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 (THESEUS)

Sanofi

Status and phase: Enrolling; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo; Drug: Lunsekimig

Study type: Interventional

Funder types: Industry

Identifiers

NCT07190222

EFC18244

2024-518213-25-00 (Registry Identifier)

Details and patient eligibility

About

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.

Participation to the study consists of 3 periods:

• Screening period of up to 4 weeks
• Randomized intervention period of approximately 48 weeks
• Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.

Full description

All eligible participants will undergo subcutaneous administrations of lunsekimig or matching placebo during a 48-weeks treatment period

Enrollment: 942 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

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 above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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942 participants in 3 patient groups, including a placebo group

Lunsekimig dose regimen A

Experimental group

Description:

Participants will receive lunsekimig dose regimen A.

Treatment:

Drug: Lunsekimig

Lunsekimig dose regimen B

Experimental group

Description:

Participants will receive lunsekimig dose regimen B.

Treatment:

Drug: Lunsekimig

Placebo

Placebo Comparator group

Description:

Participants will receive lunsekimig-matching placebo.

Treatment:

Drug: Placebo