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NCT04753697 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
A Phase 3 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 3
- Development phase
- 430
- Enrollment target
NCT04753697 is a Phase 3 study that has completed, run by Celgene. The registered enrollment target is 430 participants.
The verdict
NCT04753697, a Phase 3 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 430 participants
- Enrollment target
Study Summary
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
Interventions
- OTHER Placebo
- DRUG CC-93538
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 430 participants |
| Start Date | 2021-02-22 |
| Est. Completion | 2024-08-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04753697
The ClinicalTrials.gov registry entry for NCT04753697 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 430 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04753697 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04753697 about?
NCT04753697 is a clinical study titled "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...
What is the current status of trial NCT04753697?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 430 participants. The study started on 2021-02-22. Estimated completion is 2024-08-29.
What interventions are being tested in trial NCT04753697?
The interventions under investigation include: Placebo (OTHER), CC-93538 (DRUG).
Who is sponsoring clinical trial NCT04753697?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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