Effect of Dupilumab on Sleep Apnea in Patients With Rhinosinusitis

• Status: Unknown status
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Adults (18 to 65 years)

• BMI < 35 kg/m2

• Bilateral CRS (clinical diagnosis) with or without nasal polyposis despite intranasal corticosteroid treatment for at least 3 months.

• Patients will be required to report at least 2 of the following symptoms prior to screening: (1) nasal obstruction/blockage, (2) nasal discharge or discolored postnasal drainage, (3) facial pain or pressure, and (4) reduction or loss of sense of smell, with symptom duration of at least 3 months.

• Suffering from OSA with AHI > 10 episodes/hr based on the home sleep test (described below) and not using CPAP.

• Willing, committed, and able to return for all clinic visits and complete all study-related procedures.

• In females of childbearing potential: Negative pregnancy test. A urine pregnancy test will be performed in each site visit to ensure that the patients are not pregnant while using dupilumab.

Exclusion Criteria:

• Concurrent sleep disorder

• Previous participation in any clinical trial of dupilumab in which active treatment was administered.

• Oral corticosteroids, monoclonal antibodies, immunosuppressive treatment, or anti-immunoglobulin E (anti-IgE) therapy during the 6 weeks preceding the screening.

• Concomitant conditions making them not evaluable for the primary endpoint. Prior diagnosis of OSA will not be exclusionary.

• Lactating females or pregnant females.

• Subjects for whom there is concern about compliance with the protocol procedures.

• Any medical condition which, in the opinion of the Investigator, would interfere with participation in the study or place the subject at risk (chronic infectious diseases such as TB, HIV, Hepatitis, etc.).

• History of hypersensitivity to the study drug.

• History of substance abuse (drug or alcohol) or any other factor (e.g., serious psychiatric condition) that could limit the subject's ability to comply with study procedures.

• Subjects must refrain from intranasal decongestants for 1 week prior to starting the study.

• Subjects with a medical history of HSV1 or HSV2, or with a history of recurrent conjunctivitis.