Multicenter Single-Blind Randomized Controlled Trial of the Romiplostim Biosimilar.

Background: This was a randomized multicenter single-blinded active-controlled equivalence Phase III study evaluating the efficacy and safety of the biosimilar of romiplostim (GP40141) compared to the reference drug Nplate in patients with persistent or chronic immune thrombocytopenia (ITP).

Methods: The study included 136 adult patients randomized 1:1 to receive either the biosimilar or reference drug for 26 weeks. The primary endpoint was the proportion of patients achieving a platelet response (≥ 50 × 10/L) at Week 11.

The efficacy and safety of levilimab in severely ill COVID-19 patients not requiring mechanical ventilation: results of a multicenter randomized double-blind placebo-controlled phase III CORONA clinical study.

Objective And Design: The aim of this double-blind, placebo-controlled, phase III CORONA clinical trial was to evaluate the efficacy and safety of IL-6 receptor inhibitor levilimab (LVL) in subjects with severe COVID-19.

Subjects: The study included 217 patients. The eligible were men and non-pregnant women aged 18 years or older, hospitalized for severe COVID-19 pneumonia.