35. 天疱瘡 Pemphigus Clinical trials / Disease details


臨床試験数 : 99 薬物数 : 124 - (DrugBank : 36) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 169

  
12 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2018-002261-19-HR
(EUCTR)
22/08/201920/11/2019A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigusA Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus pemphigus vulgaris [PV] or pemphigus foliaceus [PF]
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 21.0;Classification code 10057054;Term: Pemphigus foliaceous;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: PRN1008 (Rilzabrutinib)
Product Code: PRN1008
INN or Proposed INN: not available
Other descriptive name: PRN1008
Principia BiopharmaNULLNot RecruitingFemale: yes
Male: yes
120Phase 3United States;Serbia;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Brazil;Poland;Croatia;Australia;Bulgaria;Germany
2EUCTR2018-002261-19-DE
(EUCTR)
17/05/201910/12/2018A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigusA Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor Rilzabrutinib (PRN1008) in Moderate to Severe Pemphigus pemphigus vulgaris [PV] or pemphigus foliaceus [PF]
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 21.0;Classification code 10057054;Term: Pemphigus foliaceous;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: PRN1008 (Rilzabrutinib)
Product Code: PRN1008
INN or Proposed INN: not available
Other descriptive name: PRN1008
Principia Biopharma , Inc.NULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Poland;Brazil;Croatia;Australia;Bulgaria;Germany
3EUCTR2018-002261-19-IT
(EUCTR)
08/05/201917/06/2021A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigusA Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus - NA pemphigus vulgaris [PV] or pemphigus foliaceus [PF]
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 21.0;Classification code 10057054;Term: Pemphigus foliaceous;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: PRN1008
Product Code: [PRN1008]
Other descriptive name: PRN1008
Principia Biopharma Inc.NULLNot RecruitingFemale: yes
Male: yes
120Phase 3Serbia;United Arab Emirates;United States;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Poland;Brazil;Croatia;Australia;Bulgaria;Germany
4EUCTR2018-002261-19-FR
(EUCTR)
10/04/201922/10/2018A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigusA Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus pemphigus vulgaris [PV] or pemphigus foliaceus [PF]
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10057054;Term: Pemphigus foliaceous;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: PRN1008
Product Code: PRN1008
INN or Proposed INN: not available
Other descriptive name: PRN1008
Principia BiopharmaNULLNot RecruitingFemale: yes
Male: yes
120Phase 3United States;United Arab Emirates;Serbia;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;United Kingdom;Italy;France;Canada;Croatia;Australia;Bulgaria;Germany
5EUCTR2018-002261-19-GR
(EUCTR)
03/04/201919/02/2019A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigusA Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus pemphigus vulgaris [PV] or pemphigus foliaceus [PF]
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 21.0;Classification code 10057054;Term: Pemphigus foliaceous;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: PRN1008
Product Code: PRN1008
INN or Proposed INN: not available
Other descriptive name: PRN1008
Principia BiopharmaNULLNot RecruitingFemale: yes
Male: yes
120Phase 3United States;Serbia;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Brazil;Poland;Croatia;Australia;Bulgaria;Germany
6EUCTR2018-002261-19-GB
(EUCTR)
02/04/201917/01/2019A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigusA Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus pemphigus vulgaris [PV] or pemphigus foliaceus [PF]
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 21.0;Classification code 10057054;Term: Pemphigus foliaceous;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: PRN1008 (Rilzabrutinib)
Product Code: PRN1008
INN or Proposed INN: not available
Other descriptive name: PRN1008
Principia BiopharmaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3Serbia;United Arab Emirates;United States;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Brazil;Croatia;Australia;Bulgaria;Germany
7EUCTR2018-002261-19-ES
(EUCTR)
