A5090816037- Rheumatoid Arthritis Research and Therapies
- Multiple Sclerosis Research Studies
- Psoriasis: Treatment and Pathogenesis
- Autoimmune and Inflammatory Disorders Research
- Spondyloarthritis Studies and Treatments
- Systemic Lupus Erythematosus Research
- Peripheral Neuropathies and Disorders
- Cancer Immunotherapy and Biomarkers
- Polyomavirus and related diseases
- Immunotherapy and Immune Responses
- Monoclonal and Polyclonal Antibodies Research
- CAR-T cell therapy research
- COVID-19 Clinical Research Studies
- RNA modifications and cancer
- Neurogenetic and Muscular Disorders Research
- Congenital Anomalies and Fetal Surgery
- Cytokine Signaling Pathways and Interactions
- Lymphoma Diagnosis and Treatment
- Dermatologic Treatments and Research
- Long-Term Effects of COVID-19
- COVID-19 Impact on Reproduction
- Coagulation, Bradykinin, Polyphosphates, and Angioedema
- Asthma and respiratory diseases
- Retinoids in leukemia and cellular processes
- Skin Diseases and Diabetes
BIOCAD (Russia)
2017-2025
Abstract Objective and design The aim of this double-blind, placebo-controlled, phase III CORONA clinical trial was to evaluate the efficacy safety IL-6 receptor inhibitor levilimab (LVL) in subjects with severe COVID-19. Subjects study included 217 patients. eligible were men non-pregnant women aged 18 years or older, hospitalized for COVID-19 pneumonia. Treatment 206 randomized (1:1) receive single subcutaneous administration LVL 324 mg placebo, both combination standard care (SOC). 204...
Netakimab (NTK), an original humanized anti-interleukin-17 monoclonal antibody, showed therapeutic efficacy in moderate-to-severe plaque psoriasis a phase 2 clinical study. Herein we report the results of 54 weeks 3 PLANETA trial aimed to evaluate and safety two NTK regimens vs. placebo.
The aim – to evaluate the clinical effectiveness, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of seniprutug (BCD-180) in patients with radiographic active axial spondyloarthritis (r-axSpA, or ankylosing spondylitis). Subjects methods . 260 r-axSpA inadequate response nonsteroidal anti-inflammatory drugs (NSAIDs) were randomized into three groups: at doses 5 mg/kg 7 mg/kg, placebo. BCD-180 was administered on weeks 0–12–36. Patients placebo group switched a dose week 24...
To evaluate the efficacy and safety of anti-CD20 monoclonal antibody divozilimab (DIV) used as an intravenous infusion at a dose 500 mg every 24 weeks during 100 for treatment patients with multiple sclerosis (MS), including relapsing-remitting (RRMS) secondary progressive MS (SPMS) relapses.
The search for new therapeutic options the treatment of systemic sclerosis (SSc) is an urgent issue in rheumatology. article presents results double-blind, randomized, placebo-controlled phase III clinical trial BCD-132-5/LIBERIUS on efficacy and safety divozilimab (BCD-132) SSc. Objective : to investigate patients with SSc compared placebo. Material methods . After enrolment study, received or placebo 48 weeks, after which they were switched open-label therapy until week 96. Results...
Levilimab (LVL) is a monoclonal antibody against the interleukin-6 receptor (IL6R). The article presents data obtained during 56 weeks of AURORA phase II study. Objective : to evaluate efficacy safety and immunogenicity LVL in methotrexate (MTX) resistant patients with active rheumatoid arthritis (RA). Materials methods . 105 RA were randomized 1:1:1 ratio into two or placebo groups. was administered subcutaneously at dose 162 mg every week (QW) other (Q2W). All received MTX. After...
In recent years, there has been a significant increase in the number of patients with malignancies treated immune checkpoint inhibitors (ICIs), including anti-programmed cell death protein 1 (anti–PD-1) agent pembrolizumab. One important aspects conducting clinical trials ICIs is assessment risk developing immune-related adverse events (irAEs). The aim study was to evaluate safety pembrolizumab biosimilar (BCD-201, Pembroria) compared reference medicinal product using results phase I trial...
Netakimab (NTK) is a humanized anti-interleukin-17A monoclonal antibody. To date, the drug has been approved to treat ankylosing spondylitis (AS), psoriatic arthritis, and plaque psoriasis. The paper gives data obtained during 52-week follow-up of AS patients in phase III ASTERA study. Objective : study efficacy safety NTK when used long with active AS. Patients methods . investigation enrolled 228 AS, whom nonsteroidal anti-inflammatory drugs or biological agents were ineffective....
To evaluate the efficacy and safety of samPEG-IFN-β1a 180 μg 240 administered once every 2 weeks for treatment relapsing remitting multiple sclerosis (RRMS) compared to placebo low dose interferon beta-1a (LIB) 30 weekly. The primary endpoint after 52 therapy was time first relapse, hypotheses non-inferiority superiority LIB were tested.This international, multicenter, double blind, comparative, placebo-controlled clinical study enrolled 399 patients with diagnosis RRMS, randomized in 4...
