UCNot yet recruiting
Alpha-0261 Tablets for Moderate-to-Severe Ulcerative Colitis
Phase 1 · Testing Alpha-0261 · 1 site · The First Affiliated Hospital of Anhui Medical University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Alpha-0261 (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC).
It is open-label: participants know what they are receiving.
Phase 1 studies are early tests in a small group of people, mainly checking safety and dosing.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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…
Plus 2 more requirement(s). There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 10 participants are expected to take part.
- Start date: 2026-08-03 (planned).
- Main results expected around 2027-01-09 (estimate from the record).
- 1 study site listed in China.
Main thing being measured
- Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v6.0 (From enrollment to the end of study at 12 weeks.)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC) |
| Lead sponsor | The First Affiliated Hospital of Anhui Medical University |
| Collaborators | AlphaMol Science Ltd. (Shanghai) |
| Enrollment | 10 (estimated) |
| Start date | 2026-08-03 |
| Primary completion (est.) | 2027-01-09 |
| First posted | 2026-08-04 |
| Last updated | 2026-08-04 |
| 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) |
| ClinicalTrials.gov ID | NCT07744646 |
Interventions
- Alpha-0261 (Drug)
Drug: Alpha-0261 Oral, tablet
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei, Anhui | China |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.