Trials / Recruiting
RecruitingNCT06488755
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 418 (estimated)
- Sponsor
- Simcere Pharmaceutical Co., Ltd · Academic / Other
- Sex
- All
- Age
- 12 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Phase III clinical study of SIM0718 asthma
Detailed description
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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 |
| DRUG | 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 |
Timeline
- Start date
- 2024-06-23
- Primary completion
- 2027-02-28
- Completion
- 2027-09-30
- First posted
- 2024-07-05
- Last updated
- 2026-04-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06488755. Inclusion in this directory is not an endorsement.