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

Official title

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)

Overview

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.

Interventions

• Drug Alpha-0261
  Drug: Alpha-0261 Oral, tablet

Primary outcome measures

• Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v6.0 [Time frame: From enrollment to the end of study at 12 weeks.]

Secondary outcome measures (1)

• Percentage of participants with clinical remission at Week 10 in complete modified Mayo score. [Time frame: From enrollment to the end of treatment at 10 weeks.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of Anhui Medical University — Hefei

Identifiers

NCT: NCT07744646 · Alpha-0261-UC-001 · Alpha-0261-UC-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