Clinical trials: sponsored by Biocad
Hemophilia B
Study of the Safety, Pharmacodynamics and Efficacy of ANB-002 in Patients With Hemophilia B (SAFRAN)
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.
- Trial name
- NCT06120582
- Testing
- ANB-002, dose 1, ANB-002, dose 2, ANB-002, dose 3
- Where
- 17 sites in Belarus, Russia
- Volunteers
- 28 people
- Sponsor
- Biocad
Paroxysmal Nocturnal Hemoglobinuria (PNH)
An Extension Clinical Study of BCD-148 for the Treatment of Patients With PNH Previously Treated in Clinical Study No. BCD-148-2/NOCTURN
To study the long-term safety and efficacy of BCD-148 in patients with paroxysmal nocturnal hemoglobinuria (PNH), previously treated in clinical study (CS) BCD-148-2/NOCTURN
- Trial name
- NCT06987864
- Testing
- eculizumab
- Where
- 11 sites in Russia
- Volunteers
- 24 people
- Sponsor
- Biocad
Multiple Sclerosis
An Extension Clinical Study of the Efficacy and Safety of BCD-132 in Patients With Multiple Sclerosis Who Previously Received Therapy in Clinical Studies of JSC BIOCAD
The aim of this clinical study is to assess the long-term efficacy and safety of BCD-132 (divozilimab) in patients with multiple sclerosis who previously participaded in BCD-132-2 and BCD-132-4/MIRANTIBUS studies
- Trial name
- NCT06987851
- Testing
- Divozilimab
- Where
- 15 sites in Russia
- Volunteers
- 44 people
- Sponsor
- Biocad
Hemophilia A
A Trial of the Safety and Efficacy of Single-Dose Administration of ANB-010 in Subjects With Hemophilia A
The goal of this multicenter, two-stage, open-label study is to investigate the safety, immunogenicity, and efficacy of ANB-010 in subjects with hemophilia A.
- Trial name
- EDELWEISS (NCT06185335)
- Testing
- ANB-010, dose 1, ANB-010, dose 2, ANB-010, dose 3
- Where
- 17 sites in Russia
- Volunteers
- 50 people
- Sponsor
- Biocad
Melanoma, Melanoma (Skin)
A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma
The aim of study is to investigate the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of BCD-217 followed by prolgolimab monotherapy versus prolgolimab monotherapy as first-line therapy in subjects with…
- Conditions
- Melanoma, Melanoma (Skin), Melanoma Stage III, Melanoma Stage IV
- Trial name
- OCTAVA (NCT05732805)
- Testing
- BCD-217, BCD-100
- Where
- 63 sites in Belarus, India and 1 more
- Volunteers
- 270 people
- Sponsor
- Biocad
Multiple Sclerosis
Comparative Study of the Efficacy and Safety of BCD-132 With Teriflunomide and Placebo in Multiple Sclerosis
International multicenter, randomized, double-blind, double-masked, placebo-controlled study of efficacy and safety of BCD-132 (JSC BIOСAD, Russia) using an active reference drug (teriflunomide) for the treatment of patients with…
- Trial name
- NCT04056897
- Testing
- BCD-132, 125 mg, Teriflunomide, BCD-132, 500 mg
- Where
- Russia
- Volunteers
- 271 people
- Sponsor
- Biocad
Relapsed/Refractory Multiple Myeloma
An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Patients With Relapsed/Refractory Multiple Myeloma
The aim of the study is to assess the efficacy and safety of BCD-248 as a therapy for relapsing and/or refractory multiple myeloma.
- Trial name
- FLAMMINGO (NCT06668792)
- Testing
- BCD-248
- Where
- 20 sites in Russia
- Volunteers
- 100 people
- Sponsor
- Biocad
Healthy
Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Ascending Doses BCD-261 in Healthy Subjects
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…
- Trial name
- NCT06715540
- Testing
- BCD-261, dose 1, BCD-261, dose 2, BCD-261, dose 3
- Where
- Russia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Biocad
Multiple Sclerosis
An International, Multicenter, Randomized, Double-Blind, Double-Masked Study of the Efficacy and Safety of BCD-132 (JSC BIOCAD, Russia) Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis
Clinical study BCD-132-4/MIRANTIBUS is an international, multicenter, randomized, double-blind, double-masked study using an active reference drug (teriflunomide).
- Trial name
- MIRANTIBUS (NCT05385744)
- Testing
- BCD-132, Teriflunomide
- Where
- Russia
- Volunteers
- 336 people
- Sponsor
- Biocad
Neuromyelitis Optica Spectrum Disorders
Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders (AQUARELLE)
The goal of this clinical trial is to study the efficacy and safety of BCD-132 (divozilimab) in subjects with neuromyelitis optica spectrum disorders (NMOSD).
