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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05239039
(ClinicalTrials.gov)
March 31, 20223/2/2022An Expanded Access Program in China to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment OptionsMulti-centre, Open-label, Expanded Access Program of 900mg Intravenous (i.v.) Spesolimab in Patients With Generalized Pustular Psoriasis (GPP) Presenting With a FlareGeneralized Pustular PsoriasisDrug: spesolimabBoehringer IngelheimNULLNot yet recruiting18 Years75 YearsAll30Phase 3NULL
2NCT05200247
(ClinicalTrials.gov)
February 17, 202211/1/2022An Expanded Access Trial in Japan to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment OptionsMulti-centre, Open-label, Expanded Access Trial of Spesolimab i.v. in Patients With Generalized Pustular Psoriasis (GPP) Presenting With a FlareGeneralized Pustular PsoriasisDrug: spesolimabBoehringer IngelheimNULLRecruiting20 Years75 YearsAll3Phase 3Japan
3EUCTR2021-001447-27-ES
(EUCTR)
07/02/202212/11/2021A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects with Generalized Pustular PsoriasisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects with Generalized Pustular Psoriasis - Efficacy and Safety of Imsidolimab in Subjects with Generalized Pustular Psoriasis Subjects with generalized pustular psoriasis
MedDRA version: 20.0;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: ANB019
INN or Proposed INN: anti-IL-36R monoclonal antibody
AnaptysBio Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 3Taiwan;Thailand;Malaysia;Spain;Australia;Georgia;Germany;Korea, Republic of
4EUCTR2018-003080-56-ES
(EUCTR)
07/02/202214/12/2021A 5-year study to test BI 655130 in patients with GeneralizedPustular Psoriasis who took part in previous studies with BI655130An open-label, long term extension study to assess the safety andefficacy of BI 655130 treatment in patients with GeneralizedPustular Psoriasis (GPP) Generalized Pustular Psoriasis
MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim España S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2United States;Philippines;Taiwan;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;South Africa;Netherlands;Tunisia;China;Korea, Republic of;Czechia;Turkey;Egypt;Mexico;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan
5EUCTR2021-001448-90-FR
(EUCTR)
02/02/202205/10/2021A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects with Generalized Pustular PsoriasisA Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects with Generalized Pustular Psoriasis - Long-Term Safety and Efficacy of Imsidolimab in Subjects with Generalized Pustular Psoriasis Subjects with generalized pustular psoriasis
MedDRA version: 20.0;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: ANB019
INN or Proposed INN: anti-IL-36R monoclonal antibody
AnaptysBio Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 3France;Taiwan;Spain;Malaysia;Thailand;Australia;Georgia;Germany;Korea, Republic of
6EUCTR2021-001448-90-ES
(EUCTR)
21/01/202219/10/2021A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects with Generalized Pustular PsoriasisA Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects with Generalized Pustular Psoriasis - Long-Term Safety and Efficacy of Imsidolimab in Subjects with Generalized Pustular Psoriasis Subjects with generalized pustular psoriasis
MedDRA version: 20.0;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: ANB019
INN or Proposed INN: anti-IL-36R monoclonal antibody
AnaptysBio Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 3Taiwan;Thailand;Malaysia;Spain;Australia;Georgia;Germany;Korea, Republic of
7EUCTR2021-001447-27-DE
(EUCTR)
08/12/202108/09/2021A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects with Generalized Pustular PsoriasisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects with Generalized Pustular Psoriasis - Efficacy and Safety of Imsidolimab in Subjects with Generalized Pustular Psoriasis Subjects with generalized pustular psoriasis
MedDRA version: 20.0;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: ANB019
INN or Proposed INN: anti-IL-36R monoclonal antibody
Product Code: ANB019
INN or Proposed INN: anti-IL-36R monoclonal antibody
AnaptysBio Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 3Georgia;Germany;United States;Taiwan;Spain;Thailand;United Kingdom;France;Malaysia;Poland;Romania;Australia;Korea, Republic of
8EUCTR2021-001448-90-DE
(EUCTR)
