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

Conditions

Asthma

Brief summary

Number of participants having any treatment-emergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE)

Detailed description

Annualized rate of asthma exacerbation events, Annualized rate of asthma exacerbation events, Change from parent study baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1), Change from parent study baseline in pre bronchodilator (BD) FEV1, Change from parent study baseline in Asthma Control Questionnaire-5 (ACQ-5) score, Change from parent study baseline in Asthma Control Questionnaire 5 (ACQ-5) score, Proportion of participants with ≥0.5-point reduction in each score as compared to parent study baseline score, Proportion of participants with ≥0.5-point reduction in each score as compared to parent study baseline score, Change from parent study baseline in Asthma Quality of Life Questionnaire with Standardized Activities for 12 years and older (AQLQ[S] + 12) domain and total scores, Change from parent study baseline in Asthma Quality of Life Questionnaire with Standardized Activities for 12 years and older (AQLQ[S] +12) domain and total scores, Serum lunsekimig concentrations, Incidence and titer of anti-drug antibodies (ADA) against lunsekimig

Related papers

No related papers found yet.

Interventions

DRUGSAR443765 / LUNSEKIMIG

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of participants having any treatment-emergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE)	—

Secondary

Measure	Time frame
Annualized rate of asthma exacerbation events, Annualized rate of asthma exacerbation events, Change from parent study baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1), Change from parent study baseline in pre bronchodilator (BD) FEV1, Change from parent study baseline in Asthma Control Questionnaire-5 (ACQ-5) score, Change from parent study baseline in Asthma Control Questionnaire 5 (ACQ-5) score, Proportion of participants with ≥0.5-point reduction in each score as compared to parent study baseline score, Proportion of participants with ≥0.5-point reduction in each score as compared to parent study baseline score, Change from parent study baseline in Asthma Quality of Life Questionnaire with Standardized Activities for 12 years and older (AQLQ[S] + 12) domain and total scores, Change from parent study baseline in Asthma Quality of Life Questionnaire with Standardized Activities for 12 years and older (AQLQ[S] +12) domain and total scores, Serum lunsekim	—

Measure

Time frame

Annualized rate of asthma exacerbation events, Annualized rate of asthma exacerbation events, Change from parent study baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1), Change from parent study baseline in pre bronchodilator (BD) FEV1, Change from parent study baseline in Asthma Control Questionnaire-5 (ACQ-5) score, Change from parent study baseline in Asthma Control Questionnaire 5 (ACQ-5) score, Proportion of participants with ≥0.5-point reduction in each score as compared to parent study baseline score, Proportion of participants with ≥0.5-point reduction in each score as compared to parent study baseline score, Change from parent study baseline in Asthma Quality of Life Questionnaire with Standardized Activities for 12 years and older (AQLQ[S] + 12) domain and total scores, Change from parent study baseline in Asthma Quality of Life Questionnaire with Standardized Activities for 12 years and older (AQLQ[S] +12) domain and total scores, Serum lunsekim

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Outcome results

None listed