[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Biocad\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":350},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,46,69,100,130,152,177,210,234,255,277,304,326],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100617628","phase-3-a-study-of-the-efficacy-and-safety-of-bcd-281-in-patients-with-relapsing-remitting-multiple-sclerosis-100617628",false,"NCT07321093","A Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis","A Double-blind, Randomized Clinical Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis","MUSCAT","Inclusion Criteria:\n\n* Provided written ICF to participate in the study.\n* Male and female subjects aged 18 to 55 years inclusive at the time of signing the ICF.\n* Diagnosis of multiple sclerosis, established in accordance with the McDonald criteria for the diagnosis of multiple sclerosis (2017 revision).\n* Relapsing-remitting multiple sclerosis.\n* The total EDSS score 0-5.5 inclusive.\n* Documentary evidence of the following at the time of signing the ICF:\n\n  1. at least one relapse within the last12 months, and\u002For\n  2. 2 relapses within the last 24 months, and\u002For\n  3. at least 1 T1 Gd+ lesion detected on brain MRI and 1 relapse within 24 months prior to signing the ICF.\n* Presence of IgG antibodies to the Varicella-Zoster virus.\n* Neurological stability for 30 days prior to signing the ICF.\n* Subject's willingness to discontinue previously prescribed DMTs from the day of the first administration of the IP and throughout the study.\n* The ability of the subject to follow the Protocol procedures, according to the Investigator.\n* Willingness of subjects of both sexes and their sexual partners of childbearing potential to use reliable methods of contraception from the time of signing ICF, throughout the study and for 5 months after the last dose of the drug in this study.\n\nExclusion Criteria:\n\n* Primary progressive or secondary progressive MS.\n* MS duration of more than 10 years with EDSS score of ≤2.0 at screening.\n* Malignant form of MS.\n* Other medical conditions that can affect the assessment of clinical picture of the MS.\n* Inability to obtain high-quality MRI images and\u002For the presence of contraindications to MRI and the administration of gadolinium-containing contrast agents.\n* Any comorbidities requiring treatment with systemic glucocorticoids and\u002For immunosuppressive drugs for the duration of the study, with the exception of MS.\n* History of progressive multifocal leukoencephalopathy.\n* Any acute or exacerbated chronic infections detected during screening that may have a negative impact on subject's safety during the study therapy.\n* Concomitant diseases and\u002For conditions that may affect the assessment of the clinical picture of the underlying disease and\u002For significantly increase the risk of AEs during the study.\n* Known alcohol or drug addiction, or current signs of alcohol\u002Fdrug addiction.\n* History of severe depression and\u002For a Beck Depression Inventory score of ≥16 at screening examination.\n* History of a malignant disease within 5 years prior to screening.\n* A diagnosis of HIV infection, hepatitis B or C .\n* Inability to provide the subject with venous access.\n* Pregnancy or breastfeeding, pregnancy planning and oocyte donation throughout the study and for 5 months after the last dose of ocrelizumab.\n* A history of severe allergic or anaphylactic reactions to humanized and\u002For murine monoclonal antibodies.\n* A history of using any prohibited medications or treatments defined in the study protocol.\n* Abnormal laboratory blood values, as specified in the study protocol.","ALL","18 Years","55 Years",{"count":21,"type":22},292,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The aim of this study is to compare the efficacy, safety profile, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-281 and the reference drug in subjects with relapsing multiple sclerosis.",[28],"Relapsing-remitting Multiple Sclerosis (RRMS)",[30,31,32],"Multiple Sclerosis","anti CD20","monoclonal antibody","RECRUITING","2025-12-26",{"date":36,"type":37},"2026-01-06","ACTUAL",{"date":39,"type":37},"2025-11-01",{"date":41,"type":22},"2028-12",{"name":43,"class":44},"Biocad","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100569888","phase-3-an-open-label-comparative-study-of-the-efficacy-safety-and-pharmacodynamics-of-single-dose-of-anb-002-in-patients-with-hemophilia-b-100569888","NCT06700096","An Open-Label, Comparative Study of the Efficacy, Safety and Pharmacodynamics of Single Dose of ANB-002 in Patients With Hemophilia B","MAGNOLIA","Inclusion Criteria:\n\n* Men diagnosed with hemophilia B aged 18 or older\n* FIX activity ≤2%\n* Absense of FIX inhibitor\n* ≥150 previous exposure days of treatment with FIX concentrates\n\nExclusion Criteria:\n\n* Any diseases of blood and hematopoietic organs other than hemophilia B\n* A history of any gene therapy, including ANB-002\n* Diagnosed HIV-infection, not controlled with anti-viral therapy\n* Active HBV or HCV infection\n* Anti-AAV5 antibodies\n* Any active systemic infections or recurrent infections requiring systemic therapy\n* Any other disorders associated with severe immunodeficiency\n* Relevant hepatic disorders or conditions that can be a symptom of existing liver disorder\n* Malignancies with less than 5 years of remission","MALE",{"count":55,"type":22},24,[25],"The aim of the study is to demonstrate non-inferiority of ANB-002 compared with preventive use of coagulation factor IX (FIX) in adult subjects with hemophilia B with FIX activity ≤2% and without FIX inhibitor. The study will have an open-label single-arm design.",[59],"Hemophilia B","2025-11-17",{"date":62,"type":37},"2025-11-18",{"date":64,"type":37},"2024-11-07",{"date":66,"type":22},"2032-03",{"name":43,"class":44},14,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":53,"minAge":18,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100606910","phase-1-a-study-of-pharmacokinetics-safety-and-immunogenicity-of-bcd-057-100-mgml-bcd-057-50-mgml-and-humira-100-mgml-in-healthy-subjects-100606910","NCT07181694","A Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-057 100 mg\u002FmL, BCD-057 50 mg\u002FmL, and Humira 100 mg\u002FmL in Healthy Subjects","A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of Single Subcutaneous Doses of BCD 057 100 mg\u002FmL, BCD-057 50 mg\u002FmL, and Humira 100 mg\u002FmL in Healthy Subjects","Inclusion Criteria:\n\n1. Signing the Informed Consent Form of the study.\n2. Men aged 18-45 years inclusive at the time of signing the Informed Consent Form.\n3. Body mass index (BMI) in the range of 18.5-30.0 kg\u002Fm2.\n4. The confirmed \"healthy\" status based on the conventional clinical and laboratory assessments and investigations obtained as screening.