Study of lunsekimig (SAR443765) compared with placebo in adults with high-risk asthma

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]

Trial duration

13 May 2025 → ongoing

Decision date (initial)

2025-03-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-513959-33-00

WHO UTN

U1111-1301-3938

ClinicalTrials.gov

NCT06676319

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Others, Pharmacodynamic, Efficacy

To evaluate the efficacy of lunsekimig compared to placebo on asthma exacerbations

Secondary objectives 6

1. To evaluate the effects of lunsekimig compared to placebo on lung function, asthma control, FeNO levels and LOAC events
2. To evaluate the effects of lunsekimig compared to placebo on asthma exacerbations requiring hospitalization, emergency room visits, or urgent care visit
3. To evaluate the effects of lunsekimig compared to placebo on the use of systemic corticosteroid therapy and patient-reported outcomes (PROs)
4. To evaluate the Pharmacokinetics (PK) of lunsekimig
5. To evaluate immunogenicity of lunsekimig
6. To evaluate the safety of lunsekimig

Conditions and MedDRA coding

Asthma

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 3

1. Physician-diagnosed mild-to-moderate asthma for more than 12 months based on GINA guidelines.
2. At least 1 asthma exacerbation in the year prior to Screening (Visit 1)
3. Pre-BD FEV1 of equal or more than 40% of predicted normal (by Global Lung Function Initiative [GLI] standards) at Screening (Visit 1).

Exclusion criteria 7

1. Other severe lung diseases (eg, chronic obstructive pulmonary disease [COPD],bronchiectasis, idiopathic pulmonary fibrosis, etc) which may impair lung function.
2. Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids within 1 month prior to the Screening (Visit 1) (counting from the date of completion of treatment for asthma exacerbation).
3. Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening (Visit 1).
4. Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
5. Evidence of any infection requiring systemic anti-infective treatment within 2 weeks before Screening (Visit 1) or during the screening period. Significant viral infections within 2 weeks before Screening (Visit 1) or during the screening period even if the participant has not received systemic antiviral treatment (eg, influenza receiving only symptomatic treatment).
6. Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB (such as close contact with individuals with active TB), or received Bacillus Calmette- Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1).
7. Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure, and pulmonary disease.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Annualized rate of asthma exacerbation events

Secondary endpoints 11

1. Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
2. Change from baseline in Asthma Control Questionnaire-5 (ACQ-5) score
3. Change from baseline in FeNO level
4. Annualized rate of loss of asthma control events (LOAC) events
5. Annualized rate of asthma exacerbations requiring hospitalization or emergency room or urgent care visit
6. Total systemic corticosteroid dose exposure
7. Change from baseline in Asthma Quality of Life Questionnaire Standardized (AQLQ{S}) scores
8. Change from baseline in the Asthma Daytime Symptom Diary (ADSD) daily morning and evening score
9. Serum lunsekimig concentrations
10. Incidence and titer of anti-drug antibodies (ADA) against lunsekimig
11. Incidence of participants with treatment- emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events (SAEs)

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 21

Locations

10 EU/EEA countries · 65 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 327 files

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

Application history

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