162. 類天疱瘡(後天性表皮水疱症を含む。) Pemphigoid Clinical trials / Disease details


臨床試験数 : 83 薬物数 : 128 - (DrugBank : 51) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 142

  
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04128176
(ClinicalTrials.gov)
May 25, 202312/10/2019Efficacy and Safety of Rituximab Combined With Omalizumab in Patients With Bullous PemphigoidAn Open-Label Study to Evaluate the Efficacy and Safety of Rituximab Combined With Omalizumab in Patients With Bullous PemphigoidBullous PemphigoidDrug: Rituximab combined with OmalizumabUniversity of California, DavisNULLNot yet recruiting18 Years90 YearsAll15Phase 3United States
2NCT05267600
(ClinicalTrials.gov)
March 202214/2/2022A Phase 2/3 Study of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid (BALLAD)A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Bullous PemphigoidBullous PemphigoidBiological: EFG PH20 SC;Other: PBO;Drug: PrednisoneargenxNULLNot yet recruiting18 YearsN/AAll160Phase 2/Phase 3NULL
3NCT05263505
(ClinicalTrials.gov)
February 21, 202216/2/2022Baricitinib for the Treatment of Ocular Mucous Membrane PemphigoidBaricitinib for the Treatment of Ocular Mucous Membrane PemphigoidMucous Membrane Pemphigoid;Cicatrizing ConjunctivitisDrug: Baricitinib 2 MG [Olumiant];Drug: Methotrexate;Drug: Azathioprine;Drug: MycophenolateWashington University School of MedicineEli Lilly and CompanyRecruiting18 YearsN/AAll20Phase 2United States
4EUCTR2020-005987-67-DE
(EUCTR)
22/12/202116/07/2021A study to see if 24-weeks of treatment with nomacopan works and is safe in adult patients with bullous pemphigoid who are also being treated with steroid tabletsA randomized, part A partial blinded and part B double blinded, placebo-controlled 24-week clinical study to evaluate the efficacy and safety of nomacopan therapy in adult patients with bullous pemphigoid receiving adjunct oral corticosteroid therapy (ARREST-BP) moderate to severe bullous pemphigoid
MedDRA version: 21.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: nomacopan
Product Code: rVA576
INN or Proposed INN: NOMACOPAN
Other descriptive name: rVA576
Akari Therapeutics PlcNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 3United States;Germany
5EUCTR2020-000287-32-GR
(EUCTR)
04/11/202113/09/2021A study to investigate the use of benralizumab in patients with bullous pemphigoidA Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab as a Treatment Option for Patients with Bullous Pemphigoid (FJORD) - FJORD Bullous Pemphigoid
MedDRA version: 21.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Fasenra
Product Name: benralizumab
Product Code: MEDI-563
INN or Proposed INN: benralizumab
Other descriptive name: benralizumab
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3France;United States;Greece;Spain;Australia;Bulgaria;Israel;Germany;Italy;Japan;China
6NCT05061771
(ClinicalTrials.gov)
September 202115/9/2021Nomacopan Therapy in Adult Patients With Bullous Pemphigoid Receiving Adjunct Oral Corticosteroid Therapy (ARREST-BP)A Randomized, Part A Partial Blinded and Part B Double Blinded, Placebo-controlled 24-week Clinical Study to Evaluate the Efficacy and Safety of Nomacopan Therapy in Adult Patients With Bullous Pemphigoid Receiving Adjunct Oral Corticosteroid Therapy (ARREST-BP)Bullous PemphigoidDrug: nomacopan (rVA576);Other: PlaceboAKARI TherapeuticsNULLNot yet recruiting18 Years99 YearsAll148Phase 3NULL
7EUCTR2020-000287-32-DE
(EUCTR)
12/04/202116/10/2020A study to investigate the use of benralizumab in patients with bullous pemphigoidA Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab as a Treatment Option for Patients with Bullous Pemphigoid (FJORD) - FJORD Bullous Pemphigoid
MedDRA version: 21.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Fasenra
Product Name: benralizumab
Product Code: MEDI-563
INN or Proposed INN: benralizumab
Other descriptive name: benralizumab
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;France;Greece;Spain;Australia;Israel;Bulgaria;Germany;Japan;Italy;China
8NCT04612790
(ClinicalTrials.gov)
March 31, 202112/10/2020A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid.A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab as a Treatment Option for Patients With Bullous Pemphigoid (FJORD)Bullous PemphigoidBiological: Benralizumab;Biological: PlaceboAstraZenecaNULLRecruiting18 Years130 YearsAll120Phase 3United States;Australia;Bulgaria;China;France;Germany;Greece;Israel;Italy;Japan;Spain
9NCT04776694
(ClinicalTrials.gov)
March 29, 202125/2/2021Compassionate Use of DupilumabBullous Pemphigoid;Eosinophilic Esophagitis (EoE);Pediatric Asthma;Pediatric and Adolescent Chronic Rhinosinusitis With Nasal Polyps (CRSwNP);Pediatric Atopic DermatitisDrug: DupilumabRegeneron PharmaceuticalsNULLAvailableNULL
10JPRN-jRCT2071210014
26/03/202126/04/2021A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab as a Treatment Option for Patients With Bullous Pemphigoid.The purpose of this study is to investigate the use of benralizumab is effective in the treatment of patients symptomatic Bullous Pemphigoid (BP). - FJORD Bullous PemphigoidThis study is designed to assess the efficacy and safety of a benralizumab 60 mg loading dose followed by repeat dosing of subcutaneously (SC) administered benralizumab 30 mg versus placebo in adult participants with symptomatic BP.

