A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase II Trail Evaluating the Efficacy and Safety of GR1802 Injection in Patients with Moderate to Severe Asthma
This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of GR1802 injection in comparison to placebo in patients with atopic dermatitis. Patients will receive GR1802 injection or Placebo every 2 Weeks.
• Age ≥18 and ≤70 years old, male or female.
• The subject meet the diagnostic criteria of GINA 2021 requiring a diagnosis of asthma for at least 12 months and fulfilled one of the following criteria:
⁃ (1) The subject has received medium-to-high dose ICS combined with at least one control drug, such as LABA, LTRA, theophylline, for at least 3 months before baseline visit, and maintained stable treatment regimen and dosage for at least 1 month before baseline visit; (2) The subject have been on a 3rd controlled drug for at least 3 consecutive months and on a stable dose for ≥1 month prior to baseline visit; (3) The subject must have been on maintenance therapy with ≤10mg/day prednisone or equivalent dose of OCS continuously for at least 3 months and have been receiving therapy at a stable dose for ≥1 month prior to the baseline visit.
⁃ 3\. 35%≤ Pre-bronchodilator FEV1 measured ≤ 80% of the normal predicted value at screening and baseline visits.
⁃ 4\. Asthma Control Questionnaire-5 (ACQ-5) score ≥1.5 at screening and baseline visits.
⁃ 5\. A positive bronchodilation test (≥12% increase in the FEV1 post-bronchodilator and an absolute FEV1 increase of ≥200 mL) within 12 months before screening.
⁃ 6\. Subjects must have experienced at least one severe asthma exacerbation event within 12 months before screening, denfined as: systemic use of glucocorticoids for ≥3 days (at least twice the dose of current use); and/or an emergency visit due to asthma symptoms resulting in hospitalisation, and/or asthma requiring additional systemic glucocorticoid intervention therapy.
⁃ 7\. Willingness to follow the requirements of the study protocol and willingness of the patient or his/her legal representative to sign a written informed consent.