Itepekimab
Sponsors
Sanofi-Aventis Recherche & Developpement
Conditions
BronchiectasisChronic Obstructive Pulmonary DiseaseChronic rhinosinusitis with nasal polypsRespiratory tract diseases
Phase 2
A Phase 2a, open-label, two-part study to evaluate the mechanism of action of itepekimab (anti-IL-33 mAb) on airway inflammation in patients with chronic obstructive pulmonary disease (COPD)
CompletedCTIS2024-512007-39-00
Start: 2022-06-20End: 2025-07-22Target: 65Updated: 2025-02-05
A randomized, double-blind, placebo-controlled, parallel-group, Proof-of-Concept (PoC) study to assess the efficacy, safety and tolerability of itepekimab, in participants with non-cystic fibrosis bronchiectasis
Active, not recruitingCTIS2023-508663-70-00
Start: 2024-06-18Target: 138Updated: 2026-01-21
A randomized, double blind, placebo controlled, Proof of Concept (PoC) study to assess the efficacy, safety and tolerability of itepekimab in participants with inadequately controlled chronic rhinosinusitis without nasal polyps
Active, not recruitingCTIS2024-515576-12-00
Start: 2025-03-20Target: 53Updated: 2026-01-22
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
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
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
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
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
Start: 2025-05-30Target: 135Updated: 2025-11-23