\n5. Hemodynamic parameters within the normal range: systolic blood pressure (SBP) in the range of 100-130 mmHg, diastolic (DBP) in the range of 60-90 mmHg, wrist pulse rate 60-90 bpm, obtained at screening.\n6. ECG data normal for the age (no ischemia, arrhythmia, conduction disorders).\n7. No chronic infections (HIV, hepatitis B or C) and no history of chronic inflammatory diseases.\n8. No signs of active or latent tuberculosis according to screening X-ray and tuberculosis test results.\n9. No acute infections within 4 weeks prior to the date of randomization.\n10. The ability of the subject to follow the Protocol procedures, according to the Investigator.\n11. No history of alcoholism or drug addiction and negative test results for alcohol, psychotropic and narcotic substances, psychoactive drugs at screening and before the IP administration.\n12. Willingness of subjects to use condoms during any sexual contact by penetration with persons of any sex, including pregnant women, starting from the signing of the Informed Consent Form, during the study and for 5 months after the IP administration. This requirement does not apply to subjects who have undergone surgical sterilization (bilateral orchiectomy).\n13. Willingness to refuse to donate sperm and conceive a child starting from the signing of the Informed Consent Form, during the study and for 5 months after the IP administration.\n14. Willingness not to drink alcohol within 24 hours before and after the IP administration, within 24 hours before each scheduled visit.\n15. Willingness to refrain from smoking within 2 hours before the IP administration and then 2 hours before each measurement of blood pressure (BP), wrist pulse rate, respiratory rate, blood sampling, ECG.\n16. Willingness to refrain from vaccination with live attenuated vaccines (e.g., intranasal influenza, measles, mumps, rubella, polio, BCG, yellow fever, chickenpox, and typhoid TY21a vaccines) throughout the study.\n17. Willingness to refrain from taking any medications, including over-the-counter drugs, vitamins and food supplements, with the exception of drugs prescribed by the Investigator for the treatment of AEs, throughout the study.\n\nExclusion Criteria:\n\n1. Mental illness or other conditions that may, in the Investigator's opinion, affect the subject's ability to comply with the Study Protocol.\n2. Any significant, in the Investigator's opinion, surgical procedures performed less than 30 days before the screening examination and potentially affecting clinical study results.\n3. A history of allergic reactions (anaphylactic shock or multiple drug allergy according to the Investigator's assessment).\n4. Known allergy or intolerance to monoclonal antibody products (murine, chimeric, humanized, fully human) or any other components of the IP.\n5. Impossibility of installing a venous catheter for collecting blood samples (e.g., due to skin disorders at the venipuncture sites).\n6. Administration and use of the following drugs:\n\n   1. Past use of adalimumab or any other drugs that inhibit tumor necrosis factor alpha.\n   2. Regular oral or parenteral administration of any medicinal products, including over-the-counter drugs, vitamins, and dietary supplements, less than 14 days prior to the estimated date of randomization.\n   3. Taking medications, including over-the-counter drugs, which have a pronounced effect on hemodynamics and liver function (barbiturates, omeprazole, cimetidine, etc.), less than 30 days before the estimated date of randomization.\n   4. Using drugs that affect the immune status (cytokines and their inducers, glucocorticoids, etc.) less than 30 days before the estimated date of randomization.\n   5. Systemic use of antibacterial, antifungal, antiviral or antiprotozoal drugs less than 30 days before the estimated date of randomization.\n   6. Vaccination with live attenuated vaccines within 4 weeks before the estimated date of randomization.\n7. Positive results of screening tests for HIV, hepatitis B and C viruses.\n8. Results of conventional laboratory tests or investigations out of the reference ranges accepted at the study sites.\n9. Chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, kidneys, blood.\n10. Acute infectious diseases less than 4 weeks before the estimated date of randomization, as well as chronic and other diseases that, in the Investigator's opinion, may affect the pharmacokinetics, safety, and immunogenicity of the IP.\n11. Smoking more than 10 cigarettes a day.\n12. Consumption of more than 10 units of alcohol per week (1 unit of alcohol is equivalent to ½ L of beer, 200 mL of wine or 50 mL of spirits) or a history of alcoholism, drug addiction, or drug abuse.of blood or plasma within 60 calendar days prior to the expected date of randomization.\n13. Donation of ≥450 mL of blood or plasma within 60 calendar days prior to the expected date of randomization.\n14. Participation in any clinical studies in less than 90 calendar days before the date of randomization, if the subject received a medicinal product during the clinical study.\n15. Previous participation in the same study if the subject was randomized and received the IP during the study.",true,"45 Years",{"count":79,"type":22},444,[81],"PHASE1","The aim of this study is to establish comparability of pharmacokinetic parameters and similarity of the safety and immunogenicity profiles of single subcutaneous doses of BCD 057 100 mg\u002FmL and BCD-057 50 mg\u002FmL, as well as BCD-057 100 mg\u002FmL and Humira 100 mg\u002FmL, in healthy subjects. The study is conducted in a population of healthy male subjects aged 18-45 years inclusive at the time of signing the ICF, with a body mass index in the range of 18.5 to 30.0 kg\u002Fm2.",[84],"Healthy Adult Male",[86,87,88,89,90],"Tumor Necrosis Factor Inhibitors","Anti-Inflammatory Agents","Adalimumab","Monoclonal Antibody","Pharmacokinetics","2025-09-30",{"date":93,"type":37},"2025-10-03",{"date":95,"type":37},"2025-03-12",{"date":97,"type":22},"2025-11",{"name":43,"class":44},4,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"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","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.","75 Years",{"count":110,"type":22},198,[112],"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.",[115],"Ulcerative Colitis (UC)",[117,118,119,120],"biologics","ulcerative colitis","monoclonal antibodies","TL1A","2025-09-16",{"date":123,"type":37},"2025-09-19",{"date":125,"type":37},"2025-08-14",{"date":127,"type":22},"2028-10",{"name":43,"class":44},20,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":108,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":140,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":149,"leadSponsor":151,"locationsCount":129},"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","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.",{"count":139,"type":22},204,[112],"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.",[143],"Crohn's Disease (CD)",[117,145,119,120],"Crohn's disease",{"date":147,"type":37},"2025-09-17",{"date":125,"type":37},{"date":150,"type":22},"2029-01",{"name":43,"class":44},{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":45},"100603428","phase-1-safety-pharmacokinetics-immunogenicity-bcd-256-1-and-divozilimab-in-subjects-with-systemic-lupus-erythematosus-100603428","NCT07136389","Safety, Pharmacokinetics, Immunogenicity BCD-256-1 and Divozilimab in Subjects With Systemic Lupus Erythematosus","An Open-label, Non-comparative Clinical Study of the Safety, Pharmacokinetics, Immunogenicity BCD-256 and Divozilimab in Monotherapy and Combination Therapy With Single and Multiple Intravenous Administration to Subjects With Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Signed informed consent to participate in the study and the subject's ability to comply with the requirements of the clinical study protocol.\n2. Age from 18 to 70 years at the time of signing the informed consent form.\n3. Body weight from 45 kg, BMI of 18 to 30 kg\u002Fm2.\n4. Diagnosed with SLE in accordance with at least 4 classification criteria of SLICC (2012), including 1 clinical sign or 1 immunological manifestation.\n5. Disease activity according to the SLEDAI score of 6-12.\n6. CLASI-A ≥ 9 at screening, at least one skin lesion with R-CLASI ≥ 6 at screening.\n7. Positive test for antinuclear antibodies at screening (titer ≥ 1:160) and\u002For increased level of double-stranded DNA antibody (≥ 2 ULN).\n8. History of the disease ≥24 weeks at the time of signing the informed consent form.\n9. Active skin disease according to the CLASI scale, despite the use of topical and systemic glucocorticoids and\u002For antimalarial drugs for at least 3 months at the time of signing the informed consent form.\n10. Women of childbearing potential have a negative pregnancy test at screening.\n11. Willingness of men and women of childbearing potential to use two highly effective contraception methods from the signing of the informed consent form, throughout the study and for 6 months after the administration of the last product dose. In this study, a woman is considered to be of childbearing potential if she is postmenarcheal, did not reach menopause (amenorrhea for ≥12 months, which cannot be explained by any other cause than menopause), and did not undergo surgical sterilization (removal of ovaries, fallopian tubes, and\u002For uterus).\n\nExclusion Criteria:\n\n1. Presence of active lupus nephritis or chronic kidney disease (urine protein to creatinine ratio \\>2.0 or estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73m2).\n2. A history of CNS associated with SLE, involvement including, but not limited to, the following symptoms: seizures, impaired consciousness, psychosis, delirium or confusion, aseptic meningitis, ascending or transverse myelitis, chorea, cerebellar ataxia, multiple mononeuritis, or demyelinating syndromes.\n3. The presence of uncontrolled neuropsychiatric disorders, severe depression and\u002For suicide attempts at the time of signing the ICF or within 1 year prior to signing the informed consent form, as well as the risk of suicide and\u002For any mental illness as assessed by the investigator.\n4. A history of antiphospholipid syndrome.\n5. Use of the following groups of drugs before signing ICF:\n\n   * abatacept, belimumab, tocilizumab or tumor necrosis factor (TNF) inhibitors within 3 months or 5 half-lives prior to screening (whichever is longer);\n   * rituximab, atacicept, ocrelizumab or other biological agents targeting B cells within 9 months prior to screening;\n   * cyclosporine, tacrolimus, pimecrolimus, sirolimus, imiquimod, intravenous immunoglobulin, intravenous and oral cyclophosphamide, and plasmapheresis within 3 months prior to screening;\n   * thalidomide or lenalidomide within 2 months prior to screening;\n   * receiving oral glucocorticoids at a dose of \\> 20 mg \u002Fday in terms of prednisone or dose changes for at least 4 weeks prior to screening;\n   * other immunosuppressive or disease modifying treatments for SLE under at least one of the following conditions:\n\n     1. the drugs were started less than 3 months before screening,\n     2. the dose was changed within 1 month prior to screening,\n     3. the medications were taken in doses exceeding the specified amounts: antimalarial drugs (hydroxychloroquine up to 6.5 mg\u002Fkg\u002Fday, quinacrine up to 5 mg\u002Fkg\u002Fday, chloroquine 3 mg\u002Fkg\u002Fday), dapsone 150 mg\u002Fday, methotrexate 20 mg\u002Fweek, azathioprine 200 mg\u002Fday, 6-mercaptopurine 1.5 mg\u002Fkg\u002Fday, and mycophenolate mofetil 2 g\u002Fday or mycophenolate sodium 1440 mg\u002Fday.\n6. Laboratory test values:\n\n   * absolute neutrophil count \\\u003C1,500\u002FµL (1.5×109\u002FL);\n   * lymphocyte count \\\u003C800\u002FµL cells×109\u002FL (0.8×109\u002FL);\n   * platelets \\\u003C75,000\u002FµL (75×109\u002FL);\n   * hemoglobin ≤ 9 g\u002FdL (≤ 90 g\u002FL);\n   * serum creatinine \\>1.5×ULN, OR for subjects with a creatinine level \\>1.5×ULN, creatinine clearance\u002Fglomerular filtration rate \\\u003C30 mL\u002Fmin ;\n   * total bilirubin \\> 1.5 × ULN (for subjects with Gilbert's syndrome, total bilirubin levels should not exceed 50 µmol\u002FL);\n   * AST or ALT \\>2×ULN;\n   * alkaline phosphatase \\>2×ULN.\n7. Concomitant diseases and\u002For conditions that significantly increase the risk of AEs during the study:\n\n   * uncontrolled hypertension (subjects with arterial hypertension not controlled by 3 antihypertensive drugs (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg));\n   * stable angina pectoris, functional class III-IV according to the Canadian Cardiovascular Society, CCS;\n   * acute coronary syndrome less than 6 months before the start of therapy in the study;\n   * congestive heart failure (NYHA III-IV);\n   * clinically significant arrhythmia at the opinion of the investigator that are not amenable to the maximum possible antiarrhythmic therapy (therapy should be stable for 4 weeks before the first dose of BCD 256\u002Fdivozilimab);\n   * moderate or severe asthma, stage III-IV chronic obstructive pulmonary disease, history of angioneurotic edema, severe respiratory failure;\n   * any other concomitant disease or condition, which, in the Investigator's opinion, significantly increases the risk of AEs in the study.\n8. Any active skin diseases other than SLE that may interfere with the study and effect assessment (e.g., psoriasis, drug-induced lupus, vitiligo, rosacea, local skin infections).\n9. Documented presence of one or more systemic concomitant diseases requiring systemic glucocorticoid therapy (e.g., asthma, IBD, psoriasis, acute uveitis). Oral, rectal or any injectable route of administration will be considered systemic.