Following screening, about 120 eligible participants will be randomized 1:1 to receive either benralizumab or placebo.

Double-blind treatment period (0w-36w): In the benralizumab group, 60 mg initially and 30 mg thereafter are subcutaneously administered every 4 weeks. In the placebo group, placebo is subcutaneously administered every 4 weeks.

Open-label extension period (36w-): All participants who complete the double-blind dosing period will be given the option of receiving benralizumab 30 mg subcutaneously every 4 weeks.
Hibi KazushigeNULLRecruiting>= 18age oldNot applicableBoth12Phase 3United States;Australia;Bulgaria;France;Germany;Israel;Italy;Spain;Japan
11EUCTR2020-000287-32-FR
(EUCTR)
09/02/202103/11/2020A study to investigate the use of benralizumab in patients with bullous pemphigoidA Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab as a Treatment Option for Patients with Bullous Pemphigoid - FJORD Bullous Pemphigoid
MedDRA version: 21.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: benralizumab
Product Code: MEDI-563
INN or Proposed INN: benralizumab
Other descriptive name: benralizumab
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;France;Spain;Australia;Israel;Bulgaria;Germany;Japan;Italy
12EUCTR2020-000287-32-IT
(EUCTR)
22/01/202124/05/2021A study to investigate the use of benralizumab in patients with bullous pemphigoidA Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab as a Treatment Option for Patients with Bullous Pemphigoid - FJORD Bullous Pemphigoid
MedDRA version: 21.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Benralizumab
Product Code: [MEDI-563]
INN or Proposed INN: Benralizumab
ASTRAZENECA ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3France;United States;Spain;Australia;Bulgaria;Israel;Germany;Japan;Italy
13NCT04540133
(ClinicalTrials.gov)
December 26, 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
14EUCTR2019-001059-37-BG
(EUCTR)
22/12/202013/11/2020Double-Blind, Randomized, Placebo-Controlled Trial of AKST4290 for Adjunctive Treatment of Mild to Moderate Bullous PemphigoidDouble-Blind, Randomized, Placebo-Controlled Trial of AKST4290 for Adjunctive Treatment of Mild to Moderate Bullous Pemphigoid Mild to Moderate Bullous Pemphigoid
MedDRA version: 21.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: AKST4290
Product Code: AKST4290
INN or Proposed INN: AKST4290
Other descriptive name: 2-[[[(2R)-1-[1-[(4-CHLORO-3-METHYLPHENYL)METHYL]-4- PIPERIDINYL]-5-OXO-2-PYRROLIDINYL]CARBONYL]AMINO]- N,N,6-TRIMETHYL-4-PYRIDINECARBOXAMIDE,DIHYDROCHLORIDE
Alkahest, Inc.NULLNot RecruitingFemale: yes
Male: yes
10Phase 2Bulgaria;Germany
15EUCTR2020-000287-32-BG
(EUCTR)
02/12/202006/10/2020A study to investigate the use of benralizumab in patients with bullous pemphigoidA Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab as a Treatment Option for Patients with Bullous Pemphigoid (FJORD) - FJORD Bullous Pemphigoid
MedDRA version: 21.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Fasenra
Product Name: benralizumab
Product Code: MEDI-563
INN or Proposed INN: benralizumab
Other descriptive name: benralizumab
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3France;United States;Greece;Spain;Australia;Israel;Bulgaria;Germany;Italy;Japan;China
16NCT04206553
(ClinicalTrials.gov)
October 28, 202018/12/2019A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous PemphigoidA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous PemphigoidBullous PemphigoidDrug: dupilumab;Drug: Matching Placebo;Drug: Oral corticosteroids (OCS)Regeneron PharmaceuticalsSanofiRecruiting18 Years90 YearsAll98Phase 2/Phase 3United States;Australia;France;Germany;Japan
17EUCTR2019-003520-20-DE
(EUCTR)
15/10/202026/03/2020A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients with Bullous PemphigoidA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients with Bullous Pemphigoid - LIBERTY-BP ADEPT Bullous pemphigoid (BP)
MedDRA version: 20.0;Level: PT;Classification code 10034277;Term: Pemphigoid;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
98Phase 2;Phase 3United States;France;Australia;Japan;Germany
18NCT04563923
(ClinicalTrials.gov)
October 10, 202017/9/2020Treatment of Bullous Pemphigoid With Avdoralimab (IPH5401), an Anti-C5aR1 Monoclonal AntibodyTreatment of Bullous Pemphigoid With Avdoralimab (IPH5401), an Anti-C5aR1 Monoclonal AntibodyBullous PemphigoidDrug: Avdoralimab (IPH5401);Other: ControlCentre Hospitalier Universitaire de NiceNULLRecruiting18 YearsN/AAll40Phase 2France
19NCT04744623
(ClinicalTrials.gov)
September 30, 20202/2/2021Clinical Evaluation of New Treatment Strategy of Mucous Membrane Pemphigoid Using Large Dose of Prednisolone Plus Intra-lesional of Triamcinolone Acetonide Followed by Combination of Mycophenolate Mofetil, Dapsone and Low Dose PrednisoloneClinical Evaluation of New Treatment Strategy of Mucous Membrane Pemphigoid Using Large Dose of Prednisolone Plus Intra-lesional of Triamcinolone Acetonide Followed by Combination of Mycophenolate Mofetil, Dapsone and Low Dose PrednisoloneBenign Mucous Membrane PemphigoidDrug: large dose of prednisolone plus intra-lesional of Triamcinolone Acetonide followed the systemic combination of mycophenolate mofetil (MMF), dapsone and low dose prednisolone in treatment of MMPTanta UniversityNULLActive, not recruiting40 Years60 YearsAll10Phase 2/Phase 3Egypt
