Clinical trials: sponsored by Biocad
Plaque Psoriasis
To Evaluate the Efficacy and Safety of Netakimab in Chinese Patients With Moderate to Severe Plaque Psoriasis
The goal of this clinical trial is to To evaluate the efficacy of subcutaneous (SC) Netakimab in adult Chinese patients with moderate to severe plaque psoriasis.
- Trial name
- NCT07008547
- Testing
- Netakimab
- Where
- China
- Volunteers
- 202 people
- Sponsor
- SPH-BIOCAD (HK) Limited
Anemia, Chronic Kidney Disease
Study of the Efficacy and Safety of BCD-131 and Mircera® in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis
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…
- Conditions
- Anemia, Chronic Kidney Disease, Chronic Kidney Disease Patients on Hemodialysis, Chronic Kidney Disease 5D
- Trial name
- NCT07119372
- Testing
- BCD-131 (pegdarbepoetin beta), Mircera (methoxypolyethylene glycol-epoetin beta)
- Where
- 14 sites in Russia
- Volunteers
- 228 people
- Sponsor
- Biocad
Myeloma Multiple
A Study of the Efficacy and Safety of BCD-248 in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma (AMMADINA)
The aim of the study is to assess the efficacy and safety of the BCD-248 in combination with daratumumab versus the combination of daratumumab, pomalidomide, and dexamethasone in the treatment of relapsed or refractory multiple…
- Trial name
- AMMADINA (NCT07742215)
- Testing
- BCD-248 + daratumumab, Daratumumab + pomalidomide + dexamethasone
- Where
- 16 sites in Belarus, Russia
- Volunteers
- 390 people
- Sponsor
- Biocad
Healthy Adult Male
A Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-057 100 mg/mL, BCD-057 50 mg/mL, and Humira 100 mg/mL in Healthy Subjects
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/mL and BCD-057 50 mg/mL, as well as BCD-057…
- Trial name
- NCT07181694
- Testing
- Adalimumab (BCD-057) 100 mg/mL, Adalimumab (BCD-057) 50 mg/mL, Adalimumab (Humira) 100 mg/mL
- Where
- 4 sites in Russia
- Volunteers
- 444 people, healthy volunteers welcome
- Sponsor
- Biocad
Healthy Adult Participants
Evaluate Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BCD-261 After Single Subcutaneous Injection in Healthy Chinese Volunteers
The goal of this study is to evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BCD-261 after Single Subcutaneous Injection in Healthy Chinese Volunteers
- Trial name
- NCT07535775
- Testing
- BCD-261
- Where
- 2 sites in China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- SPH-BIOCAD (HK) Limited
Systemic Scleroderma
Clinical Study of Divozilimab in Patients With Systemic Scleroderma
The study is a randomized, double-blind, placebo-controlled clinical study of the efficacy and safety of divozilimab in patients with systemic scleroderma.The study will enroll adult patients of both sexes diagnosed with active…
- Trial name
- LIBERIUS (NCT05726630)
- Testing
- Divozilimab
- Where
- 3 sites in Russia
- Volunteers
- 152 people
- Sponsor
- Biocad
Plaque Psoriasis
Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Netakimab in Children With Moderate to Severe Plaque Psoriasis
The aim of the study is to evaluate the efficacy and safety of netakimab compared with placebo in a pediatric population of subjects over 6 years of age with moderate to severe plaque psoriasis.
- Trial name
- PLANETA-KIDS (NCT06640517)
- Testing
- Netakimab, Adalimumab
- Where
- 14 sites in Russia
- Volunteers
- 140 people
- Sponsor
- Biocad
Relapsing-remitting Multiple Sclerosis (RRMS)
A Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis
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.
- Trial name
- MUSCAT (NCT07321093)
- Testing
- BCD-281, Ocrelizumab
- Where
- Russia
- Volunteers
- 292 people
- Sponsor
- Biocad
Ankylosing Spondylitis
Evaluate the Efficacy, Safety, and Pharmacokinetic Profile and Immunogenicity of Subcutaneous Netakimab in Chinese Adult Patients With Active Ankylosing Spondylitis
The goal of this clinical trial is to To evaluate the efficacy of subcutaneous (SC) Netakimab in adult Chinese patients with Active Ankylosing Spondylitis.
- Trial name
- NCT07277179
- Testing
- Netakimab
- Where
- China
- Volunteers
- 113 people
- Sponsor
- SPH-BIOCAD (HK) Limited
Hemophilia B
An Open-Label, Comparative Study of the Efficacy, Safety and Pharmacodynamics of Single Dose of ANB-002 in Patients With Hemophilia B
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.
