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Looking for participantsPhase3

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

Sponsor: Sanofi

NCT ID: NCT07190222

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Lunsekimig (drug), Placebo (drug)
How long the study runs
Study runs about 52 months (dates as stated)
About the drug or intervention
Lunsekimig — drug: Pharmaceutical form: solution for injection in prefilled syringe. · Placebo — drug: Pharmaceutical form: solution for injection.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
40 Years to 80 Years
Who
All
Number of participants
942
Started
2025-09-17
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for chronic obstructive pulmonary disease
  • • Phase3 - 942 participants
  • • This is a parallel, Phase 2b/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

Who can take part?

  • • Ages 40 Years to 80 Years
  • • Diagnosed with chronic obstructive pulmonary disease

Where?

  • • Milton Keynes - Investigational Site Number : 8260035
  • • London - Investigational Site Number : 8260007
  • • London - Investigational Site Number : 8260008
  • • Southampton - Investigational Site Number : 8260006
  • • +6 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This is a parallel, Phase 2b/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.

More detail

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

Chronic Obstructive Pulmonary Disease

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 40 Years - 80 Years
  • Who can join: All genders

What the study is looking for

  • ✓Between 40 to 80 years of age
  • ✓Physician diagnosed chronic obstructive lung disease (COPD) ≥1 year
  • ✓Post-bronchodilator forced expiratory volume in 1 second (post-BD FEV1) ≥ 20% and ≤ 70% of predicted value and...
  • ✓Former or current smokers ≥10 pack-years
  • ✓Chronic Airways Assessment Test (CAAT) ≥10

Who cannot take part

  • ✗Participants are excluded from the study if any of the following criteria apply:
  • ✗Asthma, including pediatric asthma, or asthma-COPD overlap syndrome (ACOS)
  • ✗Significant lung disease other than COPD
  • ✗Long-term oxygen therapy \>4.0 L/min or requirement of \>2.0 L/min to maintain oxygen saturation \>88% at rest
  • ✗Unstable disorder that can impact participants safety or study outcomes
See the full 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: Participants are excluded from the study if any of the following criteria apply: * Asthma, including pediatric asthma, or asthma-COPD overlap syndrome (ACOS) * Significant pulmonary disease other than COPD * Long-term oxygen therapy \>4.0 L/min or requirement of \>2.0 L/min to maintain oxygen saturation \>88% at rest * 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 phosphodiesterase Type 3 (PDE-3) or PDE-4 inhibitors unless on stable therapy for \> 6 months * any biologic therapy or systemic immunosuppressant within 4 months 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.

Where Is This Study? (10 UK sites)

Investigational Site Number : 8260035

Milton Keynes MK19 6FG, United Kingdom

Recruiting

Investigational Site Number : 8260007

London E11 1NR, United Kingdom

Recruiting

Investigational Site Number : 8260008

London W6 8RF, United Kingdom

Recruiting

Investigational Site Number : 8260006

Southampton SO16 6YD, United Kingdom

Recruiting

Investigational Site Number : 8260001

London Se1 7eh, United Kingdom

Recruiting

Investigational Site Number : 8260016

London SW1P 2PF, United Kingdom

Recruiting

Investigational Site Number : 8260030

Salford M6 8HD, United Kingdom

Recruiting

Investigational Site Number : 8260013

Chertsey KT16 0PZ, United Kingdom

Recruiting

Investigational Site Number : 8260005

Reading RG1 5AN, United Kingdom

Recruiting

Investigational Site Number : 8260017

Rotherham S61 1AH, United Kingdom

Recruiting

How to Get in Touch

Trial Transparency email recommended (Toll free for US & Canada)

Sponsor contact

CONTACT

800-633-1610 contact-us@sanofi.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09