20NCT04465292
(ClinicalTrials.gov)
September 1, 202014/5/2020The Effects of Tildrakizumab in Treatment of Bullous PemphigoidThe Effects of Tildrakizumab in Treatment of Bullous PemphigoidPemphigoid, BullousDrug: Tildrakizumab Prefilled SyringeBrigham and Women's HospitalJoseph MerolaNot yet recruiting18 YearsN/AAll16Early Phase 1NULL
21EUCTR2020-002912-34-FR
(EUCTR)
11/08/202022/06/2020Treatment of bullous pemphigoid with avdoralimab (IPH5401), an anti-C5aR1 monoclonal antibodyTreatment of bullous pemphigoid with avdoralimab (IPH5401), an anti-C5aR1 monoclonal antibody - PB Auto Immune bullous Diseases;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]Product Name: avdoralimab
Product Code: IPH5401
INN or Proposed INN: avdoralimab
Other descriptive name: NNC0215-0384
CHU NICENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2France
22EUCTR2019-003520-20-FR
(EUCTR)
19/05/202025/03/2020A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients with Bullous PemphigoidA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients with Bullous Pemphigoid - LIBERTY-BP ADEPT Bullous pemphigoid (BP)
MedDRA version: 20.0;Level: PT;Classification code 10034277;Term: Pemphigoid;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2;Phase 3United States;France;Spain;Australia;Germany;Japan
23NCT04117932
(ClinicalTrials.gov)
March 11, 20204/10/2019Efficacy and Safety of Ustekinumab in Bullous PemphigoidEfficacy and Safety of Ustekinumab in Bullous PemphigoidBullous PemphigoidDrug: UstekinumabCHU de ReimsNULLRecruiting18 Years90 YearsAll18Phase 2France
24NCT04499235
(ClinicalTrials.gov)
January 30, 202031/7/2020A Study to Assess the Therapeutic Effect and Safety of Adjunctive AKST4290 in Subjects With Bullous PemphigoidDouble-Blind, Randomized, Placebo-Controlled Trial of AKST4290 for Adjunctive Treatment of Mild to Moderate Bullous PemphigoidPemphigoid, BullousDrug: Mometasone furoate;Drug: AKST4290;Drug: PlaceboAlkahest, Inc.NULLCompleted60 Years95 YearsAll30Phase 2Germany
25ChiCTR2000028707
2020-01-012019-12-31Randomized, controlled clinical trial for low-dose interleukin-2 in the treatment of moderate to severe bullous pemphigoidRandomized, controlled clinical trial for low-dose interleukin-2 in the treatment of moderate to severe bullous pemphigoid Bullous pemphigoidModerate BP group 1:Standard treatment plan;Moderate BP group 2:low dose interleukin-2;Severe BP group 1:Standard treatment plan;Severe BP group 2:low dose interleukin-2;Dermatology Hospital, Southern Medical UniversityNULLRecruiting1290BothModerate BP group 1:34;Moderate BP group 2:34;Severe BP group 1:35;Severe BP group 2:35;China
26ChiCTR2000029007
2020-01-012020-01-11Clinical observation of subclinical dosage of cyclosporine combined with glucocorticoid in the treatment of moderate and severe bullous pemphigoidClinical observation of subclinical dosage of cyclosporine combined with glucocorticoid in the treatment of moderate and severe bullous pemphigoid Bullous Pemphigoidexperimental group:subclinical dosage of Cyclosporine, Prednisone or Methylprednisolone and Halometasone Cream.;control group:Prednisone or Methylprednisolone, Halometasone Cream;The First Affiliated Hospital of Kunming Medical UniversityNULLRecruitingBothexperimental group:30;control group:30;Phase 4China
27NCT03295383
(ClinicalTrials.gov)
July 11, 201922/9/2017Randomized Clinical Trial Comparing the Safety and Efficacy of Rituximab Versus Oral Cyclophosphamide in Severe Forms of Mucous Membrane PemphigoidRandomized Double Blind Double Dummy Control Trial Comparing the Safety and Efficacy of Rituximab Versus Oral Cyclophosphamide in Severe Forms of Mucous Membrane PemphigoidSevere Forms of Mucous Membrane PemphigoidDrug: Rituximab 1g IV;Drug: Cyclophosphamide 50Mg Oral Tablet;Drug: Placebo of Rituximab;Drug: Placebo Oral TabletUniversity Hospital, RouenNULLRecruiting18 Years80 YearsAll130Phase 3France
28EUCTR2019-001059-37-DE
(EUCTR)
21/06/201911/06/2019Double-Blind, Randomized, Placebo-Controlled Trial of AKST4290 for Adjunctive Treatment of Mild to Moderate Bullous PemphigoidDouble-Blind, Randomized, Placebo-Controlled Trial of AKST4290 for Adjunctive Treatment of Mild to Moderate Bullous Pemphigoid Mild to Moderate Bullous Pemphigoid
MedDRA version: 21.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: AKST4290
Product Code: AKST4290
INN or Proposed INN: AKST4290
Other descriptive name: 2-[[[(2R)-1-[1-[(4-CHLORO-3-METHYLPHENYL)METHYL]-4- PIPERIDINYL]-5-OXO-2-PYRROLIDINYL]CARBONYL]AMINO]- N,N,6-TRIMETHYL-4-PYRIDINECARBOXAMIDE,DIHYDROCHLORIDE
Alkahest, Inc.NULLNot RecruitingFemale: yes
Male: yes
30Phase 2Bulgaria;Germany
29EUCTR2018-002564-10-NL
(EUCTR)
23/04/201923/04/2019PDE4 inhibitor (apremilast) in pemphigoid.Short-term safety, efficacy and mode of action of apremilast in mild to moderate cutaneous pemphigoid: a phase IIa open label single arm study. - SAMP trial Pemphigoid;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]Trade Name: Otezla
