Clinical trials: sponsored by Biocad
Breast Cancer
Study of BCD-115 in Women With ER(+) HER2(-) Local Advanced and Metastatic Breast Cancer
A Multicenter Open-label Non-comparative 2-Stage Phase 1a/1b Study to Assess the Safety and Pharmacokinetics of Oral BCD-115 (JSC BIOCAD, Russia) in Combination with Endocrine Therapy in Women with ER(+) HER2(-) Local Advanced…
- Trial name
- NCT03065010
- Testing
- BCD-115
- Where
- Russia
- Volunteers
- 6 people
- Sponsor
- Biocad
Melanoma, NSCLC
A Study of BCD-135 in Patients With Advanced Solid Tumors
A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-135 (JSC BIOCAD, Russia) in Patients with Advanced Solid Tumors
- Conditions
- Melanoma, NSCLC, Renal Cell Carcinoma, Bladder Cancer
- Trial name
- NCT03464032
- Testing
- BCD-135
- Where
- Russia
- Volunteers
- 30 people
- Sponsor
- Biocad
Ankylosing Spondylitis
Comparative Clinical Trial to Evaluate Efficacy and Safety of BCD-055 and Remicade® in Patients With Ankylosing Spondylitis
BCD-055-2 is international multi-center comparative double-blind randomized clinical trial to evaluate efficacy and safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in patients with ankylosing spondylitis.
- Trial name
- NCT02762812
- Testing
- BCD-055, Remicade®
- Where
- Russia
- Volunteers
- 199 people
- Sponsor
- Biocad
Rheumatoid Arthritis
Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC "BIOCAD") With Methotrexate in First Line Biological Therapy of Patients With Active Rheumatoid Arthritis
The mail goal of this study is to establish superiority in efficacy of Acellbia® applied in a dose of 600 mg (Day 1 and Day 15) in combination with methotrexate in patients with active RA seropositive previously untreated with…
- Trial name
- ALTERRA (NCT02744196)
- Testing
- Acellbia, Methotrexate
- Volunteers
- 159 people
- Sponsor
- Biocad
Follicular Non-Hodgkin's Lymphoma, Nodal Marginal Zone Lymphoma
Safety and Efficacy Study of BCD-020 in Therapy of Indolent Non-Hodgkin's Lymphoma
This international multi-center, randomized, controlled, open-label study investigated the pharmacokinetics, pharmacodynamics, efficacy and safety of BCD-020 (INN: rituximab, CJSC Biocad) versus MabThera® (INN: rituximab, F.
- Conditions
- Follicular Non-Hodgkin's Lymphoma, Nodal Marginal Zone Lymphoma, Splenic Marginal Zone Lymphoma
- Trial name
- NCT01701232
- Testing
- rituximab
- Where
- 62 sites in Colombia, India and 3 more
- Volunteers
- 174 people
- Sponsor
- Biocad
Healthy
First-in-human Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Various Doses of BCD-121 in Healthy Subjects
This is an open label, phase 1, "3+3", placebo-controlled dose escalating study of tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single subcutaneous injection of the novel monoclonal bispecific…
- Trial name
- NCT03103451
- Testing
- BCD-121
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Biocad
Healthy
Open Label Study of Tolerability, Pharmacokinetics and Pharmacodynamics of BCD-054 (Pegylated Interferon Beta-1a), IM and SC, Compared to Rebif® and Avonex® in Healthy Volunteers
This is an international multicenter study of tolerability, pharmacokinetics and pharmacodynamics of drug product BCD-054 (CJSC BIOCAD, Russia), administrated intramuscular and subcutaneous, compared to Rebif® (Merck Serono…
- Trial name
- NCT02359877
- Testing
- BCD-054, Rebif, Avonex
- Where
- Russia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Biocad
Rheumatoid Arthritis
Study of Safety and Efficacy of BCD-020 Comparing to MabThera in Patients With Rheumatoid Arthritis
The purpose of this study is to prove that efficacy, safety and immunogenicity of BCD-020 is equivalent to MabThera when used in combination with methotrexate for the treatment of patient with rheumatoid arthritis
- Trial name
- BIORA (NCT01759030)
- Testing
- Rituximab
- Where
- 40 sites in Belarus, India and 2 more
- Volunteers
- 181 people
- Sponsor
- Biocad
Chemotherapy-induced Neutropenia
Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Patients With Breast Cancer
The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastimt a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day.
