Long-term safety and efficacy evaluation of lunsekimig (SAR443765) in adult participants with moderate-to-severe 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

11 May 2026 → ongoing

Decision date (initial)

2026-03-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2025-522896-27-00

WHO UTN

U1111-1303-3645

ClinicalTrials.gov

NCT06609239

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic, Others

To evaluate long-term safety of lunsekimig in adult participants with asthma

Secondary objectives 6

1. To evaluate long-term efficacy of lunsekimig in adult participants with asthma
2. To evaluate the long-term effects of lunsekimig on lung function
3. To evaluate the long-term effects of lunsekimig on asthma control as measured by Asthma Control Questionnaire 5 (ACQ-5)
4. To evaluate the long-term effects of lunsekimig on Asthma Quality of Life Questionnaire Standardized Activities for 12 years and older (AQLQ[S]+ 12)
5. To evaluate the pharmacokinetics (PK) of lunsekimig
6. To evaluate immunogenicity of lunsekimig

Conditions and MedDRA coding

Asthma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Participants who completed the 48-week treatment period of Study DRI16762 or ACT18301, including the EOT visit, as per protocol
2. Participants with stable background therapy with moderate or high-dose ICS in combination with the following controller medications, as maintained during the respective parent study in which they have participated: o For Study DRI16762: At least 1 and no more than 2 additional controllers (eg, LABA, LAMA, LTRA, or methylxanthines), with or without oral prednisone o For Study ACT18301: LABA with or without LTRA.
3. Participants who are able and willing to participate in the open-label extension study, and to comply with requested study visits and procedures.
4. Contraception for male and female participants For female participants: o incapable of becoming pregnant o not pregnant or breast feeding o no eggs donation or cryopreserving eggs For male participants: o No sperm donation or cryopreserving sperm
5. Capable of giving signed informed consent

Exclusion criteria 10

1. Participants are excluded from the study if any of the following criteria apply: - Participant who developed a new medical condition or a change in status of an established medical condition or requires a new treatment or medication prior to enrollment that, per Investigator’s medical judgement would adversely affect participation of the participant in this study or would require permanent lunsekimig discontinuation, or participants potentially at risk of noncompliance to study procedures.
2. Participant who was diagnosed with a new pulmonary disease which may impair lung function.
3. Current smoker or active vaping of any products and/or marijuana smoking.
4. Prescription drug or substance abuse, including alcohol, considered significant by the Investigator.
5. History of hypersensitivity or allergy to lunsekimig or to any of the excipients used in the presentation or in preparation for administration of lunsekimig, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
6. Participants who are receiving prohibited concomitant medications
7. Participants who, during their participation in the parent study, developed an AE or an SAE deemed related to lunsekimig, which in the opinion of the Investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant.
8. Concurrent participation in any other clinical study, including non-interventional studies.
9. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.
10. Participants are employees of the investigative site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Number of participants having any treatment-emergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE)

Secondary endpoints 12

1. Annualized rate of asthma exacerbation events
2. Annualized rate of asthma exacerbation events
3. Change from parent study baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
4. Change from parent study baseline in pre bronchodilator (BD) FEV1
5. Change from parent study baseline in Asthma Control Questionnaire-5 (ACQ-5) score
6. Change from parent study baseline in Asthma Control Questionnaire 5 (ACQ-5) score
7. Proportion of participants with ≥0.5-point reduction in each score as compared to parent study baseline score
8. Proportion of participants with ≥0.5-point reduction in each score as compared to parent study baseline score
9. Change from parent study baseline in Asthma Quality of Life Questionnaire with Standardized Activities for 12 years and older (AQLQ[S] + 12) domain and total scores
10. Change from parent study baseline in Asthma Quality of Life Questionnaire with Standardized Activities for 12 years and older (AQLQ[S] +12) domain and total scores
11. Serum lunsekimig concentrations
12. Incidence and titer of anti-drug antibodies (ADA) against lunsekimig

Investigational products

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

Test 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 13

Locations

9 EU/EEA countries · 59 investigational sites

By country

Investigational sites

Country notifications

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

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Results and documents

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

Documents 52 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