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NCT05575037 · ClinicalTrials.gov registry record · Phase 2

Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease

A Phase 2 study of Nasal Polyps and Aspirin-exacerbated Respiratory Disease, sponsored by Brigham and Women's Hospital.

Active
Registry status
Phase 2
Development phase
17
Enrollment target
1
Study location

NCT05575037: Active Phase 2 study of Nasal Polyps and Aspirin-exacerbated Respiratory Disease, sponsored by Brigham and Women's Hospital.

NCT05575037 is a Phase 2 study of Nasal Polyps and Aspirin-exacerbated Respiratory Disease that is active but no longer recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 17 participants, below the 100-participant average among 7 other Nasal Polyps trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05575037, a Phase 2 study of Nasal Polyps and Aspirin-exacerbated Respiratory Disease, is active but no longer recruiting, sponsored by Brigham and Women's Hospital.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
17 participants
Enrollment target
1
Study location

Study Summary

The overall aim of the study is to determine the clinical efficacy and mechanisms of action of anti-IL-4a (dupilumab) as treatment for patients with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) and Aspirin-Exacerbated Respiratory Disease (AERD).

Primary Outcome

The nasal fluid levels of LTE4 will be measured at week 8 and will serve as a surrogate biomarker of respiratory mast cell activation or burden.

Interventions

  • DRUG Dupilumab

Study Locations (1)

Massachusetts

  • Brigham and Women's Hospital - Boston

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2023-08-01
Est. Completion 2026-04-30
Phase Phase 2
Brigham and Women's Hospital

937 total trials

What the registry record for NCT05575037 still lists

NCT05575037 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 100-participant average among 7 other Nasal Polyps trials with a reported enrollment target (83% lower).

The record links to 4 conditions, with Nasal Polyps appearing as the primary indexed condition, and to 1 intervention - of which Dupilumab is the first listed.

NCT05575037 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT05575037 about?

NCT05575037 is a clinical study titled "Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease". The overall aim of the study is to determine the clinical efficacy and mechanisms of action of anti-IL-4a (dupilumab) as treatment for patients with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) and Aspirin-Exacerbated Respiratory Disease (AERD).

What is the current status of trial NCT05575037?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2023-08-01. Estimated completion is 2026-04-30.

What conditions does trial NCT05575037 study?

This clinical trial studies the following conditions: Nasal Polyps, Aspirin-exacerbated Respiratory Disease, Asthma, Aspirin-Induced, Aspirin-Sensitive Asthma With Nasal Polyps.

What interventions are being tested in trial NCT05575037?

The interventions under investigation include: Dupilumab (DRUG).

Who is sponsoring clinical trial NCT05575037?

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

Where is trial NCT05575037 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT05575037, the US trial registry maintained by the National Library of Medicine. NCT05575037 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.