NCT05528679

A Phase II Study of 610 in Participants With Severe Eosinophilic Asthma

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II, Efficacy and Safety Study of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Therapy in Adult Subjects With Severe Eosinophilic Asthma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the efficacy and safety of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 610 in adults with severe eosinophilic asthma. Plan to recruit 120 subjects, and the subjects divided into 3 groups: 610 100mg group, 610 300mg group and placebo group. The study is divided into screening period of 4 weeks, treatment period of 16 weeks and follow-up period of 8 weeks.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	610 100mg	100mg administered subcutaneously Q4W
DRUG	610 300mg	300mg administered subcutaneously Q4W
DRUG	placebo	administered subcutaneously Q4W

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2022-09-06
• Last updated: 2022-09-06

Locations

1 site across 1 country: China