08/12/202108/09/2021A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects with Generalized Pustular PsoriasisA Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects with Generalized Pustular Psoriasis - Long-Term Safety and Efficacy of Imsidolimab in Subjects with Generalized Pustular Psoriasis Subjects with generalized pustular psoriasis
MedDRA version: 20.0;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: ANB019
INN or Proposed INN: anti-IL-36R monoclonal antibody
Product Code: ANB019
INN or Proposed INN: anti-IL-36R monoclonal antibody
AnaptysBio Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 3United States;Taiwan;Spain;Thailand;United Kingdom;France;Malaysia;Poland;Romania;Australia;Georgia;Germany;Korea, Republic of
9JPRN-jRCT2041210087
01/11/202120/10/2021A 5-year study to test BI 655130 in patients with Generalized Pustular Psoriasis who took part in previous studies with BI 655130An open-label, long term extension study to assess the safety and efficacy of BI 655130 treatment in patients with Generalized Pustular Psoriasis (GPP) Generalized Pustular Psoriasis (GPP)Drug: BI 655130 (Spesolimab) / Solution for infusion
Drug: BI 655130 (Spesolimab) / Solution for injection
Yamada NobukoNULLRecruiting>= 12age old<= 75age oldBoth4Phase 2Argentina;Australia;Belgium;Bulgaria;Chile;China;Colombia;Croatia;Czech Republic;Egypt;France;Georgia;Germany;Greece;Israel;Italy;Korea;Malaysia;Mexico;Netherlands;Philippines;Poland;Russia;Singapore;South Africa;Spain;Taiwan;Thailand;Tunisia;Turkey;Japan
10EUCTR2018-003080-56-BG
(EUCTR)
08/09/202130/07/2021A 5-year study to test BI 655130 in patients with GeneralizedPustular Psoriasis who took part in previous studies with BI655130An open-label, long term extension study to assess the safety andefficacy of BI 655130 treatment in patients with GeneralizedPustular Psoriasis (GPP) Generalized Pustular Psoriasis
MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Vietnam;France;Malaysia;Australia;South Africa;Netherlands;Tunisia;China;Korea, Republic of;Czechia;Turkey;Egypt;Mexico;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan
11EUCTR2018-003081-14-HR
(EUCTR)
26/08/202103/12/2021A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular PsoriasisEffisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP Generalized Pustular Psoriasis
MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
98Phase 2United States;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan
12EUCTR2018-003081-14-BG
(EUCTR)
17/05/202114/04/2021A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular PsoriasisEffisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP Generalized Pustular Psoriasis
MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
98Phase 2United States;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Vietnam;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan
13ChiCTR2100044690
2021-04-012021-03-25A randomized, double-blind, placebo-controlled clinical trial of melatonin combined with acitretin in the treatment of children with generalized pustular psoriasisA randomized, double-blind, placebo-controlled clinical trial of melatonin combined with acitretin in the treatment of children with generalized pustular psoriasis Generalized pustular psoriasisExperimental group:Acitretin combined with melatonin;Control group:Acitretin combined with cooked flour;Department of Dermatology, Children's Hospital of Chongqing Medical UniversityNULLRecruiting018BothExperimental group:15;Control group:15;China
14ChiCTR2000037099
2020-10-012020-08-26The efficacy and safety of amino acids replacement based on metabolomics in generalized pustular psoriasis: a prospective, randomized, double-blind, controlled studyThe efficacy and safety of amino acids replacement based on metabolomics in generalized pustular psoriasis: a prospective, randomized, double-blind, controlled study Generalized pustular psoriasisexperimental group:amino acid infusion plus oral acitretin;control group:oral acitretin;Shanghai Dermatology HospitalNULLRecruitingBothexperimental group:20;control group:20;China
15EUCTR2018-003081-14-PL
(EUCTR)
24/09/202001/06/2020A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular PsoriasisEffisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP Generalized Pustular Psoriasis
MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
98Phase 2United States;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Vietnam;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Belgium;Brazil;Poland;Singapore;Croatia;Bulgaria;Georgia;Germany;Japan
16JPRN-JapicCTI-205387
