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Clinical Trials List

Protocol NumberEFC18244

NCT Number(ClinicalTrials.gov Identfier)NCT07190222

Not yet recruiting

2025-11-01 - 2030-12-31

Phase II

Not yet recruiting1

Recruiting7

A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study, to Investigate the Efficacy and Safety of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype

Trial Applicant
Sponsor

Sanofi Taiwan Co., Ltd.
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator Chau-Chyun Sheu

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 劉家榮無

National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Pin-Kuei Fu 無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jung-Yien Chien 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jia-Yih Feng 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林慶雄無

CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Pai-Chien Chou 無

Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Horng-Chyuan Lin 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Chronic obstructive pulmonary disease

Objectives

This is a parallel, Phase 2/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype.

Test Drug

prefilled syringe

Active Ingredient

Lunsekimig/ SAR443765

Dosage Form

230

Dosage

300 mg/2mL

Endpoints

To evaluate the efficacy of lunsekimig, as measured by the annualized rate of moderate-to-severe COPD exacerbations.

Inclution Criteria

Inclusion Criteria:

Between 40 to 80 years of age
Physician diagnosed chronic obstructive pulmonary disease (COPD) ≥1 year
Post-bronchodilator forced expiratory volume in 1 second (post-BD FEV1) ≥ 20% and ≤ 70% of predicted value and FEV1/FVC (forced expiratory volume in 1 second /forced vital capacity) <0.70
Former or current smokers ≥10 pack-years
Chronic Airways Assessment Test (CAAT) ≥10
≥2 moderate or ≥1 severe COPD exacerbations in the prior year
Triple (ICS+LABA+LAMA) COPD therapy ≥12 consecutive weeks
EOS (blood eosinophil count) ≥ 150 cells/μL
18.0 ≤ Body Mass Index ≤ 40.0 kg/m2

Exclusion Criteria

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

Asthma, including pediatric asthma, or ACOS
Sgnificant pulmonary disease other than COPD
Long-term oxygen therapy >4.0 L/min or requirement of >2.0 L/minO2 saturation to maintain oxygen saturation >88%
Unstable disorder that can impact participants safety or study outcomes
Active or incompletely treated tuberculosis
Current or past malignancies
Concomitant therapies:

long-term macrolides or iPDE-4 unless on stable therapy for > 6 months
any biologic therapy or systemic immunosuppressant within 8 weeks or 5 half-lives prior to Screening

The Estimated Number of Participants

Taiwan

20 participants
Global

942 participants