itepekimab: Clinical Trials

12 completed, 3 active not recruiting, 2 terminated, 1 withdrawn. 7 Phase 2, 7 Phase 3, 4 Phase 1.

By phase and status

Phase	Trials	Status
Phase 2	7	Completed 5, Terminated 2
Phase 3	7	Active not recruiting 3, Completed 3, Withdrawn 1
Phase 1	4	Completed 4

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
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Rhinosinusitis With Nasal Polyps Itepekimab (SAR440340), Placebo - Chronic Rhinosinusitis With Nasal Polyps	Phase 3	Withdrawn	Sanofi		2026-05-08	2026-08-13
An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps Itepekimab (SAR440340), Placebo - Chronic Rhinosinusitis With Nasal Polyps	Phase 3	Active not recruiting	Sanofi	59	2026-03-12	2026-10-13
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 Itepekimab (SAR440340), Placebo, Mometasone furoate nasal spray (MFNS) - Chronic Rhinosinusitis With Nasal Polyps	Phase 3	Active not recruiting	Sanofi	231	2025-02-12	2026-10-21
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 Itepekimab (SAR440340), Placebo, Mometasone furoate nasal spray (MFNS) - Chronic Rhinosinusitis With Nasal Polyps	Phase 3	Active not recruiting	Sanofi	216	2025-02-06	2026-10-21
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 Itepekimab (SAR440340), Placebo, Mometasone furoate nasal spray (MFNS) - Chronic Rhinosinusitis Without Nasal Polyps	Phase 2	Completed	Sanofi	66	2024-12-16	2026-08-25
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), Placebo - Bronchiectasis	Phase 2	Completed	Sanofi	314	2024-02-20	2026-10-07
A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD Itepekimab (SAR440340), Placebo - Chronic Obstructive Pulmonary Disease	Phase 3	Completed	Sanofi	669	2024-01-11	2026-09-18
Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD Itepekimab SAR440340 - Chronic Obstructive Pulmonary Disease	Phase 2	Completed	Sanofi	49	2022-05-19	2026-08-31
Pharmacokinetic Study to Compare Itepekimab Exposure When Administered With an Autoinjector Versus Prefilled Syringe Itepekimab AI, Itepekimab PFS - Chronic Obstructive Pulmonary Disease	Phase 1	Completed	Sanofi	90	2021-09-16	2024-09-19
Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) Itepekimab SAR440340, Placebo - Chronic Obstructive Pulmonary Disease	Phase 3	Completed	Sanofi	1234	2021-02-12	2026-10-09
Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) Itepekimab SAR440340, Placebo - Chronic Obstructive Pulmonary Disease	Phase 3	Completed	Sanofi	1127	2020-12-16	2026-10-15
Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis REGN3500, REGN3500-Matching Placebo - Atopic Dermatitis	Phase 2	Terminated	Regeneron Pharmaceuticals	129	2018-11-13	2022-06-10
Efficacy and Safety of REGN3500 Monotherapy and Combination of REGN3500 Plus Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis REGN3500, Dupilumab, REGN3500 + Dupilumab Combo - Atopic Dermatitis	Phase 2	Terminated	Regeneron Pharmaceuticals	206	2018-11-12	2021-11-01
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) SAR440340, Placebo, Any Inhaled Corticosteroids as prescribed by treating physician as standard of care - Chronic Obstructive Pulmonary Disease	Phase 2	Completed	Sanofi	343	2018-07-16	2022-11-22
Evaluation of SAR440340 and as Combination Therapy With Dupilumab in Moderate-to-Severe Asthma Participants SAR440340, Dupilumab, Fluticasone or Fluticasone/salmeterol combination - Asthma	Phase 2	Completed	Sanofi	296	2018-03-12	2022-06-14
Study of REGN3500 and Dupilumab in Patients With Asthma REGN3500, Dupilumab, Placebo - Asthma, Allergic	Phase 1	Completed	Regeneron Pharmaceuticals	32	2017-06-15	2020-01-18
Study of Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of REGN3500 in Adults With Moderate Asthma REGN3500, Placebo - Asthma, Moderate Asthma	Phase 1	Completed	Regeneron Pharmaceuticals	23	2017-02-03	2018-12-12
A Study of Intravenously or Subcutaneously Administered REGN3500 in Healthy Adult Subjects REGN3500, Placebo - Healthy Volunteers	Phase 1	Completed	Regeneron Pharmaceuticals	40	2016-08-01	2017-11-08

Conditions studied

Pulmonary Disease, Chronic Obstructive (6)  ·  Asthma (3)  ·  Dermatitis, Atopic (2)  ·  Lymphoma, Follicular (2)  ·  Bronchiectasis (1)

Sponsors

Sanofi (13)  ·  Regeneron Pharmaceuticals (5)

Countries

United States (15)  ·  Poland (12)  ·  United Kingdom (11)  ·  Argentina (10)  ·  Chile (10)  ·  Canada (9)  ·  Germany (9)  ·  Czechia (8)  ·  Spain (8)  ·  Hungary (7)  ·  South Korea (7)  ·  Turkey (Türkiye) (7)  ·  Brazil (6)  ·  China (6)  ·  Israel (6)

Results publications

PMID 34523807, PMID 39077906, PMID 34302758, PMID 34706171, PMID 36253275

NIH funding

2016 (3), 2017 (2), 2018 (2), 2023 (2), 2025 (1)