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

NCT07744646 | Not Yet Recruiting Phase 1

• 1 other identifier: Alpha-0261-UC-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ulcerative Colitis (UC)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of participants with clinical remission at Week 10 in complete modified Mayo score.

  From enrollment to the end of treatment at 10 weeks.

Study Arms (1)

Alpha-0261

EXPERIMENTAL

Participants will take Alpha-0261 tablets orally once daily for 10 consecutive weeks.

Drug: Alpha-0261

Interventions

Alpha-0261 DRUG

Drug: Alpha-0261 Oral, tablet

Alpha-0261

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Guifang Xu, Doctor of Medicine

CONTACT

13852293376; xuguifang@fy.ahmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Department of Gastroenterology

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start: August 3, 2026
• Primary Completion (Estimated): January 9, 2027
• Study Completion (Estimated): March 20, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)