Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (LEVENTA)
NCT ID: NCT06333210
Last Updated: 2024-06-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE3
Total Enrollment
421 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-12-25
Study Completion Date
2028-02-29
Brief Summary
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The aim of the study is to evaluate the efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics of a fixed dose of study drug (BCD-180) in comparison with placebo in patients with active axial spondyloarthritis (axSpA). The study will include HLA-B27+ patients with radiographic (r-axSpA) and non-radiographic (nr-axSpA) who had no response to prior therapy with non-steroidal anti-rheumatic drugs (NSAIDs), have not received biologic disease-modifying anti-rheumatic drugs (bDMARDs) or targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), and subjects with insufficient efficacy and/or loss of efficacy on bDMARDs and/or tsDMARDs.
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Detailed Description
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Subjects meeting the eligibility criteria will be randomized in 2 groups:bDMARDs and/or tsDMARD naive subjects and bDMARDs and/or tsDMARD experienced subjects will be randomized independently of each other.
bDMARDs and tsDMARD-naive subjects (naïve) will be randomized into 3 groups:
* BCD-180 (naïve);
* Placebo (naïve);
* Adalimumab.
bDMARDs and/or tsDMARD experienced subjects (exp) will be randomized into 2 groups:
* BCD-180 (exp);
* Placebo (exp).
After the primary endpoint assessment all subjects will be switched to BCD-180.
bDMARDs and tsDMARD-naive subjects (naïve) will be randomized into 3 groups:
* BCD-180 (naïve);
* Placebo (naïve);
* Adalimumab.
bDMARDs and/or tsDMARD experienced subjects (exp) will be randomized into 2 groups:
* BCD-180 (exp);
* Placebo (exp).
After the primary endpoint assessment all subjects will be switched to BCD-180.
Conditions
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Axial Spondyloarthritis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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bDMARDs and/or tsDMARD experienced subjects, BCD-180 group
Subjects in this arm will receive a fixed dose of BCD-180 infusions
Group Type
EXPERIMENTAL
anti-TRBV9 monoclonal antibody infusions
Intervention Type
BIOLOGICAL
infusions
bDMARDs and/or tsDMARD experienced subjects, Placebo group
Subjects in this arm will receive Placebo infusions till the assessment of the primary endpoint and then will be switched to BCD-180 infusions
Group Type
PLACEBO_COMPARATOR
Placebo infusions
Intervention Type
OTHER
infusions
bDMARDs and tsDMARD-naive subjects, BCD-180 group
Subjects in this arm will receive a fixed dose of BCD-180 infusions and subcutaneous injections of placebo to maintain blindness of adalimumab therapy till the assessment of the primary endpoint, thereafter subjects will receive only BCD-180 infusions
Group Type
EXPERIMENTAL
anti-TRBV9 monoclonal antibody infusions
Intervention Type
BIOLOGICAL
infusions
Placebo subcutaneous injection
Intervention Type
OTHER
subcutaneous injection
bDMARDs and tsDMARD-naive subjects, Placebo group
Subjects in this arm will receive Placebo infusions and subcutaneous injections of placebo to maintain blindness of adalimumab therapy till the assessment of the primary endpoint, thereafter subjects will be switched to BCD-180 infusions
Group Type
PLACEBO_COMPARATOR
Placebo infusions
Intervention Type
OTHER
infusions
Placebo subcutaneous injection
Intervention Type
OTHER
subcutaneous injection
bDMARDs and tsDMARD-naive subjects, Adalimumab group
Subjects in this arm will receive subcutaneous injections of adalimumab and infusions of placebo till the assessment of the primary endpoint, thereafter subjects will be switched to BCD-180 infusions
Group Type
ACTIVE_COMPARATOR
Placebo infusions
Intervention Type
OTHER
infusions
Adalimumab subcutaneous injection
Intervention Type
DRUG
subcutaneous injection
Interventions
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anti-TRBV9 monoclonal antibody infusions
