sim0718 treatment of asthma clinical study

Conditions: Asthma; Eosinophilic

Summary: phase iii clinical study of sim0718 asthma

a multicenter, randomized, double-blind, parallel-group, placebo-controlled phase iii clinical study evaluating the efficacy and safety of sim0718 in adults and adolescents with asthma

Eligibility criteria:
inclusion criteria: * age 12 to 75 years, weight ≥ 40 kg, diagnosed with asthma for at least 12 months； * currently receiving medium- to high-dose inhaled corticosteroids (ics) in combination with 1 or 2 control medications and have been on a stable dose for at least 28 days prior to randomization； * pre-bronchodilator (trough) fev1 ≤ 80% of predicted normal for adults and ≤90% of predicted normal for adolescents ； * positive bronchodilator response within 12 months prior to randomization or during the screening period; * asthma control questionnaire (acq-5) score ≥ 1.5; * at least one severe asthma exacerbation within 12 months prior to the screening visit and no occurrence within 28 days prior to randomization; * based on the investigator judgment, the subject demonstrates acceptable inhaler, peak flow meter, and spirometry techniques; * compliance with usual asthma controller use ≥ 80% based on the patient diary in 7 days prior to dosing; * voluntarily participate in this clinical study and sign the informed consent form and be able to comply with the clinical visit schedule and study-related procedures; * female subjects of childbearing potential who are sexually active with non-sterilized male partners, male subjects, and their female partners of childbearing potential agree to use adequate and effective contraception throughout the study; exclusion criteria: * current respiratory disease that may impair lung function as judged by the investigator; * diagnosis of helminth parasitic infection within 24 weeks prior to randomization and who have not received or have not responded to standard therapy; * within 28 days prior to randomization, with acute or chronic infection; or have a severe viral infection; * has a known or suspected history of immunosuppression or frequent, recurrent, or long-term infection; * history of active tuberculosis; or untreated latent tuberculosis or tuberculosis not receiving standard treatment, unless the investigator judges that the patient has been adequately treated; * people with hepatitis b, hepatitis c, or hiv infection; * history of malignancy; * major surgery within 8 weeks prior to signing the informed; * bronchial thermoplasty within 12 months prior to randomization; * treatment of systemic glucocorticoid during 4 weeks prior to signing informed to randomization; * previous use or ongoing use of systemic immunosuppressants or biologics for the treatment of autoimmune or inflammatory diseases in 8 weeks or 5 half-lives prior to randomization; * within 16 weeks or 5 half-lives prior to randomization, received a biologic agent with the same therapeutic purpose; * participated in an interventional clinical trial of any drug or medical device within 3 months or 5 half-lives prior to randomization; * poor response to or intolerance to prior anti-il-4rα antibody therapy; * within 3 months prior to randomization, received specific immunotherapy； * receipt of intravenous human immunoglobulin (ivig) or blood products within 30 days prior to randomization; * vaccination with live(attenuated) vaccine within 30 days prior to randomization or plan to receive live (attenuated) vaccine during the study; * are using concomitant medications or treatments that are prohibited in the protocol; * the following laboratory abnormalities occurred during the screening period: eosinophils≥1500 cells/mm3 or 1.5×109/l; platelets≤80,000 cells/mm3 or 80×109/l; phosphocreatine kinase (cpk) ≥5 times the upper limit of normal (uln); alanine aminotransferase (alt) ≥3-fold uln; aspartate aminotransferase (ast)≥ 3-fold uln; bilirubin ≥ 2x uln; * history of alcohol abuse or drug abuse within 12 months prior to randomization; * current smokers, or those who have been smoking in recent 6 months, or former smokers who have not been smoking for 6 months with a smoking history of ≥10 pack years; * allergy to l-histidine, trehalose, or tween 80, or history of systemic hypersensitivity to any biologic products; * females of childbearing potential have a positive pregnancy test result during the screening period; females planning to become pregnant or breastfeeding; * any clinically significant examination abnormality or serious and/or uncontrolled disease that, in the opinion of the investigator, may affect the subject safety, or affect the evaluation of efficacy, or preclude the subject completion of the entire study.