\n\n   Exception: concomitant diseases requiring the use of glucocorticoids by other methods of administration (for example, topical, inhalation, intranasal, into the conjunctival sac, etc.) are allowed. Subjects with endocrinopathy requiring only hormone replacement therapy are also eligible.\n10. A history of herpes infection: herpes encephalitis, ocular herpes, and disseminated herpes infection.\n11. Documented diagnosis of chickenpox, cytomegalovirus infection, infectious mononucleosis, herpes zoster, genital herpes, herpetic gingivostomatitis within 3 months before signing the ICF and during the screening period.\n12. A current diagnosis or a history of a severe immunodeficiency of any origin.\n13. A history of or active or latent tuberculosis (positive Diaskintest®, QuantiFERON or T-SPOT.TB test, in the absence of signs of pulmonary tuberculosis on chest X-ray or CT). Subjects who have ongoing social contacts with active tuberculosis should also not be included in the clinical study.\n14. A documented diagnosis of any other chronic infection that, in the opinion of the investigator, can increase the risk of infectious complications .\n15. Active infectious diseases (requiring hospitalization, parenteral use of antibacterial, antimycotic or antiprotozoal drugs) within 8 weeks prior to signing the ICF and during the screening period.\n16. Systemic antibacterial, antimycotic or antiprotozoal therapy within 8 weeks prior to signing the ICF and during the screening period.\n17. Scheduled vaccination with live, live attenuated vaccines or non-live vaccines within 1 month prior to screening and throughout the study, and within 4 months after the last dose of the study drug or divozilimab.\n18. Established HIV infection, hepatitis B, active hepatitis C .\n19. COVID-19, major surgery within 4 weeks prior to signing the ICF or major surgery planned for the period of participation in the study.\n20. Simultaneous participation in other clinical studies, as well as previous participation in other clinical studies less than 3 months before signing the ICF, prior participation in the main period of this study.\n\n    Exception: subjects who dropped out of this study at screening.\n21. Comorbidities (including, but not limited to, metabolic, hematological, renal, hepatic, pulmonary, neurological, endocrine, cardiac, infectious, gastrointestinal disorders), including disorders ongoing at the time of screening, which, in the opinion of the investigator, may affect the course of SLE, the results of assessment of its symptoms, or create an unacceptable risk to the subject from study therapy.\n22. Lymphoproliferative diseases or solid tumors (including basal cell carcinoma in situ) with a remission duration of less than 5 years, except for cured cervical cancer in situ.\n23. Impossibility of intravenous administration of drugs.\n24. Hypersensitivity or allergy to any of the components of BCD-256 and divozilimab. A history of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies or hybrid proteins.\n25. Pregnancy or breastfeeding, or planning pregnancy or fatherhood throughout the study and for 6 months after the last dose of the drug.","70 Years",{"count":161,"type":22},135,[81],"The goal of this clinical trial to investigate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of BCD-256 alone and in combination with anti-CD20 therapy (divozilimab) as second- or later-line therapy in subjects with skin lesions due to mild to moderate systemic lupus erythematosus. The study consists of the first stage (cohorts 1-5) and the second stage (cohorts A - D).",[165],"Systemic Lupus Erthematosus",[167,168,169],"divozilimab","anti-BDCA2","anti-CD20",{"date":171,"type":37},"2025-08-22",{"date":173,"type":37},"2025-03-27",{"date":175,"type":22},"2026-11-01",{"name":43,"class":44},{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":108,"enrollmentInfo":184,"targetDuration":4,"studyType":23,"phases":186,"briefSummary":187,"conditions":188,"keywords":193,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":209},"100602120","phase-3-study-of-the-efficacy-and-safety-of-bcd-131-and-mircera-in-the-treatment-of-anemia-in-patients-with-chronic-kidney-disease-on-dialysis-100602120","NCT07119372","Study of the Efficacy and Safety of BCD-131 and Mircera® in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis","A Randomized, Open-label, Comparative Clinical Study of the Efficacy and Safety of BCD-131 and Mircera® in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis","Inclusion Criteria:\n\n* The patient signed a written ICF for participation in the study.\n* Men and women aged 18 to 75 years inclusive at the time of signing the ICF.\n* End stage kidney disease (documented).\n* The need for dialysis sessions within at least the last 90 days prior to signing the ICF.\n* For patients on hemodialysis - hemodialysis procedures should be at least 3 times a week, for a total duration of at least 12 hours a week.\n* Documented use of recombinant erythropoietin (epoetin alfa, epoetin beta or darbepoetin alfa) for at least 90 days prior to signing the ICF.\n* The dose of recombinant erythropoietins (epoetin alfa or epoetin beta received 1, 2 or 3 times a week, or darbepoetin alfa received once a week\u002Fonce every 2 weeks) should be stable for at least 90 days prior to signing the ICF and the entire screening period (documented).\n* Target hemoglobin level (100-120 g\u002FL inclusive) based on the results of screening examination (two measurements).\n* The efficacy of dialysis established at screening or not more than 14 days before signing the ICF (dialysis dose index (Kt\u002Fv) ≥1.2 in patients on long-term hemodialysis, and weekly Kt\u002Fv ≥1.7 for patients on peritoneal dialysis).\n* Transferrin saturation ≥20%, ferritin level \\>100 ng\u002FmL at screening.\n* Cyancobalamine (vitamin B12) and folic acid levels within the laboratory reference values at screening.\n* Willingness of patients of both sexes and their sexual partners of childbearing potential to use methods of contraception in accordance with the protocol, starting from signing the informed consent form, throughout the study and for up to 90 days after receiving the last dose of the drug in the clinical study, as well as to refrain from donation of eggs for female subjects or sperm for male subjects during this period.\n* The ability of the patient to comply with the Protocol requirements, in the Investigator's opinion.\n\nExclusion Criteria:\n\n* Any other diagnosed forms of anemia, except for anemia of renal disease, including anemia in chronic diseases (C-reactive protein level \\>20 mg\u002FL at screening).\n* Diagnosed lupus nephritis or chronic kidney disease due to systemic vasculitis.\n* Platelet count \\\u003C100×109\u002FL based on the results of screening examination.\n* A high probability of early withdrawal from the study, in particular a planned (i.e., available information about a planned date and\u002For a suitable donor) kidney transplant surgery during the estimated period of participation in the study.\n* A history of severe allergic reactions (anaphylactic shock or multiple drug allergy) according to the patient, and hypersensitivity to recombinant erythropoietins, polyethylene glycol or any components of the study drugs, or to iron (III) hydroxide sucrose complex.\n* Vaccination less than 8 weeks before signing the ICF (according to the patient).\n* Diagnosed liver cirrhosis.\n* HIV infection.\n* ALT, AST \\>3хULN at screening.\n* Decompensated heart disease (NYHA Class IV CHF).\n* Resistant hypertension.\n* Unstable angina.\n* History of acute hemolysis episodes.\n* Documented hemoglobinopathy, myelodysplastic syndrome, hematological malignancy, pure red cell aplasia.\n* Severe secondary hyperparathyroidism (intact PTH\\>1000 pg\u002FmL at screening) or biopsy-confirmed bone marrow fibrosis (myelofibrosis).\n* Documented episodes of gastrointestinal or other bleeding within less than 90 days prior to signing the ICF.\n* Documented history of episodes of thrombosis (acute myocardial infarction, stroke, transient ischemic attacks, deep vein thrombosis, pulmonary thromboembolism within less than 6 months before the signing of the ICF, as well as long-term vascular access thrombosis within 30 days before the signing of the ICF.\n* Seizure syndrome, including a history of or epilepsy during the screening period.\n* Documented major surgery less than 30 days before signing the ICF.\n* Documented blood transfusion within less than 90 days prior to signing the ICF.\n* Any acute or chronic infections in the stage of exacerbation, as well as other chronic diseases that at the time of signing the informed consent, may adversely affect the patient's safety while using the study therapy in the opinion of the investigator.\n* A history of severe depression, suicidal ideation, or attempted suicide.\n* Documented malignancies other than cured basal-cell carcinoma and\u002For cervical carcinoma in situ with a remission duration of more than 5 years at the time of signing the ICF.\n* Known alcohol or drug addiction, or current signs of alcohol\u002Fdrug addiction, which, according to the investigator, is contraindication for the treatment with the test drug\u002Freference drug or limits the treatment adherence.\n* Participation in other clinical studies of medicinal products within less than 90 calendar days prior to signing the informed consent form for participation in this study.\n* Pregnancy or breastfeeding.",{"count":185,"type":22},228,[25],"BCD-131 is pegylated darbepoetin beta. This clinical study BCD-131-3 is a randomized, open-label, phase III study of the efficacy and safety of BCD-131 and Mircera used for the treatment of anemia in end-stage chronic kidney disease (CKD) patients on dialysis.",[189,190,191,192],"Anemia","Chronic Kidney Disease","Chronic Kidney Disease Patients on Hemodialysis","Chronic Kidney Disease 5D",[190,194,189,195,196,197,198,199,200],"CKD","Erythropoietin","Darbepoetin","Erythropoiesis-stimulating agent","Dialysis","Hemodialysis","Renal anemia","2025-08-07",{"date":203,"type":37},"2025-08-13",{"date":205,"type":37},"2025-03-01",{"date":207,"type":22},"2026-11",{"name":43,"class":44},2,{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":218,"minAge":18,"maxAge":219,"enrollmentInfo":220,"targetDuration":4,"studyType":23,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":233},"100601270","phase-2-bcd-236-in-combination-with-chemotherapy-in-patients-with-relapsed-andor-metastatic-triple-negative-breast-cancer-100601270","NCT07108309","BCD-236 in Combination With Chemotherapy in Patients With Relapsed and\u002For Metastatic Triple Negative Breast Cancer","A Randomized, Open-label, Comparative Clinical Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of BCD-236 in Combination With Chemotherapy in Patients With Relapsed and\u002For Metastatic Triple Negative Breast Cancer","AREAL","Main Inclusion Criteria:\n\n* Signed informed consent and the subject's ability to comply with the requirements of the Clinical Study Protocol.\n* Age ≥18 years and \\\u003C75 years at the time of signing the informed consent form.\n* Histologically verified diagnosis (there are documented results of relevant studies) of TNBC: ER 0-2 points, PR 0-2 points or ER \\\u003C1%, PR \\\u003C1% (ASCO\u002FCAP); HER2 (≤1+) or HER2 (2+) in the absence of amplification of the Her-2-neu gene by ISH.\n* TNBC is progressive or relapsing on or after systemic therapy.\n* The subject received at least 1 line of systemic therapy for locally advanced unresectable or metastatic TNBC, or she experienced a relapse \u002F progressive disease during or within 6 months after completion of post-operative (adjuvant) chemotherapy.\n* Confirmed AXL expression in tumor cells according to immunohistochemistry.\n* Availability of fresh (obtained as part of screening or before its start, but after disease progression or relapse on the last line of therapy) and archival (obtained before disease progression or relapse on the last line of therapy, if available) tumor material samples suitable for immunohistochemical examination to determine AXL expression.\n* Presence of at least 1 measurable tumor lesion according to RECIST 1.1. criteria for CIR.\n* ECOG score 0-1.\n* Life expectancy ≥ 4 months from the date of signing of the informed consent form in the opinion of the Investigator.\n\nMain Exclusion Criteria:\n\n* Indications for radical therapy or radiotherapy (excluding minor surgery or radiation therapy for palliative purposes).\n* Active CNS metastases and\u002For carcinomatous meningitis. Subjects with brain metastases may participate in the study provided that the metastases have been adequately treated with surgery or radiotherapy, and if they have been clinically stable for at least 4 weeks prior to randomization (i.e. no neurological symptoms, no need for corticosteroids, and no lesions \\>1.5 cm) and no evidence of new or increasing CNS metastases. Patients with newly diagnosed CNS metastases during screening may not be included in the study.","FEMALE","74 Years",{"count":221,"type":22},124,[112],"To study the efficacy, safety, pharmacokinetics and immunogenicity of BCD-236 in combination with chemotherapeutic agents (CHT) in 2nd and subsequent lines of therapy of subjects with relapsed and\u002For metastatic triple negative breast cancer (TNBC).",[225],"Triple Negative Breast Cancer","2025-08-04",{"date":201,"type":37},{"date":229,"type":37},"2024-07-15",{"date":231,"type":22},"2027-05",{"name":43,"class":44},47,{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":23,"phases":243,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":254},"100525349","phase-1-study-of-the-safety-pharmacodynamics-and-efficacy-of-anb-002-in-patients-with-hemophilia-b-safran-100525349","NCT06120582","Study of the Safety, Pharmacodynamics and Efficacy of ANB-002 in Patients With Hemophilia B (SAFRAN)","An Open-label, Non-comparative, Single Dose-Escalation Study of the Safety, Pharmacodynamics and Efficacy of ANB-002 in Patients With Hemophilia B","Inclusion Criteria:\n\n1. Male with hemophilia B.