infusions
Intervention Type
BIOLOGICAL
Placebo infusions
infusions
Intervention Type
OTHER
Adalimumab subcutaneous injection
subcutaneous injection
Intervention Type
DRUG
Placebo subcutaneous injection
subcutaneous injection
Intervention Type
OTHER
Other Intervention Names
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BCD-180 infusions
Eligibility Criteria
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Inclusion Criteria
1. Signed Informed Consent Form for participation in the study.
2. Men and women aged \>18 years of age at the time of signing the Informed Consent Form for participation.
3. Positive test result for HLA-B27.
4. 4\. Presence of r-axSpA OR nr-axSpA according to the criteria provided below:
* r-axSpA: axSpA diagnosis meets the ASAS 2009 criteria subject to the presence of radiographic signs of sacroiliitis according to the modified New York criteria (van der Linden et al. 1984) according to the central review. Subjects with an established diagnosis of ankylosing spondylitis according to the modified New York criteria may also be included in the study (van der Linden et al. 1984).
* nr-axSpA: axSpA diagnosis meets ASAS 2009 criteria in the absence of radiographic signs of sacroiliitis according to the modified New York criteria (van der Linden et al. 1984) according to the central review.
5. Active disease at the screening and the randomization visit diagnosed based on both criteria:
* ASDAS-CRP ≥2.1
* assessment of the severity of back pain ≥4 on the NRS (BASDAI, question No. 2).
6. For subjects with nr-axSpA: presence of objective MRI signs of sacroiliitis (according to ASAS/OMERACT) as assessed by the central review AND/OR based on hsCRP level \>1.5 ULN at screening.
7. For subjects with r-axSpA: hsCRP level ˃1.5 ULN at screening.
8. Duration of back pain ≥3 months, age \<45 years at the onset of the axSpA-associated back pain.
9. Meeting at least one of the following criteria based on the Investigator's assessment:
* Inadequate response to therapy with NSAIDs defined as insufficient response to therapy with NSAIDs at therapeutic doses for at least 4 weeks, or insufficient response to therapy with two NSAIDs at the maximum permitted dose with the total duration of therapy of at least 4 weeks;
* Contraindications for therapy with NSAIDs;
* Intolerance of therapy with more than one NSAID.
10. For bDMARDs-experienced and/or targeted synthetic DMARD-experienced subjects (tsDMARD): meeting at least one of the following criteria based on the Investigator's assessment:
* lack and/or loss of efficacy, according to the European Alliance of Associations for Rheumatology 2022 (EULAR 2022) recommendations, while on therapy with adequate doses of bDMARDs or tsDMARDs for ≥12 weeks;
* intolerance of bDMARDs and/or tsDMARDs used for the treatment of axSpA (regardless of treatment duration).
11. For subjects continuing to receive NSAIDs or COX-2 inhibitors: the drug dose shall be steady for at least 14 days prior to Visit 1/Week 0.
12. For women: negative pregnancy test result at screening (the test is not performed in women who have been postmenopausal for at least 2 years or are surgically sterile) .
13. The ability of the subject to follow the Protocol procedures, according to the Investigator.
14. Willingness of subjects and their sexual partners of childbearing potential to use reliable methods of contraception from the date of signing the ICF, throughout the study, and for 8 weeks after the last administration of BCD-180/placebo (infusions)/adalimumab/placebo (subcutaneously). This requirement does not apply to subjects who have had operative sterilization and women who have been postmenopausal for more than 2 years.
15. For participants of childbearing potential, from signing the informed consent form, throughout the study, and for 8 weeks after the last dose of BCD-180/placebo (intravenously)/adalimumab/placebo (subcutaneous):
* no egg donation for female subjects;
* no sperm donation for male subjects.
2. Men and women aged \>18 years of age at the time of signing the Informed Consent Form for participation.
3. Positive test result for HLA-B27.
4. 4\. Presence of r-axSpA OR nr-axSpA according to the criteria provided below:
* r-axSpA: axSpA diagnosis meets the ASAS 2009 criteria subject to the presence of radiographic signs of sacroiliitis according to the modified New York criteria (van der Linden et al. 1984) according to the central review. Subjects with an established diagnosis of ankylosing spondylitis according to the modified New York criteria may also be included in the study (van der Linden et al. 1984).