To find the optimal therapeutic dose of anti-B cell mAb divozilimab (DIV) based on efficacy and safety data intravenous administration at a 125 mg or 500 in patients with relapsing remitting multiple sclerosis (RRMS) compared to placebo (PBO) teriflunomide (TRF). study DIV within 24 weeks treatment.A multicenter, randomized, double-blind double-masked, placebo-controlled phase 2 clinical trial (CT) BCD-132-2 involved 271 adult RRMS from 25 centres In Russia. Patients were randomly assigned...
Levilimab is anti-interleukin-6 receptor (IL6R) monoclonal antibody. The article presents data obtained during 24 weeks of the SOLAR phase III study. Objective : to confirm efficacy and safety levilimab in combination with methotrexate (MTX) patients resistant active rheumatoid arthritis (RA). Patients methods . 154 adult patients, aged ≥18 years diagnosis RA (ACR/EULAR 2010) confirmed disease activity at screening despite treatment MTX for least 12 (in a stable dose 15-25 mg/week). were...
Netakimab is a humanized anti-interleukin-17А monoclonal antibody approved for the treatment of psoriatic arthritis, ankylosing spondylitis, moderate to severe psoriasis. Herein, we report accumulated efficacy data and safety findings 54-week netakimab during PATERA study. The aim study was assess long-term in patients with active arthritis. Materials methods. 194 arthritis despite previous therapy nonsteroidal anti-inflammatory drugs, conventional or biologic disease-modifying antirheumatic...
To assess the efficacy and safety of sampeginterferon-β1a (samPEG-IFN-β1a) 180 μg 240 administered once every 2 weeks compared to placebo low dose interferon beta-1a (LIB) 30 weekly.Patients with relapsing-remitting multiple sclerosis aged 18-60 years, Expanded Disability Status Scale score ≤5.5 were randomized at a ratio 2:2:2:1 following groups: samPEG-IFN-β1a µg, LIB, placebo. After 20 weeks, group completed study. week 52, final analysis was performed, which included primary endpoint...
To evaluate the efficacy and safety of anti-CD20 monoclonal antibody divozilimab (DIV) used as an intravenous infusion at a dose 500 mg for treatment patients with relapsing-remitting multiple sclerosis (RRMS) in comparison teriflunomide (TRF). The study use drug DIV was carried out 48 weeks therapy.The multicenter, randomized, double-blind double-masked phase III clinical trial (CT) BCD-132-4/MIRANTIBUS included 338 adult RRMS distributed 1:1 ratio into two groups: TRF 14 mg. After...
Background. In an era of breakthroughs in cancer immunotherapy, CheckMate 067 studies declared the combination PD-1 and CTLA-4 inhibitors a new standard care for patients with metastatic melanoma (MM). A significant limitation widespread use ipilimumab nivolumab routine clinical practice is high risk severe immune-mediated adverse events. Prolgolimab nurulimab are fixed doses original monoclonal antibodies (manufactured by JSC "BIOCAD," Russia) to receptor (prolgolimab) (nurulimab) (3:1...
To study the pharmacokinetics, pharmacodynamics, and immunogenicity of two intravenous dosing regimens new anti-B-cells drug BCD-132 (JSC BIOCAD, Russia) at ascending doses in patients with remitting multiple sclerosis.
To evaluate the efficacy and safety of BCD 054 180 μg 240 administered once every 2 weeks for treatment remitting multiple sclerosis compared to placebo low dose interferon beta-1a (LIB) 30 weekly. Results a 20 week blinded interim analysis from double blind, comparative, randomised, placebo-controlled clinical study are included.
Background . Previously, 24-week results of phase III double-blind, placebo-controlled randomized clinical study (SOLAR) levilimab in subjects with active rheumatoid arthritis (RA) proved a superiority over placebo. Here we present 1-year efficacy and safety data the SOLAR study. Objective – to evaluate combination methotrexate (MTX) MTX resistant RA. Methods The was conducted at 21 sites Russia Belarus. All have completed between November 2019 October 2021.154 adults, aged ≥18 years...
To prove the equivalent efficacy of teberif (BCD-033, interferon beta-1) and rebif (interferon beta-1a) in patients with remitting multiple sclerosis (RMS).A multicenter double blind placebo-controlled comparative randomized III phase study included 163 RMS. Patients were into three equal groups (teberif, or placebo).After 52 weeks, brand drug was shown. The result assessment primary endpoint, which combined unique active (CUA) lesion (the total MRI T1-weighted lesions new newly enlarging...
To evaluate efficacy, safety, and tolerability of the treatment with teberif/interferon β-1a, to analyze dynamics key efficacy variables after switching from referent drug rebif biosimilar teberif in patients remitting multiple sclerosis (RMS).During main period international multicenter randomized study were receive for 52 weeks, or placebo 16 weeks safety treatment. After period, group-independently switched take open-label during next 48 weeks.The analysis evaluation parameters efficiency...
Background. Netakimab, a recombinant humanized monoclonal antibody, specifically binding to IL-17 blocks its activity resulting in plaque psoriasis signs decrease. The results of the first year BCD-085-7/PLANETA study showed high efficacy and favorable safety profile treatment patients with moderate-to-severe psoriasis.
 Aims. Efficacy assessments netakimab through 2 years Materials methods. is ongoing Randomized, Double-blind, Placebo-Controlled Phase III clinical study. In study, 213...