- Trial name
- NCT01569087
- Testing
- empegfilrastim, filgrastim
- Where
- 5 sites in Russia
- Volunteers
- 60 people
- Sponsor
- Biocad
Chemotherapy-induced Neutropenia
Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer Patients
The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastim and daily dosing of filgrastim for prevention of neutropenia in patients receiving AT (docetaxel 75 mg/m2 + doxorubicin 50 mg/m2).
- Trial name
- NCT02104830
- Testing
- Empegfilrastim 6 mg, Filgrastim, Empegfilrastim 7.5 mg
- Where
- 13 sites in Russia
- Volunteers
- 135 people
- Sponsor
- Biocad
Deep Vein Thrombosis
A Safety and Efficacy Study of BCD-080 Compared to Clexan for Deep Vein Thrombosis Prophylaxis at Orthopedic Surgeries
The purpose of the study is to prove equivalence of efficacy and safety of BCD-080 and Clexan for deep vein thrombosis and embolism prophylaxis at orthopedic surgeries.
- Trial name
- NCT02368314
- Testing
- Sodium Enoxaparine
- Where
- Russia
- Volunteers
- 124 people
- Sponsor
- Biocad
Healthy
Pharmacokinetics and Pharmacodynamics Study of BCD-066 Compared to Aranesp® in Healthy Volunteers
This is a randomized double-blind crossover study of pharmacokinetics, pharmacodynamics and safety of BCD-066 (darbepoetin alfa manufactured by CJSC BIOCAD, Russia) and Aranesp® (Amgen Europe B.V., Netherlands) in healthy…
- Trial name
- NCT02506881
- Testing
- Darbepoetin alfa
- Where
- Russia
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Biocad
Ankylosing Spondylitis
Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis
ASART-1 clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety profile of BCD-055 (infliximab manufactured by JSC BIOCAD, Russia) and Remicade when used as multiple IV…
- Trial name
- NCT02359903
- Testing
- Infliximab (BCD-055), Infliximab (Remicade)
- Where
- 6 sites in Belarus, Russia
- Volunteers
- 90 people
- Sponsor
- Biocad
Healthy
Pharmacokinetics and Pharmacodynamics Study of BCD-033 Compared to Rebif® in Healthy Volunteers
This is a randomized double-blind crossover study of pharmacokinetics, pharmacodynamics and tolerability of BCD-033 (interferon beta-1a manufactured by CJSC BIOCAD, Russia) and Rebif® (Merck Serono S.p.A.., Italy) in healthy…
- Trial name
- NCT01766024
- Testing
- Interferon beta-1a
- Where
- Russia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Biocad
Wet Age-related Macular Degeneration
Safety and Efficacy Study of BCD-021 Compared to Lucentis® in Patients With Neovascular Wet Age-related Macular Degeneration
GALATIR is a double blind randomized clinical trial comparing efficacy and safety of BCD-021 (bevacizumab) and Lucentis® (ranibizumab) in patients with neovascular wet age-related macular degeneration.
- Trial name
- GALATIR (NCT02036723)
- Testing
- Bevacizumab, Ranibizumab
- Where
- 13 sites in Brazil, Russia
- Sponsor
- Biocad
Neovascular Age-related Macular Degeneration
Evaluation the Pharmacokinetics, Safety, Tolerability of BCD-021 in Patients With Neovascular Age-related Macular Degeneration
This clinical study is a phase 1 study which carried out to to evaluate the safety, pharmacokinetics and tolerability of multiple intravitreal injections of BCD-021(bevacizumab biosimilar candidate manufactured by CJSC BIOCAD…
- Trial name
- NCT02450981
- Testing
- Bevacizumab (BCD-021)
- Sponsor
- Biocad
Hepatitis, Hepatitis C
Algeron (Cepeginterferon Alfa-2b) Compared With PegIntron (Peginterferon Alfa-2b) for Treatment of Chronic Hepatitis C
The purpose of the study is to demonstrate the noninferiority of Algeron 1.5 and 2.0 μg/kg/week in combination with ribavirin compared to PegIntron in combination with ribavirin in the treatment of chronic hepatitis C, and to…
- Trial name
- NCT01740089
- Testing
- Algeron, PegIntron, Ribavirin
- Where
- Russia
- Volunteers
- 150 people
- Sponsor
- Biocad