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Enrolling by Invitation

NCT Number: NCT06609239

Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma

This is a phase 2, open-label extension study to evaluate the long-term safety and efficacy of lunsekimig in adult participants with asthma who have previously completed the parent studies. After completion of the parent study, eligible participants will be offered the opportunity to participate in the long-term extension (LTE) study with lunsekimig.

The study duration will be up to 148 weeks with a treatment duration being up to 144 weeks.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site Number : 0320007, Berazategui, Buenos Aires, 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

  • Participants who completed the treatment period of Study DRI16762 or ACT18301, including the EOT visit, as per protocol
  • Participants with stable background therapy with moderate or high-dose ICS in combination with the following controller medications, as maintained during the respective parent study in which they have participated:
  • For Study DRI16762: At least 1 and no more than 2 additional controllers (eg, LABA, LAMA, LTRA, or methylxanthines), with or without oral prednisone
  • For Study ACT18301: LABA with or without LTRA
  • Participants who are able and willing to participate in the open-label extension study, and to comply with requested study visits and procedures
  • Contraception for male and female participants during the study intervention period and during 8 weeks following the last administration of study intervention. And:

For female participants:

  • incapable of becoming pregnant, or
  • not pregnant or breast feeding
  • no eggs donation or cryopreserving eggs

For male participants:

-- No sperm donation or cryopreserving sperm

  • Capable of giving signed informed consent

Exclusion criteria

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

  • Participant who developed a new medical condition or a change in status of an established medical condition or requires a new treatment or medication prior to enrollment that, per Investigator's medical judgement would adversely affect participation of the participant in this study or would require permanent lunsekimig discontinuation, or participants potentially at risk of noncompliance to study procedures
  • Participant who was diagnosed with a new pulmonary disease which may impair lung function
  • Current smoker or active vaping of any products and/or marijuana smoking
  • Prescription drug or substance abuse, including alcohol, considered significant by the Investigator
  • History of hypersensitivity or allergy 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 are receiving prohibited concomitant medications
  • Participants who, during their participation in the parent study, developed an AE or an 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 participant's potential participation in a clinical trial.

Treatment and study plan

Lunsekimig

Drug
  • Pharmaceutical form: Solution for injection in vial
  • Route of administration: Subcutaneous injection

Other names: SAR443765

Primary outcomes

  1. Exposure-adjusted incidence rate of treatment-emergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE)

    Time frame: From study baseline to week 148

    Exposure-adjusted incidence rate is defined as the number of patients with at least one specific treatment emergent adverse event in question per 100 patients taking the treatment for 1 year.

Secondary outcomes

  1. Annualized rate of asthma exacerbation events

    Time frame: From study baseline to weeks 48, 96 and 144

  2. Change from parent study baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)

    Time frame: From parent study baseline to weeks 48, 96 and 144

  3. Change from parent study baseline in Asthma Control Questionnaire5 (ACQ-5) score

    Time frame: From parent study baseline to weeks 48, 96 and 144

    The ACQ-5 is a questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. The ACQ-5 has five questions on the asthma symptoms and patients are asked to recall how their asthma has been during the previous week and to respond on a 7-point scale for each question (0 = no impairment, 6 = maximum impairment). The ACQ-5 score is the mean of the 5 questions and, therefore, between 0 (totally controlled) and 6 (severely uncontrolled). A high score indicates low asthma control.

  4. Proportion of participants with ≥0.5-point reduction in each ACQ-5 score as compared to parent study baseline score

    Time frame: From parent study baseline to weeks 48, 96 and 144

    Defined as ACQ-5 responder analysis

  5. Change from parent study baseline in Asthma Quality of Life Questionnaire Standardized Activites for 12 years and older (AQLQ[S] +12) domain and total scores

    Time frame: From parent study baseline to weeks 48, 96 and 144

    The AQLQ(S) + 12 was designed as a self-administered patient reported outcome to measure the functional impairments that are most troublesome to adolescents and adults ≥12 years of age as a result of their asthma. The instrument is comprised of 32 items, each rated on a 7-point Likert scales from 1 to 7. Higher scores indicate better quality of life.

  6. Serum lunsekimig concentrations

    Time frame: From study baseline to week 144

  7. Incidence and titer of anti-drug antibodies (ADA) against lunsekimig

    Time frame: From study baseline to week 144

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

An Open Label Extension Study to Evaluate the Long-term Safety and Efficacy of Subcutaneous Lunsekimig in Adult Participants With Asthma Who Participated in Study DRI16762 or ACT18301

Acronym: AIRPHRODITE

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
Sep 24, 2024
Registry last updated
Jun 22, 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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