Product Name: Apremilast
Product Code: CC-10004
Universitair Medisch Centrum GroningenNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
10 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noNetherlands
30NCT03926377
(ClinicalTrials.gov)
April 201915/4/2019Influence of Dermocorticoids on Bone Mineral Density in Patients With Bullous PemphigoidInfluence of Dermocorticoids on Bone Mineral Density in Patients With Bullous PemphigoidOsteoporosis;Bullous PemphigoidProcedure: bone densitometry;Biological: blood test;Procedure: radiographs of the thoracic and lumbar spine;Procedure: Clobetasol propionateCentre Hospitalier Universitaire, AmiensUniversity Hospital, RouenNot yet recruiting18 YearsN/AAll50Phase 4NULL
31NCT04035733
(ClinicalTrials.gov)
September 25, 201812/4/2019rVA576 in Adult Mild to Moderate Bullous Pemphigoid SubjectsA Phase IIa Open-label Single Arm Study of Safety and Efficacy of rVA576 in Adult Mild to Moderate Bullous Pemphigoid SubjectsBullous Pemphigoid (BP)Drug: rVA576AKARI TherapeuticsNULLCompleted18 YearsN/AAll9Phase 2Germany;Netherlands
32NCT03636763
(ClinicalTrials.gov)
September 201816/8/2018Dipeptidyl Peptidase-IV Inhibitors, Risk Factor for Development of Bullous Pemphigoid?Dipeptidyl Peptidase-IV Inhibitors, Risk Factor for Development of Bullous Pemphigoid? : Multicenter Retrospective Study in France and SwitzerlandBullous PemphigoidDrug: data reportAssistance Publique Hopitaux De MarseilleNULLUnknown statusN/AN/AAll183France
33ChiCTR1800017560
2018-08-312018-08-04Association of serum D-dimer and PDF with the BP severityAssociation of serum D-dimer and PDF with the BP severity Bullous pemphigoidGold Standard:Clinical outcome;Index test:D-dimer, FDP, anti-BP180 IgG;the Second Affiliated Hospital, Xi'an Jiaotong UniversityNULLPending1890BothTarget condition:160;Difficult condition:0China
34EUCTR2017-002836-18-DE
(EUCTR)
23/07/201814/02/2018A Clinical study to investigate if rVA576 is safe and has an effect on patients who have mild or moderate Bullous Pemphigoid (a blistering disorder where the skin forms tense blisters)A Phase IIa open label single arm study of safety and efficacy of rVA576 in adult mild to moderate Bullous Pemphigoid subjects Mild to Moderate Bullous Pemphigoid
MedDRA version: 21.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: rVA576
INN or Proposed INN: rVA576
Akari Therapeutics Plc.NULLNot RecruitingFemale: yes
Male: yes
9Phase 2Netherlands;Germany
35EUCTR2018-001417-32-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
36EUCTR2017-002836-18-NL
(EUCTR)
07/05/201824/01/2018A Clinical study to investigate if rVA576 is safe and has an effect on patients who have mild or moderate Bullous Pemphigoid (a blistering disorder where the skin forms tense blisters)A Phase IIa open label single arm study of safety and efficacy of rVA576 in adult mild to moderate Bullous Pemphigoid subjects Mild to Moderate Bullous Pemphigoid
MedDRA version: 21.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: rVA576
INN or Proposed INN: rVA576
Akari Therapeutics Plc.NULLNot RecruitingFemale: yes
Male: yes
9Phase 2Germany;Netherlands
37JPRN-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
38NCT03286582
(ClinicalTrials.gov)
September 5, 201714/9/2017A Proof-of-Concept Study of Topical AC-203 in Patients With Bullous PemphigoidA Randomized, Open-Label, Controlled Trial of Topical AC-203 in Subjects With Bullous PemphigoidBullous PemphigoidDrug: AC-203 1% Topical Ointment;Drug: Clobetasol 0.05% Topical OintmentTWi Biotechnology, Inc.NULLTerminated20 Years90 YearsAll10Phase 2Taiwan
39NCT03099538
(ClinicalTrials.gov)
August 15, 201721/3/2017Ixekizumab in the Treatment of Bullous PemphigoidIxekizumab in the Treatment of Bullous PemphigoidBullous Pemphigoid;PemphigoidDrug: IxekizumabMayo ClinicEli Lilly and CompanyCompleted18 YearsN/AAll4Phase 2United States
40NCT02993133
(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
41NCT02226146
(ClinicalTrials.gov)
February 201627/7/2014Evaluation of Safety, Efficacy and Pharmacodynamic Effect of Bertilimumab in Patients With Bullous PemphigoidAn Open-Label, Proof of Concept Study Designed to Evaluate the Safety, Efficacy and Pharmacodynamic Effect of Bertilimumab in Patients With Newly Diagnosed, Moderate to Extensive Bullous PemphigoidPemphigoid, BullousBiological: BertilimumabImmune PharmaceuticalsNULLCompleted60 YearsN/AAll11Phase 2United States;Israel
42NCT02874079
(ClinicalTrials.gov)
December 201511/8/2016Genetic Susceptibility and Influence of the Microbiomae in Bullous PemphigoidGenetic Susceptibility and Influence of the Microbiomae in Bullous PemphigoidBullous PemphigoidOther: Blood sample and cotton skin swabsCHU de ReimsNULLRecruiting18 YearsN/ABoth100N/AFrance
43NCT02502903
(ClinicalTrials.gov)