\n2. Age ≥18 years.\n3. FIX activity at screening ≤2% without FIX inhibitor.\n4. ≥150 previous exposure days of treatment with FIX concentrates.\n\nExclusion Criteria:\n\n1. Previous gene therapy.\n2. Other blood or hematopoietic disorders.\n3. Positive Anti-AAV5 antibodies (for Cohorts 1-3).\n4. Diagnosed HIV-infection, not controlled with anti-viral therapy.\n5. Hepatitis B (for Cohorts 1-3), acute or chronic hepatitis C.\n6. Any active systemic infections or recurrent infections requiring systemic therapy at screening.\n7. Any other disorders associated with severe immunodeficiency.\n8. Significant hepatic disorders (liver cirrhosis, liver fibrosis, etc).\n9. Malignancies with remission \\\u003C5 years.",{"count":242,"type":22},28,[81,112],"The goal of this multicenter, two-stage, open-label study is to investigate the safety, immunogenicity, and efficacy of ANB-002 in subjects with hemophilia В. The study will have a dose-escalation design with elements of phase I\u002FII seamless adaptive design.",[59],"2025-06-10",{"date":248,"type":37},"2025-06-13",{"date":250,"type":37},"2023-05-02",{"date":252,"type":22},"2029-11",{"name":43,"class":44},17,{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":23,"phases":265,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":129},"100567484","phase-2-an-open-label-clinical-study-of-the-efficacy-and-safety-of-bcd-248-in-patients-with-relapsedrefractory-multiple-myeloma-100567484","NCT06668792","An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Patients With Relapsed\u002FRefractory Multiple Myeloma","An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Subjects With Relapsed\u002FRefractory Multiple Myeloma","FLAMMINGO","Inclusion Criteria:\n\n1. Signed informed consent form.\n2. Age ≥18 years.\n3. Documented diagnosis of multiple myeloma according to the IMWG criteria.\n4. Measurable disease at screening.\n5. Subjects who received at least 2 lines of therapy for multiple myeloma, including a proteasome inhibitor, an immunomodulatory drug, anti-CD38 therapy.\n6. Documented progression according to the IMWG criteria during or after the last line of therapy.\n7. Evidence of at least a partial response according to the IMWG criteria to at least 1 previous line of therapy.\n8. ECOG score 0-2.\n\nExclusion Criteria:\n\n1. Subjects who were previously treated with anti-BCMA or anti-CD3 drugs.\n2. Use of any investigational medicinal products or medical devices within 30 days or 5 half-lives (whichever is longer) prior to the expected start of the study therapy or planned use of investigational medicinal products or medical devices during participation in this study, except for the use described in this Protocol.\n3. Autologous hematopoietic stem cell transplantation within 12 weeks prior to the expected start of the study therapy or a history of allogenic stem cell transplantation, regardless of when it was performed.\n4. Planned hematopoietic stem cell transplantation before disease progression during this study.\n5. A history of other malignancies within 5 years before screening, excluding squamous and basal cell skin cancers, carcinoma in situ of the cervix or breast, or other malignancies, which, in the opinion of the Investigator, have been adequately treated and have a minimal risk of recurrence within 5 years.\n6. Concomitant diseases and\u002For conditions that significantly increase the risk of AEs during the study:\n\n   * Stable angina pectoris, functional class III-IV.\n   * Unstable angina and\u002For myocardial infarction within less than 6 months before the expected start of the study therapy.\n   * Chronic heart failure, NYHA class III-IV;\n   * Clinically significant (in the Investigator's opinion) cardiac arrhythmia and conduction disorders that do not respond to the maximum possible antiarrhythmic therapy (therapy should be stable for 4 weeks before the expected start of the study therapy);\n   * Moderate to severe asthma, grade III-IV chronic obstructive pulmonary disease, a history of angioedema, severe respiratory failure;\n   * Active autoimmune diseases (subjects with type 1 diabetes mellitus and hypothyroidism requiring only hormone replacement therapy, as well as with skin diseases (vitiligo, alopecia, or psoriasis) that do not require systemic therapy are eligible);\n   * Any infection within 14 days prior to the expected start of the study therapy, requiring systemic etiotropic therapy or which, in the opinion of the Investigator, may increase the risk of infectious complications;\n   * Any other concomitant disease or condition, which, in the Investigator's opinion, significantly increases the risk of AEs in the study.\n7. Subjects with amyloidosis.\n8. Clinical signs of meningeal involvement of multiple myeloma.\n9. HIV infection, active HBV infection, hepatitis C.\n10. Major surgery within less than 14 days prior to the expected start of the study therapy, incomplete recovery from surgery, or planned surgery during participation in the study.\n11. Pregnancy or breastfeeding, as well as intention to become pregnant or father a child during the study period and within 180 days after receiving the last dose of the IP.",{"count":264,"type":22},100,[112],"The aim of the study is to assess the efficacy and safety of BCD-248 as a therapy for relapsing and\u002For refractory multiple myeloma.",[268],"Relapsed\u002FRefractory Multiple Myeloma","2025-02-03",{"date":271,"type":37},"2025-02-04",{"date":273,"type":37},"2024-12-26",{"date":275,"type":22},"2028-07",{"name":43,"class":44},{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":76,"sex":53,"minAge":18,"maxAge":77,"enrollmentInfo":284,"targetDuration":4,"studyType":23,"phases":286,"briefSummary":287,"conditions":288,"keywords":290,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":45},"100571076","phase-1-safety-pharmacodynamics-pharmacokinetics-and-immunogenicity-of-ascending-doses-bcd-261-in-healthy-subjects-100571076","NCT06715540","Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Ascending Doses BCD-261 in Healthy Subjects","An Open-Label, Non-Comparative Study of the Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Ascending Doses of BCD-261 After Single Subcutaneous Injection in Healthy Subjects","Inclusion Criteria:\n\n1. Signed informed consent to participate in the study.