Phase 3 Study of GB-0895 Injection for Severe Uncontrolled Asthma in Adolescents and Adults

What this Trial Is About

Researchers are studying the investigational drug GB-0895 as an additional treatment for adolescents and adults aged 12 to 80 years with severe asthma that is not controlled by inhaled corticosteroids and other standard asthma treatments. This Phase 3, randomized, double-blind, placebo-controlled trial aims to evaluate the safety and effectiveness of GB-0895 in improving asthma control over a year. The trial includes an optional open-label extension for further assessment. Participants will be randomly assigned to receive either GB-0895 or a placebo by subcutaneous injection every six months during the 52-week treatment period. The study also includes a screening and baseline phase, a run-in phase before treatment, and a follow-up period after treatment ends. During the optional extension phase, participants may continue receiving GB-0895 at specified time points. The study involves multiple visits approximately every 1 to 2 months after the first month. Throughout the trial, participants will undergo various assessments including lung function tests, asthma symptom diaries, quality of life questionnaires, and monitoring of asthma exacerbations. Researchers will track annual asthma exacerbation rates and changes in asthma control and quality of life scores. Safety will be closely monitored during and after treatment. Total participation may last up to about 2.7 years if including the extension phase.

A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)