03/8/202023/07/2020A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular PsoriasisEffisayil(TM) 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP Generalized Pustular Psoriasis (GPP)Intervention name : spesolimab
INN of the intervention : spesolimab
Dosage And administration of the intervention : s.c. and i.v. single dose
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Boehringer IngelheimNULLcomplete1275BOTH120Phase 2Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa
17NCT04399837
(ClinicalTrials.gov)
June 4, 202020/5/2020A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular PsoriasisEffisayil™ 2: Multi-center, Randomized, Parallel Group, Double Blind, Placebo Controlled, Phase IIb Dose-finding Study to Evaluate Efficacy and Safety of BI 655130 (Spesolimab) Compared to Placebo in Preventing Generalized Pustular Psoriasis (GPP) Flares in Patients With History of GPPGeneralized Pustular PsoriasisDrug: Spesolimab;Drug: PlaceboBoehringer IngelheimNULLActive, not recruiting12 Years75 YearsAll123Phase 2United States;Argentina;Belgium;Bulgaria;Chile;China;Croatia;France;Germany;Greece;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Philippines;Poland;Russian Federation;South Africa;Spain;Taiwan;Thailand;Tunisia;Turkey;Vietnam;Australia;Colombia;Czechia;Georgia;Singapore
18EUCTR2018-003081-14-DE
(EUCTR)
16/04/202016/12/2019A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular PsoriasisEffisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP Generalized Pustular Psoriasis
MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim Pharma GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
98Phase 2United States;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Vietnam;France;Malaysia;Australia;South Africa;Netherlands;Tunisia;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Poland;Belgium;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan
19EUCTR2018-003081-14-IT
(EUCTR)
16/03/202015/06/2021A study to test whether BI 655130 (Spesolimab) prevents flare-ups inpatients with Generalized Pustular PsoriasisEffisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP - Effisayil™ 2 Generalized Pustular Psoriasis
MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Spesolimab
Product Code: [BI 655130]
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Name: Spesolimab
Product Code: [BI 655130]
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
BOEHRINGER-INGELHEIM ITALIA S.P.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
98Phase 2United States;Taiwan;Greece;Spain;Thailand;Russian Federation;Chile;Italy;Vietnam;France;Malaysia;Australia;Tunisia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Singapore;Bulgaria;Japan;New Zealand;Germany
20EUCTR2018-003081-14-GR
(EUCTR)
04/03/202014/01/2020A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular PsoriasisEffisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP Generalized Pustular Psoriasis
MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
98Phase 2United States;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Vietnam;France;Malaysia;Australia;South Africa;Netherlands;Tunisia;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Poland;Belgium;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan
21EUCTR2018-003081-14-NL
(EUCTR)
25/02/202007/01/2020A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular PsoriasisEffisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP Generalized Pustular Psoriasis
MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim Netherlands BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
98Phase 2United States;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Vietnam;France;Malaysia;Australia;South Africa;Netherlands;Tunisia;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Poland;Belgium;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan
22EUCTR2018-003081-14-FR
(EUCTR)
17/02/202011/02/2020A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular PsoriasisEffisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP Generalized Pustular Psoriasis
MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim FranceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
98Phase 2United States;Taiwan;Greece;Spain;Thailand;Chile;Russian Federation;Italy;Vietnam;France;Malaysia;Australia;Netherlands;Tunisia;China;Korea, Republic of;Turkey;Egypt;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Japan;New Zealand
23EUCTR2018-003081-14-ES
(EUCTR)
24/01/202020/12/2019A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular PsoriasisEffisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP Generalized Pustular Psoriasis
MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim España, S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
98 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Taiwan;Greece;Thailand;Spain;Russian Federation;Chile;Italy;Vietnam;France;Malaysia;Australia;Tunisia;Netherlands;China;Korea, Republic of;Turkey;Egypt;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Singapore;Germany;Japan;New Zealand
24EUCTR2018-003080-56-DE
(EUCTR)
11/11/201915/05/2019A 5-year study to test BI 655130 in patients with GeneralizedPustular Psoriasis who took part in previous studies with BI655130An open-label, long term extension study to assess the safety andefficacy of BI 655130 treatment in patients with GeneralizedPustular Psoriasis (GPP) Generalized Pustular Psoriasis
MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim Pharma GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2United States;Philippines;Taiwan;Greece;Thailand;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Viet Nam;Australia;South Africa;Tunisia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Egypt;Mexico;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Bulgaria;Georgia;Germany;Japan
25NCT03885089
(ClinicalTrials.gov)
October 21, 20194/3/2019Infliximab Biosimilar for Intravenous Drip Infusion 100 mg Pfizer Drug Use Investigation (Psoriasis)Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis)Psoriasis Vulgaris;Psoriasis Arthropathica;Pustular Psoriasis;Erythrodermic PsoriasisDrug: Infliximab [infliximab biosimilar 3]PfizerNULLRecruitingN/AN/AAll100Japan
26NCT03998683
(ClinicalTrials.gov)
September 3, 201925/6/2019A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular PsoriasisA Phase 3b, Multicenter, Interventional, Randomized, Placebo-controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular PsoriasisPsoriasisDrug: Guselkumab 100 mg;Drug: PlaceboJanssen-Cilag Ltd.NULLCompleted18 YearsN/AAll117Phase 3France;Germany;Italy;Spain;United Kingdom
27EUCTR2018-003206-58-GB
(EUCTR)
29/07/201928/05/2019A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar PsoriasisA Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis - G-PLUS Palmoplantar non-Pustular Psoriasis
MedDRA version: 20.0;Level: PT;Classification code 10037153;Term: Psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: TREMFYA®
Product Name: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Other descriptive name: GUSELKUMAB
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3France;Spain;Germany;United Kingdom
28EUCTR2018-003206-58-IT
(EUCTR)
11/07/201915/06/2021A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar PsoriasisA Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis - G-PLUS Palmoplantar non-Pustular Psoriasis
MedDRA version: 20.0;Level: PT;Classification code 10037153;Term: Psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: TREMFYA
Product Name: GUSELKUMAB
Product Code: [CNTO1959]
INN or Proposed INN: GUSELKUMAB
Other descriptive name: GUSELKUMAB
JANSSEN CILAG INTERNATIONAL NVNULLNot RecruitingFemale: yes
Male: yes
105Phase 3France;Spain;Germany;United Kingdom;Italy
29NCT03942042
(ClinicalTrials.gov)
July 5, 20197/5/2019A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic PsoriasisA Multicenter, Open-Label, Post Marketing Clinical Trial to Evaluate the Efficacy And Safety Of Ixekizumab in Patients With Generalized Pustular Psoriasis and Erythrodermic PsoriasisGeneralized Pustular Psoriasis;Erythrodermic PsoriasisDrug: IxekizumabEli Lilly and CompanyNULLCompleted20 YearsN/AAll12Phase 4Japan
30EUCTR2018-003206-58-DE
(EUCTR)
02/07/201925/04/2019A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar PsoriasisA Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis - G-PLUS Palmoplantar non-Pustular Psoriasis
MedDRA version: 20.0;Level: PT;Classification code 10037153;Term: Psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: TREMFYA®
Product Name: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Other descriptive name: GUSELKUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
105Phase 3France;Spain;Germany;Italy;United Kingdom
31EUCTR2018-003206-58-FR
(EUCTR)
29/06/201911/04/2019A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar PsoriasisA Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis - G-PLUS Palmoplantar non-Pustular Psoriasis
MedDRA version: 20.0;Level: PT;Classification code 10037153;Term: Psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: TREMFYA®
Product Name: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Other descriptive name: GUSELKUMAB
