lunsekimig (SAR443765) / Sanofi - LARVOL DELTA

COLOSSUS: A Study to Evaluate the Long-term Safety and Efficacy of Lunsekimig in Adult Participants With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P3 | N=1508 | Recruiting | Sponsor: Sanofi | Trial completion date: Oct 2031 ➔ Jul 2031 | Trial primary completion date: Oct 2031 ➔ Jul 2031

Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Efficacy and safety of lunsekimig in moderate-to-severe atopic dermatitis: Results from the phase 2b VELVET trial (EADV 2026) - No abstract available

Clinical • Late-breaking abstract • P2b data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

COLOSSUS: A Study to Evaluate the Long-term Safety and Efficacy of Lunsekimig in Adult Participants With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P3 | N=1508 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Late Breaking Abstract - Lunsekimig for chronic rhinosinusitis with nasal polyps: results from the DUET trial (ERS 2026) - No abstract available

Late-breaking abstract • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

RCT Abstract - Lunsekimig for patients with moderate-to-severe asthma: results from the AIRCULES trial (ERS 2026) - P2 | "Lunsekimig, a first-in-class molecule, demonstrated clinically meaningful improvements in exacerbations, lung function, and asthma control, and was well tolerated. These findings support dual TSLP and IL-13 targeting to address unmet need in asthma."

Clinical • Asthma • Immunology • Respiratory Diseases • IL13 • TSLP

THESEUS: Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD), Characterized by an Eosinophilic Phenotype (clinicaltrials.gov) - P3 | N=942 | Recruiting | Sponsor: Sanofi | Initiation date: Dec 2025 ➔ Sep 2025

Trial initiation date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

COLOSSUS: A Study to Evaluate the Long-term Safety and Efficacy of Lunsekimig in Adult Participants With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P3 | N=1508 | Not yet recruiting | Sponsor: Sanofi

New P3 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

AIRLYMPUS: Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma (clinicaltrials.gov) - P2 | N=556 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting | N=1147 ➔ 556

Enrollment change • Enrollment closed • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Study (clinicaltrials.gov) - P2 | N=64 | Enrolling by invitation | Sponsor: Sanofi | Recruiting ➔ Enrolling by invitation

Enrollment status • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

AIRPHRODITE: Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma (clinicaltrials.gov) - P2 | N=900 | Enrolling by invitation | Sponsor: Sanofi | Recruiting ➔ Enrolling by invitation

Enrollment status • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

AIRLYMPUS: Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma (clinicaltrials.gov) - P2 | N=1147 | Recruiting | Sponsor: Sanofi | N=673 ➔ 1147

Enrollment change • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Investigate the Efficacy and Safety of Subcutaneous Lunsekimig (SAR443765) Compared With Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=150 | Completed | Sponsor: Sanofi | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Study (clinicaltrials.gov) - P2 | N=33 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting | Active, not recruiting ➔ Recruiting | N=33 ➔ 64

Enrollment change • Enrollment closed • Enrollment open • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - P2 | N=79 | Completed | Sponsor: Sanofi | Active, not recruiting ➔ Completed

Trial completion • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Study (clinicaltrials.gov) - P2 | N=64 | Recruiting | Sponsor: Sanofi | N=26 ➔ 64

Enrollment change • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Press Release: Sanofi’s lunsekimig met primary and key secondary endpoints in phase 2 respiratory studies in asthma and CRSwNP (Yahoo Finance) - "The AIRCULES phase 2b study achieved its primary and key secondary endpoints in moderate-to-severe asthma regardless of biomarker status; The DUET phase 2a study met its primary and key secondary endpoints in chronic rhinosinusitis with nasal polyps, reinforcing lunsekimig’s potential as a respiratory treatment; The exploratory VELVET phase 2b study did not meet its primary endpoint in moderate-to-severe atopic dermatitis...In all studies, lunsekimig was well tolerated...Detailed results from the AIRCULES, DUET, and VELVET studies will be presented at upcoming medical congresses."

P2 data • Asthma • Atopic Dermatitis • Chronic Rhinosinusitis With Nasal Polyps

AIRPHRODITE: Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma. (clinicaltrials.gov) - P2 | N=900 | Recruiting | Sponsor: Sanofi | N=90 ➔ 900

Enrollment change • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

AIRCULES: Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma (clinicaltrials.gov) - P2 | N=685 | Completed | Sponsor: Sanofi | Active, not recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Study (clinicaltrials.gov) - P2 | N=64 | Recruiting | Sponsor: Sanofi

Trial initiation date • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

AIRPHRODITE: Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma. (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Sanofi | N=65 ➔ 90

Enrollment change • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Biparatopic TSLP and IL-13 VHHs Based Bispecific Antibody with Extended Half-life for Atopic Dermatitis (AAAAI 2026) - "LQ085 showed consistent TSLP activity with the biparatopic VHH and better IL-13 neutralizing activity than lebrikizumab and lunsekimig. LQ085 demonstrated exceptional efficacy in both cellular and animal models, establishing it as a frontrunner bispecific antibody targeting TSLP and IL-13 with the potential to become the best-in-class treatment for atopic dermatitis."

Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Respiratory Diseases • CRLF2 • IL13 • IL7R • TSLP

A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - P2 | N=79 | Active, not recruiting | Sponsor: Sanofi | Trial completion date: Apr 2027 ➔ Apr 2026 | Trial primary completion date: Jan 2027 ➔ Jan 2026

Trial completion date • Trial primary completion date • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Lunsekimig: Data readout from P2b AIRCULES trial (NCT06102005) for asthma in H1 2026 (Sanofi) - Q4 & FY2025 Results

P2b data • Asthma • Immunology

PERSEPHONE: Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype (clinicaltrials.gov) - P3 | N=942 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

THESEUS: Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD), Characterized by an Eosinophilic Phenotype (clinicaltrials.gov) - P3 | N=942 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases