Actively Recruiting
Phase 3
Age: 12Years - 75Years
All Genders
NCT06488755
SIM0718 Treatment of Asthma Clinical Study
Led by Simcere Pharmaceutical Co., Ltd · Updated on 2026-04-02
418
Participants Needed
1
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase III clinical study of SIM0718 asthma
CONDITIONS
Official Title
SIM0718 Treatment of Asthma Clinical Study
Who Can Participate
Age: 12Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 12 to 75 years and weight at least 40 kg
- Diagnosed with asthma for at least 12 months
- Currently on medium- to high-dose inhaled corticosteroids plus 1 or 2 control medications with stable dose for at least 28 days
- Pre-bronchodilator FEV1 80% or less of predicted normal for adults or 90% or less for adolescents
- Positive bronchodilator response within 12 months prior to randomization or during screening
- Asthma Control Questionnaire score of 1.5 or higher
- At least one severe asthma exacerbation in the 12 months before screening and none in the 28 days before randomization
- Able to demonstrate acceptable inhaler, peak flow meter, and spirometry techniques
- Compliance with asthma controller use 80% or higher in 7 days prior to dosing
- Voluntary participation with informed consent and ability to comply with study procedures
- Agreement to use effective contraception for females of childbearing potential and their male partners throughout the study
You will not qualify if you...
- Current respiratory disease impairing lung function
- Helminth parasitic infection within 24 weeks prior to randomization not treated or unresponsive to therapy
- Acute or chronic infection or severe viral infection within 28 days prior to randomization
- History of immunosuppression or frequent, recurrent, or long-term infections
- Active or untreated latent tuberculosis unless adequately treated
- Infection with hepatitis B, hepatitis C, or HIV
- History of malignancy
- Major surgery within 8 weeks prior to informed consent
- Bronchial thermoplasty within 12 months prior to randomization
- Systemic glucocorticoid treatment within 4 weeks before informed consent to randomization
- Use of systemic immunosuppressants or biologics within 8 weeks or 5 half-lives prior to randomization
- Biologic agents for similar purpose within 16 weeks or 5 half-lives prior to randomization
- Participation in other interventional clinical trials within 3 months or 5 half-lives prior to randomization
- Poor response or intolerance to anti-IL-4Rα antibody therapy
- Specific immunotherapy within 3 months prior to randomization
- Intravenous immunoglobulin or blood products within 30 days prior to randomization
- Live (attenuated) vaccine within 30 days prior to randomization or planned during study
- Use of prohibited medications or treatments per protocol
- Laboratory abnormalities including high eosinophils, low platelets, elevated CPK, ALT, AST, or bilirubin
- History of alcohol or drug abuse within 12 months prior to randomization
- Current smokers or recent smokers within 6 months or former smokers with at least 10 pack-years and less than 6 months cessation
- Allergy to L-histidine, trehalose, Tween 80, or systemic hypersensitivity to biologics
- Positive pregnancy test or pregnancy or breastfeeding
- Any serious or uncontrolled disease or condition affecting safety or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 1 location
1
China Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
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Research Team
Y
Yi Wang
CONTACT
W
wei wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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