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
105 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Spain;Germany;United Kingdom
32EUCTR2018-003206-58-ES
(EUCTR)
20/06/201908/05/2019A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar PsoriasisA Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis - G-PLUS Palmoplantar non-Pustular Psoriasis
MedDRA version: 20.0;Level: PT;Classification code 10037153;Term: Psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: TREMFYA®
Product Name: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Other descriptive name: GUSELKUMAB
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
105 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Spain;Germany;United Kingdom
33NCT03886246
(ClinicalTrials.gov)
May 27, 201921/3/2019A 5-year Study to Test BI 655130 in Patients With Generalized Pustular Psoriasis Who Took Part in Previous Studies With BI 655130An Open-label, Long Term Extension Study to Assess the Safety and Efficacy of BI 655130 Treatment in Patients With Generalized Pustular Psoriasis (GPP)Generalized Pustular PsoriasisDrug: SpesolimabBoehringer IngelheimNULLRecruiting12 Years75 YearsAll155Phase 2United States;Argentina;China;France;Germany;Japan;Korea, Republic of;Malaysia;Russian Federation;Taiwan;Thailand;Tunisia;Turkey;Singapore
34EUCTR2017-004231-37-DE
(EUCTR)
23/05/201917/12/2018A study to test BI 655130 in patients with a flare-up of a skin disease called Generalized Pustular PsoriasisEffisayil™ 1:Multi-center, double-blind, randomised, placebo-controlled, Phase II study to evaluate efficacy, safety and tolerability of BI 655130 in patients with Generalized Pustular Psoriasis (GPP) presenting with an acute flare of moderate to severe intensity. - Flare Treatment Phase II Trial in GPP Generalized Pustular Psoriasis (GPP)
MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
NULLNot RecruitingFemale: yes
Male: yes
51Phase 2United States;France;Taiwan;Thailand;Malaysia;Singapore;Tunisia;Germany;Switzerland;Japan;China;Korea, Republic of
35EUCTR2018-003080-56-FR
(EUCTR)
14/05/201927/02/2019 A 5-year study to test BI 655130 in patients with Generalized Pustular Psoriasis who took part in previous studies with BI 655130 An open-label, long term extension study to assess the safety and efficacy of BI 655130 treatment in patients with Generalized Pustular Psoriasis (GPP) Generalized Pustular Psoriasis
MedDRA version: 20.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim FranceNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
101 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Greece;Thailand;Russian Federation;Switzerland;France;Mexico;Poland;Malaysia;Singapore;Australia;Tunisia;Germany;China;Japan;Korea, Republic of
36NCT03619902
(ClinicalTrials.gov)
March 4, 201919/7/2018A Study to Evaluate the Efficacy and Safety of ANB019 in Subjects With Generalized Pustular PsoriasisA Single Arm Multiple Dose Study to Assess the Efficacy and Safety of ANB019 in Subjects With Generalized Pustular PsoriasisGeneralized Pustular PsoriasisDrug: ANB019AnaptysBio, Inc.NULLCompleted18 Years75 YearsAll8Phase 2United States;Korea, Republic of;Poland;United Kingdom
37NCT03782792
(ClinicalTrials.gov)
January 31, 201919/12/2018A Study to Test BI 655130 in Patients With a Flare-up of a Skin Disease Called Generalized Pustular PsoriasisEffisayil™ 1:Multi-center, Double-blind, Randomised, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety and Tolerability of a Single Intravenous Dose of BI 655130 in Patients With Generalized Pustular Psoriasis (GPP) Presenting With an Acute Flare of Moderate to Severe Intensity.Generalized Pustular PsoriasisDrug: Spesolimab;Drug: PlaceboBoehringer IngelheimNULLCompleted18 Years75 YearsAll53Phase 2United States;China;France;Germany;Japan;Korea, Republic of;Malaysia;Singapore;Switzerland;Taiwan;Thailand;Tunisia
38EUCTR2017-004231-37-FR
(EUCTR)
22/01/201926/11/2018A study to test BI 655130 in patients with a flare-up of a skin disease called Generalized Pustular PsoriasisMulti-center, double-blind, randomised, placebo-controlled, Phase II study to evaluate efficacy, safety and tolerability of BI 655130 in patients with Generalized Pustular Psoriasis (GPP) presenting with an acute flare of moderate to severe intensity. - Flare Treatment Phase II Trial in GPP Generalized Pustular Psoriasis (GPP)
MedDRA version: 20.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: BI 655130
INN or Proposed INN: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
