The First Affiliated Hospital of Anhui Medical University
Phase
Phase 1
Started
2026-08-03
Last updated
2026-08-04
Condition(s) studied
Ulcerative Colitis (UC)
Investigational drug(s) / intervention(s)
Alpha-0261
Alpha-0261: Drug: Alpha-0261 Oral, tablet
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.).
* Voluntarily sign the informed consent form and be willing to comply with the study procedures and complete the trial in accordance with the protocol.
Exclusion Criteria:
* 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.
* Has any active infection as specified in the protocol
* Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
* Has evidence of active tuberculosis (TB) or meets TB exclusionary parameters
* Has a history of cancer (except fully treated nonmelanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years before Randomization
* Has had major surgery within 4 weeks before Screening or has a major surgery (ie, surgical procedure requiring general anesthesia) planned during the study
* Has received protocol-specified prohibited medications
Primary outcome measure(s)
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v6.0 — From enrollment to the end of study at 12 weeks. 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).
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Anhui Medical University
Hefei
Anhui
More The First Affiliated Hospital of Anhui Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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