RecruitingPhase 3NCT06488755

SIM0718 Treatment of Asthma Clinical Study

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


Sponsor

Simcere Pharmaceutical Co., Ltd

Enrollment

418 participants

Start Date

Jun 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Phase III clinical study of SIM0718 asthma


Eligibility

Min Age: 12 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new injectable biologic drug called SIM0718 in people with moderate to severe asthma that is not well controlled despite taking inhaled corticosteroids and other controller medications. Researchers want to see if this drug safely reduces asthma attacks and improves lung function. **You may be eligible if...** - You are 12 to 75 years old (weighing at least 40 kg) with an asthma diagnosis for at least 12 months - You are currently on medium or high-dose inhaled steroids plus one or two additional controller medications - Your lung function is reduced (as measured by breathing tests) - Your asthma is not well controlled and you have had at least one severe flare-up in the past year **You may NOT be eligible if...** - You are a current smoker or have a significant smoking history - You have another serious lung condition (like COPD) - You have significant heart, liver, or immune system problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSIM0718 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

DRUGSIM0718 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


Locations(1)

China Japan Friendship Hospital

Beijing, Beijing Municipality, China

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NCT06488755


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