- Trial name
- MAGNOLIA (NCT06700096)
- Testing
- ANB-002
- Where
- 14 sites in Russia, Thailand
- Volunteers
- 24 people
- Sponsor
- Biocad
Ulcerative Colitis (UC)
Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Ulcerative Colitis
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…
- Trial name
- ULTRAMARINE (NCT07080034)
- Testing
- anti-TL1A monoclonal antibody, low dose, anti-TL1A monoclonal antibody, medium dose, anti-TL1A monoclonal antibody, high dose
- Where
- 20 sites in Russia
- Volunteers
- 198 people
- Sponsor
- Biocad
Crohn's Disease (CD)
Clinical Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Crohn's Disease
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…
- Trial name
- COMANDOR (NCT07078994)
- Testing
- anti-TL1A monoclonal antibody, low dose, anti-TL1A monoclonal antibody, medium dose, anti-TL1A monoclonal antibody, high dose
- Where
- 20 sites in Russia
- Volunteers
- 204 people
- Sponsor
- Biocad
Systemic Lupus Erthematosus
Safety, Pharmacokinetics, Immunogenicity BCD-256-1 and Divozilimab in Subjects With Systemic Lupus Erythematosus
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…
- Trial name
- NCT07136389
- Testing
- BCD-256, Divozilimab
- Where
- Russia
- Volunteers
- 135 people
- Sponsor
- Biocad
Triple Negative Breast Cancer
BCD-236 in Combination With Chemotherapy in Patients With Relapsed and/or Metastatic Triple Negative Breast Cancer
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/or metastatic triple negative…
- Trial name
- AREAL (NCT07108309)
- Testing
- BCD-236, Chemotherapy
- Where
- 47 sites in Belarus, Russia
- Volunteers
- 124 people
- Sponsor
- Biocad
Breast Cancer
Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer
The goal of this study is to compare the efficacy and safety of BCD-178 and Perjeta as neoadjuvant therapy for HER2-positive breast cancer.
- Trial name
- PREFER (NCT05802225)
- Testing
- BCD-178, Perjeta
- Where
- 3 sites in Russia
- Volunteers
- 398 people
- Sponsor
- Biocad
Psoriatic Arthritis
Clinical Study of Efficacy and Safety of BCD-085 (Monoclonal Anti-IL-17 Antibody) in Psoriatic Arthritis
Study BCD-085-8/PATERA is a multicentre double-blind placebo-controlled Phase 3 study in patients with psoriatic arthritis (PsA).
- Trial name
- PATERA (NCT03598751)
- Testing
- BCD-085
- Where
- 3 sites in Belarus, Russia
- Volunteers
- 194 people
- Sponsor
- Biocad
Advanced Melanoma
A Clinical Study of the Pharmacokinetics and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin
The aim of the study BCD-263-1 is to prove the comparability of the pharmacokinetics and similarity of the safety, immunogenicity and pharmacodynamic profiles of BCD-263 and Opdivo following intravenous administration to subjects…
- Trial name
- NCT06112808
- Testing
- BCD-263, Opdivo
- Where
- 30 sites in Belarus, Russia
- Volunteers
- 300 people
- Sponsor
- Biocad
Melanoma Stage III, Melanoma (Skin)
A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma
This study is an open-label, randomized, comparative phase III study, which will include subjects with resectable stage III skin melanoma (up to 3 resectable transient metastases are acceptable).
- Trial name
- NEO-MIMAJOR (NCT05751928)
- Testing
- BCD-217, anti-PD1, Excision of the primary lesion
- Where
- 36 sites in Belarus, Russia
- Volunteers
- 411 people
- Sponsor
- Biocad
Advanced Melanoma, Melanoma (Skin)
Clinical Study of the Efficacy and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin
The aim of the study BCD-263-2/UNIVERSE is to demonstrate comparable efficacy and similar safety and immunogenicity profile of BCD-263 and Opdivo after repeated intravenous doses in subjects with advanced unresectable or…
- Trial name
- UNIVERSE (NCT06640530)
- Testing
- BCD-263, Opdivo
- Where
- 44 sites in Belarus, Pakistan and 1 more
- Volunteers
- 392 people
- Sponsor
- Biocad
Ankylosing Spondylitis
International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing Spondylitis
BCD-085-5 is an International, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of the Efficacy and Safety of BCD-085. BCD-085 is a monoclonal antibody to interleukin 17.
- Trial name
- NCT03447704
- Testing
- BCD-085
- Where
- 7 sites in Russia
- Volunteers
- 228 people
- Sponsor
- Biocad