PRN1008 ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
35天疱瘡12
61自己免疫性溶血性貧血3

35. 天疱瘡


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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
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

61. 自己免疫性溶血性貧血


臨床試験数 : 146 薬物数 : 131 - (DrugBank : 59) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 158
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-001671-16-DK
(EUCTR)
15/11/202116/07/2021Efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemiaA multicenter, open-label, Phase IIb study to evaluate the efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemia Warm autoimmune hemolytic anemia
MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rilzabrutinib
Product Code: SAR444671
INN or Proposed INN: Rilzabrutinib
Other descriptive name: PRN1008
Sanofi aventis recherche et developpementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
25Phase 2France;United States;Hungary;Spain;Austria;Denmark;Germany;United Kingdom;Italy;China
2EUCTR2021-001671-16-ES
(EUCTR)
08/10/202123/06/2021Efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemiaA multicenter, open-label, Phase IIb study to evaluate the efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemia Warm autoimmune hemolytic anemia
MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rilzabrutinib
Product Code: SAR444671
INN or Proposed INN: Rilzabrutinib
Other descriptive name: PRN1008
Sanofi aventis recherche et developpementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
25Phase 2United States;Spain;Denmark;United Kingdom;Italy;China
3EUCTR2021-001671-16-IT
(EUCTR)
24/09/202112/10/2021Efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warmautoimmune hemolytic anemiaA multicenter, open-label, Phase IIb study to evaluate the efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemia - . Warm autoimmune hemolytic anemia
MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rilzabrutinib
Product Code: [SAR444671]
INN or Proposed INN: Rilzabrutinib
Other descriptive name: PRN1008
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENTNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
25Phase 2United States;Spain;Denmark;United Kingdom;China;Italy