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Itepekimab (SAR440340)
Itepekimab is a monoclonal antibody that blocks IL-11 signaling to reduce fibrosis and inflammation.
Itepekimab is a monoclonal antibody that blocks IL-11 signaling to reduce fibrosis and inflammation. Used for Idiopathic pulmonary fibrosis (IPF), Systemic sclerosis-associated interstitial lung disease (SSc-ILD).
At a glance
| Generic name | Itepekimab (SAR440340) |
|---|---|
| Also known as | REGN3500 |
| Sponsor | Sanofi |
| Drug class | IL-11 receptor antagonist (monoclonal antibody) |
| Target | IL-11 (Interleukin-11) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Fibrosis |
| Phase | Phase 3 |
Mechanism of action
IL-11 is a pro-fibrotic and pro-inflammatory cytokine implicated in tissue remodeling and organ damage. By neutralizing IL-11, itepekimab aims to inhibit pathological fibrosis and reduce inflammatory responses in affected tissues. This mechanism is being explored in conditions characterized by excessive fibrosis and inflammation.
Approved indications
- Idiopathic pulmonary fibrosis (IPF)
- Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
Common side effects
- Infection
- Infusion-related reactions
- Fatigue
Key clinical trials
- 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 (PHASE3)
- An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps (PHASE3)
- Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD (PHASE2)
- 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 (PHASE3)
- 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 (PHASE3)
- 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 (PHASE2)
- 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 (PHASE2)
- Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) (PHASE3)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |