35. 天疱瘡 Pemphigus Clinical trials / Disease details
臨床試験数 : 99 / 薬物数 : 124 - (DrugBank : 36) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 169
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05594472 (ClinicalTrials.gov) | November 1, 2022 | 21/10/2022 | Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid | Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid Compared to Conventional Topical Treatment | Pemphigus Vulgaris;Bullous Pemphigoid | Drug: Ozonated olive oil;Drug: Topical garamycin cream | Cairo University | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 3 | Egypt |
| 2 | NCT05000216 (ClinicalTrials.gov) | August 13, 2021 | 6/8/2021 | COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders | Booster Effects With Autoimmune Treatments in Patients With Poor Response to Initial COVID-19 Vaccine (ACV01) | Rheumatoid Arthritis (RA);Systemic Lupus Erythematosus (SLE);Pemphigus Vulgaris;Multiple Sclerosis (MS);Systemic Sclerosis (SSc);Pediatric SLE;Juvenile Idiopathic Arthritis (JIA);Juvenile Dermatomyositis (JDM);Pediatric-Onset Multiple Sclerosis (POMS) | Biological: Moderna mRNA-1273;Biological: BNT162b2;Biological: Ad26.COV2.S;Drug: Continue IS (MMF or MPA);Drug: Continue IS (MTX);Biological: Continue IS (B cell depletion therapy);Biological: Monovalent [B.1.351] CoV2 preS dTM-AS03;Drug: Withhold IS (MMF or MPA);Drug: Withhold IS (MTX);Drug: Withhold IS (B cell depletion therapy);Biological: Moderna mRNA-1273, Bivalent;Biological: BNT162b2, Bivalent | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc. | Recruiting | 2 Years | N/A | All | 2340 | Phase 2 | United States |
| 3 | NCT04598477 (ClinicalTrials.gov) | July 15, 2021 | 8/10/2020 | A 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 Pemphigus | Pemphigus Vulgaris;Pemphigus Foliaceus | Biological: efgartigimod PH20 SC;Drug: prednisone | argenx | NULL | Recruiting | 18 Years | N/A | All | 213 | Phase 3 | United States;Australia;Bulgaria;China;France;Georgia;Germany;Greece;Hungary;India;Israel;Italy;Japan;Poland;Romania;Russian Federation;Serbia;Spain;Turkey;Ukraine;United Kingdom |
| 4 | EUCTR2020-002917-16-DE (EUCTR) | 25/01/2021 | 31/08/2020 | A 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+) - 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 Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA Other descriptive name: ARGX-113 | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Georgia;Bulgaria;Germany;Japan | ||
| 5 | EUCTR2020-002915-23-DE (EUCTR) | 25/01/2021 | 27/08/2020 | A 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 Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Georgia;Bulgaria;Germany;Japan | ||
| 6 | EUCTR2020-002917-16-FR (EUCTR) | 21/01/2021 | 10/11/2020 | A 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 BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Japan | ||
| 7 | NCT04540133 (ClinicalTrials.gov) | December 26, 2020 | 28/8/2020 | Dexamethasone Solution and Dexamethasone in Mucolox™ | Dexamethasone Solution and Dexamethasone in Mucolox™ for the Treatment of Oral Inflammatory Ulcerative Diseases | Oral Lichen Planus;Mucous Membrane Pemphigoid;Pemphigus Vulgaris;Chronic Graft-versus-host-disease | Drug: dexamethasone 0.5mg/5ml solution;Drug: dexamethasone 0.5mg/5ml solution in Mucolox™ | University of California, San Francisco | NULL | Completed | 18 Years | N/A | All | 29 | Phase 2 | United States |
| 8 | EUCTR2020-002917-16-IT (EUCTR) | 17/12/2020 | 24/05/2021 | A 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 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC Product Code: [na] INN or Proposed INN: EFGARTIGIMOD ALFA Other descriptive name: ARGX-113 Trade Name: Prednison 5 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Prednison 10 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Prednison20 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Prednison 50 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | ARGENX BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Georgia;Bulgaria;Germany;Japan | ||
| 9 | EUCTR2020-002915-23-IT (EUCTR) | 11/12/2020 | 24/05/2021 | A 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 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Prednison 50 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Prednison 5 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: prednisone Trade Name: Prednison20 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Product Name: Efgartigimod PH20 SC Product Code: [na] INN or Proposed INN: EFGARTIGIMOD ALFA Trade Name: Prednison 10 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | ARGENX BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Georgia;Bulgaria;Germany;Japan | ||
| 10 | EUCTR2020-002915-23-GR (EUCTR) | 03/12/2020 | 15/10/2020 | A 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 BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Japan | ||
| 11 | EUCTR2020-002917-16-GR (EUCTR) | 03/12/2020 | 15/10/2020 | A 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 BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Japan | ||
| 12 | EUCTR2020-002915-23-FR (EUCTR) | 02/12/2020 | 09/09/2020 | A 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 BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Japan | ||
| 13 | NCT04598451 (ClinicalTrials.gov) | December 1, 2020 | 8/10/2020 | A 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 Foliaceus | Biological: efgartigimod PH20 SC;Other: Placebo;Drug: prednisone | argenx | NULL | Active, not recruiting | 18 Years | N/A | All | 222 | Phase 3 | United States;Australia;Bulgaria;China;France;Georgia;Germany;Greece;Hungary;India;Israel;Italy;Japan;Poland;Romania;Russian Federation;Serbia;Spain;Turkey;Ukraine;United Kingdom |
| 14 | EUCTR2020-002917-16-BG (EUCTR) | 30/11/2020 | 03/11/2020 | A 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+) - 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 Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA Other descriptive name: ARGX-113 | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Serbia;Portugal;United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Croatia;Romania;Australia;Georgia;Bulgaria;Netherlands;Germany;China;Japan | ||
| 15 | EUCTR2020-002915-23-BG (EUCTR) | 24/11/2020 | 24/09/2020 | A 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 Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Japan | ||
| 16 | EUCTR2020-002917-16-HU (EUCTR) | 17/11/2020 | 28/09/2020 | A 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 BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Japan | ||
| 17 | EUCTR2020-002915-23-HU (EUCTR) | 16/11/2020 | 21/09/2020 | A 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 Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Serbia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Georgia;Bulgaria;Germany;Japan | ||
| 18 | NCT04422912 (ClinicalTrials.gov) | September 29, 2020 | 2/6/2020 | Open-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 Vulgaris | Mucosal -Dominant Pemphigus Vulgaris | Biological: DSG3-CAART | Cabaletta Bio | NULL | Recruiting | 18 Years | N/A | All | 39 | Phase 1 | United States |
| 19 | NCT04400994 (ClinicalTrials.gov) | June 20, 2020 | 27/4/2020 | IVIG With Rituximab vs Rituximab as First Line Treatment of Pemphigus | The Use of IVIG in Combination With Rituximab VS Rituximab as the First Line Treatment of Pemphigus | Pemphigus | Drug: Rituximab;Other: IVIg | The University of Hong Kong | NULL | Recruiting | 18 Years | 70 Years | All | 20 | Phase 2 | Hong Kong |
| 20 | NCT04023149 (ClinicalTrials.gov) | April 2, 2020 | 3/7/2019 | Efficacy of Interleukin-2 Gargle in the Treatment of Oral Mucosa Lesion in Pemphigus Vulgaris | Short-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 Study | Pemphigus Vulgaris | Drug: recombinant human interleukin-2 (rhIL-2);Drug: placebo | Second Xiangya Hospital of Central South University | NULL | Recruiting | 18 Years | 70 Years | All | 180 | Phase 2 | China |
| 21 | NCT03790293 (ClinicalTrials.gov) | December 2019 | 8/10/2018 | Clinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the RITUXIMAB 3 Trial | Clinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the RITUXIMAB 3 Trial With Medico-economic Evaluation of the Treatment. | Autoimmune Diseases | Drug: Rituximab;Drug: corticosteroids'therapy | University Hospital, Rouen | NULL | Unknown status | 18 Years | 80 Years | All | 90 | Phase 3 | NULL |
| 22 | EUCTR2019-001727-12-DE (EUCTR) | 24/10/2019 | 12/06/2019 | First 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: TPM203 | Topas Therapeutics GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 1 | Israel;Germany;United Kingdom;Italy | ||
| 23 | EUCTR2018-002261-19-HR (EUCTR) | 22/08/2019 | 20/11/2019 | A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigus | A 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 Biopharma | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | United States;Serbia;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Brazil;Poland;Croatia;Australia;Bulgaria;Germany | ||
| 24 | EUCTR2018-002261-19-DE (EUCTR) | 17/05/2019 | 10/12/2018 | A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigus | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor Rilzabrutinib (PRN1008) in Moderate to Severe Pemphigus | pemphigus vulgaris [PV] or pemphigus foliaceus [PF] MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 MedDRA version: 21.0;Classification code 10057054;Term: Pemphigus foliaceous;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: PRN1008 (Rilzabrutinib) Product Code: PRN1008 INN or Proposed INN: not available Other descriptive name: PRN1008 | Principia Biopharma , Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Poland;Brazil;Croatia;Australia;Bulgaria;Germany | ||
| 25 | EUCTR2018-002261-19-IT (EUCTR) | 08/05/2019 | 17/06/2021 | A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigus | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus - NA | pemphigus vulgaris [PV] or pemphigus foliaceus [PF] MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 MedDRA version: 21.0;Classification code 10057054;Term: Pemphigus foliaceous;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: PRN1008 Product Code: [PRN1008] Other descriptive name: PRN1008 | Principia Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | Serbia;United Arab Emirates;United States;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Poland;Brazil;Croatia;Australia;Bulgaria;Germany | ||
| 26 | EUCTR2018-002261-19-FR (EUCTR) | 10/04/2019 | 22/10/2018 | A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigus | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus | pemphigus vulgaris [PV] or pemphigus foliaceus [PF] MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10057054;Term: Pemphigus foliaceous;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: PRN1008 Product Code: PRN1008 INN or Proposed INN: not available Other descriptive name: PRN1008 | Principia Biopharma | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | United States;United Arab Emirates;Serbia;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;United Kingdom;Italy;France;Canada;Croatia;Australia;Bulgaria;Germany | ||
| 27 | EUCTR2018-002261-19-GR (EUCTR) | 03/04/2019 | 19/02/2019 | A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigus | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus | pemphigus vulgaris [PV] or pemphigus foliaceus [PF] MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 MedDRA version: 21.0;Classification code 10057054;Term: Pemphigus foliaceous;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: PRN1008 Product Code: PRN1008 INN or Proposed INN: not available Other descriptive name: PRN1008 | Principia Biopharma | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | United States;Serbia;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Brazil;Poland;Croatia;Australia;Bulgaria;Germany | ||
| 28 | EUCTR2018-002261-19-GB (EUCTR) | 02/04/2019 | 17/01/2019 | A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigus | A 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 Biopharma | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | Serbia;United Arab Emirates;United States;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Brazil;Croatia;Australia;Bulgaria;Germany | ||
| 29 | EUCTR2018-002146-37-IT (EUCTR) | 20/03/2019 | 04/11/2020 | A study to test if increasing doses of the drug INCB050465 is safe and well tolerated in patients with Pemphigus Vulgaris | A 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 CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | France;Canada;Italy | ||
| 30 | NCT03780166 (ClinicalTrials.gov) | March 2019 | 17/12/2018 | A Study of the Safety and Tolerability of INCB050465 in Pemphigus Vulgaris | A Phase 2 Dose-Escalation Study of the Safety and Tolerability of INCB050465 in Participants With Pemphigus Vulgaris | Pemphigus Vulgaris | Drug: Parsaclisib | Incyte Corporation | NULL | Withdrawn | 18 Years | 80 Years | All | 0 | Phase 2 | NULL |
| 31 | EUCTR2018-002261-19-ES (EUCTR) | 08/02/2019 | 18/01/2019 | A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigus | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus | pemphigus vulgaris [PV] or pemphigus foliaceus [PF] MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10057054;Term: Pemphigus foliaceous;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: PRN1008 Product Code: PRN1008 INN or Proposed INN: not available Other descriptive name: PRN1008 | Principia Biopharma | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United Arab Emirates;United States;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Italy;United Kingdom;France;Canada;Poland;Croatia;Australia;Bulgaria;Germany | ||
| 32 | JPRN-JapicCTI-184231 | 28/1/2019 | 04/12/2018 | ONO-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 pemphigus | Intervention 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. | NULL | complete | 20 | BOTH | 14 | Phase 2 | Japan | |
| 33 | EUCTR2018-002146-37-FR (EUCTR) | 24/01/2019 | 01/10/2018 | A study to test if increasing doses of the drug INCB050465 is safe and well tolerated in patients with Pemphigus Vulgaris | A 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] | Product Name: INCB050465 0.3mg INN or Proposed INN: not yet assigned Other descriptive name: INCB050465 HYDROCHLORIDE Product Name: INCB050465 1.0mg INN or Proposed INN: not yet assigned Other descriptive name: INCB050465 HYDROCHLORIDE Product Name: INCB050465 2.5mg INN or Proposed INN: not yet assigned Other descriptive name: INCB050465 HYDROCHLORIDE | Incyte Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 18 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Canada;Italy | ||
| 34 | NCT03762265 (ClinicalTrials.gov) | January 8, 2019 | 29/11/2018 | A Study of PRN1008 in Patients With Pemphigus | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor Rilzabrutinib (PRN1008) in Moderate to Severe Pemphigus | Pemphigus | Drug: Rilzabrutinib Oral Tablet;Drug: Placebo Oral Tablet | Principia Biopharma, a Sanofi Company | NULL | Terminated | 18 Years | 80 Years | All | 131 | Phase 3 | United States;Argentina;Australia;Brazil;Bulgaria;Canada;Croatia;France;Germany;Greece;Israel;Italy;Poland;Serbia;Spain;Taiwan;Turkey;Ukraine;United Kingdom |
| 35 | ChiCTR1800020382 | 2019-01-01 | 2018-12-27 | Efficacy and safety of ultra-low dosage regimen of rituximab combined with corticosteroids in the treatment of pemphigus | Efficacy and safety of ultra-low dosage regimen of rituximab combined with corticosteroids in the treatment of pemphigus | Pemphigus | Group 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 University | NULL | Recruiting | 18 | 80 | Both | Group 1:14;Group 2:14;Group 3:14; | China | |
| 36 | EUCTR2018-002261-19-BG (EUCTR) | 12/12/2018 | 11/10/2018 | A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigus | A 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 Biopharma | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | Serbia;United Arab Emirates;United States;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Poland;Brazil;Croatia;Australia;Bulgaria;Germany | ||
| 37 | EUCTR2018-001417-32-FR (EUCTR) | 13/07/2018 | 11/06/2018 | Long-term Follow-up of patients participants with pemphigus From Study RITUXIMAB3 | Long-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 Rouen | NULL | Not Recruiting | Female: yes Male: yes | 77 | Phase 3 | France | ||
| 38 | ChiCTR2100042024 | 2018-06-01 | 2021-01-12 | Direct immunofluorescence of Tzanck smears for the diagnosis of pemphigus vulgaris: a diagnostic test | Direct immunofluorescence of Tzanck smears for the diagnosis of pemphigus vulgaris: a diagnostic test | Pemphigus vulgaris | Gold Standard:Gold standard: meet the diagnostic criteria of pemphigus vulgaris of Japan Dermatology Association in 2014 and the diagnosis made by two experts. Diagnostic criteria: including clinical manifestations, histopathological examination and immunodiagnostic indicators.;Index test:Direct immunofluorescence of Tzanck smears; | Peking University stomatological hospital | NULL | Recruiting | Both | Target condition:38;Difficult condition:38 | China | |||
