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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

NCT04502862 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2024-12-06

Study results available
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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

Interventions

DRUG

SAR231893

Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous

DRUG

Placebo

Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-10
Primary Completion
2023-10-03
Completion
2023-11-10
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Canada
  • Germany
  • Italy
  • Netherlands
  • Portugal
  • Russia
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04502862 on ClinicalTrials.gov