Ulcerative Colitis (UC)
Conditions
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.
Interventions
DRUGAlpha-0261
Drug: Alpha-0261 Oral, tablet
Sponsors
The First Affiliated Hospital of Anhui Medical University
AlphaMol Science Ltd. (Shanghai)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v6.0 | From enrollment to the end of study at 12 weeks. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with clinical remission at Week 10 in complete modified Mayo score. | From enrollment to the end of treatment at 10 weeks. | 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). |
Countries
China
Contacts
CONTACTGuifang Xu, Doctor of Medicine
Outcome results
None listed