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NCT Number: NCT06914908

Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Clinical Study

This is a single-arm extension study to investigate the long-term safety, tolerability, and efficacy of lunsekimig in adult participants with inadequately controlled CRSwNP who have completed a previous lunsekimig CRSwNP clinical study (also referred to as the parent study ACT18207).

The study duration will be up to approximately 148 weeks per participant, including 144 weeks of treatment period and 4 weeks of follow-up.

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Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

  • 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
  • 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

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

Mometasone Furoate Nasal Spray (MFNS)

Drug
  • Pharmaceutical form: Solution for administration via spray pump
  • Route of administration: intranasal spray

Primary outcomes

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

    Time frame: From baseline to Week 148

Secondary outcomes

  1. Change in Sino-nasal Outcome Test 22 (SNOT-22) total score

    Time frame: From the parent study baseline to Weeks 52, 96 and 144

    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).

  2. Change in Rhinosinusitis visual analog scale (VAS)

    Time frame: From the parent study baseline to Weeks 52, 96 and 144

    The VAS for rhinosinusitis is used to evaluate the total severity. 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.

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

    Time frame: From the parent study baseline to Weeks 52, 96 and 144

    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 odor. Score depends on the amount of answers out of 40 possible correct answers.

  4. Serum lunsekimig concentrations

    Time frame: From baseline to Week 144

  5. Anti-drug antibodies (ADA) against lunsekimig

    Time frame: From baseline to Week 144

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Single-arm Extension Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Clinical Study

Acronym: ENSEMBLE

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Apr 7, 2025
Registry last updated
Jul 2, 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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