Effect of Dupilumab on Sleep Apnea in Patients With Rhinosinusitis
NCT03675022 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2022-10-05
Summary
Obstructive Sleep Apnea (OSA) is a common disorder with serious consequences that remains underrecognized, with \>80% of OSA patients undiagnosed, and undertreated due to inadequate treatment options. The development of additional treatments for OSA, such as pharmacotherapy, are critically needed.
The collaboration between Regeneron and Sanofi are funding this project. Regeneron will be providing the drug and the contract will be with Regeneron. Both companies are involved as it is a collaboration across the companies.
Conditions
- Sleep Apnea
- Rhinosinusitis Chronic
Interventions
- DRUG
-
The investigational drug is dupilumab, 300mg in 2ml solution for subcutaneous application. All Patients will receive dupilumab, 300mg, every two weeks (8 subcutaneous injections total).
Sponsors & Collaborators
-
Brigham and Women's Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-08-15
- Primary Completion
- 2022-07-01
- Completion
- 2022-07-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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