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 35. 天疱瘡 [臨床試験数:57,薬物数:81(DrugBank:36),標的遺伝子数:17,標的パスウェイ数:23] 

Searched query = "Pemphigus"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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PhaseCountries
1NCT04023149August 10, 201929 July 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 UniversityNot recruiting18 Years60 YearsAll180Phase 2China
2NCT03780166March 201930 September 2019A 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 CorporationNot recruiting18 Years80 YearsAll0Phase 2
3EUCTR2018-002261-19-ES08/02/201928 February 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 Pemphiguspemphigus 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 Level: LLT 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
Pharmaceutical Form: Tablet
INN or Proposed INN: not available
CAS Number: 1575596
Current Sponsor code: PRN1008
Other descriptive name: PRN1008
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Principia BiopharmaAuthorised 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
4NCT03762265January 8, 201911 November 2019A 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.Recruiting18 Years80 YearsAll120Phase 3United States;Australia;Bulgaria;Canada;France;Germany;Greece;Israel;Italy;Poland;Serbia;Spain;Taiwan;Turkey;Ukraine;United Kingdom
5ChiCTR18000203822019-01-0114 January 2019Efficacy 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 pemphigusPemphigusGroup 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 UniversityRecruiting1880BothGroup 1:14;Group 2:14;Group 3:14;Pilot studyChina
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Inclusion_
agemin
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PhaseCountries
6JPRN-JapicCTI-18423101/12/201816 July 2019ONO-4059 phase II studyONO-4059 phase II study: Multicenter, open-label, uncontrolled, single-arm study in patients with refractory pemphigusRefractory pemphigusIntervention name : ONO-4059
INN of the intervention : Tirabrutinib
Dosage And administration of the intervention : Oral administration
ONO PHARMACEUTICAL CO.,LTD.Not Recruiting20BOTH14Phase 2
7JPRN-jRCTs05118006912/04/20182 April 2019Imatinib treatment of autoimmune bullous diseasesIntervention study on autoimmune bullous diseases with imatinib - IABDAutoimmune 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).Kenji KabashimaTakashi Nomura;Akihiko Kitoh;Tetsuya Honda;Gyohei Egawa;Yuichiro Endo;Yo Kaku;Atsushi OtsukaRecruiting20 years oldOne hundred years oldBoth10Phase 0none
8EUCTR2017-002333-40-DE31/01/201830 April 2019A 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 Level: LLT 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
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: efgartigimod
CAS Number: 1821402-21-4
Current Sponsor code: ARGX-113
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 25-
argenx BVBAAuthorised Female: yes
Male: yes
22Phase 2Hungary;Ukraine;Romania;Israel;Germany;Italy
9NCT03334058October 18, 20179 September 2019A 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-113argenx BVBARecruiting18 YearsN/AAll12Phase 2Germany;Hungary;Israel;Italy;Ukraine
10NCT03239470October 10, 201729 July 2019Polyclonal 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 ExcellenceRecruiting18 Years75 YearsAll12Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Inclusion_
agemin
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agemax
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PhaseCountries
11NCT03075904August 1, 201714 October 2019A 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: SYNT001Alexion PharmaceuticalsNot recruiting18 YearsN/AAll8Phase 1/Phase 2United States
12JPRN-jRCTs03118040511/05/201710 September 2019Rituximab therapy for refractory pemphigusSafety evaluation study about rituximab therapy for refractory pemphigusRefactory Pemphigus
Other disease of skin or skin tissue
Infuse rituximab 1000mg/body twice biweekly.Takeru FunakoshiRecruiting20 years of age80 years of ageBoth10N/Anone
13JPRN-UMIN0000260042017/05/082 April 2019Safety evaluation study about rituximab therapy for refractory pemphiguspemphigusInfuse rituximab 1000mg/body twice biweeklyKeio University, School of MedicineRecruiting20years-old80years-oldMale and Female10Not applicableJapan
14NCT02993133December 20166 May 2019Pharmacokinetics 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, LimogesNot recruiting18 YearsN/AAll53Phase 3France
15JPRN-UMIN0000242652016/10/042 April 2019Open-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 pemphigussteroid treatment-resistant pemphigusRituximab (genetic recombination)Department of Dermatology, Keio University School of MedicineHOKKAIDO UNIVERSITY HOSPITAL OKAYAMA UNIVERSITY HOSPITAL KURUME UNIVERSITY HOSPITALNot Recruiting20years-old80years-oldMale and Female10Phase 2Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16ChiCTR-OIC-170117592016-08-0121 August 2017pharmacogenomics 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 UniversityNot Recruiting1865BothCase series:60;Phase 1 studyChina
17EUCTR2015-003564-37-GR21/04/20162 May 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 VulgarisPemphigus: 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
Pharmaceutical Form: Tablet
INN or Proposed INN: Not available
CAS Number: 1575596-29-0
Current Sponsor code: PRN1008
Other descriptive name: PRN1008 Freebase
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: Not available
CAS Number: 1575596-29-0
Current Sponsor code: PRN1008
Other descriptive name: PRN1008 Freebase
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
INN or Proposed INN: Not available
CAS Number: 1575596-30-3
Current Sponsor code: PRN1008
Other descriptive name: PRN1008 Freebase
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: Not available
CAS Number: 1575596-30-3
Current Sponsor code: PRN1008
Other descriptive name: PRN1008 Freebase
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Principia Biopharma Australia Pty LtdAuthorisedFemale: yes
Male: yes
25Phase 2France;Greece;Croatia;Australia;Israel
18EUCTR2015-003564-37-HR18/04/20167 January 2019A 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 VulgarisPemphigus: 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
Pharmaceutical Form: Tablet
INN or Proposed INN: Not available
CAS Number: 1575596-29-0
Current Sponsor code: PRN1008
Other descriptive name: PRN1008 Freebase
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: Not available
CAS Number: 1575596-29-0
Current Sponsor code: PRN1008
Other descriptive name: PRN1008 Freebase
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
INN or Proposed INN: Not available
CAS Number: 1575596-30-3
Current Sponsor code: PRN1008
Other descriptive name: PRN1008 Freebase
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: Not available
CAS Number: 1575596-30-3
Current Sponsor code: PRN1008
Other descriptive name: PRN1008 Freebase
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Principia Biopharma Australia Pty LtdAuthorisedFemale: yes
Male: yes
50Phase 2France;Greece;Croatia;Australia;Israel
19NCT02704429February 201628 October 2019A 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.Not recruiting18 Years80 YearsAll42Phase 2Australia;Croatia;France;Greece;Israel
20NCT02828163January 201616 December 2017Comparison 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 UniversityNot recruitingN/AN/AAll11Phase 3Egypt
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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Target_
size
PhaseCountries
21NCT02613910December 23, 201516 December 2017Long-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/PrednisoloneGlaxoSmithKlineNot recruitingN/AN/AAll1Phase 3United States
22NCT02383589May 26, 201526 August 2019A 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.Not recruiting18 Years75 YearsAll135Phase 3United States;Argentina;Australia;Brazil;Canada;France;Germany;Israel;Italy;Spain;Turkey;Ukraine
23EUCTR2014-000382-41-DE06/03/201525 June 2018A 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 - PEMPHIXPemphigus 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]
Trade Name: MABTHERA®
Product Name: Rituximab
Product Code: RO0452294/V02
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Current Sponsor code: RO 0452294
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 500mg/50ml-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: CELLCEPT®
Product Name: Mycophenolate mofetil
Product Code: RO1061443/F02
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Mycophenolate mofetil
CAS Number: 128794-94-5
Current Sponsor code: RO1061443/F02
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
F. Hoffmann-La Roche LtdAuthorisedFemale: yes
Male: yes
132Phase 3France;United States;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
24NCT02365675January 20152 March 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
25EUCTR2013-001370-20-IT26/11/201429 August 2016Study 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 VulgarisPemphigus 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
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: OFATUMUMAB
CAS Number: 679818-59-8
Current Sponsor code: GSK1841157
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Glaxo Group LtdNot RecruitingFemale: yes
Male: yes
136Phase 3United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
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size
PhaseCountries
26JPRN-UMIN0000154512014/11/132 April 2019Exploratory 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) 2Pemphigus, 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 SchoolNot Recruiting20years-old80years-oldMale and Female20Phase 1,2Japan
27JPRN-jRCTs03118022001/05/201422 July 2019Rituximab treatment of blistering diseaseTreatment of refractory autoimmuno blistering disease with rituximabPemphigus 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.Miwa KanaokaAihara MichikoRecruiting20 age old80 age oldBoth10N/Anone
28NCT01930175December 18, 201328 October 2019Study 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: Placebo to VAY736Novartis PharmaceuticalsNot recruiting20 Years70 YearsAll16Phase 2United States;Austria;Bulgaria;Taiwan;Germany;Israel;Italy;United Kingdom
29EUCTR2013-001217-33-AT25/11/201319 March 2018Study 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 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: VAY736
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: ianalumab
Current Sponsor code: VAY736
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentration number: 3-10
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
32Phase 2United States;Taiwan;Austria;Bulgaria
30NCT01974518November 201319 February 2015Comparative 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 ResearchNot recruiting18 YearsN/ABoth20Phase 3India
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
31EUCTR2013-000211-24-DE01/10/20136 January 2015immunoglobulin 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-PVpatients 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]
Trade Name: Intratect 5%
Product Name: Intratect
Pharmaceutical Form: Infusion
Other descriptive name: WATER FOR INJECTION
Concentration unit: ml millilitre(s)
Concentration type: up to
Concentration number: 1-
Other descriptive name: GLYCINE
Concentration unit: µmol micromole(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Infusion
Route of administration of the placebo: Intravenous use
Ruprecht-Karls-University HeidelbergNot RecruitingFemale: yes
Male: yes
Germany
32NCT01920477August 13, 201311 June 2018Efficacy 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 VulgarisPemphigusBiological: Ofatumumab;Biological: PlaceboNovartis PharmaceuticalsNot recruiting18 Years70 YearsAll35Phase 3United States;Australia;Croatia;France;Greece;Israel;Italy;Japan;Korea, Republic of;Poland;Romania;Russian Federation;Ukraine
33ChiCTR-TRC-120035392011-08-0118 April 2017Use 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 DiseasesPemphigusGlucocorticoid 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 SciencesNot Recruiting1875BothGlucocorticoid hormone group:90;Glucocorticoids joint methotrexate (MTX) group:90;Post-marketChina
34ChiCTR-TRC-120035402011-08-0118 April 2017Use 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 DiseasesPemphigusGlucocorticoid 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 SciencesNot Recruiting1875BothGlucocorticoid group:90;Glucocorticoid plus MTX group:90;Post-marketChina
35NCT01299857June 201119 February 2015Long-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, RouenNot recruiting18 YearsN/ABoth22Phase 3France
No.TrialIDDate_
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sponsor
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Inclusion_
agemin
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size
PhaseCountries
36NCT01313923February 201116 December 2017Evaluating 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, IrvineNot recruiting18 YearsN/AAll3Early Phase 1United States
37JPRN-UMIN0000044282010/11/012 April 2019Exploratory 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 disorderNot Recruiting20years-oldNot applicableMale and Female20Phase 2Japan
38NCT01338103January 201019 February 2015Treatment 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
39NCT00784589July 200916 December 2017Comparison 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, RouenNot recruiting18 Years80 YearsAll90Phase 3France
40NCT00960713June 200919 February 2015The 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, ToulouseNot recruiting18 YearsN/ABoth35N/AFrance
