35. 天疱瘡
[臨床試験数:87,薬物数:114(DrugBank:37),標的遺伝子数:17,標的パスウェイ数:158

Searched query = "Pemphigus"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-002915-23-GR
(EUCTR)
03/12/202015/10/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod PH20 SC in adults with Pemphigus (Vulgaris or Foliaceus)A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus) (ADDRESS) - ADDRESS Pemphigus Vulgaris or Pemphigus Foliaceus
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Japan
2EUCTR2020-002917-16-GR
(EUCTR)
03/12/202015/10/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod PH20 SC in adults with Pemphigus (Vulgaris or Foliaceus)An Open-Label, Multicenter, Follow-up Trial of ARGX-113-1904 to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Pemphigus - ADDRESS+ Pemphigus Vulgaris or Pemphigus Foliaceus
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Other descriptive name: ARGX-113
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Japan
3EUCTR2020-002915-23-FR
(EUCTR)
02/12/202009/09/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod PH20 SC in adults with Pemphigus (Vulgaris or Foliaceus)A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus) (ADDRESS) - ADDRESS Pemphigus Vulgaris or Pemphigus Foliaceus
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Other descriptive name: ARGX-113
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Japan
4NCT04598451
(ClinicalTrials.gov)
December 20208/10/2020A Study to Assess the Efficacy and Safety of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus)Pemphigus Vulgaris;Pemphigus FoliaceusBiological: efgartigimod PH20 SC;Other: Placebo;Drug: prednisoneargenxNULLNot yet recruiting18 Years80 YearsAll150Phase 3United States;Bulgaria
5NCT04540133
(ClinicalTrials.gov)
December 202028/8/2020Dexamethasone Solution and Dexamethasone in Mucolox™Dexamethasone Solution and Dexamethasone in Mucolox™ for the Treatment of Oral Inflammatory Ulcerative DiseasesOral Lichen Planus;Mucous Membrane Pemphigoid;Pemphigus Vulgaris;Chronic Graft-versus-host-diseaseDrug: dexamethasone 0.5mg/5ml solution;Drug: dexamethasone 0.5mg/5ml solution in Mucolox™University of California, San FranciscoNULLRecruiting18 YearsN/AAll30Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2020-002915-23-BG
(EUCTR)
24/11/202024/09/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod PH20 SC in adults with Pemphigus (Vulgaris or Foliaceus)A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus) (ADDRESS) - ADDRESS Pemphigus Vulgaris or Pemphigus Foliaceus
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Japan
7EUCTR2020-002917-16-HU
(EUCTR)
17/11/202028/09/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod PH20 SC in adults with Pemphigus (Vulgaris or Foliaceus)An Open-Label, Multicenter, Follow-up Trial of ARGX-113-1904 to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Pemphigus - ADDRESS+ Pemphigus Vulgaris or Pemphigus Foliaceus
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Other descriptive name: ARGX-113
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Japan
8EUCTR2020-002915-23-HU
(EUCTR)
16/11/202021/09/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod PH20 SC in adults with Pemphigus (Vulgaris or Foliaceus)A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus) (ADDRESS) - ADDRESS Pemphigus Vulgaris or Pemphigus Foliaceus
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Japan
9NCT04598477
(ClinicalTrials.gov)
October 25, 20208/10/2020A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)An Open-Label, Multicenter, Follow-up Trial of ARGX-113-1904 to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With PemphigusPemphigus Vulgaris;Pemphigus FoliaceusBiological: efgartigimod PH20 SC;Drug: prednisoneargenxNULLNot yet recruiting18 Years80 YearsAll150Phase 3NULL
10NCT04422912
(ClinicalTrials.gov)
August 1, 20202/6/2020Open-label Study to Determine the Maximum Tolerated Dose of DSG3-CAART in Mucosal-dominant PV Patients (mPV)A Phase 1, Open-label, Safety and Dosing Study of Autologous Desmoglein 3 Chimeric Autoantibody Receptor T Cells (DSG3-CAART) in Subjects With Active, Anti-DSG3, Mucosal-dominant Pemphigus VulgarisMucosal -Dominant Pemphigus VulgarisBiological: DSG3-CAARTCabaletta BioNULLRecruiting18 YearsN/AAll30Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT04400994
(ClinicalTrials.gov)
June 20, 202027/4/2020IVIG With Rituximab vs Rituximab as First Line Treatment of PemphigusThe Use of IVIG in Combination With Rituximab VS Rituximab as the First Line Treatment of PemphigusPemphigusDrug: Rituximab;Other: IVIgThe University of Hong KongNULLRecruiting18 Years70 YearsAll20Phase 2Hong Kong
12NCT04023149
(ClinicalTrials.gov)
April 2, 20203/7/2019Efficacy of Interleukin-2 Gargle in the Treatment of Oral Mucosa Lesion in Pemphigus VulgarisShort-term Efficacy of Interleukin-2 Gargle Combined With Systemic Use of Glucocorticoids in the Treatment of Oral Mucosal Lesion in Pemphigus Vulgaris: a Randomized, Controlled, Double-blind, Multicenter Clinical StudyPemphigus VulgarisDrug: recombinant human interleukin-2 (rhIL-2);Drug: placeboSecond Xiangya Hospital of Central South UniversityNULLRecruiting18 Years70 YearsAll180Phase 2China
13NCT03790293
(ClinicalTrials.gov)
December 20198/10/2018Clinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the RITUXIMAB 3 TrialClinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the RITUXIMAB 3 Trial With Medico-economic Evaluation of the Treatment.Autoimmune DiseasesDrug: Rituximab;Drug: corticosteroids'therapyUniversity Hospital, RouenNULLUnknown status18 Years80 YearsAll90Phase 3NULL
14EUCTR2019-001727-12-DE
(EUCTR)
24/10/201912/06/2019First use of TPM203 in various doses in patients with pemphigus vulgaris to to evaluate the safety, tolerability, and metabolism and to explore early signs of effectiveness.A multi-centre, open-label, phase 1 study, Part A single ascending dose and Part B multiple dose, to evaluate the safety, tolerability and pharmacokinetics, and to explore early signs of effectiveness of induction of antigen-specific immune tolerance with TPM203 in pemphigus vulgaris patients Pemphigus vulgaris
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: TPM203Topas Therapeutics GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 1Germany
15EUCTR2018-002261-19-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 BiopharmaNULLAuthorised-recruitment may be ongoing or finishedFemale: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2018-002261-19-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 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 3United States;Serbia;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Brazil;Poland;Croatia;Australia;Bulgaria;Germany
17EUCTR2018-002261-19-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]
Principia BiopharmaNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
120Phase 3Serbia;United Arab Emirates;United States;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Italy;United Kingdom;France;Canada;Croatia;Australia;Bulgaria;Germany
18EUCTR2018-002261-19-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]
Principia BiopharmaNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
120Phase 3Serbia;United States;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Brazil;Croatia;Australia;Bulgaria;Germany
19EUCTR2018-002261-19-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
20EUCTR2018-002146-37-IT
(EUCTR)
20/03/201904/11/2020A study to test if increasing doses of the drug INCB050465 is safe and well tolerated in patients with Pemphigus VulgarisA Phase 2 Dose-Escalation Study of the Safety and Tolerability of INCB050465 in Participants With Pemphigus Vulgaris - NA 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]
Trade Name: NA
Product Name: INCB050465 1.0 mg
Product Code: [NA]
INN or Proposed INN: INCB050465
Product Name: INCB050465 0.3 mg
Product Code: [NA]
INN or Proposed INN: INCB050465
Product Name: INCB050465 2.5mg
Product Code: [NA]
INN or Proposed INN: INCB050465 HYDROCHLORIDE
INCYTE CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
18Phase 2France;Canada;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT03780166
(ClinicalTrials.gov)
March 201917/12/2018A Study of the Safety and Tolerability of INCB050465 in Pemphigus VulgarisA Phase 2 Dose-Escalation Study of the Safety and Tolerability of INCB050465 in Participants With Pemphigus VulgarisPemphigus VulgarisDrug: ParsaclisibIncyte CorporationNULLWithdrawn18 Years80 YearsAll0Phase 2NULL
22EUCTR2018-002261-19-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]
Principia BiopharmaNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
120Phase 3Serbia;United Arab Emirates;United States;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Italy;United Kingdom;France;Canada;Poland;Croatia;Australia;Bulgaria;Germany
23JPRN-JapicCTI-184231
28/1/201904/12/2018ONO-4059 phase II study(ONO-4059-06)ONO-4059 phase II study: Multicenter, open-label, uncontrolled, single-arm study in patients with refractory pemphigus(ONO-4059-06) Refractory pemphigusIntervention name : ONO-4059
INN of the intervention : Tirabrutinib
Dosage And administration of the intervention : Oral administration
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
ONO PHARMACEUTICAL CO.,LTD.NULLcomplete20BOTH14Phase 2Japan
24EUCTR2018-002146-37-FR
(EUCTR)
24/01/201901/10/2018A study to test if increasing doses of the drug INCB050465 is safe and well tolerated in patients with Pemphigus VulgarisA Phase 2 Dose-Escalation Study of the Safety and Tolerability of INCB050465 in Participants With Pemphigus Vulgaris 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]
Incyte CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
18Phase 2France;Canada;Italy
25NCT03762265
(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 PRN1008 in Moderate to Severe PemphigusPemphigusDrug: PRN1008 Oral Tablet;Drug: Placebo Oral TabletPrincipia Biopharma Inc.NULLRecruiting18 Years80 YearsAll120Phase 3United States;Argentina;Australia;Bulgaria;Canada;Croatia;France;Germany;Greece;Israel;Italy;Poland;Serbia;Spain;Taiwan;Turkey;Ukraine;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26ChiCTR1800020382
