NAZARE Study: Uncontrolled Asthma

The NAZARE Study for Uncontrolled Asthma

Broward Pulmonary and Sleep Specialists is recruiting for a Phase 2, multicenter, double-blind, randomized, placebo-controlled study to assess the safety and effectiveness of GSK5784283 in adults 18-75 years of age with uncontrolled asthma.

Why is this study being done?

The NAZARE Study is being conducted to evaluate the safety and effectiveness of GSK5784283, an investigational monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), in adults with uncontrolled asthma. Despite existing treatments, many patients continue to experience severe asthma symptoms.

GSK5784283 is designed to have an extended half-life, meaning it requires less frequent dosing, which could improve patient convenience and adherence. By inhibiting TSLP, it is hoped GSK5784283 will reduce airway inflammation and improve asthma control.

The study aims to determine the optimal dose and evaluate the safety and effectiveness of this potential new treatment, with the hope of offering an additional option for patients with poorly controlled asthma.

What will the study involve?

• Approximately 300 patients with participation lasting up to 91 weeks.
• Screening period: up to 5 weeks.
• Study treatment period: about 52 weeks divided into 2 parts.
• Follow-up period: about 34 weeks to monitor safety after the dosing has stopped.
• About 17 study center visits and 8 telephone calls.

Eligibility Criteria

Key inclusion criteria

• Documented physician-diagnosed asthma for ≥2 years.
• Documented history of ≥1 asthma exacerbation within the past 12 months.
• Regular treatment with medium- or high-dose inhaled corticosteroids for at least 6 months prior to screening.
• Uses at least 1 additional maintenance asthma controller medication according to standard practice of care for 3 months prior to screening.
• Evidence of variable airflow obstruction consistent with asthma.

Key exclusion criteria

• Any concomitant respiratory disease that will interfere with the evaluation of the investigational product or interpretation of subject safety or study results.
• Diagnosis of vocal cord dysfunction, dysfunctional breathing, or pseudo steroid resistant asthma.
• Current smokers (tobacco and marijuana) or former smokers with a smoking history ≥10 pack years and/or uses vaping products, including electronic cigarettes.
• Not responded to tezepelumab treatment.
• Use of immunosuppressive medication within 3 months prior to Visit 1.
• Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives prior to Visit 1.

Diverse representation among study participants is important to ensure that individuals most affected by asthma are represented within clinical research. Diversity includes gender, race, ethnicity, age, and background. When we have a diverse patient population, we can better understand any differences in treatment effectiveness of the investigational medication.