Clinical trials: sponsored by Biocad
Unresectable or Metastatic Melanoma
Prolgolimab 250 mg Q3W in Patients With Unresectable or Metastatic Melanoma
Multicentre, single-arm, open-label efficacy, pharmacokinetics, and safety study to demonstrate non-inferiority of prolgolimab 250 mg every 3 weeks versus historical data for prolgolimab 1 mg/kg every 2 weeks in patients with…
- Trial name
- FLAT (NCT05783882)
- Testing
- Prolgolimab
- Where
- 6 sites in Russia
- Volunteers
- 114 people
- Sponsor
- Biocad
Neuroblastoma
Phase 1 Study of BCD-245 in Subjects With Neuroblastoma
The aim of the study is to investigate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-245 after its single and multiple intravenous infusions at escalating doses in subjects with relapsed/refractory…
- Trial name
- NCT05782959
- Testing
- BCD-245
- Where
- 3 sites in Russia
- Volunteers
- 24 people
- Sponsor
- Biocad
Breast Cancer
A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers
This is a double-blind, comparative, randomized phase I study comparing pharmacokinetics, safety and immunogenicity profiles of a biosimilar pertuzumab (BCD-178) and Perjeta after a single intravenous infusion in healthy male…
- Trial name
- NCT05738993
- Testing
- BCD-178, Perjeta
- Where
- 2 sites in Russia
- Volunteers
- 100 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
Melanoma, Melanoma Metastatic
Study of Efficacy and Safety of BCD-217 (Anti-CTLA-4 and Anti-PD-1) Followed By BCD-100 (Anti-PD-1) Versus BCD-100 Monotherapy as First-Line Treatment in Patients With Unresectable or Metastatic Melanoma
This is a multicenter randomized double-blind placebo-controlled phase II clinical trial. The purpose of this trial is to evaluate efficacy and safety of therapy consisting of BCD-217 (fixed dose combination of anti-CTLA-4 and…
- Trial name
- OBERTON (NCT03913923)
- Testing
- BCD-217, BCD-100
- Where
- 23 sites in Belarus, Russia
- Volunteers
- 117 people
- Sponsor
- Biocad
Coronavirus Infection, COVID-19
Clinical Study of the Safety and Immunogenicity of a Recombinant Viral Vector AAV5 (Adeno-Associated Virus Type 5 )-RBD (Receptor Binding Domain)-S Vaccine for the Prevention of Coronavirus Infection (COVID-19)
A randomized, double-blind, placebo-controlled, adaptive, seamless phase I / II clinical study of the safety and immunogenicity of a recombinant viral vector AAV5-RBD-S vaccine for the prevention of coronavirus infection…
- Trial name
- COVER (NCT05037188)
- Testing
- Low dose BCD-250 injection, High dose BCD-250 injection, Low dose or high dose BCD-250 injection
- Where
- 2 sites in Russia
- Volunteers
- 50 people, healthy volunteers welcome
- 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
Psoriasis
Comparative Clinical Trial of Efficacy and Safety of BCD-057 and Humira® in Patients With Moderate to Severe Plaque Psoriasis
CALYPSO clinical study is a phase 3 study which is carried out to establish the efficacy, safety and pharmacokinetic equivalence of BCD-055 (adalimumab, manufactured by JSC BIOCAD, Russia) and Humira® when used in patients with…
- Trial name
- CALYPSO (NCT02762955)
- Testing
- BCD-057, Humira®
- Where
- Russia
- Volunteers
- 344 people
- Sponsor
- Biocad
Multiple Sclerosis
Dose Escalation Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of BCD-132 in Patients With Relapsing-Remitting Multiple Sclerosis
BCD-132 is a humanized monoclonal antibody against CD20. BCD-132-1 is a Multicenter Open-Label Non-Comparative Dose Escalation Study (Phase 1) of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of BCD-132 (JSC…
- Trial name
- NCT03551275
- Testing
- BCD-132
- Where
- 5 sites in Russia
- Volunteers
- 24 people
- Sponsor
- Biocad
Multiple Sclerosis, Relapsing-Remitting
Comparative Clinical Trial to Evaluate Efficacy, Safety and Tolerance of BCD-054 and Avonex® for Treatment of Patients With Remitting-relapsing Multiple Sclerosis
An International Multicenter Double-blind Placebo-controlled Randomized Study to Compare the Efficacy, Safety and Tolerability of BCD-054 (JSC BIOCAD, Russia), 180 μg and 240 μg, versus Avonex® (Biogen Idec Ltd., UK) in Patients…
- Trial name
- NCT02744222
- Testing
- BCD-054 180 mcg, Avonex®, BCD-054 240 mcg
- Where
- Russia
- Volunteers
- 399 people
- Sponsor
- Biocad
Patients With Solid Tumours Who Receive Myelosupressive Therapy
DEFENDOR: A Multicenter Prospective Observational Post-registration stuDy of Extimia® (INN: empEgfilrastim) to Evaluate Efficacy and saFEty in patieNts With soliD tumORs
This study was designed to evaluate the efficacy and safety of Extimia® (INN - empegfilgrastim) in reducing the frequency, duration of neutropenia, the incidence of febrile neutropenia and infections caused by febrile neutropenia…
- Trial name
- DEFENDOR (NCT04811443)
- Testing
- Empegfilgrastim
- Where
- 3 sites in Russia
- Volunteers
- 500 people
- Sponsor
- Biocad
Psoriasis
International Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of BCD-085 in Various Doses in Patients With Moderate to Severe Plaque Psoriasis
BCD-085-2 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal antibody to interleukin 17. During BCD-085-2 trial patients with moderate to severe plaque psoriasis, in whom poor response to previous…
- Trial name
- NCT02762994
- Testing
- BCD-085
- Where
- Russia
- Volunteers
- 120 people
- Sponsor
- Biocad
Anemia
Comparative Study of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in CKD Patients on Dialysis
BCD-131 is pegylated darbepoetin beta. BCD-131-2 is International Multicenter Randomized Open-Label Comparative Study (Phase II) of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in Chronic Kidney Disease…
- Trial name
- NCT03519243
- Testing
- BCD-131, Mircera
- Where
- 3 sites in Belarus, Russia
- Volunteers
- 75 people
- Sponsor
- Biocad
Healthy
First-in-human Study to Evaluate Safety, Tolerability and Pharmacokinetics of Various Doses of BCD-085 in Healthy Subjects
This is an open label, phase 1, "3+3" dose escalating study of tolerability, safety, pharmacokinetics and immunogenicity of a single subcutaneous injection of the novel monoclonal antibody against human IL-17 - BCD-085.
- Trial name
- NCT02380287
- Testing
- humanized monoclonal antibody against human IL-17
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Biocad