A proof-of-concept study of lunsekimig compared with placebo in adults with chronic rhinosinusitis with nasal polyps

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

5 Mar 2025 → 23 Apr 2026

Decision date (initial)

2024-08-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi-Aventis Recherche & Developpement

External identifiers

EU CT number

2024-511261-11-00

WHO UTN

U1111-1300-6978

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy, Others

To evaluate the effect of lunsekimig compared to placebo on nasal polyps in adult participants with inadequately controlled CRSwNP

Secondary objectives 8

1. To evaluate the effect of lunsekimig compared to placebo on nasal congestion and obstruction symptoms
2. To evaluate the effect of lunsekimig compared to placebo on CT imaging features of sinusitis
3. To evaluate the effect of lunsekimig compared to placebo on patient-reported outcomes
4. To evaluate the effect of lunsekimig compared to placebo on loss of smell
5. To evaluate the pharmacokinetics (PK) of lunsekimig
6. To evaluate the immunogenicity to lunsekimig
7. To evaluate the safety and tolerability to lunsekimig
8. To evaluate the effect of lunsekimig compared to placebo on lung function and asthma control in the subgroup of participants with co-morbid asthma

Conditions and MedDRA coding

Respiratory tract diseases

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. A minimum bilateral nasal polyp score of 5 out of a maximum score of 8 for both nostrils (with at least a score of 2 for each nostril) despite use of intranasal corticosteroid treatment for at least 2 months prior to screening
2. Ongoing symptoms for at least 2 months prior to screening, including: - Nasal congestion, blockage, or obstruction with moderate or severe symptom severity at screening (Score 2 or 3 on NC Score) and a weekly average severity score of at least 1 (range 0 to 3) at randomization (NC Score: 0=no symptoms, 1=mild, 2=moderate, and 3=severe). - At least 1 of the following 2 symptoms: (1) partial loss of smell (hyposmia) or total loss of smell (anosmia); (2) anterior and/or posterior rhinorrhea

Exclusion criteria 7

1. Patient who has received any therapies such as for example systemic corticosteroids, anti-IgE therapy, monoclonal antibody and some others in the specified timeframe(s) prior to the screening visit
2. Patients who have undergone any nasal/sinus surgery within 6 months before screening or for whom NPS cannot be determined accurately on endoscopy due to anatomic changes to the nasal cavity from past nasal/sinus surgery
3. Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint
4. Signs or a CT scan suggestive of Allergic fungal rhinosinusitis
5. Active/chronic helminthic infection
6. History of human immunodeficiency virus (HIV) infection or positive HIV screen (Anti-HIV- and HIV-2 antibodies) at screening visit
7. Patients with positive or indeterminate hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at screening visit

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in bilateral endoscopic nasal polyp score (NPS)

Secondary endpoints 17

1. Change in patient-reported nasal congestion/obstruction score
2. Change in Lund-Mackay CT score
3. Change in the percent of maxillary sinus volume occupied by disease on CT scan
4. Change in SNOT-22 total score
5. Change in patient-reported total symptom score (nasal congestion/obstruction, anterior or posterior rhinorrhea, and loss of smell)
6. Change in patient-reported anterior rhinorrhea and posterior rhinorrhea score
7. Change in rhinosinusitis visual analog scale (VAS)
8. Change in University of Pennsylvania Smell Identification Test (UPSIT) score
9. Change in patient-reported loss of smell score
10. Serum lunsekimig concentrations
11. Anti-drug antibodies (ADA) against lunsekimig
12. Incidence of participants with treatment-emergent adverse events (TEAEs)
13. Incidence of participants with adverse events of special interest (AESI)
14. Incidence of participants with serious adverse events (SAEs)
15. Change in asthma control questionnaire (ACQ-5)
16. Change in pre-bronchodilator forced expiratory volume in the first second (pre-BD FEV1)
17. Change in pre-BD percent predicted FEV1

Investigational products

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

Test 1

Placebo 1

Auxiliary 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 8

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 34 files

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

Application history

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