Clinical trials: completed, 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
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
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
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
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
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
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
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
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
Multiple Sclerosis
Study of Efficacy and Safety of Drugs BCD-033 and Rebif for Treatment of Patients With Multiple Sclerosis
Study design is double-blind, randomized, placebo-controlled study in 3 parallel groups with the use of active comparator and placebo. Total duration of therapy of about 2 years.
- Trial name
- NCT02727907
- Testing
- BCD-033 (interferon beta 1a), Rebif (interferon beta 1a)
- Where
- Russia
- Volunteers
- 163 people
- Sponsor
- Biocad
Moderate to Severe Plaque Psoriasis
An International Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Study of Efficacy and Safety of Two Dosing Regimens of BCD-085 (JSC BIOCAD, Russia) in Patients With Moderate to Severe Plaque Psoriasis
BCD-085 is an innovative drug, a monoclonal antibody against interleukin-17. The toxicity, safety, and pharmacokinetics of BCD-085 were investigated in animals, in phase I clinical study in healthy volunteers, and in phase III…
- Trial name
- BCD-085-7 (NCT03390101)
- Testing
- BCD-085 Q2W, BCD-085 Q4W
- Where
- Russia
- Volunteers
- 213 people
- Sponsor
- Biocad
Rheumatoid Arthritis
Study of the Efficacy and Safety of BCD-089 in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
BCD-089 is the original therapeutic monoclonal antibody binding the alpha subunit of the IL-6 receptor. The aim of the study is to demonstrate the efficacy and safety of BCD-089 in combination with methotrexate in patients with…
- Trial name
- SOLAR (NCT04227366)
- Testing
- BCD-089, Methotrexat
- Where
- Russia
- Volunteers
- 154 people
- Sponsor
- Biocad
COVID-19
A Clinical Trial of the Efficacy and Safety of Levilimab (BCD-089) in Patients With Severe COVID-19
The objective: to study the efficacy and safety of levilimab in subjects with severe COVID-19.
- Trial name
- CORONA (NCT04397562)
- Testing
- Levilimab
- Where
- 16 sites in Russia
- Volunteers
- 206 people
- Sponsor
- Biocad
Seropositive RA
The BCD-089 (aIL6R) in Patients With Active Rheumatoid Arthritis
The study is Phase II randomized, double-blind, placebo-controlled clinical trial to evaluate efficacy and safety, pharmacokinetics and pharmacodynamics of 2 dosing regimens (qw and q2w, s/c) of monoclonal antibody to IL6R…
- Trial name
- AURORA (NCT03455842)
- Testing
- BCD-089, 162 mg, s/c, qw, BCD-089, 162 mg, s/c, q2w
- Where
- 4 sites in Belarus, Russia
- Volunteers
- 105 people
- Sponsor
- Biocad
Healthy
Comparative Clinical Study of Pharmacokinetics, Tolerance and Safety of BCD-057 and Humira in Healthy Volunteers
This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety and tolerability profile of BCD-057 (adalimumab biosimilar candidate manufactured by CJSC BIOCAD, Russia) and…
- Trial name
- NCT02395055
- Testing
- Adalimumab (BCD-057), Adalimumab (Humira)
- Where
- Russia
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Biocad
Ankylosing Spondylitis
Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of Various Doses of BCD-085 in Patients With Active Ankylosing Spondylitis
BCD-085-3 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal antibody to interleukin 17. During the trial patients with active ankylosing spondylitis will receive 40, 80 or 120 mg of BCD-085…
- Trial name
- NCT02763111
- Testing
- BCD-085
- Volunteers
- 88 people
- Sponsor
- Biocad
Relapsing-remitting Multiple Sclerosis
Efficacy and Safety of BCD-063 and Copaxone-Teva in Patients With Relapsing-Remitting Multiple Sclerosis
The objective of the clinical study of the medicinal product for medical use: to compare efficacy and safety of the generic drug BCD-063 and Copaxone®-Teva in patients with relapsing-remitting multiple sclerosis.
- Trial name
- NCT02753088
- Testing
- BCD-063, Copaxone-Teva
- Volunteers
- 158 people
- Sponsor
- Biocad