Generium Trials - LARVOL Sigma

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10 Trials

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Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

Elizaria (eculizumab biosimilar) / Generium

NAP, NCT04671810: Prospective Observational Study of Long-term Pathogenic Treatment of Elizaria®

Completed

N/A

RoW

Elizaria®, Eculizumab

AO GENERIUM

Paroxysmal Nocturnal Hemoglobinuria

12/22

05/23

Genolair (omalizumab biosimilar) / Generium

OMA-COMP-I, NCT06494345: A Study of Genolair in Two Dosage Forms (Solution and Lyophilisate) and Xolair® in Healthy Volunteers

Completed

180

RoW

Genolair, solution for subcutaneous administration, 150 mg, Omalizumab biosimilar solution, Genolair, lyophilisate for the preparation of solution for subcutaneous administration, Omalizumab biosimilar lyophilisate, Xolair®, solution for subcutaneous administration, 150 mg, Omalizumab solution

AO GENERIUM

Allergic Asthma

06/24

verenafusp alfa (GNR-055) / Generium

NCT05208281: A Multi-cohort Study of Safety, Efficacy, PK and PD of GNR-055 in Patients With Mucopolysaccharidosis Type II

Recruiting

2/3

RoW

GNR-055 1.0-2.0-3.0 mg/kg, GNR-055, GNR-055 2.0 mg/kg, GNR-055 3.0 mg/kg

AO GENERIUM

Mucopolysaccharidosis Type II, Metabolic Diseases

02/25

03/28

NCT06475404: A Study of the Tolerance, Safety, and Pharmacokinetics of GNR-055 in Healthy Volunteers

Completed

RoW

verenafusp alfa 6 mg/kg, GNR-055, verenafusp alfa 9 mg/kg, verenafusp alfa 12 mg/kg

AO GENERIUM

Mucopolysaccharidosis Type II, Metabolic Diseases

09/23

GNR-051 / Generium

NCT04544748: A Phase 1 Study of GNR-051 in Subjects With Advanced Malignancies

Active, not recruiting

RoW

GNR-051

AO GENERIUM

Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Melanoma

11/22

01/25

GNR-084 / Generium

NCT04601584: GNR-084 Safety and Pharmacological Characteristics in Refractory or Relapse B-cell Precursor ALL

Recruiting

1/2

RoW

Cohort 1, GNR-084, Anti-CD19/CD3 antibody, Cohort 2, GNR-084, Cohort 3, GNR-084, Cohort 4, GNR-084, Cohort 5, GNR-084, Cohort 6, GNR-084

AO GENERIUM

B-precursor Acute Lymphoblastic Leukemia, ALL, GNR-084

02/25

06/25

GNR-067 (ranibizumab biosimilar) / Generium

NAP, NCT04667039: Efficacy, Safety, pharmacokinetiсs, Immunogenicity of GNR-067 and Lucentis®

Recruiting

408

RoW

GNR-067, Ranibizumab, Lucentis®

AO GENERIUM

Age Related Macular Degeneration (ARMD)

08/24

09/24

Stimplate (romiplostim biosimilar) / Generium

NCT05220878: Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP

Completed

160

RoW

GNR-069, romiplostim, Nplate

AO GENERIUM

Idiopathic Thrombocytopenic Purpura

08/23

10/23

NCT05492409: Study of the Safety and Immunogenicity of Long-term GNR-069 Therapy in ITP Patients

Completed

160

RoW

GNR-069, romiplostim

AO GENERIUM

Idiopathic Thrombocytopenic Purpura

04/24

GNR-060 (tenecteplase biosimilar) / Generium

NCT05601999: Study of Efficacy and Safety of GNR-060 vs Metalyse in Patients With ST Elevation Myocardial Infarction

Recruiting

244

RoW

GNR-060, Tenecteplase, Metalyse

AO GENERIUM

ST Elevation Myocardial Infarction

10/24

Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

Elizaria (eculizumab biosimilar) / Generium

NAP, NCT04671810: Prospective Observational Study of Long-term Pathogenic Treatment of Elizaria®

Completed

N/A

RoW

Elizaria®, Eculizumab

AO GENERIUM

Paroxysmal Nocturnal Hemoglobinuria

12/22

05/23

Genolair (omalizumab biosimilar) / Generium

OMA-COMP-I, NCT06494345: A Study of Genolair in Two Dosage Forms (Solution and Lyophilisate) and Xolair® in Healthy Volunteers

Completed

180

RoW

AO GENERIUM

Allergic Asthma

06/24

verenafusp alfa (GNR-055) / Generium

NCT05208281: A Multi-cohort Study of Safety, Efficacy, PK and PD of GNR-055 in Patients With Mucopolysaccharidosis Type II

Recruiting

2/3

RoW

GNR-055 1.0-2.0-3.0 mg/kg, GNR-055, GNR-055 2.0 mg/kg, GNR-055 3.0 mg/kg

AO GENERIUM

Mucopolysaccharidosis Type II, Metabolic Diseases

02/25

03/28

NCT06475404: A Study of the Tolerance, Safety, and Pharmacokinetics of GNR-055 in Healthy Volunteers

Completed

RoW

verenafusp alfa 6 mg/kg, GNR-055, verenafusp alfa 9 mg/kg, verenafusp alfa 12 mg/kg

AO GENERIUM

Mucopolysaccharidosis Type II, Metabolic Diseases

09/23

GNR-051 / Generium

NCT04544748: A Phase 1 Study of GNR-051 in Subjects With Advanced Malignancies

Active, not recruiting

RoW

GNR-051

AO GENERIUM

Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Melanoma

11/22

01/25

GNR-084 / Generium

NCT04601584: GNR-084 Safety and Pharmacological Characteristics in Refractory or Relapse B-cell Precursor ALL

Recruiting

1/2

RoW

Cohort 1, GNR-084, Anti-CD19/CD3 antibody, Cohort 2, GNR-084, Cohort 3, GNR-084, Cohort 4, GNR-084, Cohort 5, GNR-084, Cohort 6, GNR-084

AO GENERIUM

B-precursor Acute Lymphoblastic Leukemia, ALL, GNR-084

02/25

06/25

GNR-067 (ranibizumab biosimilar) / Generium

NAP, NCT04667039: Efficacy, Safety, pharmacokinetiсs, Immunogenicity of GNR-067 and Lucentis®

Recruiting

408

RoW

GNR-067, Ranibizumab, Lucentis®

AO GENERIUM

Age Related Macular Degeneration (ARMD)

08/24

09/24

Stimplate (romiplostim biosimilar) / Generium

NCT05220878: Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP

Completed

160

RoW

GNR-069, romiplostim, Nplate

AO GENERIUM

Idiopathic Thrombocytopenic Purpura

08/23

10/23

NCT05492409: Study of the Safety and Immunogenicity of Long-term GNR-069 Therapy in ITP Patients

Completed

160

RoW

GNR-069, romiplostim

AO GENERIUM

Idiopathic Thrombocytopenic Purpura

04/24

GNR-060 (tenecteplase biosimilar) / Generium

NCT05601999: Study of Efficacy and Safety of GNR-060 vs Metalyse in Patients With ST Elevation Myocardial Infarction

Recruiting

244

RoW

GNR-060, Tenecteplase, Metalyse

AO GENERIUM

ST Elevation Myocardial Infarction

10/24

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