Long-term safety and efficacy evaluation of lunsekimig in adult participants with chronic rhinosinusitis with nasal polyps (CRSwNP) who completed a previous lunsekimig CRSwNP study

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

8 Dec 2025 → ongoing

Decision date (initial)

2025-06-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi-Aventis Recherche & Developpement

External identifiers

EU CT number

2024-515912-27-00

WHO UTN

U1111-1308-9807

ClinicalTrials.gov

NCT06914908

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Safety, Others

To evaluate the long-term safety and tolerability of lunsekimig in adult participants with inadequately controlled CRSwNP

Secondary objectives 4

1. To evaluate the long-term effect of lunsekimig on patient-reported outcomes
2. To evaluate the long-term effect of lunsekimig on loss of smell
3. To evaluate the pharmacokinetics (PK) of lunsekimig
4. To evaluate the immunogenicity to lunsekimig

Conditions and MedDRA coding

Chronic rhinosinusitis with nasal polyps

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Participants who have completed the treatment period and the follow up period in CRSwNP lunsekimig parent study, including EOS visit, as per protocol
2. Participants receiving therapy with intranasal mometasone furoate nasal spray (MFNS).
3. Participants who are able and willing to participate in this extension study, and to comply with requested study visits and procedures.

Exclusion criteria 3

1. Prior hypersensitivity reaction 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.
2. Concurrent participation in any clinical study other than the parent study, including non-interventional studies.
3. Participants who, during their participation in the parent study, developed an adverse event (AE) or a serious adverse event (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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of participants with treatment-emergent adverse events (TEAEs) including adverse events of special interest (AESI), and serious adverse events (SAEs)

Secondary endpoints 5

1. Change in SNOT-22 total score
2. Change in rhinosinusitis visual analog scale (VAS)
3. Change in University of Pennsylvania Smell Identification Test (UPSIT) score
4. Serum lunsekimig concentrations
5. 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 10

Locations

3 EU/EEA countries · 10 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 38 files

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

Application history

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