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
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?
Trial 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.