[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599095":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":50,"centralContacts":55,"locations":64,"responsibleParty":303,"collaborators":40,"id":305,"slug":306,"hasResults":307,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":307,"sex":313,"minAge":314,"maxAge":315,"enrollmentInfo":316,"targetDuration":40,"studyType":319,"phases":320,"briefSummary":322,"conditions":323,"keywords":325,"overallStatus":67,"whyStopped":40,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":339},{"fullName":5,"class":6},"Biocad","INDUSTRY",[8,15,19,24,28],{"label":9,"type":10,"description":11,"interventionNames":12},"BCD-261, medium dose induction\u002F low dose maintenance regimens","EXPERIMENTAL","Group 1: Subjects in this arm will receive a medium dose of the BCD-261 subcutaneously once every 4 weeks until Week 12 during the induction regimen (Weeks 0-12), followed by a transition to a maintenance regimen with a low dose of the BCD-261 once every 8 weeks from Week 20 to Week 100.",[13,14],"Biological: anti-TL1A monoclonal antibody, low dose","Biological: anti-TL1A monoclonal antibody, medium dose",{"label":16,"type":10,"description":17,"interventionNames":18},"BCD-261, medium dose induction\u002F medium dose maintenance regimens","Group 2: Subjects in this arm will receive a medium dose of the BCD261 subcutaneously once every 4 weeks until Week 12 during the induction regimen (Weeks 0-12), followed by the maintenance regimen with the same dose of the BCD-261 once every 8 weeks from Week 20 to Week 100.",[14],{"label":20,"type":10,"description":21,"interventionNames":22},"BCD-261, high dose induction\u002F medium dose maintenance regimens","Group 3: Subjects in this arm will receive a high dose of the BCD-261 subcutaneously once every 4 weeks until Week 12 during the induction regimen (Weeks 0-12) , followed by a transition to a maintenance regimen with a medium dose of the BCD-261 once every 8 weeks from Week 20 to Week 100.",[14,23],"Biological: anti-TL1A monoclonal antibody, high dose",{"label":25,"type":10,"description":26,"interventionNames":27},"BCD-261, high dose induction\u002F high dose maintenance regimens","Group 4: Subjects in this arm will receive a high dose of the BCD261 subcutaneously once every 4 weeks until Week 12 during the induction regimen (Weeks 0-12), followed by maintenance regimen with with the same dose of the BCD-261 once every 8 weeks from Week 20 to Week 100.",[23],{"label":29,"type":30,"description":31,"interventionNames":32},"Placebo","PLACEBO_COMPARATOR","Group 5: Subjects in this arm will receive placebo subcutaneously at Weeks 0, 4, 8, and 12, followed by a medium dose of the BCD-261 subcutaneously once every 4 weeks until Week 28 , followed by a transition to a low dose of the BCD-261 once every 8 weeks from Week 36 to Week 100.",[33],"Other: Placebo",[35,41,44,47],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"BIOLOGICAL","anti-TL1A monoclonal antibody, low dose","injection",[9],null,{"type":36,"name":42,"description":38,"armGroupLabels":43,"otherNames":40},"anti-TL1A monoclonal antibody, medium dose",[20,9,16],{"type":36,"name":45,"description":38,"armGroupLabels":46,"otherNames":40},"anti-TL1A monoclonal antibody, high dose",[25,20],{"type":48,"name":29,"description":38,"armGroupLabels":49,"otherNames":40},"OTHER",[29],[51],{"name":52,"affiliation":53,"role":54},"Arina V Zinkina-Orikhan","Director of Clinical Development Department, BIOCAD","STUDY_DIRECTOR",[56,61],{"name":57,"role":58,"phone":59,"phoneExt":40,"email":60},"Anna V Gaponova","CONTACT","+7 (812) 380 49 33","gaponova@biocad.ru",{"name":62,"role":58,"phone":59,"phoneExt":40,"email":63},"Aleksey V Manziuk","manziuk@biocad.ru",[65,84,98,112,120,134,147,160,169,182,192,202,212,222,235,248,258,268,277,290],{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"LLC Medical Center \"ASTRA\"","RECRUITING","Barnaul","Altayskiy Kray","656049","Russia","RU",{"type":74,"coordinates":75},"Point",[76,77],83.72786,53.36199,{"lat":77,"lon":76},[80],{"name":81,"role":58,"phone":82,"phoneExt":40,"email":83},"Principal Investigator","+7 (3852) 59 10 49","info@astra-barnaul.ru",{"facility":85,"status":67,"city":86,"state":87,"zip":88,"country":71,"countryCode":72,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Republican Clinical Hospital named after G.G. Kuvatov","Ufa","Bashkortostan Republic","450005",{"type":74,"coordinates":90},[91,92],55.96779,54.74306,{"lat":92,"lon":91},[95],{"name":81,"role":58,"phone":96,"phoneExt":40,"email":97},"+7 (347) 246 33 30","ufa.rkbkuv@doctorrb.ru",{"facility":99,"status":67,"city":100,"state":101,"zip":102,"country":71,"countryCode":72,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Federal State Educational Institution of Higher Education \"Rostov State Medical University\" of the Ministry of Health of the Russian Federation","Rostov-on-Don","Rostov Oblast","344022",{"type":74,"coordinates":104},[105,106],39.70769,47.21997,{"lat":106,"lon":105},[109],{"name":81,"role":58,"phone":110,"phoneExt":40,"email":111},"+7 (863) 285 32 13","klinika@rostgmu.ru",{"facility":99,"status":67,"city":100,"state":101,"zip":102,"country":71,"countryCode":72,"cosmosGeoPoint":113,"geoPoint":115,"contacts":116},{"type":74,"coordinates":114},[105,106],{"lat":106,"lon":105},[117],{"name":81,"role":58,"phone":118,"phoneExt":40,"email":119},"+7 863 201 44 50","gastro@rostgmu.ru",{"facility":121,"status":67,"city":122,"state":123,"zip":124,"country":71,"countryCode":72,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"State Autonomous Institution of Healthcare \"Republican Clinical Hospital of the Ministry of Healthcare of the Republic of Tatarstan\"","Kazan'","Tatarstan Republic","420064",{"type":74,"coordinates":126},[127,128],49.12214,55.78874,{"lat":128,"lon":127},[131],{"name":81,"role":58,"phone":132,"phoneExt":40,"email":133},"+7 (843) 231 20 02","mz.rkb@tatar.ru",{"facility":135,"status":67,"city":136,"state":40,"zip":137,"country":71,"countryCode":72,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"\"South Ural State Medical University\" of the Ministry of Health of the Russian Federation","Chelyabinsk","454092",{"type":74,"coordinates":139},[140,141],61.42877,55.1611,{"lat":141,"lon":140},[144],{"name":40,"role":58,"phone":145,"phoneExt":40,"email":146},"+7 (351) 240 20 20","klinika_chgma@mail.ru",{"facility":148,"status":67,"city":149,"state":40,"zip":150,"country":71,"countryCode":72,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Federal Siberian Scientific and Clinical Center of the Federal Medical and Biological Agency","Krasnoyarsk","660022",{"type":74,"coordinates":152},[153,154],92.93136,56.03742,{"lat":154,"lon":153},[157],{"name":81,"role":58,"phone":158,"phoneExt":40,"email":159},"+7 (391) 274 31 50","skc@skc-fmba.ru",{"facility":161,"status":67,"city":149,"state":40,"zip":150,"country":71,"countryCode":72,"cosmosGeoPoint":162,"geoPoint":164,"contacts":165},"Regional State Healthcare Institution \"Regional Clinical Hospital\"",{"type":74,"coordinates":163},[153,154],{"lat":154,"lon":153},[166],{"name":81,"role":58,"phone":167,"phoneExt":40,"email":168},"+7 (391) 202 68 50","kkb@medgorod.ru",{"facility":170,"status":67,"city":171,"state":40,"zip":172,"country":71,"countryCode":72,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Llc \"Olla-Med\"","Moscow","105554",{"type":74,"coordinates":174},[175,176],37.61781,55.75204,{"lat":176,"lon":175},[179],{"name":81,"role":58,"phone":180,"phoneExt":40,"email":181},"+7 495 105 99 05","info@olla-med.ru",{"facility":183,"status":67,"city":171,"state":40,"zip":184,"country":71,"countryCode":72,"cosmosGeoPoint":185,"geoPoint":187,"contacts":188},"Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Moscow City Health Department","111123",{"type":74,"coordinates":186},[175,176],{"lat":176,"lon":175},[189],{"name":81,"role":58,"phone":190,"phoneExt":40,"email":191},"+7 (495) 304 30 39","info@mknc.ru",{"facility":193,"status":67,"city":171,"state":40,"zip":194,"country":71,"countryCode":72,"cosmosGeoPoint":195,"geoPoint":197,"contacts":198},"State Healthcare Institution of the City of Moscow \"V.M. Buyanov City Clinical Hospital of the Moscow City Healthcare Department\"","115516",{"type":74,"coordinates":196},[175,176],{"lat":176,"lon":175},[199],{"name":81,"role":58,"phone":200,"phoneExt":40,"email":201},"+7 (495) 136 22 68","gkb12@zdrav.mos.ru",{"facility":203,"status":67,"city":171,"state":40,"zip":204,"country":71,"countryCode":72,"cosmosGeoPoint":205,"geoPoint":207,"contacts":208},"Branch of the LLC \"Hadassah Medical LTD\"","121205",{"type":74,"coordinates":206},[175,176],{"lat":176,"lon":175},[209],{"name":81,"role":58,"phone":210,"phoneExt":40,"email":211},"7 495 186 41 48","info@hadassah.moscow",{"facility":213,"status":67,"city":171,"state":40,"zip":214,"country":71,"countryCode":72,"cosmosGeoPoint":215,"geoPoint":217,"contacts":218},"State Institution of Healthcare of the Moscow Region \"Moscow Regional Research Clinical Institute named after M.F. Vladimirsky\"","129110",{"type":74,"coordinates":216},[175,176],{"lat":176,"lon":175},[219],{"name":81,"role":58,"phone":220,"phoneExt":40,"email":221},"+7 499 674 07 09","mz_moniki_info@mosreg.ru",{"facility":223,"status":67,"city":224,"state":40,"zip":225,"country":71,"countryCode":72,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"Llc \"Novosibirsk Gastrocenter\"","Novosibirsk","630007",{"type":74,"coordinates":227},[228,229],82.93175,55.02259,{"lat":229,"lon":228},[232],{"name":81,"role":58,"phone":233,"phoneExt":40,"email":234},"+7 (383) 373 03 12","info@gastrocentr.ru",{"facility":236,"status":67,"city":237,"state":40,"zip":238,"country":71,"countryCode":72,"cosmosGeoPoint":239,"geoPoint":243,"contacts":244},"Federal State Educational Institution of Higher Education \"North-West State Medical University named after I.I. Mechnikov\" of the Ministry of Health of the Russian Federation","Saint Petersburg","191015",{"type":74,"coordinates":240},[241,242],30.31413,59.93863,{"lat":242,"lon":241},[245],{"name":81,"role":58,"phone":246,"phoneExt":40,"email":247},"+7 812 303 50 00","rectorat@szgmu.ru",{"facility":249,"status":67,"city":237,"state":40,"zip":250,"country":71,"countryCode":72,"cosmosGeoPoint":251,"geoPoint":253,"contacts":254},"Saint Petersburg State Healthcare Institution \"City Hospital of the Holy Martyr Elizabeth\"","195257",{"type":74,"coordinates":252},[241,242],{"lat":242,"lon":241},[255],{"name":40,"role":58,"phone":256,"phoneExt":40,"email":257},"+7 (812) 555 05 55","biocad@biocad.ru",{"facility":259,"status":67,"city":237,"state":40,"zip":260,"country":71,"countryCode":72,"cosmosGeoPoint":261,"geoPoint":263,"contacts":264},"Federal State Educational Institution of Higher Education \"First Saint Petersburg State Medical University named after Academician I.P. Pavlov\" of the Ministry of Health of the Russian Federation","197022",{"type":74,"coordinates":262},[241,242],{"lat":242,"lon":241},[265],{"name":81,"role":58,"phone":266,"phoneExt":40,"email":267},"+7 812 429 03 31","klinika@spb-gmu.ru",{"facility":269,"status":67,"city":237,"state":40,"zip":40,"country":71,"countryCode":72,"cosmosGeoPoint":270,"geoPoint":272,"contacts":273},"LLC \"Research Center Eco-Safety\"",{"type":74,"coordinates":271},[241,242],{"lat":242,"lon":241},[274],{"name":81,"role":58,"phone":275,"phoneExt":40,"email":276},"+7 (812) 500 52 03","nic@ecosafety.ru",{"facility":278,"status":67,"city":279,"state":40,"zip":280,"country":71,"countryCode":72,"cosmosGeoPoint":281,"geoPoint":285,"contacts":286},"State Healthcare Institution Ulyanovsk Regional Clinical Hospital","Ulyanovsk","432063",{"type":74,"coordinates":282},[283,284],48.38657,54.32824,{"lat":284,"lon":283},[287],{"name":81,"role":58,"phone":288,"phoneExt":40,"email":289},"+7 8422 73 62 63","info@uokb.ru",{"facility":291,"status":67,"city":292,"state":40,"zip":293,"country":71,"countryCode":72,"cosmosGeoPoint":294,"geoPoint":298,"contacts":299},"State Healthcare Institution \"Primorsky Regional Clinical Hospital No. 1\"","Vladivostok","690091",{"type":74,"coordinates":295},[296,297],131.87353,43.10562,{"lat":297,"lon":296},[300],{"name":81,"role":58,"phone":301,"phoneExt":40,"email":302},"+7 (423) 240 06 24","prim_kkb1@mail.ru",{"type":304,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100599095","phase-2-study-of-the-efficacy-safety-pharmacokinetics-pharmacodynamics-and-immunogenicity-of-bcd-261-in-subjects-with-moderate-to-severe-active-ulcerative-colitis-100599095",false,"NCT07080034","Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Ulcerative Colitis","A Randomized Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Ulcerative Colitis","ULTRAMARINE","Inclusion Criteria:\n\n1\\. Diagnosis of ulcerative colitis with involvement of the colon proximal to the rectum (≥15 cm from the distal edge of the anal canal), established ≥3 months before signing the ICF and confirmed by endoscopic examination data.\n\n2\\. Moderate to severe active ulcerative colitis with a modified Mayo score (mMS) of ≥4 and ≤9 points, which includes an endoscopic component of ≥2 points (according to a central independent review) and a stool blood score of ≥1 point.\n\n3\\. Inadequate response to therapy according to the investigator's assessment, manifested by at least one of the following signs:\n\n1. Persistent symptoms of disease activity despite treatment with at least one course of glucocorticoids including prednisolone at a dose of ≥40 mg\u002Fday or equivalent or budesonide ≥9 mg\u002Fday or equivalent for at least 2 weeks with oral administration (at least 1 week with intravenous administration at a dose equivalent to oral prednisolone ≥40 mg\u002Fday).\n2. Steroid dependence manifested by an increase in disease activity after initial improvement, with a decrease in the dose of glucocorticoids below the dose equivalent to 10 mg of oral prednisolone per day, within 3 months from the beginning of treatment, or a relapse of the disease within 3 months after the end of glucocorticoid use.\n3. Persistent symptoms of disease activity despite treatment with at least one course of immunosuppressants (azathioprine at a dose of ≥2.0 mg\u002Fkg and\u002For 6-mercaptopurine at a dose of ≥1.0 mg\u002Fkg) for ≥12 weeks, or in response to another treatment regimen with these drugs according to a regional standard of care.\n4. Primary lack of response to therapy with TNFa inhibitors and\u002For anti-integrins, and\u002For IL-12\u002F23 inhibitors, and\u002For Janus kinase inhibitors, and\u002For sphingosine-1-phosphate receptor modulators, defined as the persistence of symptoms of disease activity despite at least one course of induction of remission according to a treatment scheme approved by the regional standard.\n5. Loss of response to therapy with TNFa inhibitors and\u002For anti-integrins, and\u002For IL-12\u002F23 inhibitors, and\u002For Janus kinase inhibitors, and\u002For sphingosine-1-phosphate receptor modulators, defined as the appearance of symptoms of disease activity after initial improvement as a result of treatment with at least one course of induction of remission and at least one course of maintenance of remission according to a treatment scheme approved by the regional standard.\n6. A history of intolerance to glucocorticoids and\u002For immunosuppressants (azathioprine, 6-mercaptopurine) and\u002For biological therapy\u002Ftargeted immunosuppressants (TNFa inhibitors, anti-integrins, anti-IL-12\u002F23 monoclonal antibodies, Janus kinase inhibitors, sphingosine-1-phosphate receptor modulators) established by the treating physician.