[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599015":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":50,"centralContacts":55,"locations":64,"responsibleParty":307,"collaborators":40,"id":309,"slug":310,"hasResults":311,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":311,"sex":317,"minAge":318,"maxAge":319,"enrollmentInfo":320,"targetDuration":40,"studyType":323,"phases":324,"briefSummary":326,"conditions":327,"keywords":329,"overallStatus":67,"whyStopped":40,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":343},{"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","Subjects in this arm will receive a medium dose of the BCD-261 during the induction regimen (Weeks 0-12), followed by a transition to a maintenance regimen with a low dose of the BCD-261",[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","Subjects in this arm will receive a medium dose of the BCD261 during both the induction phase (Weeks 0-12) and the maintenance regimen",[14],{"label":20,"type":10,"description":21,"interventionNames":22},"BCD-261, high dose induction\u002F medium dose maintenance regimens","Subjects in this arm will receive a high dose of the BCD-261 during the induction regimen (Weeks 0-12), followed by a transition to a maintenance regimen with a medium dose of the BCD-261",[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","Subjects in this arm will receive a high dose of the BCD261 during both the induction phase (Weeks 0-12) and the maintenance regimen",[23],{"label":29,"type":30,"description":31,"interventionNames":32},"Placebo","PLACEBO_COMPARATOR","Subjects in this arm will receive placebo till the assessment of the primary endpoint and then will be switched to BCD-261medium studied dose",[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},"Aleksey V Manziuk","CONTACT","+7 (812) 380 49 33","manziuk@biocad.ru",{"name":62,"role":58,"phone":40,"phoneExt":40,"email":63},"Anna V Gaponova","gaponova@biocad.ru",[65,84,98,111,125,139,147,161,175,188,201,211,221,231,241,251,261,271,281,294],{"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) 228 77 77","ufa.rkbkuv@doctorrb.ru",{"facility":99,"status":67,"city":100,"state":100,"zip":101,"country":71,"countryCode":72,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"State Institution of Healthcare of the Moscow Region \"Moscow Regional Research Clinical Institute named after M.F. Vladimirsky\"","Moscow","129110",{"type":74,"coordinates":103},[104,105],37.61781,55.75204,{"lat":105,"lon":104},[108],{"name":81,"role":58,"phone":109,"phoneExt":40,"email":110},"+7 499 674 07 09","mz_moniki_info@mosreg.ru",{"facility":112,"status":67,"city":113,"state":114,"zip":115,"country":71,"countryCode":72,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Llc \"Novosibirsk Gastrocenter\"","Novosibirsk","Novosibirsk Oblast","630007",{"type":74,"coordinates":117},[118,119],82.93175,55.02259,{"lat":119,"lon":118},[122],{"name":81,"role":58,"phone":123,"phoneExt":40,"email":124},"+7 (383) 373 03 12","info@gastrocentr.ru",{"facility":126,"status":67,"city":127,"state":128,"zip":129,"country":71,"countryCode":72,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"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":131},[132,133],39.70769,47.21997,{"lat":133,"lon":132},[136],{"name":81,"role":58,"phone":137,"phoneExt":40,"email":138},"+7 (863) 285 32 13","klinika@rostgmu.ru",{"facility":126,"status":67,"city":127,"state":128,"zip":129,"country":71,"countryCode":72,"cosmosGeoPoint":140,"geoPoint":142,"contacts":143},{"type":74,"coordinates":141},[132,133],{"lat":133,"lon":132},[144],{"name":81,"role":58,"phone":145,"phoneExt":40,"email":146},"+7 863 201 44 50","gastro@rostgmu.ru",{"facility":148,"status":67,"city":149,"state":150,"zip":151,"country":71,"countryCode":72,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"LLC \"Research Center Eco-Safety\"","Saint Petersburg","Sankt-Peterburg","196143",{"type":74,"coordinates":153},[154,155],30.31413,59.93863,{"lat":155,"lon":154},[158],{"name":81,"role":58,"phone":159,"phoneExt":40,"email":160},"+7 (812) 500 52 03","nic@ecosafety.ru",{"facility":162,"status":67,"city":163,"state":164,"zip":165,"country":71,"countryCode":72,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"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":167},[168,169],49.12214,55.78874,{"lat":169,"lon":168},[172],{"name":81,"role":58,"phone":173,"phoneExt":40,"email":174},"+7 (843) 231 20 02","mz.rkb@tatar.ru",{"facility":176,"status":67,"city":177,"state":40,"zip":178,"country":71,"countryCode":72,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"\"South Ural State Medical University\" of the Ministry of Health of the Russian Federation","Chelyabinsk","454092",{"type":74,"coordinates":180},[181,182],61.42877,55.1611,{"lat":182,"lon":181},[185],{"name":40,"role":58,"phone":186,"phoneExt":40,"email":187},"+7 (351) 240 20 20","klinika_chgma@mail.ru",{"facility":189,"status":67,"city":190,"state":40,"zip":191,"country":71,"countryCode":72,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Federal Siberian Scientific and Clinical Center of the Federal Medical and Biological Agency","Krasnoyarsk","60037",{"type":74,"coordinates":193},[194,195],92.93136,56.03742,{"lat":195,"lon":194},[198],{"name":81,"role":58,"phone":199,"phoneExt":40,"email":200},"+7 (391) 262 40 28","skc@skc-fmba.ru",{"facility":202,"status":67,"city":190,"state":40,"zip":203,"country":71,"countryCode":72,"cosmosGeoPoint":204,"geoPoint":206,"contacts":207},"Regional State Healthcare Institution \"Regional Clinical Hospital","660022",{"type":74,"coordinates":205},[194,195],{"lat":195,"lon":194},[208],{"name":81,"role":58,"phone":209,"phoneExt":40,"email":210},"+7 (391) 202 68 50","kkb@medgorod.ru",{"facility":212,"status":67,"city":100,"state":40,"zip":213,"country":71,"countryCode":72,"cosmosGeoPoint":214,"geoPoint":216,"contacts":217},"Llc \"Olla-Med\"","105554",{"type":74,"coordinates":215},[104,105],{"lat":105,"lon":104},[218],{"name":81,"role":58,"phone":219,"phoneExt":40,"email":220},"+7 495 105 99 05","info@olla-med.ru",{"facility":222,"status":67,"city":100,"state":40,"zip":223,"country":71,"countryCode":72,"cosmosGeoPoint":224,"geoPoint":226,"contacts":227},"Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Moscow City Health Department","111123",{"type":74,"coordinates":225},[104,105],{"lat":105,"lon":104},[228],{"name":81,"role":58,"phone":229,"phoneExt":40,"email":230},"+7 (495) 304 30 39","info@mknc.ru",{"facility":232,"status":67,"city":100,"state":40,"zip":233,"country":71,"countryCode":72,"cosmosGeoPoint":234,"geoPoint":236,"contacts":237},"State Healthcare Institution of the City of Moscow \"V.M. Buyanov City Clinical Hospital of the Moscow City Healthcare Department\"","115516",{"type":74,"coordinates":235},[104,105],{"lat":105,"lon":104},[238],{"name":81,"role":58,"phone":239,"phoneExt":40,"email":240},"+7 (495) 136 22 68","gkb12@zdrav.mos.ru",{"facility":242,"status":67,"city":100,"state":40,"zip":243,"country":71,"countryCode":72,"cosmosGeoPoint":244,"geoPoint":246,"contacts":247},"Branch of the LLC \"Hadassah Medical LTD\"","121205",{"type":74,"coordinates":245},[104,105],{"lat":105,"lon":104},[248],{"name":81,"role":58,"phone":249,"phoneExt":40,"email":250},"+7 495 186 41 48","info@hadassah.moscow",{"facility":252,"status":67,"city":149,"state":40,"zip":253,"country":71,"countryCode":72,"cosmosGeoPoint":254,"geoPoint":256,"contacts":257},"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","191015",{"type":74,"coordinates":255},[154,155],{"lat":155,"lon":154},[258],{"name":81,"role":58,"phone":259,"phoneExt":40,"email":260},"+7 812 303 50 00","rectorat@szgmu.ru",{"facility":262,"status":67,"city":149,"state":40,"zip":263,"country":71,"countryCode":72,"cosmosGeoPoint":264,"geoPoint":266,"contacts":267},"Saint Petersburg State Healthcare Institution \"City Hospital of the Holy Martyr Elizabeth\"","195257",{"type":74,"coordinates":265},[154,155],{"lat":155,"lon":154},[268],{"name":81,"role":58,"phone":269,"phoneExt":40,"email":270},"+7 (812) 555 05 55","biocad@biocad.ru",{"facility":272,"status":67,"city":149,"state":40,"zip":273,"country":71,"countryCode":72,"cosmosGeoPoint":274,"geoPoint":276,"contacts":277},"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":275},[154,155],{"lat":155,"lon":154},[278],{"name":81,"role":58,"phone":279,"phoneExt":40,"email":280},"+7 812 429 03 31","klinika@spb-gmu.ru",{"facility":282,"status":67,"city":283,"state":40,"zip":284,"country":71,"countryCode":72,"cosmosGeoPoint":285,"geoPoint":289,"contacts":290},"State Healthcare Institution Ulyanovsk Regional Clinical Hospital","Ulyanovsk","432063",{"type":74,"coordinates":286},[287,288],48.38657,54.32824,{"lat":288,"lon":287},[291],{"name":81,"role":58,"phone":292,"phoneExt":40,"email":293},"+7 8422 73 62 63","info@uokb.ru",{"facility":295,"status":67,"city":296,"state":40,"zip":297,"country":71,"countryCode":72,"cosmosGeoPoint":298,"geoPoint":302,"contacts":303},"State Healthcare Institution \"Primorsky Regional Clinical Hospital No. 1\"","Vladivostok","690091",{"type":74,"coordinates":299},[300,301],131.87353,43.10562,{"lat":301,"lon":300},[304],{"name":81,"role":58,"phone":305,"phoneExt":40,"email":306},"+7 (423) 240 06 24","prim_kkb1@mail.ru",{"type":308,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100599015","phase-2-clinical-study-of-the-efficacy-safety-pharmacokinetics-pharmacodynamics-and-immunogenicity-of-bcd-261-in-subjects-with-moderate-to-severe-active-crohns-disease-100599015",false,"NCT07078994","Clinical Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Crohn's Disease","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 Crohn's Disease","COMANDOR","Inclusion Criteria:\n\n1. The diagnosis of Crohn's disease involving the terminal ileum or colon (types L1-L3 according to the Montreal classification), established ≥3 months prior to signing the informed consent form and confirmed by endoscopic findings.