- Trial name
- AQUARELLE (NCT05730699)
- Testing
- divozilimab
- Where
- 19 sites in Russia
- Volunteers
- 105 people
- Sponsor
- Biocad
Axial Spondyloarthritis
Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (LEVENTA)
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…
- Trial name
- NCT06333210
- Testing
- anti-TRBV9 monoclonal antibody infusions, Adalimumab subcutaneous injection
- Where
- 32 sites in Belarus, Russia
- Volunteers
- 421 people
- Sponsor
- Biocad
Multiple Myeloma
A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma
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…
- Trial name
- DARVIVA (NCT06296121)
- Testing
- BCD-264, Darzalex
- Where
- 14 sites in Russia
- Volunteers
- 252 people
- Sponsor
- Biocad
Spinal Muscular Atrophy (SMA)
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)
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.
- Trial name
- BLUEBELL (NCT05747261)
- Testing
- ANB-004, dose 1, ANB-004, dose 2, ANB-004, dose 3
- Where
- 7 sites in Belarus, Russia
- Volunteers
- 40 people
- Sponsor
- Biocad
Healthy
Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of Single Escalating Doses of BCD-180 in Healthy Volunteers
The aim of the study is to investigate the pharmacodynamics, pharmacokinetics, safety, and immunogenicity of BCD-180 after a single intravenous administration in escalating doses to healthy volunteers.
- Trial name
- NCT05407779
- Testing
- BCD-180, dose 1, BCD-180, dose 2, BCD-180, dose 3
- Where
- Russia
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Biocad
Non-small Cell Lung Cancer
A Safety and Efficacy Study of BCD-021 With Paclitaxel and Carboplatin Compared to Avastin With Paclitaxel and Carboplatin in Non-Small Cell Lung Cancer
BCD-021-02 is a double-blind randomized clinical trial comparing efficacy of BCD-021 (INN: bevacizumab) and paclitaxel + carboplatin to Avastin and paclitaxel + carboplatin in inoperable or advanced non-squamous NSCLC patients…
- Trial name
- NCT01763645
- Testing
- Bevacizumab, Paclitaxel, Carboplatin
- Where
- 44 sites in Belarus, India and 2 more
- Volunteers
- 353 people
- Sponsor
- Biocad
Healthy
A Study to Assess the PK, PD, Safety and Immunogenicity of Single IV Infusion of BCD-264 and Darzalex in Healthy Subjects
The goal of this clinical study is to establish the comparability of the pharmacokinetics and similarity of the safety, immunogenicity and pharmacodynamic profiles of BCD-264 and Darzalex following a single intravenous infusion…
- Trial name
- NCT05974969
- Testing
- BCD-264, Darzalex
- Where
- 3 sites in Russia
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Biocad
Melanoma (Skin)
Clinical Study of the Efficacy and Safety of BCD-201 and Keytruda in Subjects With Advanced Melanoma
This clinical study is designed as a randomized, double-blind trial. Subjects with unresectable, metastatic, or recurrent skin melanoma will be randomized to one of the two study groups (BCD-201 group and Keytruda group) at a 1:1…
- Trial name
- NCT05986331
- Testing
- BCD-201, Keytruda
- Where
- 3 sites in Russia
- Volunteers
- 366 people
- Sponsor
- Biocad
Melanoma, Non Small Cell Lung Cancer
Clinical Trial to Evaluate the PK and Safety of BCD-201 and Keytruda® in Patients With Advanced Malignancies
Clinical study BCD-201-1 is a double-blind randomized study of the pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity of BCD-201 versus Keytruda following intravenous administration to subjects with advanced…
- Trial name
- NCT05739006
- Testing
- BCD-201, Keytruda
- Where
- 3 sites in Russia
- Volunteers
- 131 people
- Sponsor
- Biocad
Axial Spondyloarthritis
Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis
The aim of the study is to evaluate the efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics of two doses of study drug (BCD-180) in comparison with placebo in patients with active radiographic axial…
- Trial name
- ELEFTA (NCT05445076)
- Testing
- anti-TRBV9 monoclonal antibody, low dose, anti-TRBV9 monoclonal antibody, high dose
- Where
- 2 sites in Russia
- Volunteers
- 250 people
- Sponsor
- Biocad
Rheumatoid Arthritis
A Two-Stage Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Various Doses of Levilimab When Administered Intravenously and Subcutaneously to Healthy Subjects and Subjects With Active Rheumatoid Arthritis
This is a two-stage study of efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of various doses of levilimab when administered intravenously and subcutaneously to healthy subjects and subjects with active…
- Trial name
- NCT05800327
- Testing
- Levilimab
- Where
- Russia
- Volunteers
- 261 people, healthy volunteers welcome
- Sponsor
- Biocad