Alpha-0261 Tablets for Adults With Moderate-to-Severe Ulcerative Colitis
Tests Alpha-0261 tablets for safety in adults with active ulcerative colitis.
Plain-language title generated from the registry record
Registry title: Alpha-0261 Tablets for Moderate-to-Severe Ulcerative Colitis
Key facts
- Where
- Hefei, ChinaSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderate-to-severe active ulcerative colitis who did not respond to, or could not tolerate, at least one earlier treatment.
- Age
- 18 to 75 years
- Sex
- Men and women can join.
- Disease stage
- Moderate-to-severe active ulcerative colitis, diagnosed at least 3 months before screening and confirmed by endoscopy or histology. The mMS score must be 4 to 9.
- Earlier treatment
- Must have had an inadequate response to, or been unable to tolerate, 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.).
Main reasons for not taking part
- Crohn's disease, indeterminate colitis or other types of colitis or enteritis
- Fulminant colitis or toxic megacolon
- Ulcerative colitis limited to the rectum
- Known hepatitis B, hepatitis C or HIV infection, active tuberculosis or other active infection
- History of cancer disease free for less than 5 years (some skin and cervical cancers excepted)
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07744646, who can take part
Where in China
- The First Affiliated Hospital of Anhui Medical UniversityHefei, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- The First Affiliated Hospital of Anhui Medical University
- Trial code
- NCT07744646
- Record updated
- 4 August 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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; 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 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 a current diagnosis of fulminant colitis and/or toxic megacolon; Has UC limited to the rectum.