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Active, not recruitingPhase 2

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

Key facts

Who runs it
Sanofi
Where
Boise, Dallas, Houston, La Jolla, McKinney, Norfolk, Roseville, San Antonio, and Tulsa, United StatesSee the 9 sitesAlso in 5 other countries, 15 sites
Trial code
Status
Active, not recruiting
Phase
Phase 2
People taking part
71 people enrolled
Started
12 May 2025
Expected to end
22 Feb 2029
Type of study
Interventional
Treatments tested
  • Lunsekimig
  • Mometasone furoate nasal spray (MFNS)
Record updated
28 October 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • 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

Who cannot take part

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

Where in United States

Also in 5 other countries, 15 sites

  • Treasure Valley Medical Research- Site Number : 8400002Boise, United States
  • Pharmaceutical Research & Consulting- Site Number : 8400004Dallas, United States
  • The University of Texas Health Science Center- Site Number : 8400017Houston, United States
  • Orso Health- Site Number : 8400005La Jolla, United States
  • ENT Associates of Texas - McKinney- Site Number : 8400014McKinney, United States
  • Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400008Norfolk, United States
  • Capital Allergy & Respiratory Disease Center- Site Number : 8400003Roseville, United States
  • San Antonio, TexasHospital not named in the registry
  • Essential Medical Research- Site Number : 8400020Tulsa, United States

About the trial

What the trial wants to find out

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).

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

The group in the trial

  • LunsekimigTreatment being tested

    Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) daily for 144 weeks

    Treatment: Lunsekimig and Mometasone furoate nasal spray (MFNS)

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official 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
Record updated
28 October 2026