37. 膿疱性乾癬(汎発型) Generalised pustular psoriasis Clinical trials / Disease details


臨床試験数 : 79 薬物数 : 57 - (DrugBank : 21) / 標的遺伝子数 : 20 - 標的パスウェイ数 : 102

  
12 trials found
No.TrialIDDate_
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PhaseCountries
1JPRN-JapicCTI-184065
22/8/201815/08/2018I6T-MC-AMAJA Multicenter Randomized Double-Blind Placebo-Controlled Study Comparing the Efficacy and Safety of Mirikizumab to Secukinumab and Placebo in Patients with Moderate-to-Severe Plaque Psoriasis OASIS-2 Psoriasis valgaris, Generalized pustular psoriasis, Erythrodermic psoriasisIntervention name : LY3074828
INN of the intervention : mirikizumab
Dosage And administration of the intervention : Administered subcutaneous injection
Control intervention name : Secukinumab
INN of the control intervention : secukinumab
Dosage And administration of the control intervention : Administered subcutaneous injection
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Administered subcutaneous injection
Eli Lilly Japan K.K.NULLcomplete20BOTH120Phase 3Japan, Asia except Japan, North America, South America, Europe, Oceania
2EUCTR2013-003086-34-PL
(EUCTR)
18/04/201410/03/2014Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular PsoriasisA 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks moderate to severe chronic palmoplantar pustular psoriasis
MedDRA version: 17.1;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 17.1;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
210Phase 3France;Belgium;Spain;Poland;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden
3EUCTR2013-003086-34-IT
(EUCTR)
04/03/201412/12/2013Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular PsoriasisA 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis moderate to severe chronic palmoplantar pustular psoriasis
MedDRA version: 14.1;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 14.1;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Other descriptive name: SECUKINUMAB
NOVARTIS FARMA S.p.A.NULLNot RecruitingFemale: yes
Male: yes
210Phase 3France;Belgium;Spain;Poland;Austria;Russian Federation;Germany;United Kingdom;Italy;Sweden
4EUCTR2013-003086-34-BE
(EUCTR)
10/02/201409/12/2013Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular PsoriasisA 52-week, multicenter, randomized, double-blind, placebo-controlledstudy of subcutaneous secukinumab to demonstrate efficacy as assessedby palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at16 weeks of treatment, compared to placebo, and to assess long-termsafety, tolerability, and efficacy in subjects with moderate to severechronic palmoplantar pustular psoriasis - amended with an optionalextension treatment period of up to a total of 148 weeks moderate to severe chronic palmoplantar pustular psoriasis
MedDRA version: 20.0;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 100000018190;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Secukinumab 150 mg/1 mL Solution for injection
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
210Phase 3France;Poland;Spain;Belgium;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden
5EUCTR2013-003086-34-DE
(EUCTR)
27/12/201305/12/2013Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular PsoriasisA 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks moderate to severe chronic palmoplantar pustular psoriasis
MedDRA version: 19.0;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 19.0;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Secukinumab
Product Code: AIN457, 150mg
INN or Proposed INN: SECUKINUMAB
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
210Phase 3France;Poland;Belgium;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden
6NCT02008890
(ClinicalTrials.gov)
December 26, 20138/12/2013Palmoplantar Pustular Psoriasis Efficacy and Safety With SecukinumabA 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Palmoplantar Pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 Weeks of Treatment, Compared to Placebo, and to Assess Long-term Safety, Tolerability, and Efficacy in Subjects With Moderate to Severe Chronic Palmoplantar Pustular Psoriasis - Amended With an Optional Extension Treatment Period of up to a Total of 148 WeeksPalmoplantar Pustular PsoriasisBiological: Secukinumab 300mg;Biological: Secukinumab 150mg;Biological: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll237Phase 3Austria;Belgium;France;Germany;Italy;Poland;Russian Federation;Spain;Sweden;United Kingdom
7EUCTR2013-003086-34-AT
(EUCTR)
17/12/201328/11/2013Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular PsoriasisA 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks moderate to severe chronic palmoplantar pustular psoriasis
MedDRA version: 18.0;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 18.0;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
210Phase 3France;Poland;Belgium;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden
8EUCTR2013-003086-34-GB
(EUCTR)
12/12/201328/11/2013Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular PsoriasisA 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks. moderate to severe chronic palmoplantar pustular psoriasis
MedDRA version: 17.1;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 17.1;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Poland;Belgium;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden
9EUCTR2013-003086-34-ES
(EUCTR)
09/12/201305/12/2013Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular Psoriasis.A 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis. Moderate to severe chronic palmoplantar pustular psoriasis.
MedDRA version: 14.1;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 14.1;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
210Phase 3France;Belgium;Poland;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden
10EUCTR2013-003086-34-SE
(EUCTR)
04/12/201322/11/2013Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular PsoriasisA 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis Moderate to severe chronic palmoplantar pustular psoriasis
MedDRA version: 16.1;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 16.1;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
210Phase 3France;Spain;Belgium;Poland;Austria;Russian Federation;Germany;United Kingdom;Italy;Sweden
11NCT01952015
(ClinicalTrials.gov)
August 21, 201324/9/2013Study to Assess the Efficacy, Safety and Tolerability of Secukinumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)A Multi-center, Open Label Study of Subcutaneous Secukinumab in Prefilled Syringes as Mono- or Co-therapy to Assess the Efficacy, Safety and Tolerability in Japanese Subjects With Generalized Pustular PsoriasisPsoriasisBiological: SecukinumabNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll12Phase 3Japan
12JPRN-JapicCTI-132305
01/8/201318/10/2013Study to assess the efficacy, safety and tolerability of secukinumab in Japanese subjects with GPPA multi-center, open label study of subcutaneous secukinumab in prefilled syringes as mono- or co-therapy to assess the efficacy, safety and tolerability up to 52 weeks in Japanese subjects with generalized pustular psoriasis Generalized Pustular Psoriasis (GPP)Intervention name : AIN457
INN of the intervention : Secukinumab
Dosage And administration of the intervention : Secukinumab 150 mg, provided in a 1 mL prefilled syringe (one syringe for 150 mg dose, two syringes for the 300 mg dose)
Control intervention name : null
Novartis Pharma K.K.NULL18BOTHPhase 3NULL