| 39 | ChiCTR2100042023 | 2018-06-01 | 2021-01-12 | Evaluation of salivary anti Dsg1 and Dsg3 antibodies in diagnosis and monitoring of pemphigus vulgaris | Evaluation of salivary anti Dsg1 and Dsg3 antibodies in diagnosis and monitoring of pemphigus vulgaris | Pemphigus vulgaris | Gold Standard:Gold standard: At the same time, it met the diagnostic criteria of pemphigus vulgaris of Japan Dermatology Association in 2014 and was confirmed by two experts. Diagnostic criteria: including clinical manifestations, histopathological examination and immunodiagnostic indicators.;Index test:Salivary Dsg1 and Dsg3 titer; | Peking University School and Hospital of Stomatology | NULL | Recruiting | Both | Target condition:38;Difficult condition:38 | China | |||
| 40 | JPRN-jRCTs051180069 | 12/04/2018 | 19/02/2019 | Imatinib treatment of autoimmune bullous diseases | Intervention study on autoimmune bullous diseases with imatinib - IABD | Autoimmune bullous disease including pemphigus group and pemphigoid group;D012872 | Imatinib 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 Kenji | Endo Yuichiro | Complete | >= 20age old | < 100age old | Both | 20 | Japan | |
| 41 | EUCTR2017-002333-40-DE (EUCTR) | 31/01/2018 | 14/07/2017 | A 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 BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 22 | Phase 2 | Hungary;Ukraine;Romania;Israel;Germany;Italy | ||
| 42 | EUCTR2017-002333-40-IT (EUCTR) | 05/01/2018 | 29/01/2021 | A 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) - A study to evaluate the safety and efficacy of ARGX-113 in patients with Mild to Moderate Pemphigus | 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 | ARGEN-X BVBA | NULL | Not Recruiting | Female: yes Male: yes | 22 | Phase 2 | Hungary;Ukraine;Romania;Israel;Germany;Italy | ||
| 43 | NCT03334058 (ClinicalTrials.gov) | October 18, 2017 | 23/10/2017 | A Study to Evaluate the Safety, PD, PK and Efficacy of ARGX-113 in Patients With Pemphigus | 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 and Foliaceus) | Pemphigus Vulgaris;Pemphigus Foliaceus | Drug: ARGX-113 | argenx | NULL | Completed | 18 Years | N/A | All | 34 | Phase 2 | Germany;Hungary;Israel;Italy;Ukraine |
| 44 | NCT03239470 (ClinicalTrials.gov) | October 10, 2017 | 2/8/2017 | Polyclonal Regulatory T Cells (PolyTregs) for Pemphigus | A 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 Vulgaris | Biological: Cohort 1: 1.0 x 10^8 PolyTregs;Biological: Cohort 2: 2.5x10^8 PolyTregs | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc. | Active, not recruiting | 18 Years | 75 Years | All | 5 | Phase 1 | United States |
| 45 | EUCTR2017-002333-40-HU (EUCTR) | 20/09/2017 | 20/07/2017 | A 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 BVBA | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Hungary;Ukraine;Romania;Israel;Germany;Italy | ||
| 46 | NCT03075904 (ClinicalTrials.gov) | July 18, 2017 | 6/3/2017 | A 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 Foliaceus | Drug: ALXN1830 | Alexion Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 8 | Phase 1/Phase 2 | United States |
| 47 | NCT05284929 (ClinicalTrials.gov) | May 17, 2017 | 10/3/2022 | Human Leukocyte Antigen Class II (DRB1 and DQB1) Alleles and Haplotypes Frequencies in Patients With Pemphigus Vulgaris Among the Russian Population | Increased Frequencies of Certain HLA Class II Alleles DRB1 and DQB1 in PV Patients Compared to Those in Healthy Donors Have Been Reported in Various Populations and Repeatedly Confirmed. Among the Russian Population, no Studies About the Association of PV and HLA Class II Genes Have Been Conducted. Thus, the Purpose of This Study Was to Investigate HLA Class II Alleles and Haplotypes in Russian Patients With Pemphigus Vulgaris. | Pemphigus;Bullous Pemphigoid;Stevens-Johnson Syndrome;Toxic Epidermal Necrolyses | Genetic: A single blood sample for HLA typing | Sechenov University | Pirogov Russian National Research Medical University | Recruiting | N/A | N/A | All | 120 | Russian Federation | |
| 48 | JPRN-jRCTs031180405 | 11/05/2017 | 22/03/2019 | Rituximab therapy for refractory pemphigus | Safety evaluation study about rituximab therapy for refractory pemphigus | Refactory Pemphigus Other disease of skin or skin tissue | Infuse rituximab 1000mg/body twice biweekly. | Funakoshi Takeru | NULL | Not Recruiting | >= 20age old | <= 80age old | Both | 20 | N/A | Japan |
| 49 | JPRN-UMIN000026004 | 2017/05/11 | 08/03/2017 | Safety evaluation study about rituximab therapy for refractory pemphigus | Safety evaluation study about rituximab therapy for refractory pemphigus - Rituximab therapy for refractory pemphigus | pemphigus | Infuse rituximab 1000mg/body twice biweekly | Keio University, School of Medicine | NULL | Recruiting | 20years-old | 80years-old | Male and Female | 20 | Not applicable | Japan |
