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NCT04678856 · ClinicalTrials.gov registry record · Phase 3

Dupilumab in CRSsNP

A Phase 3 study, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
71
Enrollment target

NCT04678856 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 71 participants.

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The verdict

NCT04678856, a Phase 3 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
71 participants
Enrollment target

Study Summary

Primary Objective: To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on computerized tomography (CT) scan in the dupilumab group only Secondary Objectives: * To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on CT scan and sinus total symptom score (sTSS) compared to placebo * To evaluate the safety and tolerability of dupilumab in CRSsNP patients compared to placebo * To evaluate the pharmacokinetics (PK) of dupilumab in CRSsNP patients compared to placebo * Assessment of immunogenicity to dupilumab over time compared to placebo

Interventions

  • DRUG Placebo
  • DRUG Dupilumab SAR231893

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2020-12-02
Est. Completion 2024-01-29
Phase Phase 3

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT04678856

The ClinicalTrials.gov registry entry for NCT04678856 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04678856 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04678856 about?

NCT04678856 is a clinical study titled "Dupilumab in CRSsNP". Primary Objective: To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on computerized tomography (CT) scan in the dupilumab group only Secondary Objectives: * To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus o...

What is the current status of trial NCT04678856?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 71 participants. The study started on 2020-12-02. Estimated completion is 2024-01-29.

What interventions are being tested in trial NCT04678856?

The interventions under investigation include: Placebo (DRUG), Dupilumab SAR231893 (DRUG).

Who is sponsoring clinical trial NCT04678856?

This trial is sponsored by Sanofi, which has 713 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.