Clinical trials: in Russia
Systemic Lupus Erythematosus
Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus
This is a multinational, randomized, placebo-controlled, parallel treatment, Phase 2, double-blind, 2 arm study evaluating the efficacy and safety of SAR441344 in comparison with placebo in the treatment of participants aged 18…
- Trial name
- APATURA (NCT05039840)
- Testing
- SAR441344 IV, SAR441344 SC
- Where
- 73 sites in United States, Argentina and 14 more
- Volunteers
- 109 people
- Sponsor
- Sanofi
AML With FLT3 Mutation
A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation
The purpose of this study was to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated AML who were refractory to or had relapse after first-line AML therapy as shown with…
- Trial name
- NCT03182244
- Testing
- Gilteritinib, Cytarabine, Mitoxantrone
- Where
- 49 sites in China, Malaysia and 3 more
- Volunteers
- 276 people
- Sponsor
- Astellas Pharma Inc
Clear Cell Renal Cell Carcinoma
A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread
The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is…
- Trial name
- CheckMate-67T (NCT04810078)
- Testing
- Nivolumab and rHuPH20, Nivolumab
- Where
- 89 sites in United States, Argentina and 15 more
- Volunteers
- 681 people
- Sponsor
- Bristol-Myers Squibb
Solid Tumors
Avelumab Program Rollover Study
The main purpose of this study is to monitor the safety and tolerability of avelumab in participants with solid tumors who continue treatment with avelumab under the same treatment regimen as in the parent avelumab study.
- Trial name
- NCT03815643
- Testing
- Avelumab
- Where
- 104 sites in United States, Argentina and 20 more
- Volunteers
- 205 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Healthy Volunteers
A Safety and Pharmacokinetics Study of Complarate (Tocilizumab Biosimilar Solution) and Actemra® in Healthy Volunteers
This is a randomized single-blind comparative parallel group study of the safety, pharmacokinetics of the solution form of Complarate and Actemra® in healthy volunteers.
- Trial name
- NCT06488521
- Testing
- Complarate, Actemra®
- Where
- 3 sites in Russia
- Volunteers
- 256 people, healthy volunteers welcome
- Sponsor
- AO GENERIUM
Relapsing Multiple Sclerosis
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS.
- Trial name
- FENhance (NCT04586010)
- Testing
- Fenebrutinib, Teriflunomide
- Where
- 158 sites in United States, Argentina and 21 more
- Volunteers
- 746 people
- Sponsor
- Hoffmann-La Roche
Ovarian Cancer, Breast Cancer
Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies
This research is designed to determine if experimental treatment with PARP inhibitor, AZD5305, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced solid…
- Conditions
- Ovarian Cancer, Breast Cancer, Pancreatic Cancer, Prostate Cancer
- Trial name
- PETRA (NCT04644068)
- Testing
- AZD5305, Paclitaxel, Carboplatin
- Where
- 68 sites in United States, Australia and 12 more
- Volunteers
- 702 people
- Sponsor
- AstraZeneca
ST Elevation Myocardial Infarction
Study of Efficacy and Safety of GNR-060 vs Metalyse in Patients With ST Elevation Myocardial Infarction
GNR-060(JSC "GENERIUM", Russia) is a proposed biosimilar to the referent product Metalyse. This study is to compare the clinical efficacy and safety of GNR-060 vs Metalyse as a thrombolitic agent in patients with with ST…
- Trial name
- NCT05601999
- Testing
- GNR-060, Metalyse
- Where
- 11 sites in Russia
- Volunteers
- 244 people
- Sponsor
- AO GENERIUM
Rhinitis, Allergic, Seasonal
A Clinical Trial for Evaluation of Efficacy, Safety and Immunogenicity of GNR-127 (Recombinant ABP Antigen Protein Which Carries a Birch Pollen Allergen [BET V 1] and an Apple Allergen [MAL D 1]) in Patients With Birch Pollen Allergic Rhinitis.
This is first-in-human phase 1/2 clinical trial to evaluate the safety, systemic and local reactogenicity of GNR-127 at the first stage in sequential cohorts of patients with allergic rhinitis with sensitization to the birch…
- Trial name
- NCT07155499
- Testing
- GNR-127, 20 mcg, GNR-127, 40 mcg, GNR-127, 80 mcg
- Where
- Russia
- Volunteers
- 150 people
- Sponsor
- AO GENERIUM
Mucopolysaccharidosis Type II, Metabolic Diseases
A Multi-cohort Study of Safety, Efficacy, PK and PD of GNR-055 in Patients With Mucopolysaccharidosis Type II
This is phase 2/3 study to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of the investigational product GNR-055 in MPS II (Hunter syndrome) patients of different age groups.
- Trial name
- NCT05208281
- Testing
- GNR-055 1.0-2.0-3.0 mg/kg, GNR-055 2.0 mg/kg, GNR-055 3.0 mg/kg
- Where
- 5 sites in Russia
- Volunteers
- 32 people
- Sponsor
- AO GENERIUM
B-precursor Acute Lymphoblastic Leukemia, ALL
GNR-084 Safety and Pharmacological Characteristics in Refractory or Relapse B-cell Precursor ALL
It is an open-label dose-escalating study in sequential cohorts to assess safety and pharmacokinetics of GNR-084.
- Conditions
- B-precursor Acute Lymphoblastic Leukemia, ALL, GNR-084
- Trial name
- NCT04601584
- Testing
- Cohort 1, GNR-084, Cohort 2, GNR-084, Cohort 3, GNR-084
- Where
- 3 sites in Russia
- Volunteers
- 14 people
- Sponsor
- AO GENERIUM
Psychological Stress, Anesthesia
RELIEF OF PSYCHOEMOTIONAL STRESS USING XENON SEDATION
The goal of this clinical trial is to propose for implementation and evaluate the effectiveness of xenon sedation for the relief of psychoemotional stress disorder before the operation of refractive laser vision correction…
- Conditions
- Psychological Stress, Anesthesia, Anxiety, Xenon
- Trial name
- NCT06080100
- Testing
- Xenon, premedication hydroxyzine 25 mg
- Where
- Russia
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- The S.N. Fyodorov Eye Microsurgery State Institution
Plaque Psoriasis
An Efficacy and Safety Study of GNR-068 (Ustekinumab Biosimilar) and Stelara® in the Treatment of Patients With Moderate to Severe Plaque Psoriasis
This is a randomized single-blind comparative parallel group efficacy and safety study of ustekinumab biosimilar GNR-068 (45 mg) and reference product Stelara® (45 mg) in the treatment of patients with moderate and severe forms…
- Trial name
- NCT06488664
- Testing
- GNR-068, Stelara®
- Where
- 34 sites in Russia
- Volunteers
- 422 people
- Sponsor
- AO GENERIUM
Heterozygous or Homozygous Familial Hypercholesterolemia
Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20, or ORION-19 Studies
The purpose of this open-label, single arm, multicenter extension study is to evaluate the long-term safety and tolerability of inclisiran in participants with HeFH or HoFH who have completed the ORION-16 (CKJX839C12301)…
- Trial name
- V-PEDS-OLE (NCT05682378)
- Testing
- Inclisiran
- Where
- 52 sites in United States, Argentina and 24 more
- Volunteers
- 195 people
- Sponsor
- Novartis Pharmaceuticals
Pudendal Neuralgia Pudendal Nerve Entrapment Chronic Pelvic Pain
Pudendal Nerve Block With Articaine and Triamcinolone for Pudendal Neuralgia
This study is testing whether an injection of local anesthetic (articaine) combined with a steroid (triamcinolone), placed near the pudendal nerve under ultrasound guidance, can reduce pain in people with pudendal neuralgia - a…
- Trial name
- NCT07828574
- Testing
- Articaine and triamcinolone
- Where
- Russia
- Volunteers
- 120 people
- Sponsor
- Irkutsk State Medical University
Advanced Malignancies, Ovarian Cancer
BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)
The goal of this first in human clinical trial is to test BI-1808 administered as single agent and in combination with pembrolizumab in subjects with advanced malignancies whose disease has progressed after standard therapy.
- Conditions
- Advanced Malignancies, Ovarian Cancer, T-cell Lymphoma, Melanoma
- Trial name
- NCT04752826
- Testing
- BI-1808, Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection, Paclitaxel 80 mg/m2 weekly
- Where
- 25 sites in United States, Denmark and 5 more
- Volunteers
- 250 people
- Sponsor
- BioInvent International AB
Gestational Diabetes Mellitus (GDM)
The Role of Hormonal and Metabolic Disorders in the Debelopment of Gestational Diabetes Mellitus
The work was carried out at the V. P. Demikhov City Clinical Hospital, a clinical base of the Department, and consisted of two consecutive stages, during which clinical material was collected between 2019 and 2021≥5.1mmol/L, but…
- Trial name
- GDM (NCT07652554)
- Where
- Russia
- Volunteers
- 601 people
- Sponsor
- Pirogov Russian National Research Medical University
Endometrial Neoplasms
Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)
The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the…
- Trial name
- NCT04634877
- Testing
- Pembrolizumab, Carboplatin, Paclitaxel
- Where
- 231 sites in United States, Argentina and 26 more
- Volunteers
- 990 people
- Sponsor
- Merck Sharp & Dohme LLC
Bleeding Post-mechanical Valve Replacement, Thromboembolism Post-mechanical Valve Replacement
Low INR to Minimize Bleeding With Mechanical Valves Trial
This study evaluates the use of a lower INR target (1.5 to 2.5) in patients with a mechanical bileaflet heart valve in the aortic position.
- Trial name
- LIMIT (NCT03636295)
- Testing
- Warfarin
- Where
- 45 sites in Belgium, Botswana and 16 more
- Volunteers
- 2,625 people
- Sponsor
- Population Health Research Institute
Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell
A Phase 1 Study of GNR-051 in Subjects With Advanced Malignancies
It is a Phase 1 Multicenter Open-Label Multi-Cohort Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GNR-051 in Subjects with Advanced Solid Malignancies.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Melanoma
- Trial name
- NCT04544748
- Testing
- GNR-051
- Where
- 12 sites in Russia
- Volunteers
- 48 people
- Sponsor
- AO GENERIUM
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