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627

Phase 2

Ulcerative Colitis (UC) | Small molecule | Gastrointestinal |Sunshine Biopharma Inc.|Last Updated: Apr 2, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment288
FDA Designations
No designations recorded
Clinical trial landscape

627 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT07507513The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UCUlcerative Colitis (UC)
NOT YET_RECRUITING288 Analytics
PHASE2NOT YET_RECRUITING
The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UC
Ulcerative Colitis (UC)Unlock trial analytics
Study Endpoints
Primary Endpoints
Number of participants with Adverse Events
During the 36-week study period
Secondary Endpoints
Clinical remission based on Mayo Score (MMS)
Week 14
Clinical response based on Mayo Score (MMS)
Week 14
Endoscopic improvement
Week 14
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group M1EXPERIMENTALdose level 1 of 627
Group M2EXPERIMENTALdose level 2 of 627
Group M3EXPERIMENTALdose level 3 of 627
Group M4EXPERIMENTALdose level 4 of 627
Group AEXPERIMENTAL627 Dose A subcutaneous (SC) injection.
Group BEXPERIMENTAL627 Dose B subcutaneous (SC) injection.
PlaceboPLACEBO_COMPARATORPlacebo subcutaneous (SC) injection.
Group CEXPERIMENTAL627 subcutaneous (SC) injection.
627EXPERIMENTAL -
Interventions
NameTypeDescription
627DRUG627 subcutaneous (SC) injection.
PlaceboDRUGPlacebo subcutaneous (SC) injection.
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Eligibility Criteria
Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Able to understand and comply with the requirements of the study protocol, and sign the written informed consent form (ICF). 2. Male or female subjects aged 18-75 years old when signing the ICF. 3. Subjects must have been diagnosed with UC for at least 3 months prior to rando...

Countries:China
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Recent Changes (Last 90 Days)
LOWJul 5, 2026NCT07065136primaryCompletionDate: changed
LOWJul 5, 2026NCT07507513primaryCompletionDate: changed
LOWJul 5, 2026NCT07065136primaryCompletionDate: changed
LOWJul 5, 2026NCT07507513primaryCompletionDate: changed
LOWJul 5, 2026NCT07065136primaryCompletionDate: changed
LOWJul 5, 2026NCT07507513primaryCompletionDate: changed
LOWMay 24, 2026NCT07065136studyFirstPostDate: changed
LOWMay 24, 2026NCT07507513studyFirstPostDate: changed