Long-term safety and efficacy of subcutaneous lunsekimig in adults with asthma: An open-label extension study

The primary objective is to evaluate the long-term safety of lunsekimig in adult participants with asthma. 4: Safety.

The secondary objectives include the following:

• Evaluation of long-term efficacy. 5: Efficacy.
• Assessment of effects on lung function.
• Evaluation of asthma control using the Asthma Control Questionnaire 5 (ACQ-5).
• Assessment of quality of life via the Asthma Quality of Life Questionnaire Standardized Activities for 12 years and older (AQLQ[S]+ 12).
• Evaluation of pharmacokinetics. 6: Pharmacokinetic.
• Evaluation of immunogenicity.

This clinical trial involves 780 adult participants diagnosed with asthma. The study population includes both male and female individuals. Participants consist of patients who have completed a 48-week treatment period in either Study DRI16762 or Study ACT18301, including the end-of-treatment visit. Eligible subjects must maintain stable background therapy involving moderate or high-dose inhaled corticosteroids in combination with specific controller medications, such as long-acting beta-agonists, long-acting muscarinic antagonists, leukotriene receptor antagonists, or methylxanthines. The cohort is restricted to those capable of providing informed consent and adhering to requirements for contraception. The study population includes vulnerable groups.

This phase 4 open-label extension study is designed to evaluate the long-term safety and efficacy of subcutaneous lunsekimig in adults with asthma. The study includes participants who have completed the 48-week treatment period of either study DRI16762 or ACT18301, including the end-of-treatment visit. The primary objective is to monitor the occurrence of treatment-emergent adverse events, including serious adverse events and adverse events of special interest. Secondary endpoints include the annualized rate of asthma exacerbation events, changes in pre-bronchodilator forced expiratory volume in 1 second, asthma control questionnaire-5 scores, and asthma quality of life questionnaire scores, as well as assessment of serum lunsekimig concentrations and anti-drug antibodies. The study is estimated to take place between July 2026 and August 2029.

The investigational product consists of lunsekimig, which is administered via subcutaneous injection. The specific dosage and frequency of administration are determined by the study protocol for adult participants with asthma.

The efficacy of subcutaneous lunsekimig in adults with asthma is assessed through several secondary endpoints. The annualized rate of asthma exacerbation events is evaluated to determine clinical impact. Pulmonary function is monitored via the change from the parent study baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1).

Patient-reported outcomes are measured using the Asthma Control Questionnaire-5 (ACQ-5) and the Asthma Quality of Life Questionnaire with Standardized Activities for 12 years and older (AQLQ[S]+12). Assessments include changes from the parent study baseline in total scores and specific domains, as well as the proportion of participants achieving a reduction of at least 0.5 points in these scores. Additionally, serum lunsekimig concentrations and the incidence and titer of anti-drug antibodies (ADA) are monitored.