Phase 2b/3 Randomized Double‑Blind Placebo‑Controlled Study Evaluating Efficacy and Safety of Lunsekimig in Adults with Inadequately Controlled Eosinophilic COPD

The primary objective is to assess the efficacy of lunsekimig by measuring the annualized rate of moderate to severe COPD exacerbations in adults with inadequately controlled chronic obstructive pulmonary disease with an eosinophilic phenotype, reflecting its impact on disease progression and healthcare utilization. Secondary objectives include evaluation of the drug’s effect on lung function, on health related quality-of-life, on symptoms and disease burden, and on the incidence of moderate or severe COPD exacerbations; assessment of its safety profile; characterization of its pharmacokinetics; and determination of its immunogenicity.

The trial enrolled 1,810 participants aged 40 to 80 years, including both male and female individuals. All subjects had a physician‑diagnosed chronic obstructive pulmonary disease for at least one year and met lung‑function thresholds (post‑bronchodilator FEV1 20‑70 % of predicted and FEV1/FVC <0.70). Eligibility required a smoking history of at least 10 pack‑years (former or current), a CAAT score ≥10, and a record of ≥2 moderate or ≥1 severe exacerbations in the previous year while receiving triple inhaled therapy for at least 12 weeks. Additional requirements were a blood eosinophil count ≥150 cells/μL and a body‑mass index between 18.0 and 40.0 kg/m². The population comprised patients without gender restriction and included vulnerable individuals as defined by the protocol.

The study is a Phase 2b/Phase 3, multicenter, randomized, double‑blind, placebo‑controlled trial evaluating the efficacy and safety of the investigational injectable solution LUNSEKIMIG compared with a matched placebo in adult participants with inadequately controlled chronic obstructive pulmonary disease exhibiting an eosinophilic phenotype. After an initial screening visit to verify eligibility criteria, eligible subjects are randomly assigned in a 1:1 ratio to receive either LUNSEKIMIG or placebo administered by injection, with blinding maintained for participants, investigators, and study staff. Participants attend scheduled follow‑up visits at predefined intervals throughout the study period, during which spirometric measurements, patient‑reported outcomes (including SGRQ‑C, CAAT, and E‑RS:COPD), blood eosinophil counts, and safety assessments (adverse events, laboratory tests, antidrug antibodies) are collected to support the primary endpoint of the annualized rate of moderate to severe exacerbations and the secondary efficacy and safety endpoints. The trial commenced recruitment on 7 July 2026 and is planned to conclude on 22 January 2030, encompassing the total participant involvement from randomization to the final end‑of‑study visit. Early termination of individual participation may occur if a participant experiences a serious adverse event, demonstrates clinically significant laboratory abnormalities, withdraws consent, or fails to comply with protocol‑required procedures.

The investigational product LUNSEKIMIG is supplied as a solution for injection in a pre‑filled syringe. It is administered by the intravenous route at a dose of 00.00 mg per injection. The dosing frequency and schedule are defined in the study protocol and are identical for all participants receiving the active treatment.

The control arm receives a matched placebo that is indistinguishable in appearance from the active product. The placebo contains no active pharmaceutical ingredient and is administered using the same route, formulation, and schedule as the investigational product to maintain blinding.

All study drug administrations are performed by qualified personnel at scheduled study visits. Compliance is monitored through documentation of administered doses, inspection of returned syringes, and review of site‑maintained dosing logs. The trial evaluates efficacy in adult participants with inadequately controlled chronic obstructive pulmonary disease characterized by an eosinophilic phenotype.

The primary efficacy assessment will be the annualized rate of moderate to severe chronic obstructive pulmonary disease (COPD) exacerbations, calculated from recorded exacerbation events throughout the treatment period.

Secondary efficacy parameters include changes from baseline in post‑bronchodilator and pre‑bronchodilator Forced Expiratory Volume in 1 second (FEV1) measured by spirometry, changes in the St George’s Respiratory Questionnaire for COPD (SGRQ‑C) total score, and responder status defined by an improvement of ≥4 points in the SGRQ‑C total score. Additional secondary measures comprise changes in the Chronic Airways Assessment Test (CAAT) score with responder definition of ≥2‑point improvement, changes in the Exacerbations of COPD Respiratory Symptoms (E‑RS:COPD) total score with responder definition of ≥2‑point improvement, the annualized rate of severe COPD exacerbations, and time to first moderate or severe and time to first severe COPD exacerbation. Safety‑related efficacy endpoints include incidence of treatment‑emergent adverse events, serious adverse events, and potentially clinically significant laboratory abnormalities, as well as serum concentration of lunsekimig and incidence and titer of antidrug antibodies.

Assessments will be performed using validated instruments: spirometry for FEV1, the SGRQ‑C, CAAT, and E‑RS:COPD questionnaires for patient‑reported outcomes, and standard laboratory assays for pharmacokinetic and immunogenicity evaluations.