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NCT Number: NCT06454240

A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps

This is a parallel, Phase 2, 2-arm, multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study for treatment of CRSwNP.

The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous lunsekimig in adult participants (aged 18 to 70 years, inclusive) with CRSwNP who are inadequately controlled on intranasal corticosteroid treatment. Participants with and without co-morbid asthma will be included in the study, and lung function will be assessed in both groups.

The study duration will be up to approximately 40 weeks per participant, including 4 weeks of screening run-in period, 24 weeks of intervention period, and 12 weeks of follow-up.

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Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site Number : 0320002, Rosario, Santa Fe Province, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Participants are excluded from the study if any of the following criteria apply:

  • 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
  • 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
  • Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint
  • Signs or a CT scan suggestive of Allergic fungal rhinosinusitis
  • Active/chronic helminthic infection
  • History of human immunodeficiency virus (HIV) infection or positive HIV screen (Anti-HIV- and HIV-2 antibodies) at screening visit
  • Patients with positive or indeterminate hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at screening visit NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Treatment and study plan

Lunsekimig

Drug

Pharmaceutical form:solution for injection-Route of administration:subcutaneous

Other names: SAR443765

Placebo

Drug

Pharmaceutical form:solution for injection-Route of administration:subcutaneous

Primary outcomes

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

    Time frame: From baseline to Week 24

    This score (NPS) is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. NP is graded based on polyp size where: 0- no polyps and 4- large polyps causing complete obstruction of the inferior nasal cavity.

Secondary outcomes

  1. Change in patient-reported nasal congestion/obstruction score

    Time frame: From baseline to Week 24

    Patient-reported nasal congestion/obstruction score. Score is using a 0-3 categorical scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms

  2. Change in Lund-Mackay CT score

    Time frame: From baseline to Week 24

    Lund-Mackay system is based on scoring bilateral areas of opacification with points given for degree of sinus opacification in each reagion: 0 = normal, 1 = partial opacification, 2 = total opacification.

  3. Change in the percent of maxillary sinus volume occupied by disease on CT scan.

    Time frame: From baseline to Week 24

  4. Change in SNOT-22 total score.

    Time frame: From baseline to Week 24

    The SNOT-22 is a 22-item health-related outcomes assessment. The 22-question SNOT-22 is scored as 0 (no problem) to 5 (problem as bad as it can be) with a total range from 0 to 110 (higher scores indicate poorer outcomes).

  5. Change in patient-reported total symptom score (nasal congestion/obstruction, anterior or posterior rhinorrhea, and loss of smell).

    Time frame: From baseline to Week 24

    Score is using a 0-3 categorical scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms

  6. Change in patient-reported anterior rhinorrhea and posterior rhinorrhea score

    Time frame: From baseline to Week 24

    0-3 scale, component of patient-reported total symptom score

  7. Change in rhinosinusitis visual analog scale (VAS).

    Time frame: From baseline to Week 24

    The VAS for rhinosinusitis is used to evaluate the total severity (30). Rhinosinusitis disease can be divided into Mild, Moderate and Severe based on total severity VAS score (0 to 10 cm):

    • MILD = VAS 0 to 3.
    • MODERATE = VAS >3 to 7.
    • SEVERE = VAS >7 to 10. The participant is asked to indicate along a 10 centimeter straight horizontal line (VAS) the answer to the question: "How troublesome are your symptoms of your rhinosinusitis". The VAS ranks from 0 (Not troublesome) to 10 (Worst thinkable troublesome) and is measured in centimeters.

  8. Change in University of Pennsylvania Smell Identification Test (UPSIT) score.

    Time frame: From baseline to Week 24

    The UPSIT test is a rapid and easy-to-administer method to quantitatively assess human olfactory function. The test consists of four booklets, each containing 10 odorants with one odorant per page. Above each odorant strip is a multiple-choice question with four alternative words to describe the odour. Score depends on the amount of answers out of 40 possible correct answers.

  9. Change in patient-reported loss of smell score

    Time frame: From baseline to Week 24

    0-3 scale, component of patient-reported total symptom score

  10. Serum lunsekimig concentrations

    Time frame: From baseline to end of study (approximately 36 weeks)

  11. Anti-drug antibodies (ADA) against lunsekimig

    Time frame: From baseline to end of study (approximately 36 weeks)

  12. Incidence of participants with treatment-emergent adverse events (TEAEs)

    Time frame: From baseline to end of study (approximately 36 weeks)

  13. Incidence of participants with adverse events of special interest (AESI)

    Time frame: From baseline to end of study (approximately 36 weeks)

  14. Incidence of participants with serious adverse events (SAEs)

    Time frame: From baseline to end of study (approximately 36 weeks)

  15. Change in asthma control questionnaire (ACQ-5)

    Time frame: From baseline to Week 24

    ACQ-5 is Asthma control questionnaire assessing symptoms. Lower score shows better asthma control

  16. Change in pre-bronchodilator forced expiratory volume in the first second (pre-BD FEV1)

    Time frame: From baseline to Week 24

  17. Change in pre-BD percent predicted FEV1

    Time frame: From baseline to Week 24

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Randomized Phase 2, Double-blind, Placebo-controlled, Parallel-group, 2-arm Study to Assess the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2024
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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