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Itepekimab

DRUG8 trials

Sponsors

Sanofi-Aventis Recherche & Developpement

Conditions

BronchiectasisChronic Obstructive Pulmonary DiseaseChronic rhinosinusitis with nasal polypsRespiratory tract diseases

Phase 2

Phase 3

A double-blinded extension study to evaluate the long-term safety and tolerability of itepekimab in patients with chronic obstructive pulmonary disease (COPD) who participated in either EFC16750 or EFC16819 clinical studies
Active, not recruitingCTIS2023-508085-15-00
Sanofi-Aventis Recherche & DeveloppementChronic Obstructive Pulmonary Disease
Start: 2024-05-15Target: 247Updated: 2026-01-20
Randomized, double-blind, placebo-controlled, parallel-group Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/REGN3500/itepekimab (anti-IL-33 mAb) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) (AERIFY-1)
CompletedCTIS2024-512013-41-00
Sanofi-Aventis Recherche & DeveloppementChronic Obstructive Pulmonary Disease
Start: 2021-03-22End: 2025-06-24Target: 686Updated: 2025-03-25
Randomized, double-blind, placebo-controlled, parallel-group Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/REGN3500/itepekimab (anti-IL-33 mAb) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD)
CompletedCTIS2024-512012-21-00
Sanofi-Aventis Recherche & DeveloppementChronic Obstructive Pulmonary Disease
Start: 2021-04-08End: 2025-08-05Target: 747Updated: 2025-03-24
A randomized, double blind, placebo controlled, parallel group, 52­week Phase 3 trial to investigate the efficacy, safety, and tolerability of itepekimab in adult participants with inadequately-controlled chronic rhinosinusitis with nasal polyps
RecruitingCTIS2024-516814-39-00
Sanofi-Aventis Recherche & DeveloppementChronic rhinosinusitis with nasal polyps
Start: 2025-05-20Target: 131Updated: 2026-01-23
A randomized, double blind, placebo controlled, parallel group, 52­week Phase 3 trial to investigate the efficacy, safety, and tolerability of itepekimab in adult participants with inadequately-controlled chronic rhinosinusitis with nasal polyps
RecruitingCTIS2024-516815-26-00
Sanofi-Aventis Recherche & DeveloppementChronic rhinosinusitis with nasal polyps
Start: 2025-05-30Target: 135Updated: 2025-11-23