Itepekimab (SAR440340) Clinical Trials (2026): 11 Studies for Chronic Obstructive Pulmonary Disease & Chronic Rhinosinusitis With Nasal Polyps
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
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11 Itepekimab (SAR440340) clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 4 indications (including Chronic Obstructive Pulmonary Disease & Chronic Rhinosinusitis With Nasal Polyps) and 4,089 total planned enrollment. 7 Phase 3 Itepekimab (SAR440340) trials and 3 Phase 2 are listed. Most recent activity: NCT07484230 (Oct 2028).
Itepekimab (SAR440340) clinical trials at a glance: phase × recruitment status
| Phase | active not recruiting | completed | withdrawn | Total |
|---|---|---|---|---|
| P1 | 1 | 1 | ||
| P2 | 3 | 3 | ||
| P3 | 4 | 2 | 1 | 7 |
Itepekimab (SAR440340) clinical trials by indication
Chronic Obstructive Pulmonary Disease (5)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06208306 | AERIFY-4 | P3 | active not recruiting | A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD |
| NCT04751487 | AERIFY-2 | P3 | completed | Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) |
| NCT04701983 | AERIFY-1 | P3 | completed | Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) |
| NCT05326412 | AERIFY-3 | P2 | completed | Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD |
| NCT06114238 | — | P1 | completed | Pharmacokinetic Study to Compare Itepekimab Exposure When Administered With an Autoinjector Versus Prefilled Syringe |
Chronic Rhinosinusitis With Nasal Polyps (4)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07484230 | CEREN-4 | P3 | withdrawn | A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps |
| NCT06834360 | CEREN-2 | P3 | active not recruiting | A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps |
| NCT06834347 | CEREN-1 | P3 | active not recruiting | A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps |
| NCT07424144 | CEREN-3 | P3 | active not recruiting | An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps |
Chronic Rhinosinusitis Without Nasal Polyps (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06691113 | — | P2 | completed | 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 |
Bronchiectasis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06280391 | — | P2 | completed | A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis |
Itepekimab (SAR440340) pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| CEREN-4 | NCT07484230 | P3 | withdrawn | Chronic Rhinosinusitis With Nasal Polyps | 0 | — |
| CEREN-2 | NCT06834360 | P3 | active not recruiting | Chronic Rhinosinusitis With Nasal Polyps | 216 | — |
| CEREN-1 | NCT06834347 | P3 | active not recruiting | Chronic Rhinosinusitis With Nasal Polyps | 231 | — |
| CEREN-3 | NCT07424144 | P3 | active not recruiting | Chronic Rhinosinusitis With Nasal Polyps | 59 | — |
| AERIFY-4 | NCT06208306 | P3 | active not recruiting | Chronic Obstructive Pulmonary Disease | 700 | — |
| AERIFY-2 | NCT04751487 | P3 | completed | Chronic Obstructive Pulmonary Disease | 1,239 | — |
| AERIFY-1 | NCT04701983 | P3 | completed | Chronic Obstructive Pulmonary Disease | 1,127 | — |
| AERIFY-3 | NCT05326412 | P2 | completed | Chronic Obstructive Pulmonary Disease | 49 | — |
Terminated and withdrawn Itepekimab (SAR440340) trials (1)
Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.
- NCT07484230withdrawnA Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
All Itepekimab (SAR440340) trials (11)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT07484230 | CEREN-4 | A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps | P3 | withdrawn | 0 | Sanofi | May 2026 |
| NCT06834360 | CEREN-2 | A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps | P3 | active not recruiting | 216 | Sanofi | Feb 2025 |
| NCT06834347 | CEREN-1 | A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps | P3 | active not recruiting | 231 | Sanofi | Feb 2025 |
| NCT07424144 | CEREN-3 | An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps | P3 | active not recruiting | 59 | Sanofi | Mar 2026 |
| NCT06208306 | AERIFY-4 | A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD | P3 | active not recruiting | 700 | Sanofi | Jan 2024 |
| NCT06691113 | 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 | P2 | completed | 66 | Sanofi | Dec 2024 | |
| NCT06280391 | A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis | P2 | completed | 312 | Sanofi | Feb 2024 | |
| NCT04751487 | AERIFY-2 | Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) | P3 | completed | 1,239 | Sanofi | Feb 2021 |
| NCT04701983 | AERIFY-1 | Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) | P3 | completed | 1,127 | Sanofi | Dec 2020 |
| NCT05326412 | AERIFY-3 | Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD | P2 | completed | 49 | Sanofi | May 2022 |
| NCT06114238 | Pharmacokinetic Study to Compare Itepekimab Exposure When Administered With an Autoinjector Versus Prefilled Syringe | P1 | completed | 90 | Sanofi | Sep 2021 |
Itepekimab (SAR440340) clinical trials: frequently asked questions
- How many Itepekimab (SAR440340) clinical trials are there?
- 11 Itepekimab (SAR440340) clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 6 are marked completed.
- Are Itepekimab (SAR440340) clinical trials recruiting in 2026?
- No active Itepekimab (SAR440340) trials are recruiting on ClinicalTrials.gov as of the current AACT refresh. Trials may resume; this page is updated daily.
- What conditions is Itepekimab (SAR440340) being studied for?
- Itepekimab (SAR440340) is being studied for Chronic Obstructive Pulmonary Disease, Chronic Rhinosinusitis With Nasal Polyps, Bronchiectasis, Chronic Rhinosinusitis Without Nasal Polyps. The trials are grouped by indication on this page.
- What phase is Itepekimab (SAR440340) in?
- Itepekimab (SAR440340) clinical trials span 7 Phase 3, 3 Phase 2, 1 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Itepekimab (SAR440340) clinical trials?
- The lead sponsor across the most Itepekimab (SAR440340) trials is Sanofi. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Itepekimab (SAR440340)as an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
Last refreshed .
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