27Phase 2United States;France;Taiwan;Thailand;Malaysia;Singapore;Tunisia;Germany;Switzerland;Japan
39JPRN-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
40EUCTR2017-004021-33-GB
(EUCTR)
04/05/201820/12/2017To Assess the Efficacy and Safety of ANB019 in Subjects with Generalized Pustular PsoriasisA Single Arm Multiple Dose Study to Assess the Efficacy and Safety of ANB019 in Subjects with Generalized Pustular Psoriasis - ANB019-002 - Generalized Pustular Psoriasis Generalized Pustular Psoriasis (GPP)
MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: ANB019
INN or Proposed INN: anti-IL-36R monoclonal antibody
Other descriptive name: Alvarez 2
AnaptysBio Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
10 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;United Kingdom
41JPRN-jRCTs031180367
20/02/201818/03/2019The effect of infliximab on endothelial function in patients with psoriasisA pilot study for the effect of infliximab on endothelial function in patients with psoriasis Psoriasis vulgaris, Psoriatic arthritis, Pustular psoriasis, Erythrodermic psoriasis
Psoriasis vulgaris, Psoriatic arthritis, Pustular psoriasis, Erythrodermic psoriasis;D011565, D015535
Endothelial function is measured in patients with psoriasis treated with infliximab before and after the first, second, and third infusions.TOYAMA SATOSHINULLNot Recruiting>= 20age old< 80age oldBoth25N/AJapan
42ChiCTR2100043193
2018-01-012021-02-08Clinical study of oxymatrine in the treatment of psoriasisClinical study of oxymatrine in the treatment of erythrodermic psoriasis and pustular psoriasis PsoriasisErythrodermic psoriasis group:Oxymatrine;Generalized pustular psoriasis:Oxymatrine;Normal control group:Nil;General Hospital of Ningxia Medical UniversityNULLRecruiting1875BothErythrodermic psoriasis group:10;Generalized pustular psoriasis:10;Normal control group:10;China
43JPRN-UMIN000027208
2017/06/0101/06/2017A pilot study for the effect of infliximab on endothelial function in patients with psoriasisA pilot study for the effect of infliximab on endothelial function in patients with psoriasis - The effect of infliximab on endothelial function in patients with psoriasis Psoriasis vulgaris, Psoriatic arthritis, Pustular psoriasis, Erythrodermic psoriasisEndothelial function is measured in patients with psoriasis treated with infliximab before and after the first, second, and third infusions.The University of Tokyo HospitalNULLRecruiting20years-old80years-oldMale and Female25Not applicableJapan
44NCT03051217
(ClinicalTrials.gov)
February 21, 20179/2/2017A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic PsoriasisPhase 2/3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic PsoriasisModerate to Severe Psoriasis;Generalized Pustular Psoriasis and Erythrodermic PsoriasisOther: Placebo;Drug: Certolizumab PegolUCB Biopharma S.P.R.L.NULLCompleted20 YearsN/AAll127Phase 2/Phase 3Japan
45NCT03022045
(ClinicalTrials.gov)
January 26, 201713/1/2017A Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic PsoriasisA Phase 3, Randomized, Open-Label Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic PsoriasisPsoriasisDrug: risankizumabAbbVieNULLCompleted20 YearsN/AAll18Phase 3Japan
46NCT02978690
(ClinicalTrials.gov)
December 19, 201629/11/2016BI655130 Single Dose in Generalized Pustular PsoriasisMulti-centre, Open-label, Single Arm, Phase I Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacogenomics and Efficacy of a Single Intravenous Dose of BI 655130 in Patients With Active Generalized Pustular Psoriasis.PsoriasisDrug: BI655130Boehringer IngelheimNULLCompleted18 Years75 YearsAll7Phase 1France;Japan;Korea, Republic of;Malaysia;Taiwan;Tunisia;Singapore
47NCT04183881
(ClinicalTrials.gov)
July 4, 201629/11/2019A Phase 4 Clinical Study of BrodalumabAn Extension Study of Brodalumab in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic ErythrodermaPsoriasis Vulgaris;Psoriatic Arthritis;Pustular; Psoriasis, Palmaris Et Plantaris;Psoriatic ErythrodermaDrug: Brodalumab 210mg SCKyowa Kirin Co., Ltd.NULLCompleted18 YearsN/AAll138Phase 4Japan
48EUCTR2015-003600-23-GB
(EUCTR)
01/04/201628/01/2016Comparing Anakinra versus placebo in the treatment of pustular psoriasisTreatment of Pustular Psoriasis with the IL-1 receptor antagonist anakinra: a randomised, placebo controlled trial and associated mechanistic studies Acral Pustular Psoriasis, specifically but not limited to Palmo-Plantar Pustulosis will be the target population for therapeutic intervention with Anakinra in this study.
MedDRA version: 20.0;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Anakinra
Product Name: Anakinra
INN or Proposed INN: ANAKINRA
Guy's and St Thomas NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
64Phase 4United Kingdom
49NCT02533375
(ClinicalTrials.gov)
September 28, 201520/8/2015Study to Investigate Efficacy and Safety of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)A Multicenter, Open-Label Study of Adalimumab in Japanese Subjects With Generalized Pustular PsoriasisGeneralized Pustular Psoriasis (GPP);Adalimumab;JapaneseDrug: AdalimumabAbbVieNULLCompleted15 Years75 YearsAll10Phase 3Japan
50NCT02343744
(ClinicalTrials.gov)
January 19, 201516/1/2015An Efficacy and Safety Study of CNTO1959 (Guselkumab) in the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic PsoriasisA Phase 3, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of CNTO1959 (Guselkumab) in the Treatment of Subjects With Generalized Pustular Psoriasis or Erythrodermic PsoriasisPustular PsoriasisDrug: GuselkumabJanssen Pharmaceutical K.K.NULLCompleted20 YearsN/AAll21Phase 3Japan
51EUCTR2013-003086-34-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
52EUCTR2013-003086-34-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
53EUCTR2013-003086-34-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
54JPRN-JapicCTI-142430
01/2/2014A Phase 3 Clinical Study of KHK4827An Extension Study of KHK4827 Subjects with Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma PsoriasisIntervention name : KHK4827
INN of the intervention : brodalumab
Dosage And administration of the intervention : Subcutaneous administration
Control intervention name : null
Kyowa Hakko Kirin Co., Ltd.NULL18BOTH165Phase 3NULL
55NCT02052609
(ClinicalTrials.gov)
February 201430/1/2014A Phase 3 Clinical Study of KHK 4827An Extension Study of KHK4827 in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic ErythrodermaPsoriasis Vulgaris;Psoriatic Arthritis;Pustular; Psoriasis, Palmaris Et Plantaris;Psoriatic ErythrodermaDrug: KHK4827 140mg SC;Drug: KHK4827 210mg SCKyowa Kirin Co., Ltd.NULLCompleted18 YearsN/AAll155Phase 3Japan
56EUCTR2013-003086-34-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
57NCT02008890
(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
58EUCTR2013-003086-34-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
59EUCTR2013-003086-34-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
60EUCTR2013-003086-34-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
61EUCTR2013-003086-34-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
62NCT01952015
(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
63JPRN-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
64NCT01794117
(ClinicalTrials.gov)
July 22, 201315/2/2013Anakinra for Inflammatory Pustular Skin DiseasesA Phase 2 Study of Anakinra in Inflammatory Pustular Dermatoses: Evaluation of Therapeutic Efficacy and Validation of Pathogenic MechanismsSneddon-Wilkinson;Acrodermatitis Continua of Hallopeau;Pustular Psoriasis;Palmoplantar PustulosisDrug: AnakinraNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLCompleted18 Years110 YearsAll18Phase 2United States
65JPRN-JapicCTI-132057
01/2/2013An open-label, non-controlled study of KHK4827 in subjects with psoriasisA Long-Term Study of KHK4827 in Subjects with Pustular Psoriasis (Generalized) and Psoriatic Erythroderma PsoriasisIntervention name : KHK4827
INN of the intervention : brodalumab
Dosage And administration of the intervention : Subcutaneous administration
Control intervention name : null
Kyowa Hakko Kirin Co., Ltd.NULL18BOTHPhase 3NULL
66NCT01782937
(ClinicalTrials.gov)
February 201327/1/2013An Open-label, Non-controlled Study of KHK4827 in Subjects With PsoriasisA Long-Term Study of KHK4827 in Subjects With Pustular Psoriasis (Generalized) and Psoriatic ErythrodermaPsoriasisDrug: KHK4827Kyowa Hakko Kirin Company, LimitedNULLCompleted18 YearsN/ABoth30Phase 3Japan
67NCT01680159
(ClinicalTrials.gov)
July 201228/8/2012A Clinical Study of Increased Dose of TA-650 in Patients With PsoriasisPlaque Psoriasis;Psoriatic Arthritis;Pustular Psoriasis (Excluding a Localized);Psoriatic ErythrodermaDrug: TA-650Mitsubishi Tanabe Pharma CorporationNULLCompleted16 Years75 YearsAll51Phase 3Japan
68ChiCTR-TRC-12003542
