Lunsekimig
Drug- Pharmaceutical form: Solution for injection in vial
- Route of administration: Subcutaneous injection
Other names: SAR443765
NCT Number: NCT06609239
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Investigational Site Number : 0320007, Berazategui, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For female participants:
For male participants:
-- No sperm donation or cryopreserving sperm
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Other names: SAR443765
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.
Time frame: From study baseline to weeks 48, 96 and 144
Time frame: From parent study baseline to weeks 48, 96 and 144
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.
Time frame: From parent study baseline to weeks 48, 96 and 144
Defined as ACQ-5 responder analysis
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.
Time frame: From study baseline to week 144
Time frame: From study baseline to week 144
Sanofi
Industry
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
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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