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

StatusActive, Not Recruiting
PhasePhase 2
Started2024-12-20
View on ClinicalTrials.gov ↗

Amendment history

2026-01-27
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v2
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2026-09→2027-02
Completion date2027-04→2027-09
Study sitesdetails revised at 1 of 1 site
2026-01-04
Not Yet Recruiting→Recruiting Study Status, Study Description, Arms and Interventions, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-11→confirmed 2024-12-20
Study sites0→1
Secondary endpoints7 entries, revised
Percentage change from baseline in pre-bronchodilator FEV1 at weeks 4, 8,12,16, 20, 28, 36, 44, 52 Number of asthma exacerbation through study week 3652 Change from baseline in Asthma Control Questionnaire (ACQ) score.
Primary endpoints1 entry, revised
Change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 3652
Study descriptionrevised
[...] treatment period of 16 weeks, prolonged treatment period of 2036 weeks and follow-up period of 8 weeks.
2024-11-07
Original filing
This study will assess the effcacy and safety of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.
Trial Details
NCT Number NCT06680947
Lead Sponsor Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Conditions Asthma
Enrollment 225 participants
Start Date 2024-12-20
Primary Completion 2027-02 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-01-29