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NCT03675022 · ClinicalTrials.gov registry record · Early Phase 1

Effect of Dupilumab on Sleep Apnea in Patients With Rhinosinusitis

A Early Phase 1 study, sponsored by Brigham and Women's Hospital.

Terminated
Registry status
Early Phase 1
Development phase
9
Enrollment target

NCT03675022: Clinical Trial Early Phase 1 study, sponsored by Brigham and Women's Hospital.

NCT03675022 is a Early Phase 1 study that was terminated before completion, run by Brigham and Women's Hospital. The registered enrollment target is 9 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03675022, a Early Phase 1 study, was terminated before completion, sponsored by Brigham and Women's Hospital.

TERMINATED
Registry status
Early Phase 1
Development phase
9 participants
Enrollment target

Study 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.

Primary Outcome

The effect of dupilumab on OSA severity in patients with nasal obstruction due to chronic rhinosinusitis with or without nasal polyposis (Bilateral CRS). AHI is the amount of respiratory events that a patient has per hours of sleep.

Interventions

  • DRUG Dupilumab

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2018-08-15
Est. Completion 2022-07-01
Phase Early Phase 1
Brigham and Women's Hospital

937 total trials

Why NCT03675022 stopped before completion

NCT03675022 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 1 intervention - of which Dupilumab is the first listed.

NCT03675022 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03675022 about?

NCT03675022 is a clinical study titled "Effect of Dupilumab on Sleep Apnea in Patients With Rhinosinusitis". 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. ...

What is the current status of trial NCT03675022?

This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 9 participants. The study started on 2018-08-15. Estimated completion is 2022-07-01.

What interventions are being tested in trial NCT03675022?

The interventions under investigation include: Dupilumab (DRUG).

Who is sponsoring clinical trial NCT03675022?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03675022's enrollment target sits among peer trials

9 1745th of 2000 higher than 219 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03675022, the US trial registry maintained by the National Library of Medicine. NCT03675022 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.