"A PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS"

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506278-10-00

Acronym

CC-93538-EE-002

Enrollment

Registered

2024-04-18

Start date

2022-04-22

Completion date

2025-08-11

Last updated

2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic esophagitis

Brief summary

Safety and tolerability of long-term treatment with CC-93538 evaluated by the incidence, severity, and relationship to CC-93538 of adverse events (AEs), serious adverse events (SAEs), clinical laboratory abnormalities, changes in vital signs, and physical examination abnormalities.

Detailed description

Immunogenicity of CC-93538 assessed through the incidence of anti-drug antibodies to CC-93538 including neutralizing antibodies when warranted.

Interventions

DRUGCendakimab

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Immunogenicity of CC-93538 assessed through the incidence of anti-drug antibodies to CC-93538 including neutralizing antibodies when warranted.	—

Primary

Measure	Time frame
Safety and tolerability of long-term treatment with CC-93538 evaluated by the incidence, severity, and relationship to CC-93538 of adverse events (AEs), serious adverse events (SAEs), clinical laboratory abnormalities, changes in vital signs, and physical examination abnormalities.	—

Countries

Austria, Belgium, Germany, Italy, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026