66. IgA腎症 IgA nephropathy Clinical trials / Disease details


臨床試験数 : 275 薬物数 : 258 - (DrugBank : 82) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 140

  
28 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-001049-38-SK
(EUCTR)
08/07/202231/05/2022Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Slovakia;Thailand;Spain;Russian Federation;Israel;Chile;Colombia;Italy;India;France;Malaysia;Viet Nam;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Norway;Germany;Japan;Sweden
2EUCTR2020-001049-38-SI
(EUCTR)
01/07/202202/06/2022Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Slovakia;Thailand;Spain;Russian Federation;Israel;Chile;Colombia;Italy;India;France;Malaysia;Viet Nam;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Norway;Germany;Japan;Sweden
3EUCTR2020-002200-40-DK
(EUCTR)
11/01/202202/07/2021A rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathyA multicenter rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy who have completed study CLNP023X2203 or CLNP023A2301 IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
427Phase 3United States;Hong Kong;Taiwan;Spain;Thailand;Israel;Russian Federation;Colombia;Italy;India;France;Malaysia;Viet Nam;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
4EUCTR2020-002200-40-NO
(EUCTR)
14/10/202126/08/2021A rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathyA multicenter rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy who have completed study CLNP023X2203 or CLNP023A2301 IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
427Phase 3Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden;United States;Hong Kong;Taiwan;Spain;Thailand;Israel;Russian Federation;Colombia;Italy;India;Vietnam;France
5EUCTR2020-002200-40-CZ
(EUCTR)
11/10/202121/07/2021A rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathyA multicenter rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy who have completed study CLNP023X2203 or CLNP023A2301 IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
427Phase 3United States;Hong Kong;Taiwan;Spain;Thailand;Israel;Russian Federation;Colombia;Italy;India;France;Malaysia;Viet Nam;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
6EUCTR2020-002200-40-NL
(EUCTR)
14/09/202123/07/2021A rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathyA multicenter rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy who have completed study CLNP023X2203 or CLNP023A2301 IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
427Phase 3Colombia;Italy;India;France;Malaysia;Viet Nam;Australia;Denmark;United States;Hong Kong;Taiwan;Spain;Thailand;Israel;Russian Federation;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
7EUCTR2020-002200-40-DE
(EUCTR)
05/08/202124/06/2021A rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathyA multicenter rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy who have completed study CLNP023X2203 or CLNP023A2301 IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
427Phase 3United States;Hong Kong;Taiwan;Spain;Thailand;Israel;Russian Federation;Colombia;Italy;India;France;Malaysia;Viet Nam;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
8EUCTR2020-001049-38-CZ
(EUCTR)
13/05/202102/02/2021Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Spain;Thailand;Israel;Russian Federation;Colombia;Italy;India;France;Malaysia;Viet Nam;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
9EUCTR2020-001049-38-NL
(EUCTR)
04/05/202117/11/2020Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Spain;Thailand;Israel;Russian Federation;Colombia;Italy;India;France;Malaysia;Viet Nam;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
10EUCTR2020-001049-38-NO
(EUCTR)
16/03/202119/11/2020Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Spain;Thailand;Russian Federation;Israel;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
11EUCTR2020-001049-38-SE
(EUCTR)
23/02/202102/11/2020Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Spain;Thailand;Israel;Russian Federation;Colombia;Italy;India;France;Malaysia;Viet Nam;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
12EUCTR2020-001049-38-BE
(EUCTR)
17/02/202117/02/2021Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Spain;Thailand;Russian Federation;Israel;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
13EUCTR2020-001049-38-FR
(EUCTR)
13/01/202102/11/2020Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Thailand;Spain;Israel;Russian Federation;Colombia;Italy;Vietnam;India;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
14EUCTR2020-001049-38-DK
(EUCTR)
07/01/202111/11/2020Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Spain;Thailand;Israel;Russian Federation;Colombia;Italy;India;France;Malaysia;Viet Nam;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
15EUCTR2020-001049-38-FI
(EUCTR)
31/12/202010/12/2020Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Slovakia;Thailand;Spain;Russian Federation;Israel;Chile;Colombia;Italy;India;France;Malaysia;Viet Nam;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Norway;Germany;Japan;Sweden
16EUCTR2020-001049-38-HU
(EUCTR)
17/12/202027/10/2020Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Thailand;Spain;Israel;Russian Federation;Colombia;Italy;Vietnam;India;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
17EUCTR2020-001049-38-DE
(EUCTR)
17/12/202006/11/2020Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Slovakia;Thailand;Spain;Russian Federation;Israel;Chile;Colombia;Italy;India;France;Malaysia;Viet Nam;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Norway;Germany;Japan;Sweden
18EUCTR2017-000891-27-IT
(EUCTR)
18/12/201930/09/2019Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
19EUCTR2017-000891-27-FR
(EUCTR)
29/10/201912/08/2019Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
20EUCTR2017-000891-27-CZ
(EUCTR)
10/10/201903/07/2019Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
96Phase 2United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
21EUCTR2017-000891-27-HU
(EUCTR)
25/09/201930/07/2019Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 2Germany;Norway;Japan;Sweden;United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore
22EUCTR2017-000891-27-DK
(EUCTR)
25/05/201811/04/2018A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
96Phase 2United States;Philippines;Hong Kong;Taiwan;Spain;Thailand;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
23EUCTR2017-000891-27-NL
(EUCTR)
25/05/201809/04/2018A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
96Phase 2United States;Philippines;Hong Kong;Taiwan;Spain;Thailand;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
24EUCTR2017-000891-27-BE
(EUCTR)
22/05/201819/03/2018A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
25EUCTR2017-000891-27-DE
(EUCTR)
06/04/201824/11/2017A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
96Phase 2Belgium;Singapore;Germany;Norway;Japan;Sweden;United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil
26EUCTR2017-000891-27-SE
(EUCTR)
19/02/201817/10/2017A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
96Phase 2United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
27EUCTR2017-000891-27-FI
(EUCTR)
09/01/201823/11/2017A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
96Phase 2United States;Philippines;Hong Kong;Taiwan;Spain;Thailand;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
28EUCTR2017-000891-27-GB
(EUCTR)
21/11/201706/10/2017A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 2United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden