SIM0718 Treatment of Asthma Clinical Study

Официальное название

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

Обзор

Phase III clinical study of SIM0718 asthma

Подробное описание

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

Вмешательства

• Препарат SIM0718 injection
  Dosage form: injection Specification: 300mg/2ml/bottle Dosage: A loading dose of 600 mg is injected subcutaneously on day 1, followed by 300 mg SIM0718 subcutaneously every two weeks. Duration of medication: 52 weeks
• Препарат SIM0718 injection of placebo
  Dosage form: injection Specification: 2ml/bottle Dosage: 4ml subcutaneously on day 1, followed by 2ml of placebo subcutaneously every two weeks. Duration of medication: 52 weeks

Первичные конечные точки

• Annualized rate of severe asthma exacerbation events [Срок оценки: 52 weeks]

Вторичные конечные точки (12)

• Change from baseline in forced expiratory volume in the first second before bronchodilator use [Срок оценки: 12 weeks]
• Change from baseline in Forced Vital Capacity (FVC) [Срок оценки: During the 52-week treatment period]
• Change from baseline in pre-bronchodilator forced expiratory volume in 1 second [Срок оценки: During the 52-week treatment period]
• Change from baseline in Peak Expiratory Flow (PEF) [Срок оценки: During the 52-week treatment period]
• Time from baseline to the first severe asthma exacerbation event, proportion of subjects with ≥ 1 severe asthma exacerbation [Срок оценки: During the 52-week treatment period]
• Annualized rate of "loss of asthma control" events, time from baseline to "loss of asthma control"event [Срок оценки: During the 52-week treatment period]
• Change from baseline in annualized rate of hospitalization or emergency department visits, utilization of medical resources [Срок оценки: During the 52-week treatment period]
• Change from baseline in ASTHMA CONTROL QUESTIONNAIRE(ACQ-5) score [Срок оценки: During the 52-week treatment period]
• Asthma symptom score [Срок оценки: During the 52-week treatment period]
• Use of rescue medication [Срок оценки: During the 52-week treatment period]
• Number of days of awakenings due to asthma and number of awakenings due to asthma [Срок оценки: During the 52-week treatment period]
• Change from baseline in standardized asthma quality of life questionnaire score ASTHMA QUALITY OF LIFE QUESTIONNAIRES(AQLQ(S)) [Срок оценки: During the 52-week treatment period]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• China Japan Friendship Hospital — Пекин

Идентификаторы

NCT: NCT06488755 · SIM0718-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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