* nr-axSpA: axSpA diagnosis meets ASAS 2009 criteria in the absence of radiographic signs of sacroiliitis according to the modified New York criteria (van der Linden et al. 1984) according to the central review.
5. Active disease at the screening and the randomization visit diagnosed based on both criteria:
* ASDAS-CRP ≥2.1
* assessment of the severity of back pain ≥4 on the NRS (BASDAI, question No. 2).
6. For subjects with nr-axSpA: presence of objective MRI signs of sacroiliitis (according to ASAS/OMERACT) as assessed by the central review AND/OR based on hsCRP level \>1.5 ULN at screening.
7. For subjects with r-axSpA: hsCRP level ˃1.5 ULN at screening.
8. Duration of back pain ≥3 months, age \<45 years at the onset of the axSpA-associated back pain.
9. Meeting at least one of the following criteria based on the Investigator's assessment:
* Inadequate response to therapy with NSAIDs defined as insufficient response to therapy with NSAIDs at therapeutic doses for at least 4 weeks, or insufficient response to therapy with two NSAIDs at the maximum permitted dose with the total duration of therapy of at least 4 weeks;
* Contraindications for therapy with NSAIDs;
* Intolerance of therapy with more than one NSAID.
10. For bDMARDs-experienced and/or targeted synthetic DMARD-experienced subjects (tsDMARD): meeting at least one of the following criteria based on the Investigator's assessment:
* lack and/or loss of efficacy, according to the European Alliance of Associations for Rheumatology 2022 (EULAR 2022) recommendations, while on therapy with adequate doses of bDMARDs or tsDMARDs for ≥12 weeks;
* intolerance of bDMARDs and/or tsDMARDs used for the treatment of axSpA (regardless of treatment duration).
11. For subjects continuing to receive NSAIDs or COX-2 inhibitors: the drug dose shall be steady for at least 14 days prior to Visit 1/Week 0.
12. For women: negative pregnancy test result at screening (the test is not performed in women who have been postmenopausal for at least 2 years or are surgically sterile) .
13. The ability of the subject to follow the Protocol procedures, according to the Investigator.
14. Willingness of subjects and their sexual partners of childbearing potential to use reliable methods of contraception from the date of signing the ICF, throughout the study, and for 8 weeks after the last administration of BCD-180/placebo (infusions)/adalimumab/placebo (subcutaneously). This requirement does not apply to subjects who have had operative sterilization and women who have been postmenopausal for more than 2 years.
15. For participants of childbearing potential, from signing the informed consent form, throughout the study, and for 8 weeks after the last dose of BCD-180/placebo (intravenously)/adalimumab/placebo (subcutaneous):
* no egg donation for female subjects;
* no sperm donation for male subjects.
Exclusion Criteria
1. Refusal to take NSAIDs for the treatment of axSpA for any subjective reasons that do not have a clinical justification.
2. Use of the following medicines/procedures:
* at any time before signing the ICF: total lymphoid irradiation;
* at any time before signing the ICF: bone marrow transplantation, including stem and hematopoietic cell transplantation for any indications;
* at any time before signing the ICF: splenectomy;
* within 8 weeks before signing the ICF: treatment with immunoglobulins;
* within 12 months before signing the ICF: use of immunosuppressants. Exception: glucocorticoids. A subject receiving glucocorticoids may be included in the study provided that the daily dose of glucocorticoids is ≤10 mg/day (calculated with reference to prednisolone) and was stable for at least 4 weeks prior to the Randomization Visit.
* within 4 weeks before signing the ICF and during the screening period: use of synthetic DMARDs and thiopurines, including, but not limited to: 6-mercaptopurine, azathioprine, and others.
Exception: the medicinal products listed below if their dose was stable for 4 weeks before signing the ICF and during the screening period:
* oral or parenteral methotrexate at a dose ≤25 mg/week, therapy shall be started at least 8 weeks before signing the ICF;
* 5-aminosalicylic acid and its derivatives, including sulfasalazine, at a dose not exceeding 3 g/day, provided that therapy was started at least 8 weeks before signing the ICF. Subjects with inflammatory bowel disease (IBD) may be treated with topical 5-aminosalicylic acid at therapeutic doses;
* intra-articular and paraspinal glucocorticoids within 4 weeks prior to the Randomization Visit, intramuscular glucocorticoids within 2 weeks prior to the Randomization Visit;
* use of alkylating agents at any time within 12 months prior to signing the ICF;
* BCD-180 administration at any time before signing the ICF.
3. Vaccination with any vaccines within 12 weeks prior to signing the ICF.
4. Documented presence of one or more of the listed conditions:
* within 8 weeks before signing the ICF and during the screening period: exacerbated IBD (attack of Crohn's disease or exacerbation (relapse, attack) of ulcerative colitis), severe, generalized, pustular, exudative, psoriasis of the hands and feet;
* acute uveitis within less than 2 weeks prior to signing the ICF and during the screening period.
Clarification: for subjects with IBD: IBD therapy must be stable for 8 weeks prior to signing the ICF. For subjects with psoriasis: topical products may be used.
5. A current diagnosis or a history of a severe immunodeficiency of any origin.
6. A diagnosis of HIV infection, hepatitis B, hepatitis C.
7. The following laboratory test results at screening:
* Transaminase (ALT and/or AST) activity \>1.5×ULN;
* ALP activity \>1.5×ULN;
* WBC count \<3.0 cells×109/L;
* Neutrophil count \<1.5 cells×109/L;
* Lymphocyte count \<0.8 cells×109/L;
* Platelet count \<100 cells × 109/L;
* Hemoglobin level \<100 g/L;
* Serum blood creatinine \>ULN.
8. Clinically significant thyroid disease and/or clinically significant deviation of the TSH level from the reference values at screening.
9. Diagnosis of active or latent tuberculosis, including a history of tuberculosis .
10. Major surgery within 4 weeks prior to signing the ICF or major surgery planned for the period of participation in the study.
11. Documented diagnosis of infectious mononucleosis within 8 weeks prior to signing the ICF and during the screening period, any active infection or recurrent infection within 4 weeks prior to signing the ICF and during the screening period, including fever ≥38°C at the Randomization Visit.
12. Documented diagnosis of any other chronic infection that, in the opinion of the investigator, can increase the risk of infectious complications.
13. Severe 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.
14. Systemic antibacterial, antimycotic or antiprotozoal therapy within 8 weeks prior to signing the ICF and during the screening period.
15. Epileptic seizures, a history of seizures.
16. A history of or current (at the time of signing the ICF and during the screening period) significant uncontrolled neuropsychiatric disorders, severe depression and/or suicide attempts, a risk of suicide and/or any psychiatric illness that, in the opinion of the investigator, may pose an excessive risk to the subject or have an impact on the subject's ability to follow the protocol.
17. Known (including from historical data) alcohol or drug dependence, psychoactive substance or drug abuse, evidence of alcohol/drug dependence or current abuse that, in the investigator's opinion, is a contraindication to AS therapy or limits treatment adherence.
18. The following diseases:
* at screening and/or in the past and at the Randomization Visit: non-axSpA inflammatory joint disease (including rheumatoid arthritis, gout, psoriatic arthritis, Lyme disease, etc.),
* at screening and/or at the Randomization Visit: reactive arthritis,
* at screening and/or in the past and at the Randomization Visit: systemic autoimmune diseases (including systemic lupus erythematosus, systemic scleroderma, inflammatory myopathy, mixed forms of inflammatory connective tissue diseases, overlap syndrome, etc.).
Exception: the following subjects may be included in the study:
* eligible patients with psoriasis;
* diagnosed with IBD, at the stage of remission without the need for systemic therapy;
* with uveitis associated with axSpA, except for subjects with severe visual impairment or with sight in one eye, subjects with corneal opacity, significant cataract, posterior capsule opacity, or posterior synechia in the studied eye of such severity that makes assessment of uveitis severity insufficient or impossible. Clarification: the study may include subjects with prior acute uveitis 2 weeks after the resolution, including those receiving topical therapy, including intra-bulbar administration of glucocorticoids.
19. 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 radiographic axSpA, the results of assessment of its symptoms, or create an unacceptable risk to the subject from study therapy.
20. Known allergy or intolerance to any component of the test drug, premedication drugs used in this clinical study. For bDMARDs and/or tsDMARD-naive subjects: known allergy or intolerance of any components of adalimumab.
21. For bDMARDs and/or tsDMARD-naive subjects: contraindications for the use of adalimumab.
22. A history of angioedema.
23. Fibromyalgia, or other conditions associated with chronic pain .
24. Lymphoproliferative diseases or malignancies with a remission duration of less than 5 years, with the exception of cured basal cell carcinoma and cervical cancer in situ.
25. Pregnancy, pregnancy planning (including pregnancy of female sexual partners of male study subjects) less than 8 weeks after the last administration of BCD-180/placebo (intravenously)/adalimumab/placebo (subcutaneous), breastfeeding.
26. Contraindications to MRI.
27. 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 this study.
Exception: subjects who dropped out of this study at screening.
2. Use of the following medicines/procedures:
* at any time before signing the ICF: total lymphoid irradiation;
* at any time before signing the ICF: bone marrow transplantation, including stem and hematopoietic cell transplantation for any indications;
* at any time before signing the ICF: splenectomy;
* within 8 weeks before signing the ICF: treatment with immunoglobulins;
* within 12 months before signing the ICF: use of immunosuppressants. Exception: glucocorticoids. A subject receiving glucocorticoids may be included in the study provided that the daily dose of glucocorticoids is ≤10 mg/day (calculated with reference to prednisolone) and was stable for at least 4 weeks prior to the Randomization Visit.
* within 4 weeks before signing the ICF and during the screening period: use of synthetic DMARDs and thiopurines, including, but not limited to: 6-mercaptopurine, azathioprine, and others.
Exception: the medicinal products listed below if their dose was stable for 4 weeks before signing the ICF and during the screening period:
* oral or parenteral methotrexate at a dose ≤25 mg/week, therapy shall be started at least 8 weeks before signing the ICF;
* 5-aminosalicylic acid and its derivatives, including sulfasalazine, at a dose not exceeding 3 g/day, provided that therapy was started at least 8 weeks before signing the ICF. Subjects with inflammatory bowel disease (IBD) may be treated with topical 5-aminosalicylic acid at therapeutic doses;
* intra-articular and paraspinal glucocorticoids within 4 weeks prior to the Randomization Visit, intramuscular glucocorticoids within 2 weeks prior to the Randomization Visit;
* use of alkylating agents at any time within 12 months prior to signing the ICF;
* BCD-180 administration at any time before signing the ICF.
3. Vaccination with any vaccines within 12 weeks prior to signing the ICF.
4. Documented presence of one or more of the listed conditions:
* within 8 weeks before signing the ICF and during the screening period: exacerbated IBD (attack of Crohn's disease or exacerbation (relapse, attack) of ulcerative colitis), severe, generalized, pustular, exudative, psoriasis of the hands and feet;
* acute uveitis within less than 2 weeks prior to signing the ICF and during the screening period.
Clarification: for subjects with IBD: IBD therapy must be stable for 8 weeks prior to signing the ICF. For subjects with psoriasis: topical products may be used.
5. A current diagnosis or a history of a severe immunodeficiency of any origin.
6. A diagnosis of HIV infection, hepatitis B, hepatitis C.
7. The following laboratory test results at screening:
* Transaminase (ALT and/or AST) activity \>1.5×ULN;
* ALP activity \>1.5×ULN;
* WBC count \<3.0 cells×109/L;
* Neutrophil count \<1.5 cells×109/L;
* Lymphocyte count \<0.8 cells×109/L;
* Platelet count \<100 cells × 109/L;
* Hemoglobin level \<100 g/L;
* Serum blood creatinine \>ULN.