July 13, 20157/7/2015Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated DisordersSafety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement-mediated Disorders. A Single/Multiple Ascending Dose Phase 1 Study.Bullous Pemphigoid (BP);Cold Agglutinin Disease (CAD);Warm Autoimmune Hemolytic Anemia (WAIHA);End-stage Renal Disease (ESRD)Drug: BIV009;Other: PlaceboBioverativ, a Sanofi companyCelerion Clinical Research GmbH;Assign Data Management and Biostatistics GmbH;ABF Pharmaceutical Services GmbH;Quest Diagnostics-Nichols Insitute;Covance Laboratories - Chantilly;PPD Laboratories - Virginia;Softworld Inc. - Cambridge, MACompleted18 YearsN/AAll122Phase 1Austria
44NCT02360202
(ClinicalTrials.gov)
April 20157/1/2015Evaluation of Fluid Retention Due to Superpotent Topical CorticosteroidEvaluation of Fluid Retention Due to Superpotent Topical Corticosteroid in Patients With Bullous PemphigoidBullous PemphigoidProcedure: Impedance analysis;Drug: Clobetasol Propionate cream treatmentUniversity Hospital, RouenSociété de Dermatologie FrançaiseRecruiting18 YearsN/AAll35Phase 4France
45NCT02365675
(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
46JPRN-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 1,2Japan
47NCT02126020
(ClinicalTrials.gov)
November 201427/4/2014Topical Infliximab in Autoimmune Eyes With KeratoprosthesisTopical Infliximab in Autoimmune Eyes With KeratoprosthesisStevens-Johnson Syndrome;Toxic Epidermal Necrolysis (Lyell) Syndrome;Mucous Membrane PemphigoidDrug: topical infliximabJames Chodosh, MD, MPHMassachusetts Eye and Ear Infirmary;Fonds de recherche en ophtalmologie de l'Université de Montréal (FROUM)Withdrawn18 Years80 YearsAll0Phase 1/Phase 2United States;Canada
48JPRN-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
49NCT02149732
(ClinicalTrials.gov)
May 201414/5/2014Clinical Trial on the Effect of Autologous Oral Mucosal Epithelial Sheet TransplantationAn Investigator-initiated Trial (IIT) on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation in Corneal Limbal Deficiency PatientsLimbal Stem Cell Deficiency;Stevens-johnson Syndrome;Ocular Cicatricial Pemphigoid;Chemical BurnBiological: cultivated oral mucosal epithelial sheet transplantationSeoul National University HospitalMinistry of Health & Welfare, KoreaAvailable16 YearsN/ABothPhase 1/Phase 2Korea, Republic of
50EUCTR2012-003370-10-FR
(EUCTR)
24/05/201328/09/2015Safety, efficacy and PK/PD of QGE031 vs. placebo in patients with active bullous phemphigoid despite oral steroid treatment.A randomized, double-blind, placebo controlled, parallel group study evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of QGE031 in the treatment of patients with bullous pemphigoid with disease refractory to oral steroid treatment refractory bullous pemphigoid
MedDRA version: 18.0;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: QGE031Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
42Phase 2United States;France;Taiwan;Austria;Germany
51NCT02837965
(ClinicalTrials.gov)
April 201324/6/2016Observational Study Assessing Outcomes, Treatment Patterns and Related Costs in Patients in Bullous PemphigoidMulticenter Prospective Observational Study Assessing Outcomes, Adverse Events, Treatment Patterns and Related Costs in Patients Diagnosed With Bullous PemphigoidBullous PemphigoidDrug: treatment with topical superpotent corticosteroid therapy;Drug: treatment with systemic therapy (methotrexate);Drug: treatment systemic therapy (prednisone);Drug: treatment with systemic therapy (prednisone);Drug: treatment with systemic therapy (doxycycline)CHU de ReimsNULLRecruiting18 YearsN/ABoth150N/AFrance
52EUCTR2011-004361-32-DE
(EUCTR)
26/02/201322/05/2012Effect of simvastatin in combination with a superpotent topical corticosteroid in bullous pemphigoidEffect of simvastatin in combination with a superpotent topical corticosteroid in bullous pemphigoidA prospective multi-centre randomised double-blind placebo-controlled pilot study - SICOPEM Bullous pemphigoid (BP) is the most frequent blistering autoimmune disease of the skin. The disease itself is characterized by the development of bullous lesions, frequently following a prodromal phase with severe itching. Between 10 to 30 percent of patients exhibit mucosal membrane involvement in addition to the skin lesions.;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]Trade Name: Simvastatin-ratiopharm®
Product Name: Simvastatin-ratiopharm
Other descriptive name: SIMVASTATIN
Philipps-Universität MarburgNULLNot RecruitingFemale: yes
Male: yes
Germany
53NCT01705795
(ClinicalTrials.gov)
February 13, 20135/10/2012Anti-IL-5 Therapy in Bullous Pemphigoid (BP)Anti-IL-5 Therapy in Bullous Pemphigoid. Randomized, Placebo-controlled, Double-blind Study Evaluating the Effect of Anti-IL-5 Therapy in Patients With Bullous Pemphigoid.Pemphigoid, BullousDrug: Mepolizumab (a-IL-5 antibody);Drug: PlaceboUniversity Hospital Inselspital, BerneNULLCompleted18 YearsN/AAll32Phase 2Switzerland
54EUCTR2012-003370-10-DE
(EUCTR)
23/01/201323/10/2012Safety, efficacy and PK/PD of QGE031 vs. placebo in patients with active bullous phemphigoid despite oral steroid treatment.A randomized, double-blind, placebo controlled, parallel group study evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of QGE031 in the treatment of patients with bullous pemphigoid with disease refractory to oral steroid treatment Refractory Bullous Pemphigoid
MedDRA version: 16.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: QGE031
INN or Proposed INN: QGE031
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
42United States;Taiwan;Austria;Germany
55NCT01688882
(ClinicalTrials.gov)
January 201317/9/2012Safety, Efficacy and PK/PD of QGE031 vs. Placebo in Patients With Active Bullous Pemphigoid Despite Oral Steroid TreatmentA Randomized, Double-blind, Placebo Controlled, Parallel Group Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of QGE031 in the Treatment of Patients With Bullous Pemphigoid With Disease Refractory to Oral Steroid TreatmentBullous PemphigoidDrug: QGE031;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated20 Years80 YearsAll20Phase 2United States;Austria;France;Germany;Japan;Taiwan
56EUCTR2012-003370-10-AT
(EUCTR)
13/11/201203/10/2012Safety, efficacy and PK/PD of QGE031 vs. placebo in patients with active bullous phemphigoid despite oral steroid treatment.A randomized, double-blind, placebo controlled, parallel group study evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of QGE031 in the treatment of patients with bullous pemphigoid with disease refractory to oral steroid treatment Refractory Bullous Pemphigoid
MedDRA version: 15.0;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: QGE031Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
42United States;Taiwan;Austria;Germany
57NCT01582880
(ClinicalTrials.gov)
March 201210/4/2012Use of Cross-linked Donor Corneas as Carriers for the Boston KeratoprosthesisThe Use of Riboflavin/Ultraviolet A Cross-linked Human Donor Corneas as Carriers for the Boston KeratoprosthesisChemical Injuries;Unspecified Complication of Corneal Transplant;Autoimmune Diseases;Ocular Cicatricial Pemphigoid;Stevens Johnson Syndrome;Lupus Erythematosus, Systemic;Rheumatoid Arthritis;Other Autoimmune DiseasesDrug: RiboflavinJoseph B. Ciolino, MDNULLCompleted18 YearsN/AAll1Phase 1/Phase 2United States
58NCT01571895
(ClinicalTrials.gov)
February 20, 20124/4/2012Pilot Efficacy and Safety Study of Oral DF2156A in Patients With Active Bullous PemphigoidA Phase 2, Multicentre, Single Arm, Pilot Study to Assess the Efficacy and the Safety of 150 mg Twice a Day Oral DF2156A in Patients With Active Bullous Pemphigoid.Bullous PemphigoidDrug: DF2156ADompé Farmaceutici S.p.ANULLTerminated18 YearsN/AAll4Phase 2Germany;Italy
59NCT02202642
(ClinicalTrials.gov)
January 201221/4/2011The Improvement of Limbal Epithelial Culture Technique by Using Collagenase to Isolate Limbal Stem CellsThe Improvement of Limbal Epithelial Culture Technique for the Treatment of Unilateral Limbal Insufficiency by Using Collagenase to Isolate Limbal Stem CellsAlkaline Chemical Burn Of Cornea And Conjunctival Sac;Acid Chemical Burn Of Cornea And Conjunctival Sac;Benign Mucous Membrane Pemphigoid With Ocular InvolvementProcedure: collagenaseNational Taiwan University HospitalNULLRecruiting18 Years70 YearsBoth10Phase 1Taiwan
60ChiCTR-TRC-12003593
2011-08-012012-12-30Use of Oral Methotrexate plus Glucocorticoid for the Treatment of bullous pemphigoid:A multicenter,randomized and controlled clinincal trialGuideline-oriented Research in the Management of Some Common and Severe Skin Diseases bullous pemphigoidGlucocorticoids 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.;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 Academy of Medical SciencesNULLCompleted18BothGlucocorticoids group:90;Glucocorticoid plus MTX group:90;China
61ChiCTR-TRC-12003592
2011-08-012012-12-30Use of Tripterygium glycosides and Nicotinamide plus Minocycline for the Treatment of bullous pemphigoid: A multicenter,randomized and controlled clinincal trialGuideline-oriented Research in the Management of Some Common and Severe Skin Diseases Bullous pemphigoidTripterygium glycosides group:Take tripterygium glycosides orally at 20 mg, 3 times a day;Nicotinamide plus Minocycline group:Take nicotinamide at 500 mg, 3 times a day and minocycline 100 mg, twice a day.;Institute of dermatology, Chinese Academy of Medical SciencesNULLCompleted18BothTripterygium glycosides group:100;Nicotinamide plus Minocycline group:100;China
62ChiCTR-TRC-12003538
2011-08-012012-12-27Use of inravenous Methotrexate plus Glucocorticoid for the Treatment of bullous pemphigoid:A multicenter,randomized and controlled clinincal trialGuideline-oriented Research in the Management of Some Common and Severe Skin Diseases Bullous pemphigoidGlucocorticoids 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;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 Academy of Medical SciencesNULLRecruiting180BothGlucocorticoids group:90;Glucocorticoid plus MTX group:90;China
63NCT01408550
(ClinicalTrials.gov)
August 201127/7/2011Phase III Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to CorticosteroidsNPB-01(Intravenous Immunoglobulin) Therapy for Patients With Bullous Pemphigoid Unresponsive to Corticosteroids: Randomized, Double-Blind, Placebo Control,Parallel Assignment Study(Phase III)Bullous PemphigoidDrug: NPB-01;Drug: PlaceboNihon Pharmaceutical Co., LtdNULLCompleted20 YearsN/ABoth56Phase 3Japan