2019-01-012018-12-27Efficacy and safety of ultra-low dosage regimen of rituximab combined with corticosteroids in the treatment of pemphigusEfficacy and safety of ultra-low dosage regimen of rituximab combined with corticosteroids in the treatment of pemphigus PemphigusGroup 1:Rituximab 500mg single infusion combined with routinedose of corticosteriods therapy;Group 2:Rituximab 100mg single infusion combined with routinedose of corticosteriods therapy;Group 3:Oral or intravenous infusion of routinedose of corticosteriods (prednisone or methylprednisolone);West China Hospital, Sichuna UniversityNULLRecruiting1880BothGroup 1:14;Group 2:14;Group 3:14;China
27EUCTR2018-002261-19-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 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
28EUCTR2018-001417-32-FR
(EUCTR)
13/07/201811/06/2018Long-term Follow-up of patients participants with pemphigus From Study RITUXIMAB3Long-term Follow-up of patients participants with pemphigus From Study RITUXIMAB3. Immunological, clinical and medicoeconomic evaluation Patients with Bullous pemphigoid included in RITUXIMAB3 study
MedDRA version: 20.0;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: MABTHERA
INN or Proposed INN: RITUXIMAB
Trade Name: Prednisone
Product Name: CORTANCYL 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Prednisone
Product Name: CORTANCYL 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
CHU-Hôpitaux de RouenNULLNot RecruitingFemale: yes
Male: yes
77Phase 3France
29JPRN-jRCTs051180069
12/04/201819/02/2019Imatinib treatment of autoimmune bullous diseasesIntervention study on autoimmune bullous diseases with imatinib - IABD Autoimmune bullous disease including pemphigus group and pemphigoid group;D012872Imatinib 800 mg a day p.o. for seven days will be started within 14 days of starting steroid therapy (and when the bed is secured). Imatinib 800 mg a day p.o. for seven days will be started afterregistered in the trial (and when the bed is secured) in patients with mild symptoms and will not take systemic steroid therapy.Kabashima KenjiEndo YuichiroRecruiting>= 20age old< 100age oldBoth20Japan
30EUCTR2017-002333-40-DE
(EUCTR)
31/01/201814/07/2017A study to evaluate the safety and efficacy of ARGX-113 in patients with Mild to Moderate Pemphigus Vulgaris or Foliaceus)An Open-label, Non-controlled, Phase II Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, Efficacy and Conditions of Use of ARGX-113 in Patients with Mild to Moderate Pemphigus (Vulgaris or Foliaceus) Pemphigus (Vulgaris or Foliaceus)
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: ARGX-113
Product Code: ARGX-113
INN or Proposed INN: efgartigimod
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
22Phase 2Hungary;Ukraine;Romania;Israel;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT03334058
(ClinicalTrials.gov)
October 18, 201723/10/2017A Study to Evaluate the Safety, PD, PK and Efficacy of ARGX-113 in Patients With PemphigusAn Open-label, Non-controlled, Phase II Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, Efficacy and Conditions of Use of ARGX-113 in Patients With Mild to Moderate Pemphigus (Vulgaris and Foliaceus)Pemphigus Vulgaris;Pemphigus FoliaceusDrug: ARGX-113argenxNULLCompleted18 YearsN/AAll34Phase 2Germany;Hungary;Israel;Italy;Ukraine
32NCT03239470
(ClinicalTrials.gov)
October 10, 20172/8/2017Polyclonal Regulatory T Cells (PolyTregs) for PemphigusA Phase I, Open-Label, Multicenter Trial Exploring the Safety and Tolerability of Autologous Polyclonal Regulatory T Cell Therapy in Adults With Active Pemphigus (APG01)Pemphigus Foliaceus;Pemphigus VulgarisBiological: Cohort 1: 1.0 x 10^8 PolyTregs;Biological: Cohort 2: 2.5x10^8 PolyTregsNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceActive, not recruiting18 Years75 YearsAll4Phase 1United States
33EUCTR2017-002333-40-HU
(EUCTR)
20/09/201720/07/2017A study to evaluate the safety and efficacy of ARGX-113 in patients with Mild to Moderate Pemphigus (Vulgaris or Foliaceus)An Open-label, Non-controlled, Phase II Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, Efficacy and Conditions of Use of ARGX-113 in Patients with Mild to Moderate Pemphigus (Vulgaris or Foliaceus) Pemphigus (Vulgaris or Foliaceus)
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: ARGX-113
Product Code: ARGX-113
INN or Proposed INN: efgartigimod
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
12Phase 2Hungary;Ukraine;Romania;Israel;Germany;Italy
34NCT03075904
(ClinicalTrials.gov)
July 18, 20176/3/2017A Safety and Dose-Finding Study of SYNT001 in Subjects With Pemphigus (Vulgaris or Foliaceus)A Phase 1B/2, Multicenter, Open-Label, Safety, and Dose-Finding Study of SYNT001 in Subjects With Pemphigus (Vulgaris or Foliaceus)Pemphigus;Pemphigus Vulgaris;Pemphigus FoliaceusDrug: ALXN1830Alexion PharmaceuticalsNULLTerminated18 YearsN/AAll8Phase 1;Phase 2United States
35JPRN-jRCTs031180405
