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Taking people in Saudi ArabiaPhase 3

Testing lunsekimig against placebo in adults with eosinophilic COPD

Tests lunsekimig injections against placebo in adults with chronic obstructive pulmonary disease.

Key facts

Who runs it
Sanofi
Where
Jeddah and Riyadh, Saudi ArabiaSee the 3 sitesAlso in 24 other countries, 311 sites
Trial code
Registry title
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
Status
Recruiting
Phase
Phase 3
People taking part
942 people, planned
Started
16 Sept 2025
Expected to end
22 Jan 2030
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Lunsekimig
  • Placebo
Record updated
19 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 40 to 80 with COPD that is not well controlled, who have a higher level of eosinophils (a type of white blood cell) in the blood and have had flare-ups in the past year.

Age
40 to 80 years
Sex
All sexes can join.
Disease stage
COPD diagnosed by a doctor for at least 1 year, with 2 or more moderate flare-ups or at least 1 severe flare-up in the past year. Lung function after bronchodilator (FEV1) between 20% and 70% of predicted value and FEV1/FVC below 0.70. Chronic Airways Assessment Test (CAAT) score of 10 or more.
Earlier treatment
Must have been on triple COPD therapy (ICS+LABA+LAMA) for at least 12 weeks in a row. Cannot have had any biologic therapy or systemic immunosuppressant within 4 months or 5 half-lives before screening.
Biomarker or test result
Blood eosinophil count of 150 cells/μL or more. Former or current smoker with at least 10 pack-years. Body Mass Index from 18.0 to 40.0 kg/m2.

Main reasons for not taking part

  • Asthma, or asthma-COPD overlap syndrome
  • Significant lung disease other than COPD
  • Long-term oxygen therapy above 4.0 L/min, or more than 2.0 L/min needed to keep oxygen saturation above 88% at rest
  • Active or incompletely treated tuberculosis
  • Current or past cancer

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Long-term oxygen therapy >4.0 L/min or requirement of >2.0 L/min to maintain oxygen saturation >88% at rest
  • 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
  • Asthma, including pediatric asthma, or asthma-COPD overlap syndrome (ACOS)
  • Significant pulmonary disease other than COPD
  • Unstable disorder that can impact participants safety or study outcomes
  • Active or incompletely treated tuberculosis
  • Current or past malignancies
  • Participants are excluded from the study if any of the following criteria apply:

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 40 and 80 years old?

Where in Saudi Arabia

Also in 24 other countries, 311 sites

  • JeddahHospital not named in the registryTaking people
  • RiyadhHospital not named in the registryTaking people
  • RiyadhHospital not named in the registryTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 3 groups in the trial

  • Lunsekimig dose regimen ATreatment being tested

    Participants will receive lunsekimig dose regimen A.

    Treatment: Lunsekimig

  • Lunsekimig dose regimen BTreatment being tested

    Participants will receive lunsekimig dose regimen B

    Treatment: Lunsekimig

  • PlaceboPlacebo, for comparison

    Participants will receive lunsekimig-matching placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 2b/Phase 3, Randomized, Double-blind, Placebocontrolled, 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
Plain-language title
Testing lunsekimig against placebo in adults with eosinophilic COPDGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07190209, who can take part
Record updated
19 October 2026