64EUCTR2011-000756-42-IT
(EUCTR)
30/06/201120/03/2012pilot phase 2 clinical trial performed in some hospitals to evaluate the efficacy and the adverse events in a group of patients with active bullous pemphigoid that will receive DF2156A at the dose of 150 mg, oral route, twice a day.A phase 2, multicentre, single arm, pilot study to assess the efficacy and the safety of 150 mg twice a day oral DF2156A in patients with active bullous pemphigoid. - DF2156A in bullous pemphigoid active bullous pemphigoid
MedDRA version: 14.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: NA
Product Code: DF2156A
INN or Proposed INN: ladarixin
DOMPE' s.p.a.NULLNot RecruitingFemale: yes
Male: yes
12Phase 2Germany;Italy
65JPRN-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
66EUCTR2007-006658-24-DE
(EUCTR)
16/12/200908/09/2009A randomised controlled trial to compare the safety and effectiveness of doxycycline (200 mg/day) with prednisolone (0.5 mg/kg/day) for initial treatment of bullous pemphigoid - Bullous Pemphigoid Steroids & Tetracyclines StudyA randomised controlled trial to compare the safety and effectiveness of doxycycline (200 mg/day) with prednisolone (0.5 mg/kg/day) for initial treatment of bullous pemphigoid - Bullous Pemphigoid Steroids & Tetracyclines Study BP is a serious condition with a significant associated morbidity and mortality rate. Widespread tense and haemorrhagic blisters, skin erosions and severe itching cause patients a great deal of distress and pain. It occurs mainly in the elderly. The mortality rate in treated patients is estimated to range from 20% - 40% at one year.
MedDRA version: 9.1;Level: LLT;Classification code 10006568;Term: Bullous pemphigoid NOS
MedDRA version: 9.1;Classification code 10006567;Term: Bullous pemphigoid
Product Name: prednisolone
INN or Proposed INN: prednisolone
Product Name: doxycycline
INN or Proposed INN: doxycycline
Universitätsklinikum Schleswig-HolsteinNULLNot RecruitingFemale: yes
Male: yes
256Phase 4Germany;United Kingdom
67ChiCTR-IOR-15007146
2009-10-012015-09-17Combined treatment with low dose systemic steroids andtopical steroids in bullous pemphigoid andfactors of treatment-refractory bullous pemphigoidEfficacy of low dose systemic steroids combined with topical steroids in the treatment of bullous pemphigoid andrisk factors for treatment-refractory patients:A Randomized Controlled Trial bullous pemphigoidControl Group (C):apply 0.05% halometasone cream daily;Treatment Group (T):apply 0.05% halometasone cream daily+low-dose systemic steroids;Rui Jin Hospital, Shanghai Jiao Tong University School of MedicineNULLCompletedBothControl Group (C):40;Treatment Group (T):40;China
68EUCTR2007-006658-24-GB
(EUCTR)
05/03/200922/10/2008 A randomised controlled trial to compare the safety and effectiveness of doxycycline (200 mg/day) with prednisolone (0.5 mg/kg/day) for initial treatment of bullous pemphigoid - Bullous Pemphigoid Steroids & Tetracyclines Study A randomised controlled trial to compare the safety and effectiveness of doxycycline (200 mg/day) with prednisolone (0.5 mg/kg/day) for initial treatment of bullous pemphigoid - Bullous Pemphigoid Steroids & Tetracyclines Study BP is a serious condition with a significant associated morbidity and mortality rate. Widespread tense and haemorrhagic blisters, skin erosions and severe itching cause patients a great deal of distress and pain. It occurs mainly in the elderly. The mortality rate in treated patients is estimated to range from 20% - 40% at one year.
MedDRA version: 14.0;Level: LLT;Classification code 10006568;Term: Bullous pemphigoid NOS;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 14.0;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Product Name: prednisolone
INN or Proposed INN: prednisolone
Product Name: doxycycline
INN or Proposed INN: doxycycline
Product Name: prednisolone
INN or Proposed INN: prednisolone
Product Name: prednisolone
INN or Proposed INN: prednisolone
Product Name: doxycycline
INN or Proposed INN: doxycycline
University of NottinghamNULLNot Recruiting Female: yes
Male: yes
256 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): yesGermany;United Kingdom
69EUCTR2008-005266-31-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
70NCT00525616
(ClinicalTrials.gov)
December 200820/7/2007Efficiency and Tolerance of Rituximab (mabthéra) in Bullous PemphigoidAssessment of Rituximab Efficiency and Tolerance in Treatment of Bullous Pemphigoid.Bullous PemphigoidDrug: MabtheraUniversity Hospital, RouenNULLCompleted18 Years80 YearsBoth18Phase 3France
71NCT00809822
(ClinicalTrials.gov)
November 200811/12/2008Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids.NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Bullous Pemphigoid Unresponsive to Corticosteroids: Randomized, Double-Blind, Placebo Control,Parallel Assignment Study(Phase?).Bullous PemphigoidDrug: NPB-01;Drug: PlaceboNihon Pharmaceutical Co., LtdNULLCompleted20 YearsN/ABoth20Phase 2Japan
72EUCTR2008-000480-41-IT
(EUCTR)
27/05/200810/06/2008Multicenter, randomised, double masked, controlled clinical trial on the safety and efficacy of Cyclosporine A eyedrop treatment on patients with ocular cicatricial pemphigoid. - NDMulticenter, randomised, double masked, controlled clinical trial on the safety and efficacy of Cyclosporine A eyedrop treatment on patients with ocular cicatricial pemphigoid. - ND Ocular cicatricial pemphigoid (OCP)
MedDRA version: 9.1;Level: LLT;Classification code 10010746;Term: Conjunctivitis chronic
Trade Name: RESTASIS
INN or Proposed INN: Cyclosporine
UNIVERSITA' CAMPUS BIOMEDICONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
73NCT02313870
(ClinicalTrials.gov)
January 22, 20088/12/2014Topical Steroids Alone or Associated With Methotrexate in Bullous PemphigoidComparison of Monotherapy With Protracted Superpotent Topical Steroids to Superpotent Topical Steroids Associated With Methotrexate in Bullous PemphigoidBullous PemphigoidDrug: clobetasol propionate + Methotrexate;Drug: clobetasol propionate aloneUniversity Hospital, MontpellierNULLCompleted18 YearsN/AAll322Phase 3France
74EUCTR2007-003545-32-FR
(EUCTR)
14/09/200723/07/2007Etude prospective ouverte de l'efficacité du leflunomide dans le traitement de la pemphigoïde bulleuse en association aux dermocorticoïdes. - ARABULEtude prospective ouverte de l'efficacité du leflunomide dans le traitement de la pemphigoïde bulleuse en association aux dermocorticoïdes. - ARABUL Pemphigoïde bulleuse
MedDRA version: 9.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid
Trade Name: ARAVA
Trade Name: DERMOVAL
CHU de LimogesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
75NCT00802243
(ClinicalTrials.gov)
September 20073/12/2008Leflunomide Associated With Topical Corticosteroids for Bullous PemphigoidLeflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid. An Open Prospective StudyBullous PemphigoidDrug: leflunomideUniversity Hospital, LimogesNULLRecruiting65 YearsN/ABoth54Phase 2France
76NCT00472030
(ClinicalTrials.gov)
August 20078/5/2007Efficacy and Safety of Omalizumab in Bullous PemphigoidAn Open Label Case Series on the Effects of Xolair (Omalizumab) in Bullous PemphigoidBullous PemphigoidDrug: Omalizumab;Drug: prednisoneUniversity of IowaGenentech, Inc.Completed18 YearsN/AAll2Phase 4United States
77NCT00584935
(ClinicalTrials.gov)
January 200626/12/2007Clinical Trial Evaluating Rituximab in Ocular Cicatricial PemphigoidPhase I/II Clinical Trial Evaluating Rituximab in Ocular Cicatricial PemphigoidOcular Cicatricial PemphigoidDrug: RituximabUniversity of Alabama at BirminghamGenentech, Inc.;BiogenCompleted19 YearsN/AAll3Phase 1/Phase 2United States
78EUCTR2005-001827-12-DE
(EUCTR)
29/12/200512/07/2005Myfortic ® zur Therapie des Bullösen Pemphigoids. Eine offene monozentrische proof-of-concept StudieMyfortic ® zur Therapie des Bullösen Pemphigoids. Eine offene monozentrische proof-of-concept Studie Bullous PemphigoidTrade Name: Myfortic 180 mg
Product Name: Myfortic 180 mg Filmtabletten
Georg-August-Universität Göttingen, Bereich HumanmedizinNULLNot RecruitingFemale: yes
Male: yes
10Phase 2Germany
79EUCTR2005-002391-14-GB
(EUCTR)
29/09/200523/08/2005Pulsed Intravenous Methylprednisolone for Ocular Pemphigoid- A Pilot Study - IVMP for ocular pemphigoidPulsed Intravenous Methylprednisolone for Ocular Pemphigoid- A Pilot Study - IVMP for ocular pemphigoid ocular mucous membrane pemphigoidTrade Name: Solu-MedroneMoorfields Eye Hospital NHS Foundation TrustNULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
80NCT00286325
(ClinicalTrials.gov)
March 20051/2/2006Rituximab in the Treatment of Patients With Bullous PemphigoidRituximab in the Treatment of Patients With Bullous PemphigoidBullous PemphigoidDrug: RituximabDuke UniversityGenentech, Inc.Completed18 YearsN/AAll8Phase 1/Phase 2United States
81NCT00213421
(ClinicalTrials.gov)
August 200113/9/2005Comparison of Two Therapeutic Strategies of Dermoval in Treatment of Bullous PemphigusBullous PemphigoidDrug: DermovalUniversity Hospital, RouenNULLCompleted18 YearsN/ABoth330France
82NCT00431119
(ClinicalTrials.gov)
October 19972/2/2007Azathioprine or Mycophenolate Mofetil for Bullous PemphigoidA Comparison of Oral Methylprednisolone Plus Azathioprine or Mycophenolate Mofetil for the Treatment of Bullous PemphigoidBullous PemphigoidDrug: Azathioprine or Mycophenolate mofetilUniversity Hospital MuensterHoffmann-La RocheCompleted18 Years90 YearsBoth70Phase 2Germany
83EUCTR2011-000756-42-DE
(EUCTR)
08/06/2011Pilot phase 2 clinical trial performed in some hospitals to evaluate the efficacy and the adverse events in a group of patients with active bullous pemphigoid that will receive DF2156A at the dose of 150 mg, oral route, twice a day.A phase 2, multicentre, single arm, pilot study to assess the efficacy and the safety of 150 mg twice a day oral DF2156A in patients with active bullous pemphigoid. - DF2156A in patients with active bullous pemphigoid active bullous pemphigoid
MedDRA version: 14.0;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: not applicable
Product Code: DF2156A
INN or Proposed INN: ladarixin
Dompé s.p.a.NULLNot RecruitingFemale: yes
Male: yes
12Phase 2Germany;Italy