Alpha-0261 Tablets for Moderate-to-Severe Ulcerative Colitis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ulcerative Colitis (UC)
• Intervention / Treatment: Drug: Alpha-0261

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Guifang Xu, Doctor of Medicine; Phone Number: 13852293376; Email: xuguifang@fy.ahmu.edu.cn

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • The First Affiliated Hospital of Anhui Medical University
      • Contact: Guifang Xu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alpha-0261; Participants will take Alpha-0261 tablets orally once daily for 10 consecutive weeks.	Drug: Alpha-0261; Drug: Alpha-0261 Oral, tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From enrollment to the end of study at 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From enrollment to the end of treatment at 10 weeks.

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Anhui Medical University
• Collaborators: AlphaMol Science Ltd. (Shanghai)

Study record dates

Study Major Dates

• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): January 9, 2027
• Study Completion (Estimated): March 20, 2027

Study Registration Dates

• First Submitted: July 30, 2026
• First Submitted That Met QC Criteria: July 30, 2026
• First Posted (Actual): August 4, 2026

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: July 30, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: Alpha-0261-UC-001 (Other Grant/Funding Number: AlphaMol Science Ltd. (Shanghai))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No