\n2. For cohorts 1-8: Male subjects aged 18 to 45 years at the time of signing the ICF. For cohorts 9-10: Asian male subjects aged 18 to 45 years inclusive at the time of signing the ICF.\n3. The ability of the subject to follow the Protocol procedures, in the Investigator's opinion.\n4. A diagnosis of \"healthy\", established according to standard clinical, laboratory, and instrumental methods of examination carried out at screening, according to the assessment of the Investigator, as well as historical data (absence of acute and chronic diseases of the respiratory, cardiovascular, nervous systems, gastrointestinal tract, impaired liver or kidney function).\n5. Hemodynamic parameters within the normal range: systolic blood pressure (SBP) ranging 100 to 130 mmHg, diastolic (DBP) ranging 60 to 90 mmHg, pulse ranging 60 to 90 bpm at screening.\n6. Willingness of the subjects and their female partners of childbearing potential to use reliable contraceptive methods from the moment of signing the ICF, throughout the main study period, and up to Day 57 inclusive. This requirement does not apply to participants who have undergone surgical sterilization.\n7. Willingness of subjects with reproductive potential to refrain from donating sperm, starting from the moment of signing the ICF, throughout the main study period until Day 57 inclusive.\n8. Willingness to refrain from participating in any other clinical trials, starting from the moment of signing the ICF and throughout the study.\n9. Willingness to refrain from vaccination with any vaccines during the period from the moment of signing the ICF until Day 127 of the study inclusive.\n\nExclusion Criteria:\n\n1. Any medical or social condition that, in the opinion of the Investigator, prevents participation in this study.\n2. Any confirmed or suspected immunosuppressive or immunodeficiency condition.\n3. Any acute infectious and non-infectious diseases, including the period of convalescence, within 4 weeks from the moment of clinical recovery to signing the ICF, as well as during screening.\n4. Diagnosis of infectious mononucleosis (documented or reported by the subject) within 2 months before signing the ICF and during screening.\n5. Vaccination with live vaccines within 8 weeks and with any other vaccines within 4 weeks prior to signing the ICF and during screening.\n6. A history of allergies and signs of other significant adverse reactions after the administration of any medicinal products.\n7. Hypersensitivity to the components of BCD-261.\n8. Body mass index (BMI) outside the normal range (18.0 to 30.0 kg\u002Fm2).\n9. Results of standard laboratory and instrumental tests outside the normal ranges adopted at the study site.\n10. Positive results of screening tests for HIV, hepatitis B and C, tuberculosis.\n11. Repeated positive urine drug test, repeated positive saliva alcohol test at screening.\n12. Impossibility of venipuncture for blood sampling (e.g., due to skin diseases at the sites of venipuncture).\n13. Administration and use of the following drugs:\n\n    * Regular oral or parenteral administration of any medicinal products, including over-the-counter drugs, vitamins, and dietary supplements, within less than 14 calendar days prior to estimated date of ID assignment.\n    * A history of using anti-TL1A monoclonal antibodies.\n    * Taking medications, including over-the-counter drugs, that have a pronounced effect on hemodynamics and liver function (barbiturates, omeprazole, cimetidine, etc.), within less than 30 days before the estimated date of ID assignment.\n    * Taking drugs that affect the immune status (cytokines and their inducers, glucocorticoids, etc.) within less than 60 days before the estimated date of ID assignment.\n14. Smoking of more than 10 cigarettes a day.\n15. Consumption of more than 10 units of alcohol per week (1 unit of alcohol is equivalent to ½ L of beer, 200 mL of wine or 20 mL of spirits) or a history of alcoholism, drug addiction or drug abuse.\n16. Surgical interventions performed less than within 90 days before the signing of the ICF.\n17. Donation of 450 mL or more of blood or plasma within 60 days prior to signing the ICF.\n18. Participation in any clinical study of medicinal products within 90 days before signing the ICF; previous participation in the same study with the exception of subjects who withdrew before the administration of the investigational product.",{"count":285,"type":22},48,[81],"The goal of this clinical trial is to investigate the safety, tolerability, pharmacodynamics, pharmacokinetics, and immunogenicity of BCD-261 after single subcutaneous injection at ascending doses and proposed therapeutic doses to healthy male subjects aged from 18 to 45 years old.\n\nThe study consists of the first stage (dose escalation) and the second stage (dose expansion).",[289],"Healthy",[291,292,293,294,295],"anti-TL1A","anti-TNF-like ligand 1A","Ulcerative Colitis","Inflammatory Bowel Disease","Crohn's Disease","2024-12-10",{"date":298,"type":37},"2024-12-16",{"date":300,"type":37},"2024-03-29",{"date":302,"type":22},"2025-12",{"name":43,"class":44},{"id":305,"slug":306,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":23,"phases":314,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":68},"100538844","phase-3-a-study-of-the-efficacy-and-safety-of-monotherapy-with-bcd-264-and-darzalex-in-subjects-with-relapsed-and-refractory-multiple-myeloma-100538844","NCT06296121","A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma","A Double-Blind, Randomized Clinical Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex® in Subjects With Relapsed and Refractory Multiple Myeloma","DARVIVA","Inclusion Criteria:\n\n1. Signed informed consent form.\n2. Age ≥ 18 years at the time of signing of the informed consent form.\n3. Documented diagnosis of multiple myeloma according to IMWG criteria\n4. Measurable disease at screening:\n\n   1. M-protein in serum ≥ 1.0 g\u002FdL (10 g\u002FL) or in 24-hour urine ≥ 200 mg; or\n   2. light chain myeloma: serum \"involved\" FLC level ≥ 10 mg\u002FdL (100 mg\u002FL) and abnormal κ\u002Fλ FLC ratio .\n5. At least a partial response according to IMWG criteria to at least 1 prior line of therapy.\n6. Subjects with relapsed and refractory multiple myeloma who previously received therapy with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy\n7. ECOG score 0-2.\n8. Not pregnant and willing to use contraception.\n9. Consent to bone marrow biopsy in the study.\n\nExclusion Criteria:\n\n1. Prior treatment with daratumumab or other anti-CD38 therapy.\n2. Prior treatment for multiple myeloma within 2 weeks or 5 half-lives before the date of randomization, except for a short course of glucocorticoids\n3. Autologous hematopoietic stem cell transplantation within 12 weeks prior to the date of randomization.\n4. Allogeneic hematopoietic stem cell transplantation, regardless of timing.