[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650309":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":42,"collaborators":45,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":19,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":19,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":19,"overallStatus":68,"whyStopped":19,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"The First Affiliated Hospital of Anhui Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Alpha-0261","EXPERIMENTAL","Participants will take Alpha-0261 tablets orally once daily for 10 consecutive weeks.",[13],"Drug: Alpha-0261",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Drug: Alpha-0261 Oral, tablet",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Guifang Xu, Doctor of Medicine","CONTACT","13852293376","xuguifang@fy.ahmu.edu.cn",[27],{"facility":5,"status":19,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Hefei","Anhui","230000","China","CN",{"type":34,"coordinates":35},"Point",[36,37],117.28083,31.86389,{"lat":37,"lon":36},[40],{"name":41,"role":23,"phone":19,"phoneExt":19,"email":19},"Guifang Xu",{"type":43,"investigatorFullName":41,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Chief of the Department of Gastroenterology",[46],{"name":47,"class":48},"AlphaMol Science Ltd. (Shanghai)","INDUSTRY","100650309","phase-1-alpha-0261-tablets-for-moderate-to-severe-ulcerative-colitis-100650309",false,"NCT07744646","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)","Inclusion Criteria:\n\n* Aged 18 to 75 years (inclusive), male or female.\n* Diagnosed with ulcerative colitis at least 3 months prior to screening; this diagnosis must be confirmed by endoscopy or histology.\n* 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).\n* 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\u002F23 antibodies, etc.).\n* Voluntarily sign the informed consent form and be willing to comply with the study procedures and complete the trial in accordance with the protocol.\n\nExclusion Criteria:\n\n* 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\n* Has a current diagnosis of fulminant colitis and\u002For toxic megacolon\n* Has UC limited to the rectum\n* 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.\n* Has any active infection as specified in the protocol\n* Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)\n* Has evidence of active tuberculosis (TB) or meets TB exclusionary parameters\n* 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 \\\u003C5 years before Randomization\n* Has had major surgery within 4 weeks before Screening or has a major surgery (ie, surgical procedure requiring general anesthesia) planned during the study\n* Has received protocol-specified prohibited medications","ALL","18 Years","75 Years",{"count":60,"type":61},10,"ESTIMATED","INTERVENTIONAL",[64],"PHASE1","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.",[67],"Ulcerative Colitis (UC)","NOT_YET_RECRUITING","2026-07-30",{"date":71,"type":72},"2026-08-04","ACTUAL",{"date":74,"type":61},"2026-08-03",{"date":76,"type":61},"2027-03-20",{"name":5,"class":6},1]