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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2020-12-02 |
| Est. Completion | 2024-01-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗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.
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