At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 25 enrolled
Drug / intervention
Dupilumab SAR231893drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-arm, 52 Weeks, Phase 4 Study to Assess the Efficacy and Safety of Dupilumab in Patients With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) Who Are Not Adequately Controlled With Existing Therapies
In Brief
A Phase 4 clinical trial evaluating Dupilumab SAR231893 for Chronic Rhinosinusitis With Nasal Polyps. Completed, enrolled 25 participants across 1 site.
Detailed Summary
This was a Phase 4, open-label, single-arm, multicenter study to evaluate the efficacy and safety of dupilumab subcutaneous (SC) injection monotherapy in Japanese participants aged 18 or older with CRSwNP that is not adequately controlled with existing therapies. Duration of study period (per participant): * Screening Period (2 to 4 weeks) * Intervention Period (up to 52 weeks±3 days)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Rhinosinusitis With Nasal Polyps
CountriesJapan
CollaboratorsRegeneron Pharmaceuticals
Timeline
Phase 4CompletedFinished
20222023202420252026
First PostedSep 2021
Enrollment StartOct 2021
Primary CompletionDec 2022
Study CompletionJul 2023
TodayJul 2026
First PostedSep 17, 2021
Enrollment StartOct 22, 2021
Primary CompletionDec 21, 2022
Study CompletionJul 5, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.8 years ago
Interventions
Dupilumab SAR231893drug
Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC)