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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.

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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

FieldValue
Enrollment Target 430 participants
Start Date 2021-02-22
Est. Completion 2024-08-29
Phase Phase 3

Sponsor

Celgene

308 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.