-93538 and PlaceboEXPERIMENTALCC-93538 360 mg SC once weekly for 24 weeks followed by CC-93538 360 mg SC once every other week for 24 weeks. During the Maintenance Phase, matching placebo will be administered once every other week on alternate weeks to maintain the blind.
Administration of PlaceboPLACEBO_COMPARATORMatching placebo SC once weekly for 24 weeks followed by matching placebo SC once weekly for 24 weeks
Interventions
NameTypeDescription
CC-93538DRUGCC-93538
PlaceboOTHERSubcutaneous
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Eligibility Criteria
Age Range12 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites167

Inclusion Criteria: * Previously participated in prior clinical study CC-93538-EE-001 and either: 1. Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Induction Phase and has completed Week 24 of the Induction Phase; OR 2. Sub...

Countries:United StatesArgentinaAustraliaAustriaBelgiumCanadaGermanyIsraelItalyJapanPolandPortugalSpainSwitzerlandUnited Kingdom
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT04991935TRIAL_REMOVED: changed
LOWMay 24, 2026NCT04991935studyFirstPostDate: changed