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A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti--IL-33 mAb) in Participants With Chronic Rhinosinusitis Without Nasal Polyps

Name: A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti--IL-33 mAb) in Participants With Chronic Rhinosinusitis Without Nasal Polyps — clinical trial record (NCT06691113)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusCompleted

PhasePhase 2

SponsorSanofi

Started2024-12-16

View on ClinicalTrials.gov ↗

ACT18421 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of the study is to evaluate the efficacy, safety and tolerability of 2 dosing regimens of itepekimab compared to placebo in male and female participants with chronic rhinosinusitis without nasal polyps (CRSsNP) aged 18 years of age and older. Study details include: * The study duration (4-week screening, 24--week intervention, 20--week safety followup) will be 48 weeks. * The intervention duration will be 24 weeks. * The number of visits will be 7 site visits and 8 phone/remote visits.

Amendment history 1 change detected by DataLookout

2026-08-26

Trial completed

Trial Details

NCT Number	NCT06691113
Lead Sponsor	Sanofi Collaborators: Regeneron Pharmaceuticals
Conditions	Chronic Rhinosinusitis Without Nasal Polyps
Enrollment	66 participants
Start Date	2024-12-16
Primary Completion	2026-03-31 (estimated)
Study Completion	2026-08-12 (estimated)
Updated on ClinicalTrials.gov	2026-08-25