The purpose of this protocol is to evaluate the safety and efficacy of Alpha-0261 in participants with moderately to severely active ulcerative colitis. The primary hypothesis is that Alpha-0261 is safe, and the secondary hypothesis is that Alpha-0261 is effective, as assessed by the proportion of participants achieving clinical remission per the complete modified Mayo score at Week 10.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Drug: Alpha-0261 Oral, tablet
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v6.0
Safety endpoints: These include, but are not limited to, adverse events (AEs) and serious adverse events (SAEs), vital signs, physical examinations, 12-lead electrocardiograms (ECGs), and clinical laboratory tests (complete blood count, urinalysis, blood chemistry, and coagulation tests).
Time frame: From enrollment to the end of study at 12 weeks.
Percentage of participants with clinical remission at Week 10 in complete modified Mayo score.
Percentage of participants with clinical remission at Week 10 (complete modified Mayo score: stool frequency ≤1, rectal bleeding =0, and site-read endoscopy subscore ≤1).
Time frame: From enrollment to the end of treatment at 10 weeks.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.