Clinical trials: completed, sponsored by 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
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
Healthy
First-in-human Study of Safety, Pharmacokinetics and Pharmacodynamics of Various Doses of BCD-089 in Healthy Subjects
This is an open label, phase 1, "3+3" dose escalating study of tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single subcutaneous injection of the novel monoclonal antibody against the…
- Trial name
- NCT03103438
- Testing
- BCD-089
- Where
- Russia
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Biocad
Paroxysmal Nocturnal Hemoglobinuria
Clinical Trial of BCD-148 and Soliris® for the Treatment of Patients With Paroxysmal Nocturnal Hemoglobinuria
This clinical study is a randomized, open-label, international, multi-center, comparative study of efficacy and safety of BCD-148 and Soliris® in PNH patients.
- Trial name
- NCT04060264
- Testing
- BCD-148, Soliris
- Where
- Russia
- Volunteers
- 28 people
- Sponsor
- Biocad
Healthy
First-In-Human Study to Evaluate Safety And Pharmacokinetics of Single Escalating Doses of BCD-147 (Bispecific Anti-HER2/HER2 Antibody) in Healthy Subjects
This is an open-label, phase 1, "3+3 trial" of pharmacokinetics, safety and immunogenicity of BCD-147 (JSC "BIOCAD", Russia) after single administration of escalating doses in healthy male volunteers
- Trial name
- NCT03912441
- Testing
- BCD-147
- Where
- Russia
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Biocad
Healthy Subjects
Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®
A Double-blind, Randomized Clinical Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 (JSC BIOCAD, Russia) and Soliris® in Healthy Volunteers
- Trial name
- NCT04027803
- Testing
- BCD-148, Soliris
- Where
- Russia
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Biocad
Chronic Kidney Disease, End Stage Renal Failure on Dialysis
Safety and Efficacy Study of BCD-066 Compared to Aranesp® for Anemia Treatment in Chronic Kidney Disease Patients
The purpose of the study is to prove equivalence of efficacy and safety of BCD-066 and Aranesp® in treatment of anemia in end-stage chronic kidney disease patients on dialysis.
- Conditions
- Chronic Kidney Disease, End Stage Renal Failure on Dialysis, Anemia
- Trial name
- NCT02506868
- Testing
- Darbepoetin alfa
- Where
- 30 sites in Russia
- Volunteers
- 196 people
- Sponsor
- Biocad
Healthy
The Study of PK, PD, Safety of Multiple Intravenous Injections of BCD-066 and Aranesp in Healthy Volunteers
BCD-066 is a darbepoetin alfa. Clinical study BCD-066-3 is a double-blind controlled, randomized, parallel-group study of the pharmacokinetics, pharmacodynamics, tolerability, and safety of multiple intravenous injections of…
- Trial name
- NCT03693950
- Testing
- BCD-066, Aranesp
- Where
- Russia
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Biocad
Reticulocyte Count
Study of Pharmacokinetics, Pharmacodynamics, Safety of BCD-131 Compared to Mircera and Aranesp in Healthy Volunteers
BCD-131-1 is an Open-Label Clinical Study of the Pharmacokinetics, Pharmacodynamics, Tolerability, Safety and Immunogenicity of Single Ascending Doses of BCD-131 in Healthy Volunteers
- Trial name
- NCT02731469
- Testing
- BCD-131, Mircera®, Aranesp®
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Biocad
Rheumatoid Arthritis
Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
BCD-055-3 is international multi-center comparative double-blind randomized clinical trial of efficacy and safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in combination with methotrexate in patients with active rheumatoid…
- Trial name
- NCT02762838
- Testing
- BCD-055, Remicade®, Methotrexate
- Where
- 39 sites in Belarus, India and 1 more
- Volunteers
- 426 people
- Sponsor
- Biocad
Melanoma
Phase I Study of BCD-145 (Anti-CTLA-4) in Patients With Unresectable/Metastatic Melanoma
A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of BCD-145 (JSC BIOCAD, Russia) Monotherapy in Patients with Unresectable/Metastatic Melanoma.
- Trial name
- NCT03472027
- Testing
- BCD-145
- Where
- 4 sites in Russia
- Volunteers
- 15 people
- Sponsor
- Biocad
Leucocytosis
Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® Compared to Neupogen®
BCD-002-1 is 1 phase clinical trial to evaluate pharmacokinetics, pharmacodynamics and safety of single-injection of Leucostim® to healthy volunteers compared to Neupogen®
- Trial name
- NCT02762799
- Testing
- Leucostim®, Neupogen®
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Biocad
Human Epithelial Receptor (HER)-2 Positive Breast Cancer
A Safety and Efficacy Study of BCD-022 With Paclitaxel Compared to Herceptin With Paclitaxel in HER2+ Metastatic Breast Cancer Patients
BCD-022-02 is a double-blind randomized clinical trial comparing efficacy of BCD-022 (INN: trastuzumab) and paclitaxel to Herceptin and paclitaxel in HER2-positive metastatic breast cancer with pharmacokinetics substudy.
- Trial name
- NCT01764022
- Testing
- Trastuzumab, Paclitaxel
- Where
- 36 sites in Belarus, India and 2 more
- Volunteers
- 225 people
- Sponsor
- Biocad
Hepatitis, Hepatitis C
An Open-label Randomized Multicenter Phase III Clinical Study Comparing Safety and Efficacy of Algeron (Cepeginterferon Alfa-2b) and and PegIntron (Peginterferon Alfa-2b) in Combination With Ribavirin as Combined Treatment of Chronic Hepatitis C in Human Immunodeficiency Virus-1 Infected Patients
The purpose of the study is to demonstrate the noninferiority of Algeron in combination with ribavirin compared to PegIntron in combination with ribavirin in treatment of chronic hepatitis C in Human Immunodeficiency Virus-1…
- Conditions
- Hepatitis, Hepatitis C, Hepatitis C/ Human Immunodeficiency Virus Coinfection
- Trial name
- NCT02103439
- Testing
- Algeron, PegIntron
- Where
- 6 sites in Russia
- Volunteers
- 140 people
- Sponsor
- Biocad
Hepatitis, Hepatitis C
An Open-label Comparative Efficacy and Safety Study of Algeron (Cepeginterferon Alfa-2b) in Treatment-naive Patients With Chronic Hepatitis C
The purpose of the study is to demonstrate the noninferiority of Algeron in combination with ribavirin compared to Pegasys in combination with ribavirin in the treatment of chronic hepatitis C.
- Trial name
- NCT01889433
- Testing
- Algeron, Pegasys
- Where
- 19 sites in Belarus, India and 2 more
- Volunteers
- 170 people
- Sponsor
- 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