11/05/201722/03/2019Rituximab therapy for refractory pemphigusSafety evaluation study about rituximab therapy for refractory pemphigus Refactory Pemphigus
Other disease of skin or skin tissue
Infuse rituximab 1000mg/body twice biweekly.Funakoshi TakeruNULLRecruiting>= 20age old<= 80age oldBoth20N/AJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36JPRN-UMIN000026004
2017/05/0808/03/2017Safety evaluation study about rituximab therapy for refractory pemphigus pemphigusInfuse rituximab 1000mg/body twice biweeklyKeio University, School of MedicineNULLRecruiting20years-old80years-oldMale and Female10Not applicableJapan
37NCT02993133
(ClinicalTrials.gov)
December 201612/12/2016Pharmacokinetics Study of Mycophenolic Acid in Patients With an Autoimmune Bullous Dermatose, Pemphigus or Cicatricial Pemphigoid.Pharmacokinetics Study of Mycophenolic Acid in Patients With an Autoimmune Bullous Dermatose, Pemphigus or Cicatricial Pemphigoid.Autoimmune Bullous DermatoseDrug: Cellcept® in autoimmune bullous dermatosesUniversity Hospital, LimogesNULLCompleted18 YearsN/AAll53Phase 3France
38JPRN-UMIN000024265
2016/10/0404/10/2016Open-label, single-arm, multicenter, investigators initiated phase II clinical trial to evaluate the efficacy and safety of IDEC-C2B8 in patients with steroid treatment-resistant pemphigusOpen-label, single-arm, multicenter, investigators initiated phase II clinical trial to evaluate the efficacy and safety of IDEC-C2B8 in patients with steroid treatment-resistant pemphigus - Open-label, single-arm, multicenter, investigators initiated phase II clinical trial to evaluate the efficacy and safety of IDEC-C2B8 in patients with steroid treatment-resistant pemphigus steroid treatment-resistant pemphigusRituximab (genetic recombination)Department of Dermatology,Keio University School of MedicineHOKKAIDO UNIVERSITY HOSPITALOKAYAMA UNIVERSITY HOSPITALKURUME UNIVERSITY HOSPITALComplete: follow-up complete20years-old80years-oldMale and Female10Phase 2Japan
39ChiCTR-OIC-17011759
2016-08-012017-06-26pharmacogenomics of Azathioprine induced myelosuppression in the treatment of Pemphigus Vulgaris--study of mutation in TPMT*3 and NUDT15 gene in Chinese people and changes in blood configuration(hemogram).pharmacogenomics of Azathioprine induced myelosuppression in the treatment of Pemphigus Vulgaris--study of mutation in TPMT*3 and NUDT15 gene in Chinese people and changes in blood configuration(hemogram). Pemphigus VulgarisCase series:Azathioprine;Dermatological Department, West China hospital, Sichuan UniversityNULLCompleted1865BothCase series:60;I (Phase 1 study)China
40EUCTR2015-003564-37-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2015-003564-37-HR
(EUCTR)
18/04/201606/07/2016A 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: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Principia Biopharma Australia Pty LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
50Phase 2France;Greece;Croatia;Australia;Israel
42NCT02704429
(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
43NCT02828163
(ClinicalTrials.gov)
January 201627/6/2016Comparison Between Injections of Steroids and Autologous Platelet Rich Plasma in the Oral Erosions of Pemphigus VulgarisComparative Study Between Intralesional Autologous Platelet Rich Plasma and Intralesional Triamcinolone Acetonide in the Oral Erosions of Pemphigus Vulgaris PatientsOral Pemphigus VulgarisOther: Autologous Platelet rich plasma;Drug: Triamcinolone AcetonideCairo UniversityNULLCompletedN/AN/AAll11Phase 3Egypt
44NCT02613910
(ClinicalTrials.gov)
December 23, 201523/11/2015Long-Term Extension Study of Ofatumumab in Subjects With Pemphigus VulgarisOPV117059: A Long-Term Extension Study of Ofatumumab Injection for Subcutaneous Use in Subjects With Pemphigus VulgarisPemphigusDrug: Ofatumumab;Drug: Acetaminophen/paracetamol;Drug: Antihistamine (cetirizine or equivalent);Drug: Prednisone/PrednisoloneGlaxoSmithKlineNULLTerminatedN/AN/AAll1Phase 3United States
45EUCTR2013-001370-20-PL
(EUCTR)
03/07/201523/04/2015Study of subcutaneous Ofatumumab Injections for Pemphigus VulgarisOPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris Pemphigus Vulgaris
MedDRA version: 19.1;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: ofatumumab
Product Code: GSK1841157
INN or Proposed INN: OFATUMUMAB
Product Name: ofatumumab
Product Code: GSK1841157
INN or Proposed INN: OFATUMUMAB
Glaxo Group LtdNULLNot RecruitingFemale: yes
Male: yes
136Phase 3United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT02383589
(ClinicalTrials.gov)
May 26, 20154/3/2015A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV)A Randomized, Double-Blind, Double-Dummy, Active-Comparator, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus VulgarisPemphigus VulgarisDrug: Mycophenolate Mofetil Placebo;Drug: Mycophenolate Mofetil;Drug: Rituximab;Drug: Rituximab PlaceboHoffmann-La RocheGenentech, Inc.Completed18 Years75 YearsAll135Phase 3United States;Argentina;Australia;Brazil;Canada;France;Germany;Israel;Italy;Spain;Turkey;Ukraine