08/02/201918/01/2019A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigusA Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus pemphigus vulgaris [PV] or pemphigus foliaceus [PF]
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10057054;Term: Pemphigus foliaceous;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: PRN1008
Product Code: PRN1008
INN or Proposed INN: not available
Other descriptive name: PRN1008
Principia BiopharmaNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United Arab Emirates;United States;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Italy;United Kingdom;France;Canada;Poland;Croatia;Australia;Bulgaria;Germany
8NCT03762265
(ClinicalTrials.gov)
January 8, 201929/11/2018A Study of PRN1008 in Patients With PemphigusA Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor Rilzabrutinib (PRN1008) in Moderate to Severe PemphigusPemphigusDrug: Rilzabrutinib Oral Tablet;Drug: Placebo Oral TabletPrincipia Biopharma, a Sanofi CompanyNULLTerminated18 Years80 YearsAll131Phase 3United States;Argentina;Australia;Brazil;Bulgaria;Canada;Croatia;France;Germany;Greece;Israel;Italy;Poland;Serbia;Spain;Taiwan;Turkey;Ukraine;United Kingdom
9EUCTR2018-002261-19-BG
(EUCTR)
12/12/201811/10/2018A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigusA Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus pemphigus vulgaris [PV] or pemphigus foliaceus [PF]
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 21.0;Classification code 10057054;Term: Pemphigus foliaceous;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: PRN1008 (Rilzabrutinib)
Product Code: PRN1008
INN or Proposed INN: not available
Other descriptive name: PRN1008
Principia BiopharmaNULLNot RecruitingFemale: yes
Male: yes
120Phase 3Serbia;United Arab Emirates;United States;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Poland;Brazil;Croatia;Australia;Bulgaria;Germany
10EUCTR2015-003564-37-GR
(EUCTR)
21/04/201613/01/2016A Pilot Study Investigating the Safety, Clinical Activity, Drug Levels, and Effects on PRN 1008 in Patients with Newly Diagnosed or Relapsing Pemphigus VulgarisAn Open-Label, Phase 2, Pilot Study Investigating the Safety, Clinical Activity, Pharmacokinetics, and Pharmacodynamics of Oral Treatment with the BTK Inhibitor PRN1008 in Patients with Newly Diagnosed or Relapsing Pemphigus Vulgaris Pemphigus: Pemphigus Vulgaris
MedDRA version: 18.1;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: PRN1008
INN or Proposed INN: Not available
Other descriptive name: PRN1008 Freebase
INN or Proposed INN: Not available
Other descriptive name: PRN1008 Freebase
INN or Proposed INN: Not available
Other descriptive name: PRN1008 Freebase
INN or Proposed INN: Not available
Other descriptive name: PRN1008 Freebase
Principia Biopharma Australia Pty LtdNULLNot RecruitingFemale: yes
Male: yes
25Phase 2France;Greece;Croatia;Australia;Israel
11EUCTR2015-003564-37-HR
(EUCTR)
18/04/201606/07/2016An Open-Label, Phase 2, Pilot Study Investigating the Safety, Clinical Activity, Pharmacokinetics, and Pharmacodynamics of Oral Treatment with the BTK Inhibitor PRN1008 in Patients with Newly Diagnosed or Relapsing Pemphigus Vulgaris An Open-Label, Phase 2, Pilot Study Investigating the Safety, Clinical Activity, Pharmacokinetics, and Pharmacodynamics of Oral Treatment with the BTK Inhibitor PRN1008 in Patients with Newly Diagnosed or Relapsing Pemphigus Vulgaris Pemphigus: Pemphigus Vulgaris
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: PRN1008
INN or Proposed INN: Not available
Other descriptive name: PRN1008 Freebase
INN or Proposed INN: Not available
Other descriptive name: PRN1008 Freebase
INN or Proposed INN: Not available
Other descriptive name: PRN1008 Freebase
INN or Proposed INN: Not available
Other descriptive name: PRN1008 Freebase
Principia Biopharma Australia Pty LtdNULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Greece;Croatia;Australia;Israel
12NCT02704429
(ClinicalTrials.gov)
January 22, 201624/2/2016A Study of PRN1008 in Adult Patients With Pemphigus VulgarisAn Open-Label, Phase 2, Pilot Study Investigating the Safety, Clinical Activity, Pharmacokinetics, and Pharmacodynamics of Oral Treatment With the BTK Inhibitor PRN1008 in Patients With Newly Diagnosed or Relapsing Pemphigus VulgarisPemphigus VulgarisDrug: PRN1008Principia Biopharma Inc.Principia Biopharma Australia Pty Ltd.Completed18 Years80 YearsAll42Phase 2Australia;Croatia;France;Greece;Israel