Cure8 trial brief
This trial tests a new oral drug (Alpha-0261) for moderate-to-severe ulcerative colitis and could matter to people who haven’t responded to standard medicines. Early-phase studies mainly assess safety but also collect preliminary data on symptom improvement.
Adults with moderate-to-severe ulcerative colitis, especially those with prior inadequate response or intolerance to conventional therapies or biologics; clinicians and researchers tracking new oral therapies for UC.
This is a clinicaltrials.gov record for a Phase 1, not-yet-recruiting interventional study testing Alpha-0261 oral tablets in adults with moderately to severely active ulcerative colitis.
The trial will enroll about 10 participants who will take Alpha-0261 once daily for 10 weeks; primary safety monitoring is treatment-related adverse events assessed through 12 weeks, and the protocol also measures clinical remission by the modified Mayo score at Week 10.
The study is small and early-stage (Phase 1) and is primarily focused on safety, with secondary efficacy assessments. Eligibility requires documented moderate-to-severe UC and prior inadequate response or intolerance to conventional therapies or biologics. The single listed site is The First Affiliated Hospital of Anhui Medical University in Hefei, China.
If you are considering trial participation, note this record describes the planned protocol and does not report results. Contact the study site listed on clinicaltrials.gov for up-to-date recruitment status, detailed eligibility screening, and any questions about risks and procedures.
This is a Phase 1, small (planned N=10) safety-focused study listed on clinicaltrials.gov and does not report any outcomes. As a registry record its purpose is to describe the planned trial; it is not evidence that the drug is effective or safe.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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