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.
Aged 18 to 75 years (inclusive), male or female.
Diagnosed with ulcerative colitis at least 3 months prior to screening; this diagnosis must be confirmed by endoscopy or histology.
Patients must have moderate-to-severe active ulcerative colitis, as defined by an mMS score of 4 to 9 (blood in stool subscore ≥ 1, frequency of bowel ovements subscore ≥ 1, and colonoscopy subscore ≥ 2 [as confirmed by the study site's image reviewer]; the sum of these three subscores must be at least 4).
The investigator determines that the participant has had an inadequate response to or is intolerant of at least one conventional therapy aminosalicylates, corticosteroids, or immunosuppressants) or a biologic agent (anti-TNF-α, anti-α4β7 integrin, or anti-IL-12/23 antibodies, etc.).
Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment
Has a current diagnosis of fulminant colitis and/or toxic megacolon
Has UC limited to the rectum
Has a history of or is anticipated to require surgical intervention for ulcerative colitis during the study, including but not limited to ostomy, ileal pouch-anal anastomosis, and intestinal resection.
Single group
Alpha-0261
DrugDrug: Alpha-0261 Oral, tablet
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).
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).
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The First Affiliated Hospital of Anhui Medical University
Lead sponsor
AlphaMol Science Ltd. (Shanghai)
Collaborator
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