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NCT04502862 · ClinicalTrials.gov registry record · Phase 4

A Phase 4, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Persistent Asthma

A Phase 4 study of Asthma, sponsored by Sanofi.

Completed
Registry status
Phase 4
Development phase
202
Enrollment target
20
Study locations

NCT04502862 is a Phase 4 study of Asthma that has completed, run by Sanofi. The registered enrollment target is 202 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT04502862, a Phase 4 study of Asthma, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 4
Development phase
202 participants
Enrollment target
20
Study locations

Study Summary

Primary Objective: To assess the effect of dupilumab on sleep Secondary Objectives: * To evaluate the effect of dupilumab on additional participant reported sleep outcomes * To evaluate the effect of dupilumab on objective sleep assessment * To evaluate the effect of dupilumab on asthma symptoms * To evaluate the effect of dupilumab on lung function * To evaluate the safety of dupilumab

Conditions Studied

Asthma

Interventions

  • DRUG Placebo
  • DRUG SAR231893

Study Locations (20)

California

  • Kern Allergy and Medical Research. Inc. Site Number : 8400003 - Bakersfield
  • Todd Astor MD Site Number : 8400016 - Culver City
  • Southern California Institute for Respiratory Diseases Site Number : 8400009 - Los Angeles
  • Allergy & Asthma Associates of Santa Clara Valley Site Number : 8400001 - San Jose

Buenos Aires

  • Investigational Site Number : 0320003 - CABA
  • Investigational Site Number : 0320001 - CABA

Santa Fe Province

  • Investigational Site Number : 0320004 - Rosario
  • Investigational Site Number : 0320005 - Rosario

Other

  • Investigational Site Number : 0320002 - Buenos Aires
  • Investigational Site Number : 1240009 - Québec

Ontario

  • Investigational Site Number : 1240012 - Ajax
  • Investigational Site Number : 1240005 - Toronto

Colorado

  • Asthma and Allergy Associates, PC Site Number : 8400011 - Colorado Springs

Florida

  • Sarasota Clinical Research Site Number : 8400012 - Sarasota

Kentucky

  • Allergy & Asthma Specialists, PSC Site Number : 8400004 - Owensboro

Trial Details

FieldValue
Enrollment Target 202 participants
Start Date 2020-08-10
Est. Completion 2023-11-10
Phase Phase 4

Sponsor

Sanofi

713 total trials

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What the Registry Record Tells You About NCT04502862

The ClinicalTrials.gov registry entry for NCT04502862 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 202 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (87% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04502862 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Buenos Aires, Santa Fe Province.

Frequently Asked Questions

What is clinical trial NCT04502862 about?

NCT04502862 is a clinical study titled "A Phase 4, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Persistent Asthma". Primary Objective: To assess the effect of dupilumab on sleep Secondary Objectives: * To evaluate the effect of dupilumab on additional participant reported sleep outcomes * To evaluate the effect of dupilumab on objective sleep assessment * To evaluate the effect of dupilumab on asthma symptoms ...

What is the current status of trial NCT04502862?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 202 participants. The study started on 2020-08-10. Estimated completion is 2023-11-10.

What conditions does trial NCT04502862 study?

This clinical trial studies the following conditions: Asthma.

What interventions are being tested in trial NCT04502862?

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

Who is sponsoring clinical trial NCT04502862?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04502862 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Kentucky, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.