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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PhaseCountries
41EUCTR2008-005266-31-FR06/02/200919 March 2012COMPARAISON 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 IIIPemphogoide bulleuse
MedDRA version: 9.1 Level: LLT Classification code 10006567 Term: Bullous pemphigoid
Trade Name: mabthéra
Product Name: mathéra
Pharmaceutical Form: Solution for injection
Trade Name: Prednisone
Product Name: CORTANCYL 20 mg
Pharmaceutical Form: Tablet
CHU-Hôpitaux de RouenAuthorisedFemale: yes
Male: yes
France
42NCT00626678January 200819 February 2015Azathioprine 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 SciencesNot recruiting10 Years75 YearsBoth48Phase 2Iran, Islamic Republic of
43NCT00656656January 200816 December 2017Immunoadsorption, 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 LuebeckNot recruiting18 YearsN/AAll23Phase 2Germany
44EUCTR2007-005711-26-IT15/11/200719 March 2012An 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 - NDPemphigus vulgaris, pemphigus foliaceus
MedDRA version: 9.1 Level: LLT Classification code 10034280 Term: Pemphigus
Trade Name: MABTHERA
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
ISTITUTO DERMOPATICO IMMACOLATAAuthorisedFemale: yes
Male: yes
Italy
45NCT00606749November 200719 February 2015Use 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, IncNot recruiting18 YearsN/ABoth20Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
Inclusion_
agemax
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gender
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PhaseCountries
46NCT00483119April 200719 October 2017Randomized 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 MedicineNot recruiting18 Years85 YearsAll9Phase 2United States
47NCT00283712March 200616 December 2017Use 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 ExcellenceNot recruiting18 YearsN/AAll20Phase 2United States
48EUCTR2004-000526-75-ES06/02/200619 March 2012Estudio 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 VulgarisPénfigo vulgar
MedDRA version: 8.1 Level: LLT Classification code 10052802
Trade Name: CellCept®500 mg comprimidos
Product Name: CellCept 500 mg comprimidos recubiertos
Pharmaceutical Form: Tablet
INN or Proposed INN: micofenolato mofetilo
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Aspreva pharmaceuticals CorporationAuthorisedFemale: yes
Male: yes
72Spain
49NCT00135720June 200429 June 2015Study 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 UniversityNot recruiting18 Years65 YearsBoth12Phase 2United States
50NCT00683930May 200419 October 2017A 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 PharmaceuticalsNot recruiting18 Years70 YearsAll96Phase 3United States;Canada;Germany;Israel;Switzerland;Turkey;Ukraine;United Kingdom;India
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Inclusion_
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PhaseCountries
51NCT00063752July 200319 February 2015Safety 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-0824PeptimmuneNot recruiting18 YearsN/ABoth15Phase 1United States
52NCT00213512June 200319 February 2015Effect of Anti CD20 in Pemphigus DeseaseTraitment of Patients Presenting Pemphigus With Anti CD20 (Mabthera).PemphigusDrug: MabtheraUniversity Hospital, RouenNot recruiting18 YearsN/ABoth22Phase 2/Phase 3France
53NCT00278642September 200219 February 2015Hematopoietic 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, MDNot recruiting18 Years60 YearsBoth1Phase 1United States
54NCT00213421August 200119 February 2015Comparison of Two Therapeutic Strategies of Dermoval in Treatment of Bullous PemphigusBullous PemphigoidDrug: DermovalUniversity Hospital, RouenNot recruiting18 YearsN/ABoth330Phase 4France
55NCT00127764January 200119 February 2015European 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 GroningenNot recruiting18 YearsN/ABoth60Phase 2/Phase 3Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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PhaseCountries
56NCT00010413April 199919 February 2015Phase II Study of High-Dose Cyclophosphamide in Patients With Refractory PemphigusPemphigusDrug: cyclophosphamide;Drug: filgrastimJohns Hopkins UniversityNot recruiting18 Years70 YearsBoth35Phase 2United States
57NCT00429533November 199619 February 2015Efficacy 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 PharmaceuticalNot recruiting18 Years80 YearsBoth48Phase 2United States

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