37. 膿疱性乾癬（汎発型） Generalised pustular psoriasis Clinical trials / Disease details
臨床試験数 : 74 / 薬物数 : 53 - (DrugBank : 20) / 標的遺伝子数 : 20 - 標的パスウェイ数 : 101
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2013-003086-34-PL (EUCTR) | 18/04/2014 | 10/03/2014 | Study 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 - 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;Belgium;Spain;Poland;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden | ||
| 2 | EUCTR2013-003086-34-IT (EUCTR) | 04/03/2014 | 12/12/2013 | Study 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 FARMA S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;Belgium;Spain;Poland;Austria;Russian Federation;Germany;United Kingdom;Italy;Sweden | ||
| 3 | EUCTR2013-003086-34-BE (EUCTR) | 10/02/2014 | 09/12/2013 | Study 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-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 AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;Poland;Spain;Belgium;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden | ||
| 4 | EUCTR2013-003086-34-DE (EUCTR) | 27/12/2013 | 05/12/2013 | Study 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 - 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;Poland;Belgium;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden | ||
| 5 | EUCTR2013-003086-34-AT (EUCTR) | 17/12/2013 | 28/11/2013 | Study 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 - 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;Poland;Belgium;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden | ||
| 6 | EUCTR2013-003086-34-GB (EUCTR) | 12/12/2013 | 28/11/2013 | Study 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 - 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 AG | NULL | Not 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): no | France;Poland;Belgium;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden | ||
| 7 | EUCTR2013-003086-34-ES (EUCTR) | 09/12/2013 | 05/12/2013 | Study 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. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;Belgium;Poland;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden | ||
| 8 | EUCTR2013-003086-34-SE (EUCTR) | 04/12/2013 | 22/11/2013 | Study 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: 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;Spain;Belgium;Poland;Austria;Russian Federation;Germany;United Kingdom;Italy;Sweden | ||
| 9 | JPRN-JapicCTI-132305 | 01/8/2013 | 18/10/2013 | Study to assess the efficacy, safety and tolerability of secukinumab in Japanese subjects with 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 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. | NULL | 18 | BOTH | Phase 3 | NULL |