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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: Completed Phase 3 study, sponsored by Celgene.
NCT04753697 is a Phase 3 study that has completed, run by Celgene. The registered enrollment target is 430 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Dysphagia Days (DD) was assessed using a modified daily symptom diary (mDSD). The DD was evaluated over the prior 14-day period using the mDSD, which includes 6 primary questions. These questions assess solid food consumption that day (Q1), experience with trouble swallowing (Q2), food going down slowly (Q3), food getting stuck in the throat or chest (Q4), actions taken by participants to obtain relief (Q5), and any pain associated with swallowing (Q6). The number of DD was normalized by calcula
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 |
What the finished NCT04753697 record still lists
NCT04753697 is an interventional study that assigns participants to a tested intervention. The registered 430 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04753697 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04753697's enrollment target sits among peer trials
430 877th of 2000 higher than 1,123 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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