NCT06680947

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 225 (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 effcacy 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 effcacy and safety of 610 in adults with severe eosinophilic asthma. Subjects divided into 3 groups: A group,B group and placebo group. The study is divided into screening period of 4 weeks, treatment period of 16 weeks, prolonged treatment period of 36 weeks and follow-up period of 8 weeks.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	610	Subcutaneously injection.
DRUG	610	Subcutaneously injection.
DRUG	Placebo	Subcutaneously injection.

Timeline

• Start date: 2024-12-20
• Primary completion: 2027-02-01
• Completion: 2027-09-01
• First posted: 2024-11-08
• Last updated: 2026-01-29

Locations

1 site across 1 country: China