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Alpha-0261 Tablets for Moderate-to-Severe Ulcerative Colitis
Sponsor: The First Affiliated Hospital of Anhui Medical University
Summary
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.
Official title: An Open-Label, Single-Arm, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Alpha-0261 Tablets in Patients With Moderate to Severe Active Ulcerative Colitis (UC)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2026-08-03
Completion Date
2027-03-20
Last Updated
2026-08-04
Healthy Volunteers
No
Conditions
Interventions
Alpha-0261
Drug: Alpha-0261 Oral, tablet
Locations (1)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China