To Evaluate The Safety and Initial Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome

Summary

To evaluate the safety and initial efficacy of STSA-1002 injection in patients with acute respiratory distress syndrome.

Timeline

Start

2023-12-09

Primary completion

2025-03-20

Completion

2025-04-27

Outcome

Missed primary endpoint

paper A subdistribution hazard ratio of 1.55 (95% CI, 0.68-3.55) was reported for the STSA-1002 1,350 mg group and 1.04 (95% CI, 0.46-2.38) for the STSA-1002 750 mg group according to a competing risk model, both compared with the control group. PMID 42142803 ↗

Publications

• Wang Y, Huang X, Cheng Z, Chu Z, Li H, Zhang Y, Jiang M, Gan X, Li L, Yang X, Zhang Z, Suo L, Li Y, Huang X, Wang X, Yun S, Xiang X, Li Z, Cao B. Anti-C5a Antibody STSA-1002 for Patients With ARDS Due to Viral Pneumonia: A Phase 1b/2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Chest. 2026 May 15:S0012-3692(26)00638-0. doi: 10.1016/j.chest.2026.04.052. Online ahead of print.

Drugs

Indications