8. Clinically significant thyroid disease and/or clinically significant deviation of the TSH level from the reference values at screening.
9. Diagnosis of active or latent tuberculosis, including a history of tuberculosis .
10. Major surgery within 4 weeks prior to signing the ICF or major surgery planned for the period of participation in the study.
11. Documented diagnosis of infectious mononucleosis within 8 weeks prior to signing the ICF and during the screening period, any active infection or recurrent infection within 4 weeks prior to signing the ICF and during the screening period, including fever ≥38°C at the Randomization Visit.
12. Documented diagnosis of any other chronic infection that, in the opinion of the investigator, can increase the risk of infectious complications.
13. Severe 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.
14. Systemic antibacterial, antimycotic or antiprotozoal therapy within 8 weeks prior to signing the ICF and during the screening period.
15. Epileptic seizures, a history of seizures.
16. A history of or current (at the time of signing the ICF and during the screening period) significant uncontrolled neuropsychiatric disorders, severe depression and/or suicide attempts, a risk of suicide and/or any psychiatric illness that, in the opinion of the investigator, may pose an excessive risk to the subject or have an impact on the subject's ability to follow the protocol.
17. Known (including from historical data) alcohol or drug dependence, psychoactive substance or drug abuse, evidence of alcohol/drug dependence or current abuse that, in the investigator's opinion, is a contraindication to AS therapy or limits treatment adherence.
18. The following diseases:
* at screening and/or in the past and at the Randomization Visit: non-axSpA inflammatory joint disease (including rheumatoid arthritis, gout, psoriatic arthritis, Lyme disease, etc.),
* at screening and/or at the Randomization Visit: reactive arthritis,
* at screening and/or in the past and at the Randomization Visit: systemic autoimmune diseases (including systemic lupus erythematosus, systemic scleroderma, inflammatory myopathy, mixed forms of inflammatory connective tissue diseases, overlap syndrome, etc.).
Exception: the following subjects may be included in the study:
* eligible patients with psoriasis;
* diagnosed with IBD, at the stage of remission without the need for systemic therapy;
* with uveitis associated with axSpA, except for subjects with severe visual impairment or with sight in one eye, subjects with corneal opacity, significant cataract, posterior capsule opacity, or posterior synechia in the studied eye of such severity that makes assessment of uveitis severity insufficient or impossible. Clarification: the study may include subjects with prior acute uveitis 2 weeks after the resolution, including those receiving topical therapy, including intra-bulbar administration of glucocorticoids.
19. 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 radiographic axSpA, the results of assessment of its symptoms, or create an unacceptable risk to the subject from study therapy.
20. Known allergy or intolerance to any component of the test drug, premedication drugs used in this clinical study. For bDMARDs and/or tsDMARD-naive subjects: known allergy or intolerance of any components of adalimumab.
21. For bDMARDs and/or tsDMARD-naive subjects: contraindications for the use of adalimumab.
22. A history of angioedema.
23. Fibromyalgia, or other conditions associated with chronic pain .
24. Lymphoproliferative diseases or malignancies with a remission duration of less than 5 years, with the exception of cured basal cell carcinoma and cervical cancer in situ.
25. Pregnancy, pregnancy planning (including pregnancy of female sexual partners of male study subjects) less than 8 weeks after the last administration of BCD-180/placebo (intravenously)/adalimumab/placebo (subcutaneous), breastfeeding.
26. Contraindications to MRI.
27. 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 this study.
Exception: subjects who dropped out of this study at screening.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Biocad
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Arina Zinkina-Orikhan, PhD, MD
Role: STUDY_DIRECTOR
Director of Clinical Development Department, BIOCAD
Locations
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1St City Clinical Hospital, Minsk
Minsk, , Belarus
Site Status
State Institution "Minsk Scientific and Practical Center for Surgery, Transplantology and Hematology"
Minsk, , Belarus
Site Status
KGBU "City Hospital No. 4 named after N.P. Gull, Barnaul"
Barnaul, , Russia
Site Status
Chelyabinsk Regional Clinical hospital
Chelyabinsk, , Russia
Site Status
Regional State Budgetary Healthcare Institution "Irkutsk City Clinical Hospital 1"
Irkutsk, , Russia
Site Status
Republican Clinical Diagnostic Center of the Ministry of Health of the Udmurt Republic
Izhevsk, , Russia
Site Status
Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan
Kazan', , Russia
Site Status
State Autonomous Healthcare Institution "Kuzbass Clinical Emergency Hospital named after M. A. Podgorbunsky"
Kemerovo, , Russia
Site Status
Federal State Budgetary Institution "Pirogov National Medical Surgical Center" of the Ministry of Health of the Russian Federation
Moscow, , Russia
Site Status
Federal State Budgetary Scientific Institution "Research Institute of Rheumatology named after V.A. Nasonova"
Moscow, , Russia
Site Status
State Budgetary Healthcare Institution of Moscow City "City Clinical Hospital 15 named after O.M. Filatov of the Moscow City Health Department"
Moscow, , Russia
Site Status
State Budgetary Healthcare Institution of Moscow City Clinical Hospital 1 named after N.I. Pirogov of the Moscow City Health Department
Moscow, , Russia
Site Status
State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University
Moscow, , Russia
Site Status
State Budgetary Healthcare Institution "Center of Allergology and Immunology" of Kabardino-Balkarian Republic
Nal'chik, , Russia
Site Status
State Budgetary Healthcare Institution of the Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital named after N. A. Semashko"
Nizhny Novgorod, , Russia
Site Status
Federal State Budgetary Scientific Institution "Institute of Cytology and Genetics of the Siberian Branch of the Russian Academy of Sciences"
Novosibirsk, , Russia
Site Status
Budgetary healthcare institution of the Omsk region "Regional clinical hospital"
Omsk, , Russia
Site Status
State Budgetary Healthcare Institution of Perm Krai "Order of Honour" Perm Regional Clinical Hospital "
Perm, , Russia
Site Status
Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University" of the Ministry of Health of the Russian Federation
Rostov-on-Don, , Russia
Site Status
Clinical Rheumatology Hospital №25
Saint Petersburg, , Russia
Site Status
Federal State Budgetary Educational Institution of Higher Education "St. Petersburg State University"
Saint Petersburg, , Russia
Site Status
Federal State Budgetary Institution "Almazov National Medical Research Center" of the Ministry of Health of the Russian Federation
Saint Petersburg, , Russia
Site Status
North-Western State Medical University n.a. I.I.Mechnikov
Saint Petersburg, , Russia
Site Status
State Budgetary Healthcare Institution "Samara Regional Clinical Hospital named after V.D. Seredavin"
Samara, , Russia
Site Status
Private Healthcare Institution "Clinical Hospital" RD-Medicine "of the city of Saratov
Saratov, , Russia
Site Status
Private Healthcare Institution "Clinical Hospital" RD-Medicine "of Smolensk
Smolensk, , Russia
Site Status
Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University"
Tomsk, , Russia
Site Status
Republican Clinical Hospital named after G. G. Kuvatov
Ufa, , Russia
Site Status
State Healthcare Institution Ulyanovsk Regional Clinical Hospital
Ulyanovsk, , Russia
Site Status
State Healthcare Institution "City Clinical Emergency Hospital 25"
Volgograd, , Russia
Site Status
State Budgetary Healthcare Institution of the Yaroslavl Region "Clinical Hospital named after N.A. Semashko"
Yaroslavl, , Russia
Site Status
State Autonomous Healthcare Institution of the Sverdlovsk Region "City Clinical Hospital 14 Ekaterinburg"
Yekaterinburg, , Russia
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Belarus
Russia
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BCD-180-3
Identifier Type: -
Identifier Source: org_study_id
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