{"id":"itepekimab-sar440340","safety":{"commonSideEffects":[{"rate":null,"effect":"Infection"},{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Fatigue"}]},"_chembl":{"chemblId":"CHEMBL4594594","moleculeType":"Antibody"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"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.","oneSentence":"Itepekimab is a monoclonal antibody that blocks IL-11 signaling to reduce fibrosis and inflammation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:17:21.675Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Idiopathic pulmonary fibrosis (IPF)"},{"name":"Systemic sclerosis-associated interstitial lung disease (SSc-ILD)"}]},"trialDetails":[{"nctId":"NCT07484230","phase":"PHASE3","title":"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","status":"NOT_YET_RECRUITING","sponsor":"Sanofi","startDate":"2026-05-08","conditions":"Chronic Rhinosinusitis With Nasal Polyps","enrollment":20},{"nctId":"NCT07424144","phase":"PHASE3","title":"An Extension Study to Investigate the Long-term 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Polyps","enrollment":60},{"nctId":"NCT04751487","phase":"PHASE3","title":"Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"Sanofi","startDate":"2021-02-12","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":1239},{"nctId":"NCT04701983","phase":"PHASE3","title":"Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"Sanofi","startDate":"2020-12-16","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":1127},{"nctId":"NCT06208306","phase":"PHASE3","title":"A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sanofi","startDate":"2024-01-11","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":700},{"nctId":"NCT06114238","phase":"PHASE1","title":"Pharmacokinetic Study to Compare Itepekimab Exposure When Administered With an Autoinjector Versus Prefilled Syringe","status":"COMPLETED","sponsor":"Sanofi","startDate":"2021-09-16","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":90},{"nctId":"NCT03546907","phase":"PHASE2","title":"Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of SAR440340 (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"Sanofi","startDate":"2018-07-16","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":343},{"nctId":"NCT03387852","phase":"PHASE2","title":"Evaluation of SAR440340 and as Combination Therapy With Dupilumab in Moderate-to-Severe Asthma Participants","status":"COMPLETED","sponsor":"Sanofi","startDate":"2018-03-12","conditions":"Asthma","enrollment":296}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["REGN3500"],"phase":"phase_3","status":"active","brandName":"Itepekimab (SAR440340)","genericName":"Itepekimab (SAR440340)","companyName":"Sanofi","companyId":"sanofi","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Itepekimab (SAR440340) is an interleukin-33 inhibitor, a type of antibody that belongs to the drug class of inhibitors. It is being studied for various conditions, including Chronic Obstructive Pulmonary Disease, Bronchiectasis, Chronic Rhinosinusitis With Nasal Polyps, and Asthma.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}