2011-08-012012-12-18A Multi-center, randomized, double-blinded, double-dummy, parallel-controlled clinical trial to determine the efficacy and safety of Tripterygium Glycosides and Acitretin in patients with generalized pustular psoriasisGuideline-oriented Research in the Management of Some Common and Severe Skin Diseases Generalized pustular psoriasisTG treatment group:Take TG tablet 2 slices every time, thrice a day, the placebo of Acitretin Capsules 2 pills every time, twice a day;Acitretin treatment group:Take the placebo of TG tablet 2 slices every time, thrice a day, Acitretin Capsules 2 pills every time, twice a day;Institute of dermatology, Chinese Academy of Medical SciencesNULLCompleted1675BothTG treatment group:180;Acitretin treatment group:180;China
69NCT01091051
(ClinicalTrials.gov)
March 201018/3/2010Safety and Efficacy of Ustekinumab in Patients With Palmo-Plantar Pustular Psoriasis or With Palmo-Plantar PustulosisSafety and Efficacy of Ustekinumab in the Treatment of Patients With Palmo-Plantar Pustular Psoriasis or With Palmo-Plantar PustulosisPalmo-Plantar Pustular Psoriasis;Palmo-Plantar PustulosisDrug: Ustekinumab;Drug: Placebo (Soduim Chloride)Innovaderm Research Inc.Janssen-Ortho LLCTerminated18 YearsN/ABoth33Phase 3Canada
70EUCTR2007-003922-70-DE
(EUCTR)
28/11/200708/08/2007Uncontrolled, open Phase IIa study to investigate efficacy and safety of efalizumab in patients with moderate to severe palmoplantar pustular psoriasis (PPP) - PPP StudyUncontrolled, open Phase IIa study to investigate efficacy and safety of efalizumab in patients with moderate to severe palmoplantar pustular psoriasis (PPP) - PPP Study moderate to severe palmoplantar pustular psoriasis
MedDRA version: 9.1;Level: LLT;Classification code 10037159;Term: Psoriasis pustular
Trade Name: Raptiva
INN or Proposed INN: Efalizumab
Technische Universität DresdenNULLNot RecruitingFemale: yes
Male: yes
42Phase 2Germany
71EUCTR2006-005344-83-DE
(EUCTR)
09/02/200707/11/2006A Randomized, Double-blind, Placebo and Active Treatment-Controlled Study in Psoriatic Patients to Assess the Tolerability, Pharmacokinetics and Efficacy of a Cream Formulation Containing 3% of P32/98A Randomized, Double-blind, Placebo and Active Treatment-Controlled Study in Psoriatic Patients to Assess the Tolerability, Pharmacokinetics and Efficacy of a Cream Formulation Containing 3% of P32/98 Psoriasis is a common inherited autoimmune disease that affects 2-3% of the world-wide population. There are several recognized forms of psoriasis, such as plaque psoriasis, which is also known as psoriasis vulgaris and guttate, inverse, erythrodermic and pustular psoriasis, which can coexist within the same patient. The most common form is the plaque psoriasis.
MedDRA version: 8.1;Level: LLT;Classification code 10037153;Term: Psoriasis
Product Name: P32/98 3%
Product Code: P32/98
Trade Name: Silikis 3µg/g Salbe
INN or Proposed INN: Calcitriol
Probiodrug AGNULLNot RecruitingFemale: yes
Male: yes
Germany
72NCT00301002
(ClinicalTrials.gov)
June 20058/3/2006Study to Evaluate the Efficacy of Alefacept to Treat Palmar Plantar PustulosisA Pilot Open-Label Study to Evaluate the Safety and Observe the Effectiveness of 16 Weeks of Alefacept in Palmar Plantar Pustulosis (IST 92)Psoriasis;Palmoplantaris Pustulosis;Pustular Psoriasis of Palms and Soles;Pustulosis Palmaris et Plantaris;Pustulosis of Palms and SolesDrug: AlefaceptThe Guenther Dermatology Research CentreBiogen IdecCompleted18 YearsN/ABoth15Phase 2Canada
73EUCTR2018-003081-14-BE
(EUCTR)
19/12/2019A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular PsoriasisEffisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP Generalized Pustular Psoriasis
MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
SCS Boehringer Ingelheim Comm. VNULLNAFemale: yes
Male: yes
98Phase 2United States;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Vietnam;France;Malaysia;Australia;South Africa;Netherlands;Tunisia;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Poland;Belgium;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan
74EUCTR2018-003081-14-CZ
(EUCTR)
28/04/2020A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular PsoriasisEffisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP Generalized Pustular Psoriasis
MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
98Phase 2United States;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Vietnam;France;Malaysia;Australia;South Africa;Netherlands;Tunisia;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Poland;Belgium;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan