Secukinumab 300 mg ( DrugBank: Secukinumab )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
41巨細胞性動脈炎12

41. 巨細胞性動脈炎


臨床試験数 : 131 薬物数 : 139 - (DrugBank : 36) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 125
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PhaseCountries
1NCT05380453
(ClinicalTrials.gov)
September 21, 202222/2/2022Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical RemissionA Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Trial to Investigate the Efficacy and Safety of Subcutaneously Administered Secukinumab in Patients With New-onset of Giant Cell Arteritis (GCA) Who Are in Clinical Remission and Eligible for Treatment With Glucocorticoid-monotherapyGiant Cell ArteritisBiological: Secukinumab 300 mg, s.c.;Drug: Placebo to match Secukinumab, s.c.Novartis PharmaceuticalsNULLRecruiting50 YearsN/AAll146Phase 3Germany
2EUCTR2020-004809-31-SE
(EUCTR)
11/01/202221/10/2021Study of efficacy and safety of secukinumab 300 mg and 150 mg in patients with giant cell arteritis (GCA).A randomized, parallel-group, double-blind, placebo-controlled, multicenter Phase III trial to investigate the efficacy and safety of secukinumab 300 mg and 150 mg administered subcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cell arteritis (GCA) giant cell arteritis
MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe
INN or Proposed INN: SECUKINUMAB
Trade Name: PredniSONE Tablets, USP, 1 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets, USP 2.5 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets, USP 5 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets, USP 10 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
348Phase 3United States;Portugal;Estonia;Spain;Russian Federation;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
3EUCTR2020-004809-31-DK
(EUCTR)
18/11/202101/08/2021Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA).A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (GCA) giant cell arteritis
MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe
INN or Proposed INN: SECUKINUMAB
Trade Name: PredniSONE Tablets USP, 1 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 2.5 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 5 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 10 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Australia;Denmark;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
4EUCTR2020-004809-31-NO
(EUCTR)
16/11/202128/06/2021Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA).A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (GCA) giant cell arteritis
MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe
Product Name: Cosentyx
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Trade Name: PredniSONE Tablets USP, 1 mg
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 2.5 mg
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 5 mg
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 10 mg
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
5EUCTR2020-004809-31-BG
(EUCTR)
08/11/202126/08/2021Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA).A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (GCA) giant cell arteritis
MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cosentyx 300mg solution for injection in pre-filled syringe
INN or Proposed INN: SECUKINUMAB
Trade Name: PredniSONE Tablets USP, 1mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 2.5mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 5mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 20mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
6EUCTR2020-004809-31-DE
(EUCTR)
19/10/202112/07/2021Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA).A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (GCA) giant cell arteritis
MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe
INN or Proposed INN: SECUKINUMAB
Trade Name: PredniSONE Tablets USP, 1 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 2.5 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 5 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 10 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
7EUCTR2020-004809-31-PT
(EUCTR)
13/10/202107/07/2021Study of efficacy and safety of secukinumab 300 mg and 150 mg in patients with giant cell arteritis (GCA).A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate the efficacy and safety of secukinumab 300 mg and 150 mg administered subcutaneously versus placebo, in combination with a glucocorticoid taper regimen, in patients with giant cell arteritis (GCA) giant cell arteritis
MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe
INN or Proposed INN: SECUKINUMAB
Trade Name: PredniSONE Tablets USP, 1 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 2.5 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 5 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 10 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
348Phase 3Russian Federation;United States;Czechia;Portugal;Sweden;Netherlands;Brazil;Guatemala;Poland;France;Bulgaria;Argentina;Hungary;United Kingdom;Switzerland;Spain;New Zealand;Canada;Turkey;Belgium;Norway;Finland;Denmark;South Africa;Italy;Australia;Germany;Estonia
8NCT04930094
(ClinicalTrials.gov)
October 6, 202115/6/2021Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA)A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase III Trial to Investigate the Efficacy and Safety of Secukinumab 300 mg and 150 mg Administered Subcutaneously Versus Placebo, in Combination With a Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA)Giant Cell Arteritis (GCA)Biological: Secukinumab 300 mg;Other: Placebo;Biological: Secukinumab 150 mgNovartis PharmaceuticalsNULLRecruiting50 YearsN/AAll349Phase 3United States;Argentina;Australia;Belgium;Bulgaria;Canada;Czechia;Denmark;Estonia;Finland;France;Germany;Guatemala;Hungary;Italy;Poland;Portugal;Russian Federation;South Africa;Spain;Switzerland;Turkey;United Kingdom
9EUCTR2020-004809-31-FI
(EUCTR)
05/10/202116/07/2021Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA).A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (GCA) giant cell arteritis
MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe
INN or Proposed INN: SECUKINUMAB
Trade Name: PredniSONE Tablets USP, 1 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 2.5 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 5 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 10 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
10EUCTR2020-004809-31-FR
(EUCTR)
24/09/202122/06/2021Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA).A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (GCA) giant cell arteritis
MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cosentyx
Product Name: Cosentyx
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Trade Name: Prednisone
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: Prednisone
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: Prednisone
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: Prednisone
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Belgium;Brazil;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
11EUCTR2020-004809-31-IT
(EUCTR)
16/09/202122/10/2021Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA).A randomized, parallel-group, double-blind, placebo-controlled, multicenter Phase III trial to investigate the efficacy and safety of secukinumab 300 mg administered subcutaneously versus placebo, in combination with a glucocorticoid taper regimen, in patients with giant cell arteritis (GCA) - - Giant cell arteritis
MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Prednisone
Product Name: Prednisone
Product Code: [-]
INN or Proposed INN: PREDNISONE
Trade Name: Prednisone
Product Name: Prednisone
Product Code: [-]
INN or Proposed INN: PREDNISONE
Trade Name: Prednisone
Product Name: Prednisone
Product Code: [-]
INN or Proposed INN: PREDNISONE
Trade Name: Prednisone
Product Name: Prednisone
Product Code: [-]
INN or Proposed INN: PREDNISONE
Trade Name: Cosentyx
Product Name: Cosentyx
Product Code: [AIN457]
INN or Proposed INN: SECUKINUMAB
NOVARTIS PHARMA AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Portugal;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Belgium;Brazil;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
12NCT03765788
(ClinicalTrials.gov)
January 30, 20193/12/2018A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell ArteritisA Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab (AIN457) in Patients With Giant Cell Arteritis (TitAIN)Giant Cell ArteritisDrug: Secukinumab 300 mg, s.c.;Drug: Prednisolone;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted50 YearsN/AAll52Phase 2Germany