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MARINERNCT05575037

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

StatusActive, Not Recruiting
PhasePhase 2
Primary completion
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 5 versions: 5 with changes below. See every version on ClinicalTrials.gov ↗

  1. Notable Results posted: Nov 13, 2026 Show 4 more changesShow less
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints revised (8)
    • Primary endpoint revised
    • Site details revised
  2. Minor Study completion pushed from Apr 30, 2026 to Dec 30, 2026v4
  3. Minor Trial status: Recruiting to Active, Not Recruitingv3 Show 4 more changesShow less
    • Enrollment target: estimated 33 to confirmed 17
    • Secondary endpoints: details revised at 5 of 8 entries
    • Site details revised
    • Study description expanded, about 2 words
  4. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 8 more changesShow less
    • Start date changed from estimate of Nov 2022 to Aug 1, 2023
    • Eligibility criteria shortened, about 49 words
    • Primary and study completion dates moved earlier to Apr 30, 2026
    • Interventions: Dupilumab (Drug), Placebo (Drug) to Dupilumab (Drug)
    • Secondary endpoints: details revised at 8 of 8 entries
    • Site details revised
    • Study arms: 2 to 1
    • Study description shortened, about 5 words
  5. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Nasal Fluid Levels of LTE4
Timeframe: At Week 8 (Visit 3)

Secondary (8)

Nasal Fluid Levels of Albumin
Sense of Smell - University of Pennsylvania Smell Identification Test (UPSIT)
Rhinoscopic Total Polyp Score (TPS)
Peak Nasal Inspiratory Flow (PNIF)
Quality of Life - 22-Item Sino-Nasal Outcome Test (SNOT-22)
Show 3 moreShow less
Lung Function - Forced Expiratory Volume 1 (FEV1)
Asthma Control - Asthma Control Questionnaire-6 (ACQ-6)
Number of Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs) Leading to Study Drug Discontinuation

Arms and interventions

DupilumabExperimental

Subjects will receive dupilumab (300mg every-other-week for 8 weeks).

Drugs: Dupilumab

Sites

1 site in 1 country

  • Brigham and Women's HospitalBoston, Massachusetts, United States