Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
This study is an open-label, uncontrolled study design to evaluate the longer-term safety profile as well as durability of response of administration of a single dose level of CC-93538. The study will enroll participants who participated in the CC-93538-EE-001 study.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 259 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-Center, Multi-National, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects With Active Eosinophilic Esophagitis.
Actual Study Start Date: September 14, 2021
Estimated Primary Completion Date: August 1, 2026
Estimated Study Completion Date: August 1, 2026
Arm:
- Experimental: Administration of CC-93538
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 259 |
| Actual Study start date | 14 September 2021 |
| Estimated Study Completion Date | 01 August 2026 |