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610

Phase 3

Asthma | Small molecule | Respiratory |Sunshine Biopharma Inc.|Last Updated: Jan 29, 2026

Success Probability
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment705
FDA Designations
No designations recorded
Clinical trial landscape

610 · 2 trials · 1 indication

Phase 3 1Phase 2 1
NCT06323213Efficacy and Safety Study of 610 in Patients With Severe AsthmaAsthma
RECRUITING480 Analytics
PHASE3RECRUITING
Efficacy and Safety Study of 610 in Patients With Severe Asthma
AsthmaUnlock trial analytics
Study Endpoints
Primary Endpoints
Annualized rate of severe exacerbation events
Up to 52 weeks

Annualized rate of severe exacerbation events during the 52-week placebo-controlled treatment period

Change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 52
Baseline (Day 1) and at week 52

FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry.

Secondary Endpoints
Time to first severe exacerbation event
Up to 52 weeks
Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit
Up to 52 weeks
Change from baseline in ACQ score
Up to 52 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
610 groupEXPERIMENTALSubjects will receive 610 for 52 weeks.
placebo groupPLACEBO_COMPARATORSubjects will receive placebo for 52 weeks.
Group AEXPERIMENTALSubjects will receive 610 for 52 weeks.
Group BEXPERIMENTALSubjects will receive 610 for 52 weeks.
Interventions
NameTypeDescription
610DRUG610 subcutaneously injection.
PlaceboDRUGPlacebo subcutaneously injection.
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Eligibility Criteria
Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Able to give written informed consent prior to participation in the study. 2. Male or female adults ages 18 to 75 years old when signing the informed consent. 3. Documented diagnosis of asthma for at least one year prior to screening. 4. History of physician-diagnosed asthma ...

Countries:China
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Recent Changes (Last 90 Days)
LOWJul 5, 2026NCT06323213primaryCompletionDate: changed
LOWJul 5, 2026NCT06680947primaryCompletionDate: changed
LOWJul 5, 2026NCT06323213primaryCompletionDate: changed
LOWJul 5, 2026NCT06680947primaryCompletionDate: changed
LOWJul 5, 2026NCT06323213primaryCompletionDate: changed
LOWJul 5, 2026NCT06680947primaryCompletionDate: changed
LOWMay 24, 2026NCT06323213studyFirstPostDate: changed
LOWMay 24, 2026NCT06680947studyFirstPostDate: changed