47EUCTR2013-001370-20-FR
(EUCTR)
20/04/201513/07/2015Study of subcutaneous Ofatumumab Injections for Pemphigus VulgarisOPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris Pemphigus Vulgaris
MedDRA version: 18.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: ofatumumab
Product Code: GSK1841157
INN or Proposed INN: OFATUMUMAB
Glaxo Group LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
136United States;France;Poland;Ukraine;Croatia;Australia;Russian Federation;Israel;Italy;Japan;China;Korea, Republic of
48EUCTR2014-000382-41-FR
(EUCTR)
02/04/201524/06/2015A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus VulgarisA randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX Pemphigus Vulgaris (PV)
MedDRA version: 18.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
124Phase 3United States;France;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
49EUCTR2014-000382-41-IT
(EUCTR)
12/03/201502/02/2015A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus VulgarisA randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX Pemphigus Vulgaris (PV)
MedDRA version: 17.1;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: MABTHERA®
Product Name: Rituximab
Product Code: RO0452294/V02
INN or Proposed INN: RITUXIMAB
Trade Name: CELLCEPT®
Product Name: Mycophenolate mofetil
Product Code: RO1061443/F02
INN or Proposed INN: Mycophenolate mofetil
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
124Phase 3United States;France;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
50EUCTR2014-000382-41-ES
(EUCTR)
09/03/201522/12/2014A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus VulgarisA randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX Pemphigus Vulgaris (PV)
MedDRA version: 17.1;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
124Phase 3France;United States;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2014-000382-41-DE
(EUCTR)
06/03/201509/12/2014A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Patients With Pemphigus VulgarisA randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX Pemphigus Vulgaris (PV)
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
132Phase 3France;United States;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
52NCT02365675
(ClinicalTrials.gov)
January 201511/2/2015Wound Dressings for Pemphigus and PemphigoidAn Open Randomized Comparative Trial of Four Different Dressings for Cutaneous Coverage in Pemphigus and PemphigoidPemphigus;PemphigoidDevice: Cotton gauze with petrolatum;Device: Cellulose acetate with petrolatum;Device: Nanocrystalline silver (Acticoat);Device: Carboxymethylcellulose with ionic silver (Aquacel Ag)Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranRecruiting18 YearsN/ABoth12N/AMexico
53EUCTR2013-001370-20-GR
(EUCTR)
12/12/201411/12/2014Study of subcutaneous Ofatumumab Injections for Pemphigus VulgarisOPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris Pemphigus Vulgaris
MedDRA version: 17.1;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: ofatumumab
Product Code: GSK1841157
INN or Proposed INN: OFATUMUMAB
Glaxo Group LtdNULLNot RecruitingFemale: yes
Male: yes
136Phase 3United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of
54EUCTR2013-001370-20-IT
(EUCTR)
26/11/201425/08/2014Study of subcutaneous Ofatumumab Injections for Pemphigus VulgarisOPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris Pemphigus Vulgaris
MedDRA version: 17.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: ofatumumab
Product Code: GSK1841157
INN or Proposed INN: OFATUMUMAB
Glaxo Group LtdNULLNot RecruitingFemale: yes
Male: yes
136Phase 3United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of
55EUCTR2013-001370-20-HR
(EUCTR)
17/11/201402/12/2014Study of subcutaneous Ofatumumab Injections for Pemphigus VulgarisOPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris Pemphigus Vulgaris
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: ofatumumab
Product Code: GSK1841157
INN or Proposed INN: OFATUMUMAB
Product Name: ofatumumab
Product Code: GSK1841157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
136Phase 3United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56JPRN-UMIN000015451
2014/11/1325/10/2014Exploratory research on effectiveness and safety of Rituximab treatment including maintenance administration for steroid intractable autoimmune bullous diseases of the skin.Rtx-BD Trial (Rituximab of Intractable Autoimmune Bullous Disease Trial) 2 Pemphigus, PemphigoidRituximab 375mg/sqm, q1w, 4 doses.
Maintenance administration of rituximab is possible if PDA or BPDAI is between 1 and 10 on week 24 to 48
Department of Dermatology,Keio University School of MedicineHokkaido University, Kurume University, Okayama University, Kawasaki Medical SchoolComplete: follow-up complete20years-old80years-oldMale and Female20Phase 1;Phase 2Japan
57JPRN-jRCTs031180220
01/05/201415/03/2019Rituximab treatment of blistering diseaseTreatment of refractory autoimmuno blistering disease with rituximab Pemphigus vulgaris, paraneoplastic pemphigus, bullous pemphigoidInfusion of rituximab (1000mg) intravenously. Approximately two weeks after the first dose, a second dose of rituximab is administered in a similar manner.Kanaoka MiwaMichiko AiharaNot Recruiting>= 20age old< 80age oldBoth10N/AJapan
58NCT01930175
(ClinicalTrials.gov)
December 18, 201323/8/2013Study of Efficacy and Safety of VAY736 in Patients With Pemphigus VulgarisA Randomized, Partial-blind, Placebo-controlled Trial Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of VAY736 in the Treatment of Patients With Pemphigus VulgarisPemphigus VulgarisDrug: VAY736;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated20 Years70 YearsAll13Phase 2United States;Austria;Bulgaria;Taiwan;Germany;Israel;Italy;United Kingdom
59EUCTR2013-001217-33-AT
(EUCTR)
25/11/201303/10/2013Study of efficacy and safety of VAY736 in patients with Pemphigus vulgarisA randomized, partial-blind, placebo-controlled trial evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of VAY736 in the treatment of patients with pemphigus vulgaris 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]
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
32Phase 2United States;Taiwan;Austria;Bulgaria
60NCT01974518
(ClinicalTrials.gov)
November 20134/10/2013Comparative Study of Rituximab Versus Combination of Rituximab and Intravenous Cyclophosphamide in Severe PemphigusA PILOT STUDY TO ASSESS THE EFFICACY OF RITUXIMAB VERSUS COMBINATION OF RITUXIMAB AND INTRAVENOUS CYCLOPHOSPHAMIDE IN THE TREATMENT OF REFRACTORY PEMPHIGUSPemphigusDrug: Rituximab and Cyclophosphamide IVUprety ShraddhaPostgraduate Institute of Medical Education and ResearchActive, not recruiting18 YearsN/ABoth20Phase 3India
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2013-000211-24-DE
(EUCTR)
01/10/201308/07/2013immunoglobulin infusion as adjuvant therapy in patients with Pemphigus VulgarisA multicenter, randomized, placebo-controlled, double-blind proof of concept study to evaluate the efficacy and safety of the human normal immunoglobulin Intratect® 5% for intravenous use as adjuvant therapy in patients with Pemphigus Vulgaris - IMAT-PV patients with Pemphigus vulgaris
MedDRA version: 16.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Ruprecht-Karls-University HeidelbergNULLNot Recruiting Female: yes
Male: yes
10Phase 2Germany
62NCT01920477
(ClinicalTrials.gov)
August 13, 20133/7/2013Efficacy and Safety of Ofatumumab in Treatment of Pemphigus VulgarisOPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects With Pemphigus VulgarisPemphigus VulgarisBiological: Ofatumumab;Biological: PlaceboNovartis PharmaceuticalsNULLTerminated18 Years70 YearsAll35Phase 3United States;Australia;Greece;Israel;Italy;Japan;Poland;Romania;Croatia;France;Korea, Republic of;Russian Federation;Ukraine
63ChiCTR-TRC-12003540
2011-08-012012-12-19Use of intravenous Methotrexate plus Glucocorticoid for the Treatment of Pemphigus:A multicenter,randomized and controlled clinical trialGuideline-oriented Research in the Management of Some Common and Severe Skin Diseases PemphigusGlucocorticoid group:This group receives systemic glucocorticoid, initially, with prednisone at 1mg/kg/day.;Glucocorticoid plus MTX group:This group receives systemic glucocorticoid plus MTX and starts with prednisone at 1mg/kg/day and MTX IV drip infusion at 15mg/week. Then we adjust the dose of glucocorticoid according to the patients' responses. ;Institute of dermatology, Chinese Academyof Medical SciencesNULLCompleted1875BothGlucocorticoid group:90;Glucocorticoid plus MTX group:90;China
64ChiCTR-TRC-12003539
2011-08-012012-12-27Use of Oral Methotrexate plus Glucocorticoid for the Treatment of Pemphigus:A multicenter,randomized and controlled clinincal trialGuideline-oriented Research in the Management of Some Common and Severe Skin Diseases PemphigusGlucocorticoid hormone group:This group receives systemic glucocorticoid , initially ,with prednisone at 1mg/kg/day. Then we adjust the dose of glucocorticoid according to the patients' responses. ;Glucocorticoids joint methotrexate (MTX) group:This group receives systemic glucocorticoid plus MTX and starts with prednisone at 1mg/kg/day and MTX oral intake at 15mg/week. Then we adjust the dose of glucocorticoid according to the patients' responses. ;Institute of dermatology, Chinese Academyof Medical SciencesNULLCompleted1875BothGlucocorticoid hormone group:90;Glucocorticoids joint methotrexate (MTX) group:90;China
65NCT01299857
(ClinicalTrials.gov)
June 201117/2/2011Long-term Clinical and Biological Evaluation of Patients With Severe Forms of Pemphigus Treated by RituximabEVALUATION CLINIQUE ET BIOLOGIQUE A LONG TERME DES PATIENTS ATTEINTS DE FORMES SEVERES DE PEMPHIGUS TRAITES PAR LE RITUXIMABPemphigusDrug: RituximabUniversity Hospital, RouenNULLCompleted18 YearsN/ABoth22Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT01313923
(ClinicalTrials.gov)
February 201110/3/2011Evaluating Sirolimus to Treat Autoimmune Blistering Dermatosis PemphigusEvaluation of Sirolimus for the Treatment of the Autoimmune Blistering Dermatosis PemphigusPemphigusDrug: Sirolimus (formerly known as Rapamycin)University of California, IrvineNULLTerminated18 YearsN/AAll3Early Phase 1United States
67JPRN-UMIN000004428
2010/11/0101/11/2010Exploratory research on effectiveness and safety of Rituximab treatment for steroid intractable pemphygus, bullous pemphigoid and epidermolysis bullosa acquisita. pemphigus, bullous pemphigoid, epidermolysis bullosa acquisitaRituximabResearch group of rare intractable dermatologial disorderNULLComplete: follow-up complete20years-oldNot applicableMale and Female20Phase 2Japan
68NCT01338103
(ClinicalTrials.gov)
January 201017/4/2011Treatment of Pemphigus Patients With Rituximab 1000mgX2 and Assessment of Immune Status Via CylexTreatment of Moderate to Severe Patients With Pemphigus With the Monoclonal Anti CD20 Antibody Rituximab at a Protocol of 1000mgX2 and Assessment of Their Immune Status Via the Cylex TestPemphigusDrug: RituximabRabin Medical CenterLeumit Health ServicesRecruiting18 Years70 YearsBoth10N/AIsrael
69NCT00784589
(ClinicalTrials.gov)
July 20093/11/2008Comparison Between Rituximab Treatment and General Corticotherapy Treatment in Patients With PemphigusComparison Between Monoclonal Antibody CD20 Treatment (Rituximab (mabthéra))and General Corticotherapy Treatment in Patients With PemphigusPemphigus DiseaseDrug: General Corticotherapy;Drug: RituximabUniversity Hospital, RouenNULLCompleted18 Years80 YearsAll90Phase 3France
70NCT00960713
(ClinicalTrials.gov)
June 200916/7/2009The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune DisordersThe RITAI Cohort. An Observational Study on Serious Adverse Events Occuring After Rituximab Off-label Use for Auto-immune DisordersPemphigus;Auto-immune Thrombocytopenic Purpura;Hemolytic Auto-immune Anaemia;Cold Agglutinin Disease;CryoglobulinemiaDrug: Rituximab (MABTHERA® or RITUXAN®).University Hospital, ToulouseNULLCompleted18 YearsN/ABoth35N/AFrance
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2008-005266-31-FR
(EUCTR)
06/02/200913/03/2009COMPARAISON D'UN TRAITEMENT PAR L'ANTICORPS MONOCLONAL ANTI-CD 20 : RITUXIMAB (MABTHERA®) ASSOCIE A UNE CORTICOTHERAPIE GENERALE COURTE PAR RAPPORT A UNE CORTICOTHERAPIE GENERALE DE LONGUE DUREE CHEZ LES PATIENTS ATTEINTS DE PEMPHIGUS - Rituximab IIICOMPARAISON D'UN TRAITEMENT PAR L'ANTICORPS MONOCLONAL ANTI-CD 20 : RITUXIMAB (MABTHERA®) ASSOCIE A UNE CORTICOTHERAPIE GENERALE COURTE PAR RAPPORT A UNE CORTICOTHERAPIE GENERALE DE LONGUE DUREE CHEZ LES PATIENTS ATTEINTS DE PEMPHIGUS - Rituximab III Pemphogoide bulleuse
MedDRA version: 9.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid
Trade Name: mabthéra
Product Name: mathéra
Trade Name: Prednisone
Product Name: CORTANCYL 20 mg
CHU-Hôpitaux de RouenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
72NCT00626678
(ClinicalTrials.gov)
January 200821/2/2008Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With PrednisoloneA Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Adjuvant Azathioprine Therapy in New Cases of Pemphigus Vulgaris Receiving PrednisonePemphigus VulgarisDrug: Azathioprine;Drug: Prednisone;Drug: PlaceboTehran University of Medical SciencesNULLCompleted10 Years75 YearsBoth48Phase 2Iran, Islamic Republic of
73NCT00656656
(ClinicalTrials.gov)
January 20087/4/2008Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for PemphigusCombined Treatment of Autoimmune Bullous Diseases With Protein A Immunoadsorption, Dexamethasone Pulse Therapy and RituximabPemphigusDrug: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus AzathioprineUniversity of LuebeckNULLCompleted18 YearsN/AAll23Phase 2Germany
74EUCTR2007-005711-26-IT
(EUCTR)
15/11/200705/02/2008An open prospective, monocenter, consecutive non randomized clinical trial on therapy with monoclonal antibodies anti-CD20 in the treatment of pemphigus vulgare or foliaceus, serious and resistant to common therapies - NDAn open prospective, monocenter, consecutive non randomized clinical trial on therapy with monoclonal antibodies anti-CD20 in the treatment of pemphigus vulgare or foliaceus, serious and resistant to common therapies - ND Pemphigus vulgaris, pemphigus foliaceus
MedDRA version: 9.1;Level: LLT;Classification code 10034280;Term: Pemphigus
Trade Name: MABTHERA
INN or Proposed INN: Rituximab
ISTITUTO DERMOPATICO IMMACOLATANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
75NCT00606749
(ClinicalTrials.gov)
November 200722/1/2008Use of KC706 for the Treatment of Pemphigus VulgarisA Phase 2 Open-Label Uncontrolled Pilot Study of KC706 in Patients With Stable, Active Pemphigus VulgarisPemphigus VulgarisDrug: KC706Kemia, IncNULLCompleted18 YearsN/ABoth20Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT00483119
(ClinicalTrials.gov)
April 20075/6/2007Randomized Trial of IVIg With or Without Cyclophosphamide in PemphigusPhase 2 Randomized Trial of IVIg With or Without Cyclophosphamide in PemphigusPemphigus VulgarisDrug: intravenous immunoglobulin;Drug: cyclophosphamideNew York University School of MedicineNULLTerminated18 Years85 YearsAll9Phase 2United States
77NCT00283712
(ClinicalTrials.gov)
March 200626/1/2006Use of Infliximab for the Treatment of Pemphigus VulgarisA Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Infliximab in Subjects With Pemphigus Vulgaris Receiving PrednisonePemphigusDrug: Infliximab;Other: Placebo ComparatorNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceCompleted18 YearsN/AAll20Phase 2United States
78EUCTR2004-000526-75-ES
(EUCTR)
06/02/200612/12/2005Estudio multicéntrico, prospectivo, aleatorizado, con doble enmascaramiento, controlado con placebo, de grupos paralelos y 52 semanas de duración para evaluar la eficacia y la seguridad del micofenolato mofetilo (MMF) como tratamiento complementario para conseguir remisión con una dosis reducida de corticosteroides en pacientes con pénfigo vulgar - Seguridad y Eficacia de micofenolato mofetilo en Pemphigus VulgarisEstudio multicéntrico, prospectivo, aleatorizado, con doble enmascaramiento, controlado con placebo, de grupos paralelos y 52 semanas de duración para evaluar la eficacia y la seguridad del micofenolato mofetilo (MMF) como tratamiento complementario para conseguir remisión con una dosis reducida de corticosteroides en pacientes con pénfigo vulgar - Seguridad y Eficacia de micofenolato mofetilo en Pemphigus Vulgaris Pénfigo vulgar
MedDRA version: 8.1;Level: LLT;Classification code 10052802
Trade Name: CellCept®500 mg comprimidos
Product Name: CellCept 500 mg comprimidos recubiertos
INN or Proposed INN: micofenolato mofetilo
Aspreva pharmaceuticals CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Spain
79NCT00135720
(ClinicalTrials.gov)
June 200424/8/2005Study of Etanercept (Enbrel) in the Treatment of Pemphigus VulgarisA Double-Blinded, Placebo-Controlled Study of Etanercept (Enbrel) in the Treatment of Pemphigus VulgarisPemphigus VulgarisDrug: Enbrel (Etanercept)Massachusetts General HospitalBrigham and Women's Hospital;Stanford UniversityCompleted18 Years65 YearsBoth12Phase 2United States
80NCT00683930
(ClinicalTrials.gov)
May 200419/5/2008A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)A Prospective, Randomised, Double-blind, Placebo-controlled, Parallel Group, Mult-center, 52-week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Achieve Remission With Reduced Corticosteroid in Subjects With Pemphigus VulgarisPemphigus Vulgaris (PV)Drug: Mycophenolate Mofetil 2 g/Day;Drug: Mycophenolate Mofetil (MMF) 3 g/Day;Drug: PlaceboHoffmann-La RocheAspreva PharmaceuticalsCompleted18 Years70 YearsAll96Phase 3United States;Canada;Germany;Israel;Switzerland;Turkey;Ukraine;United Kingdom;India
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT00063752
(ClinicalTrials.gov)
July 20033/7/2003Safety Study of PI-0824 to Treat Pemphigus VulgarisAn Open-Label, Dose-Escalation, Phase I Clinical Study to Assess the Safety of PI-0824 in Patient With Pemphigus Vulgaris Requiring Daily Corticosteroid TherapyPemphigus VulgarisDrug: PI-0824PeptimmuneNULLCompleted18 YearsN/ABoth15Phase 1United States
82NCT00213512
(ClinicalTrials.gov)
June 200313/9/2005Effect of Anti CD20 in Pemphigus DeseaseTraitment of Patients Presenting Pemphigus With Anti CD20 (Mabthera).PemphigusDrug: MabtheraUniversity Hospital, RouenNULLCompleted18 YearsN/ABoth22Phase 2;Phase 3France
83NCT00278642
(ClinicalTrials.gov)
September 200216/1/2006Hematopoietic Stem Cell Support in Patients With Autoimmune Bullous Skin DisordersHigh Dose Cyclophosphamide & ATG With Hematopoietic Stem Cell Support in Patients With Autoimmune Bullous Skin Disorders: A Phase I TrialPemphigusBiological: Hematopoietic stem cell transplantationRichard Burt, MDNULLTerminated18 Years60 YearsBoth1Phase 1United States
84NCT00213421
(ClinicalTrials.gov)
August 200113/9/2005Comparison of Two Therapeutic Strategies of Dermoval in Treatment of Bullous PemphigusBullous PemphigoidDrug: DermovalUniversity Hospital, RouenNULLCompleted18 YearsN/ABoth330France
85NCT00127764
(ClinicalTrials.gov)
January 20014/8/2005European Trial of Adjuvant Oral Glucocorticoid Pulse Therapy in PemphigusEuropean Randomised Placebo-Controlled Trial of Adjuvant Oral Glucocorticoid Pulse Therapy in Pemphigus (Pempuls Trial)PemphigusDrug: dexamethasone (50mg 1dd6, 3 consecutive days/month)University Medical Centre GroningenNULLCompleted18 YearsN/ABoth60Phase 2;Phase 3Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT00010413
(ClinicalTrials.gov)
April 19992/2/2001Phase II Study of High-Dose Cyclophosphamide in Patients With Refractory PemphigusPemphigusDrug: cyclophosphamide;Drug: filgrastimJohns Hopkins UniversityNULLCompleted18 Years70 YearsBoth35Phase 2United States
87NCT00429533
(ClinicalTrials.gov)
November 199629/1/2007Efficacy of Dapsone as a Steroid Sparing Agent in Pemphigus VulgarisA Prospective Randomized Placebo-Controlled Clinical Trial of Dapsone as a Glucocorticoid-Sparing Agent in Maintenance Phase Pemphigus VulgarisPemphigus VulgarisDrug: DapsoneJacobus PharmaceuticalNULLTerminated18 Years80 YearsBoth48Phase 2United States