\n5. Scheduled hematopoietic stem cell transplantation prior to progressive disease during this study.\n6. Plasma cell leukemia, POEMS syndrome or amyloidosis.\n7. Waldenstrom macroglobulinemia or other concomitant diseases with hyperproduction of monoclonal IgM (M-protein) in the absence of clonal proliferation of plasma cells with lytic bone involvement.\n8. A history of other malignancies within the last 5 years, with the exception of squamous cell and basal cell skin cancer, cervical, breast carcinoma in situ, or other non-invasive malignancies that, in the Investigator's opinion are considered to have been adequately treated and have a minimal risk of recurrence for 5 years.\n9. Plasmapheresis within 28 days prior to randomization.\n10. Clinical signs of meningeal involvement of multiple myeloma.\n11. Pregnancy or breastfeeding, as well as planning pregnancy throughout the study and within 3 months after the last dose of daratumumab; for male subjects, planning to conceive a child throughout the study and within 3 months after the last dose of daratumumab.",{"count":313,"type":22},252,[25],"The aim of this study is to confirm the comparability of the efficacy and safety profiles of BCD-264 and Darzalex as monotherapy for relapsed and refractory multiple myeloma in subjects previously treated with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy.",[317],"Multiple Myeloma","2024-02-28",{"date":320,"type":37},"2024-03-06",{"date":322,"type":37},"2023-12-21",{"date":324,"type":22},"2026-07",{"name":43,"class":44},{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":334,"enrollmentInfo":335,"targetDuration":4,"studyType":23,"phases":337,"briefSummary":338,"conditions":339,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":349},"100496671","phase-1-study-of-the-safety-and-efficacy-of-an-adeno-associated-viral-vector-carrying-the-smn-gene-after-a-single-intravenous-administration-of-escalating-doses-in-children-with-spinal-muscular-atrophy-bluebell-100496671","NCT05747261","Study of the Safety and Efficacy of an Adeno-Associated Viral Vector Carrying the SMN Gene After a Single Intravenous Administration of Escalating Doses in Children With Spinal Muscular Atrophy (BLUEBELL)","An Open-Label, Non-Comparative Clinical Study of the Safety and Efficacy of an Adeno-Associated Viral Vector Carrying the SMN Gene (ANB-004 (JSC BIOCAD, Russia)) After a Single Intravenous Administration of Escalating Doses in Children With Spinal Muscular Atrophy","BLUEBELL","Inclusion Criteria:\n\n1. Informed consent form for participation in the study signed by the subject's legal representative;\n2. Subjects of either sex under the age of 240 days at the time of signing the Information Sheet for the Legal Representative of the Clinical Study Subject with Informed Consent Form;\n3. A diagnosis of 5q-SMA (homozygous deletion of exon 7 of the SMN1 gene or heterozygous deletion of exon 7 + confirmed point mutation of the SMN1 gene) and 2 or 3 copies of the SMN2 gene established based on molecular genetic testing;\n4. Subjects with 2 copies of the SMN2 gene can be included in the study both at the presymptomatic stage of the disease and in the presence of SMA symptoms. If symptoms are present, the age of onset of the disease should be up to 180 days from birth.\n5. Subjects with 3 copies of the SMN2 gene can be included in the study if they have symptoms of SMA type 1 and the disease began before the age of 180 days.\n6. The ability of the subject's legal representative, in the Investigator's opinion, to perceive information and follow the Protocol procedures\n\nExclusion Criteria:\n\n1. A diagnosis of HIV infection, hepatitis B, hepatitis C, congenital syphilis in the study subject, as well as a documented diagnosis of HIV infection in the study subject's mother. Note: documented hepatitis B and\u002For hepatitis C and\u002For syphilis in the mother of a study subject is not an exclusion criterion in this clinical study, provided that standard breastfeeding rules are followed or the subject is not breastfed due to the low risk of transmission of hepatitis B and C viruses and Treponema pallidum from mother to child with breast milk;\n2. Unwillingness of the legal representative to use alternative feeding methods (nasogastric tube, gastrostomy) in case of swallowing disorders and a risk of aspiration;\n3. Anti-AAV9 antibody titer \\>1:50 determined by ELISA. Note: if a subject's screening anti-AAV9 antibody titer is \\>1:50, the anti-AAV9 antibody titer may be determined again. Subjects with anti-AAV9 antibody titers ≤1:50 in the second test may be included in the study;\n4. Need for respiratory support for ≥16 hours per day or tracheostomy ;\n5. Treatment with nusinersen, risdiplam, branaplam, onasemnogene abeparvovec or other antisense oligonucleotides\u002Fselective SMN2 splicing modifiers or gene therapy drugs for SMN1 transduction or other AAV-based gene therapy drugs regardless of serotype used previously (from birth) or planned for the main study period, i.e., within 12 months after the administration of the investigational product.\n6. A need to use any medications for the treatment of myopathy or neuropathy, drugs for the treatment of diabetes, ongoing immunosuppressive therapy, or the need for immunosuppressive therapy after the start of the study (for example, glucocorticoids (except for premedication and post-medication), cyclosporine, tacrolimus, methotrexate, cyclophosphamide, intravenous immunoglobulin, rituximab, etc.);\n7. Subjects with the following laboratory test results at screening:\n\n   * increased activity of transaminases (ALT, AST) or GGT \\>2×ULN;\n   * total bilirubin level ≥34 µmol\u002FL;\n   * creatinine level ≥160 µmol\u002FL;\n   * hemoglobin \\\u003C80 g\u002FL and \\>180 g\u002FL;\n   * WBC count \\>20x109\u002FL;\n   * Troponin I level \\> ULN.\n8. Any concomitant diseases that, in the Investigator's opinion, may affect the safety of ANB-004 in the subject or have a significant impact on the assessment of the outcomes of SMA therapy;\n9. A diagnosis of acute or chronic hepatic failure at screening;\n10. A known allergy or intolerance to any components of the investigational product or pre- and post-medication drug (glucocorticoids);\n11. Simultaneous participation of the subject in other clinical studies or previous participation in another clinical study using an experimental therapy.","240 Days",{"count":336,"type":22},40,[81,112],"The goal of this multicenter, open-label, non-comparative, cohort study is to investigate the safety, immunogenicity, and efficacy of ANB-004 in children with spinal muscular atrophy. The study will have a standard 3+3 dose-escalation design.",[340],"Spinal Muscular Atrophy (SMA)","2024-02-21",{"date":343,"type":37},"2024-02-22",{"date":345,"type":37},"2023-02-02",{"date":347,"type":22},"2030-08",{"name":43,"class":44},7,""]