\n2. Moderate to severe active Crohn's disease, manifested by the following signs:\n\n(1) Crohn's Disease Activity Index (CDAI) ≥220 and ≤450 points.\n\n(2) Simple Endoscopic Score for Crohn's Disease (SES-CD) ≥6 points or ≥4 points for the disease form with isolated involvement of the ileum (according to central independent review).\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 and\u002For methotrexate at a dose of ≥15.0 mg\u002Fweek) 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 targeted immunosuppressors (upadacitinib), 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 targeted immunosuppressors (upadacitinib), 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 glucocorticoid therapy and\u002For immunosuppressors (azathioprine, 6-mercaptopurine, methotrexate) and\u002For biologic therapies (TNFα inhibitors, anti-integrins, IL-12\u002F23 inhibitors) and\u002For targeted immunosuppressors (upadacitinib), as determined 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 for ≥4 weeks prior to signing the\n\nICF and in the screening period for immunosuppressants (azathioprine, 6-mercaptopurine, methotrexate).\n\nExclusion Criteria:\n\n1. A history of or current at the time of signing the ICF ulcerative colitis, unspecified colitis, ischemic colitis, radiation colitis, microscopic colitis, complicated form of diverticular disease.\n2. A history of primary sclerosing cholangitis.\n3. Presence of active intra-abdominal or perianal abscess at the time of signing the ICF.\n4. Presence of an endoscopically obstructed stricture\u002Fstenosis of the intestine at the time of signing the ICF.\n5. A history of toxic megacolon, intestinal obstruction, intestinal perforation (except for those caused by injury or appendicitis).\n6. A history of dysplasia in any part of the gastrointestinal tract at the time of signing the ICF.\n7. Previous resections of the small intestine with a total length of resected segments \\>100 cm and\u002For resection of \\>2 segments of the large intestine (ascending colon (including the cecum), transverse colon, descending colon (including the sigmoid colon), rectum)3.\n8. Presence of intestinal stoma or artificial rectum or the need for them.\n9. Failure of ≥3 classes of biologics\u002Ftargeted immunosuppressors (according to INN) with different mechanisms of action (TNFa inhibitors, anti-integrins, IL-12\u002F23 inhibitors, upadacitinib) or ≥4 biologics\u002Ftargeted immunosuppressants (according to INN), regardless of the mechanism of actio\n\n   * 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 TNFa inhibitors within 8 weeks prior to signing the ICF or during the screening period.\n     2. Use of anti-integrins or IL-12\u002F23 inhibitors within 12 weeks before signing the ICF or during the screening period.\n     3. Use of Janus kinase inhibitors (upadacitinib) within 2 weeks prior to signing the ICF or during the screening period.\n     4. 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 2 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     5. 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     6. 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     7. 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 signing the ICF or during screening.","ALL","18 Years","75 Years",{"count":321,"type":322},204,"ESTIMATED","INTERVENTIONAL",[325],"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 Crohn's Disease. The study will be conducted in a population of male and female subjects ≥18 years and ≤75 years with moderate to severe active Crohn's Disease and an inadequate response to prior treatment with glucocorticoids, immunosuppressants, or biologics\u002Ftargeted immunosuppressants.",[328],"Crohn's Disease (CD)",[330,331,332,333],"biologics","Crohn's disease","monoclonal antibodies","TL1A","2025-09-16",{"date":336,"type":337},"2025-09-17","ACTUAL",{"date":339,"type":337},"2025-08-14",{"date":341,"type":322},"2029-01",{"name":5,"class":6},20]