\n\n4\\. Maintaining a stable dose of concomitant medications for ≥2 weeks prior to signing the ICF and in the screening period for glucocorticoids and 5-ASCs and for ≥4 weeks prior to signing the ICF and in the screening period for immunosuppressants (azathioprine, 6-mercaptopurine).\n\nExclusion Criteria:\n\n1. A history of or current at the time of signing the ICF Crohn's disease, unspecified colitis, ischemic colitis, radiation colitis, microscopic colitis, complicated form of diverticular disease.\n2. A history of primary sclerosing cholangitis.\n3. A history of fulminant colitis, toxic dilation of the colon, intestinal obstruction, intestinal perforation (except for those caused by injury or appendicitis).\n4. A history of dysplasia of any grade in any part of the gastrointestinal tract at the time of signing the ICF.\n5. Presence of intestinal stoma or artificial rectum or the need for them.\n6. Failure of ≥3 classes of biologics\u002Ftargeted immunosuppressors (according to INN) with different mechanisms of action (TNFa inhibitors, anti-integrins, IL-12\u002F23 inhibitors, Janus kinase inhibitors, sphingosine-1-phosphate receptor modulators) or ≥4 biologics\u002Ftargeted immunosuppressants, regardless of the mechanism of action.\n7. Use of any of the indicated therapies within the specified time frame or need for therapy with these drugs during the study period:\n\n(1) Use of Janus kinase inhibitors within 2 weeks prior to signing the ICF or during the screening period.\n\n(2) Use of TNFa inhibitors within 8 weeks prior to signing the ICF or during the screening period.\n\n(3) Using modulators of sphingosine-1-phosphate receptors within 10 weeks prior to signing the ICF or during the screening period.\n\n(4) Use of anti-integrins, IL-12\u002F23 inhibitors within 12 weeks before signing the ICF or during the screening period.\n\n(5) Use of oral glucocorticoids at a dose equivalent to prednisone \\>20 mg\u002Fday or budesonide \\>9 mg\u002Fday or rectal administration of glucocorticoids at any dose within\n\n2 weeks prior to signing the ICF or during the screening period or parenteral administration of glucocorticoids at any dose within 4 weeks prior to signing the ICF or during the screening period.\n\n(6) Rectal administration of 5-ASCs within 2 weeks prior to signing the ICF or during the screening period.\n\n(7) Use of immunosuppressants not included in the approved therapy (tacrolimus, cyclosporine, mycophenolate mofetil, rapamycin, leflunomide, penicillamine, etc.) within 4 weeks before signing the ICF or during the screening period.\n\n(8) Long-term regular use of non-steroidal anti-inflammatory drugs (≥3 times a week for ≥6 weeks) for 2 weeks prior to signing the ICF.\n\n(9) Use of any other investigational drugs in other clinical trials at the time of signing the ICF or less than 8 weeks or 5 half-lives (whichever is longer) before the date of randomization.","ALL","18 Years","75 Years",{"count":317,"type":318},198,"ESTIMATED","INTERVENTIONAL",[321],"PHASE2","The aim of the study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of study drug (BCD-261) in comparison with placebo and to characterize the dose-response relationship in patients with moderate to severe active ulcerative colitis. The study will be conducted in a population of male and female subjects ≥18 years and ≤75 years with moderate to severe active ulcerative colitis and an inadequate response to prior treatment with glucocorticoids, immunosuppressants, or biologics\u002Ftargeted immunosuppressants.",[324],"Ulcerative Colitis (UC)",[326,327,328,329],"biologics","ulcerative colitis","monoclonal antibodies","TL1A","2025-09-16",{"date":332,"type":333},"2025-09-19","ACTUAL",{"date":335,"type":333},"2025-08-14",{"date":337,"type":318},"2028-10",{"name":5,"class":6},20]