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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi-Aventis Recherche & Developpement

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2026-07-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi-Aventis Recherche & Developpement

External identifiers

EU CT number

2024-518213-25-00

WHO UTN

U1111-1308-9980

ClinicalTrials.gov

NCT07190222

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Pharmacokinetic, Efficacy, Pharmacoeconomic, Pharmacodynamic

To evaluate the efficacy of lunsekimig as measured by the annualized rate of moderate to severe chronic obstructive pulmonary disease (COPD) exacerbations

Secondary objectives 7

1. • To evaluate the efficacy of lunsekimig on lung function
2. • To evaluate the efficacy of lunsekimig on health related quality-of-life
3. • To evaluate the efficacy of lunsekimig on symptoms and disease burden
4. • To evaluate the efficacy of lunsekimig on moderate or severe COPD exacerbations
5. • To evaluate the safety of lunsekimig
6. • To evaluate the pharmacokinetics of lunsekimig
7. • To evaluate the immunogenicity of lunsekimig

Conditions and MedDRA coding

Respiratory tract diseases

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org​

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. - Between 40 to 80 years of age
2. - Physician diagnosed chronic obstructive pulmonary disease (COPD) ≥1 year
3. - 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
4. - Former or current smokers ≥10 pack-years
5. - Chronic Airways Assessment Test (CAAT) ≥10
6. - ≥2 moderate or ≥1 severe COPD exacerbations in the prior year
7. - Triple (ICS+LABA+LAMA) COPD therapy ≥12 consecutive weeks
8. - EOS (blood eosinophil count) ≥ 150 cells/μL
9. - 18.0 ≤ Body Mass Index ≤ 40.0 kg/m2

Exclusion criteria 7

1. - Asthma, including pediatric asthma, or asthma-COPD overlap syndrome (ACOS)
2. - Significant pulmonary disease other than COPD
3. - Long-term oxygen therapy >4.0 L/min or requirement of >2.0 L/min to maintain oxygen saturation >88% at rest
4. - Unstable disorder that can impact participants safety or study outcomes
5. - Active or incompletely treated tuberculosis
6. - Current or past malignancies
7. - Concomitant therapies: o long-term macrolides or phosphodiesterase Type 3 (PDE-3) or PDE-4 inhibitors unless on stable therapy for >6 months o any biologic therapy or systemic immunosuppressant within 4 months or 5 half-lives prior to Screening .

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Annualized rate of moderate to severe chronic obstructive pulmonary disease (COPD) exacerbations

Secondary endpoints 15

1. Change from baseline in post-Bronchodilator Forced Expiratory Volume in 1 second (post-BD FEV1)
2. Change from baseline in pre-Bronchodilator Forced Expiratory Volume in 1 second (pre-BD FEV1)
3. Change from baseline in the SGRQ-C total score
4. SGRQ responder defined as an improvement of ≥4 points in the SGRQ-C total score
5. Change from baseline in the Chronic airways assessment Test (CAAT) score
6. CAAT responder defined as an improvement of ≥2 points in the CAAT) total score
7. Change from baseline in the E-RS:COPD total score
8. E-RS:COPD responder defined as an improvement of ≥2 points in the E RS:COPD total score
9. Annualized rate of severe COPD exacerbations
10. Time to first moderate or severe COPD exacerbation
11. Time to first severe COPD exacerbation
12. Incidence of participants with TEAEs, including AESIs, and SAEs
13. Incidence of potentially clinically significant laboratory abnormalities
14. Serum concentration of lunsekimig
15. Incidence and titer of antidrug antibodies (ADAs)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi-Aventis Recherche & Developpement

Sponsor organisation

Sanofi-Aventis Recherche & Developpement

Address

82 Avenue Raspail

City

Gentilly

Postcode

94250

Country

France

Scientific contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Third parties 11

Locations

6 EU/EEA countries · 32 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 81 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications