Trial Outcomes & Findings for Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis (NCT NCT04991935)

NCT ID: NCT04991935

Last Updated: 2026-04-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

367 participants

Primary outcome timeframe

From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)

Results posted on

2026-04-06

Participant Flow

Participants were enrolled in 14 countries.

Participant milestones

Participant milestones
Measure	Administration of CC-93538 Participants were administered CC-93538 360 mg subcutaneously once weekly
Overall Study STARTED	367
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	361

Reasons for withdrawal

Reasons for withdrawal
Measure	Administration of CC-93538 Participants were administered CC-93538 360 mg subcutaneously once weekly
Overall Study Adverse Event	4
Overall Study Site closed by sponsor	297
Overall Study Withdrawal by Subject	34
Overall Study Lost to Follow-up	11
Overall Study Lack of Efficacy	3
Overall Study Physician Decision	5
Overall Study Other reasons	5
Overall Study Non compliance with study drug	1
Overall Study Pregnancy	1

Baseline Characteristics

Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Administration of CC-93538 n=367 Participants Participants were administered CC-93538 360 mg subcutaneously once weekly
Age, Continuous	36.1 years STANDARD_DEVIATION 11.65 • n=5 Participants
Sex: Female, Male Female	104 Participants n=5 Participants
Sex: Female, Male Male	263 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	355 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	24 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	337 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)

Population: Open label extension population included all the enrolled participants.

Outcome measures

Outcome measures
Measure	Administration of CC-93538 n=367 Participants Participants were administered CC-93538 360 mg subcutaneously once weekly
Number of Participants With Treatment Emergent Adverse Events (TEAE) Adverse Events (Mild)	100 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) Adverse Events (Moderate)	167 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) Adverse Events (Severe)	31 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) Any TEAEs	298 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) Any TESAEs	25 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) TEAEs related to CC-93538	72 Participants

PRIMARY outcome

Timeframe: From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)

Population: Open label extension population included all the enrolled participants. Only participants with data available at the timepoint were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Administration of CC-93538 n=357 Participants Participants were administered CC-93538 360 mg subcutaneously once weekly
Number of Participants With Clinically Significant Maximum Post Baseline Shifts in Laboratory Parameters Eosinophil High to High	34 Participants
Number of Participants With Clinically Significant Maximum Post Baseline Shifts in Laboratory Parameters Alanine Amino Transferase Normal to High	64 Participants
Number of Participants With Clinically Significant Maximum Post Baseline Shifts in Laboratory Parameters Alanine Amino Transferase High to High	26 Participants
Number of Participants With Clinically Significant Maximum Post Baseline Shifts in Laboratory Parameters Aspartate Amino Transferase Normal to High	45 Participants
Number of Participants With Clinically Significant Maximum Post Baseline Shifts in Laboratory Parameters Aspartate Amino Transferase High to High	10 Participants
Number of Participants With Clinically Significant Maximum Post Baseline Shifts in Laboratory Parameters Gamma Glutamyl Transferase Normal to High	21 Participants
Number of Participants With Clinically Significant Maximum Post Baseline Shifts in Laboratory Parameters Gamma Glutamyl Transferase High to High	19 Participants

PRIMARY outcome

Timeframe: From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)

Population: Open label extension population included all the enrolled participants. Only participants with data available at the timepoint were included in the analysis.

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

Outcome measures

Outcome measures
Measure	Administration of CC-93538 n=357 Participants Participants were administered CC-93538 360 mg subcutaneously once weekly
Number of Participants With Clinically Meaningful Mean Changes in Vital Signs and Physical Parameters Heart Rate > 100 AND CHANGE FROM BASELINE > 30	12 Participants
Number of Participants With Clinically Meaningful Mean Changes in Vital Signs and Physical Parameters Heart Rate < 55 AND CHANGE FROM BASELINE < -15	14 Participants
Number of Participants With Clinically Meaningful Mean Changes in Vital Signs and Physical Parameters SBP > 140 AND CHANGE FROM BASELINE > 20	51 Participants
Number of Participants With Clinically Meaningful Mean Changes in Vital Signs and Physical Parameters SBP < 90 AND CHANGE FROM BASELINE < -20	0 Participants
Number of Participants With Clinically Meaningful Mean Changes in Vital Signs and Physical Parameters DBP > 90 AND CHANGE FROM BASELINE > 10	73 Participants
Number of Participants With Clinically Meaningful Mean Changes in Vital Signs and Physical Parameters DBP < 55 AND CHANGE FROM BASELINE < -10	13 Participants
Number of Participants With Clinically Meaningful Mean Changes in Vital Signs and Physical Parameters Physical Examination	0 Participants

SECONDARY outcome

Timeframe: From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)

Population: Open label extension population included all the enrolled participants. Only participants with data available at the timepoint were included in the analysis.

Blood samples were collected to assess Anti-CEN antibodies. Post-Baseline ADA Positive define as 1) at least 1 positive post-baseline given baseline is negative or missing; or 2) at least 1 positive post-baseline with titer \>= 4-fold baseline titer given positive baseline.

Outcome measures

Outcome measures
Measure	Administration of CC-93538 n=357 Participants Participants were administered CC-93538 360 mg subcutaneously once weekly
Number of Participants With Incidence of Treatment Emergent Anti-CEN Antibodies	48 Participants

Adverse Events

CC-93538 360 mg QW

Serious events: 25 serious events

Other events: 158 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CC-93538 360 mg QW n=367 participants at risk Participants were administered CC-93538 360 mg subcutaneously once weekly
Cardiac disorders Atrial fibrillation	0.27% 1/367 • Number of events 1 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Gastrointestinal disorders Abdominal pain	0.27% 1/367 • Number of events 1 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Gastrointestinal disorders Eosinophilic oesophagitis	0.54% 2/367 • Number of events 3 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Gastrointestinal disorders Oesophageal rupture	0.27% 1/367 • Number of events 1 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Gastrointestinal disorders Pancreatitis	0.27% 1/367 • Number of events 1 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Gastrointestinal disorders Vomiting	0.27% 1/367 • Number of events 1 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Hepatobiliary disorders Cholecystitis acute	0.27% 1/367 • Number of events 1 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Immune system disorders Anaphylactic reaction	1.4% 5/367 • Number of events 8 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Injury, poisoning and procedural complications Gastrointestinal procedural complication	0.27% 1/367 • Number of events 1 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.27% 1/367 • Number of events 1 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Nervous system disorders Intracranial pressure increased	0.27% 1/367 • Number of events 1 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Cardiac disorders Pericarditis	0.27% 1/367 • Number of events 1 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Gastrointestinal disorders Colitis ulcerative	0.27% 1/367 • Number of events 1 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Gastrointestinal disorders Crohn's disease	0.27% 1/367 • Number of events 1 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Gastrointestinal disorders Oesophageal food impaction	0.27% 1/367 • Number of events 1 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Gastrointestinal disorders Omental infarction	0.27% 1/367 • Number of events 1 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Immune system disorders Drug hypersensitivity	0.27% 1/367 • Number of events 1 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Immune system disorders Food allergy	0.27% 1/367 • Number of events 1 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Injury, poisoning and procedural complications Anaesthetic complication neurological	0.27% 1/367 • Number of events 1 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Injury, poisoning and procedural complications Road traffic accident	0.27% 1/367 • Number of events 1 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.27% 1/367 • Number of events 1 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Nervous system disorders Migraine	0.27% 1/367 • Number of events 1 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Nervous system disorders Status migrainosus	0.27% 1/367 • Number of events 1 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Respiratory, thoracic and mediastinal disorders Asthma	0.27% 1/367 • Number of events 1 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.

Other adverse events

Other adverse events
Measure	CC-93538 360 mg QW n=367 participants at risk Participants were administered CC-93538 360 mg subcutaneously once weekly
General disorders Injection site reaction	10.9% 40/367 • Number of events 449 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Infections and infestations COVID-19	12.8% 47/367 • Number of events 48 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Infections and infestations Nasopharyngitis	9.8% 36/367 • Number of events 53 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Infections and infestations Influenza	6.5% 24/367 • Number of events 29 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Infections and infestations Upper respiratory tract infection	10.9% 40/367 • Number of events 49 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Musculoskeletal and connective tissue disorders Arthralgia	6.5% 24/367 • Number of events 24 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.
Nervous system disorders Headache	5.2% 19/367 • Number of events 38 • All-cause mortality, Non Serious and Serious Adverse events were collected from first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months) Serious AEs and Non-Serious Adverse Events were collected for all the open label extension population. Open label extension population included all the enrolled participants.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
Publication restrictions are in place

Restriction type: OTHER