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

  
42 trials found
No.TrialIDDate_
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PhaseCountries
1NCT05366855
(ClinicalTrials.gov)
April 21, 202225/4/2022Long-Term Safety and Efficacy of Imsidolimab (ANB019) in 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 PsoriasisGeneralized Pustular PsoriasisBiological: Imsidolimab;Other: PlaceboAnaptysBio, Inc.NULLRecruiting18 Years80 YearsAll45Phase 3United States;Australia;France;Georgia;Germany;Korea, Republic of;Malaysia;Morocco;Poland;Romania;Spain;Taiwan;Thailand;Tunisia;Turkey
2NCT05352893
(ClinicalTrials.gov)
April 14, 202225/4/2022Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPPA 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 PsoriasisGeneralized Pustular PsoriasisDrug: Imsidolimab high dose;Drug: Imsidolimab low dose;Other: PlaceboAnaptysBio, Inc.NULLRecruiting18 Years80 YearsAll45Phase 3United States;Australia;Georgia;Germany;Korea, Republic of;Malaysia;Morocco;Poland;Romania;Slovakia;Spain;Taiwan;Thailand;Tunisia;Turkey
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
4EUCTR2021-001447-27-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
5EUCTR2018-003081-14-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
6EUCTR2018-003081-14-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
7ChiCTR2100044690
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
8EUCTR2018-003081-14-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
9JPRN-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
10NCT04399837
(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 IngelheimNULLCompleted12 Years75 YearsAll123Phase 2United States;Argentina;Belgium;Chile;China;France;Germany;Greece;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Philippines;Russian Federation;South Africa;Spain;Taiwan;Thailand;Tunisia;Turkey;Vietnam;Australia;Bulgaria;Colombia;Croatia;Czechia;Georgia;Poland;Singapore
11EUCTR2018-003081-14-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;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;France;Malaysia;Viet Nam;Australia;South Africa;Tunisia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Belgium;Poland;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan
12EUCTR2018-003081-14-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;Germany;New Zealand;Japan
13EUCTR2018-003081-14-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
14EUCTR2018-003081-14-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
15EUCTR2018-003081-14-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
16EUCTR2018-003081-14-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
17NCT03998683
(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
18EUCTR2018-003206-58-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
19EUCTR2018-003206-58-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
20EUCTR2018-003206-58-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
21EUCTR2018-003206-58-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
22EUCTR2018-003206-58-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
23EUCTR2017-004231-37-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
24NCT03782792
(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
25EUCTR2017-004231-37-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
26JPRN-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
27NCT03051217
(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
28EUCTR2015-003600-23-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
29EUCTR2013-003086-34-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
30EUCTR2013-003086-34-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
31EUCTR2013-003086-34-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
32EUCTR2013-003086-34-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
33NCT02008890
(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
34EUCTR2013-003086-34-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
35EUCTR2013-003086-34-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
36EUCTR2013-003086-34-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
37EUCTR2013-003086-34-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
38ChiCTR-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
39NCT01091051
(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
40EUCTR2006-005344-83-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
41EUCTR2018-003081-14-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
42EUCTR2018-003081-14-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