Asthma
Conditions
Brief summary
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 100 weeks with a treatment duration being up to 96 weeks.
Detailed description
Enter Intervention Groups
Interventions
DRUGLunsekimig
* Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants who completed the 48-week treatment period of Study DRI16762 or ACT18301, including the EOT visit, as per protocol 2. 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 3. Participants who are able and willing to participate in the open-label extension study, and to comply with requested study visits and procedures 4. Contraception for male and female participants For female participants: * must agree to use contraception/barrier * not pregnant or breast feeding * no eggs donation or cryopreserving eggs For male participants: * No sperm donation or cryopreserving sperm 5. Capable of giving signed informed consent
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: 1. 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 2. Participant who was diagnosed with a new pulmonary disease which may impair lung function 3. Current smoker or active vaping of any products and/or marijuana smoking 4. Prescription drug or substance abuse, including alcohol, considered significant by the Investigator 5. 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 6. Participants who are receiving prohibited concomitant medications 7. 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 8. Concurrent participation in any other clinical study, including non-interventional studies 9. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized 10. Participants are employees of the investigative site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants having any treatmentemergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE) | From study baseline to week 100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annualized rate of asthma exacerbation events | From study baseline to week 48 | — |
| Change from parent study baseline in prebronchodilator (BD) forced expiratory volume in 1 second (FEV1) | From parent study baseline to week 48 | — |
| Change from parent study baseline in pre bronchodilator (BD) FEV1 | From parent study baseline to week 96 | — |
| Change from parent study baseline in Asthma Control Questionnaire5 (ACQ-5) score | From parent study baseline to week 48 | 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. |
| Change from parent study baseline in Asthma Control Questionnaire 5 (ACQ-5) score | From parent study baseline to week 96 | — |
| Proportion of participants with ≥0.5-point reduction in each score as compared to parent study baseline score | From parent study baseline to week 48 | Defined as ACQ-5 responder analysis |
| 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 | From parent study baseline to week 48 | 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. |
| Change from parent study baseline in Asthma Quality of Life Questionnaire Standardized Activities for 12 years and older (AQLQ[S] +12) domain and total scores | From parent study baseline to week 96 | — |
| Serum lunsekimig concentrations | From study baseline to week 100 | — |
| Incidence and titer of anti-drug antibodies (ADA) against lunsekimig | From study baseline to week 100 | — |
Countries
Argentina, Brazil, Canada, Chile, China, India, Israel, Japan, Mexico, South Africa, South Korea, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed