A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
Study CC-93538-EE-001 is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC- 93538 in adult and adolescent participants with eosinophilic esophagitis (EoE). The study will incorporate a 24-week Induction Phase followed by a 24-week Maintenance Phase.
Participants will be randomized at the beginning of the study into 3 treatment arms:
- Placebo for Induction and Maintenance
- CC-93538 360 mg Subcutaneous (SC) once weekly for Induction followed by 360 mg SC once every other week for Maintenance
- CC-93538 360 mg SC once weekly for Induction and Maintenance
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 399 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Long-term Controlled Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects With Active Eosinophilic Esophagitis.
Actual Study Start Date: February 22, 2021
Estimated Primary Completion Date: May 1, 2024
Estimated Study Completion Date: August 21, 2024
Arm:
- Experimental: Administration of CC-93538
- Experimental: Administration of CC-93538 and Placebo
- Placebo Comparator: Administration of Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 399 |
| Actual Study start date | 22 February 2021 |
| Estimated Study Completion Date | 21 August 2024 |