| 50 | NCT02993133 (ClinicalTrials.gov) | December 2016 | 12/12/2016 | Pharmacokinetics 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 Dermatose | Drug: Cellcept® in autoimmune bullous dermatoses | University Hospital, Limoges | NULL | Completed | 18 Years | N/A | All | 53 | Phase 3 | France |
| 51 | JPRN-UMIN000024265 | 2016/10/04 | 04/10/2016 | 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 | 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 - 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 pemphigus | Rituximab (genetic recombination) | Department of Dermatology,Keio University School of Medicine | HOKKAIDO UNIVERSITY HOSPITALOKAYAMA UNIVERSITY HOSPITALKURUME UNIVERSITY HOSPITAL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 10 | Phase 2 | Japan |
| 52 | ChiCTR-OIC-17011759 | 2016-08-01 | 2017-06-26 | 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). | 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 Vulgaris | Case series:Azathioprine; | Dermatological Department, West China hospital, Sichuan University | NULL | Completed | 18 | 65 | Both | Case series:60; | I (Phase 1 study) | China |
| 53 | EUCTR2015-003564-37-GR (EUCTR) | 21/04/2016 | 13/01/2016 | A Pilot Study Investigating the Safety, Clinical Activity, Drug Levels, and Effects on PRN 1008 in Patients with Newly Diagnosed or Relapsing Pemphigus Vulgaris | An Open-Label, Phase 2, Pilot Study Investigating the Safety, Clinical Activity, Pharmacokinetics, and Pharmacodynamics of Oral Treatment with the BTK Inhibitor PRN1008 in Patients with Newly Diagnosed or Relapsing Pemphigus Vulgaris | Pemphigus: Pemphigus Vulgaris MedDRA version: 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 25 | Phase 2 | France;Greece;Croatia;Australia;Israel | ||
| 54 | EUCTR2015-003564-37-HR (EUCTR) | 18/04/2016 | 06/07/2016 | An Open-Label, Phase 2, Pilot Study Investigating the Safety, Clinical Activity, Pharmacokinetics, and Pharmacodynamics of Oral Treatment with the BTK Inhibitor PRN1008 in Patients with Newly Diagnosed or Relapsing Pemphigus Vulgaris | An Open-Label, Phase 2, Pilot Study Investigating the Safety, Clinical Activity, Pharmacokinetics, and Pharmacodynamics of Oral Treatment with the BTK Inhibitor PRN1008 in Patients with Newly Diagnosed or Relapsing Pemphigus Vulgaris | Pemphigus: Pemphigus Vulgaris MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: PRN1008 INN or Proposed INN: Not available Other descriptive name: PRN1008 Freebase INN or Proposed INN: Not available Other descriptive name: PRN1008 Freebase INN or Proposed INN: Not available Other descriptive name: PRN1008 Freebase INN or Proposed INN: Not available Other descriptive name: PRN1008 Freebase | Principia Biopharma Australia Pty Ltd | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;Greece;Croatia;Australia;Israel | ||
| 55 | NCT02704429 (ClinicalTrials.gov) | January 22, 2016 | 24/2/2016 | A Study of PRN1008 in Adult Patients With Pemphigus Vulgaris | An Open-Label, Phase 2, Pilot Study Investigating the Safety, Clinical Activity, Pharmacokinetics, and Pharmacodynamics of Oral Treatment With the BTK Inhibitor PRN1008 in Patients With Newly Diagnosed or Relapsing Pemphigus Vulgaris | Pemphigus Vulgaris | Drug: PRN1008 | Principia Biopharma Inc. | Principia Biopharma Australia Pty Ltd. | Completed | 18 Years | 80 Years | All | 42 | Phase 2 | Australia;Croatia;France;Greece;Israel |
| 56 | NCT02828163 (ClinicalTrials.gov) | January 2016 | 27/6/2016 | Comparison Between Injections of Steroids and Autologous Platelet Rich Plasma in the Oral Erosions of Pemphigus Vulgaris | Comparative Study Between Intralesional Autologous Platelet Rich Plasma and Intralesional Triamcinolone Acetonide in the Oral Erosions of Pemphigus Vulgaris Patients | Oral Pemphigus Vulgaris | Other: Autologous Platelet rich plasma;Drug: Triamcinolone Acetonide | Cairo University | NULL | Completed | N/A | N/A | All | 11 | Phase 3 | Egypt |
| 57 | NCT02613910 (ClinicalTrials.gov) | December 23, 2015 | 23/11/2015 | Long-Term Extension Study of Ofatumumab in Subjects With Pemphigus Vulgaris | OPV117059: A Long-Term Extension Study of Ofatumumab Injection for Subcutaneous Use in Subjects With Pemphigus Vulgaris | Pemphigus | Drug: Ofatumumab;Drug: Acetaminophen/paracetamol;Drug: Antihistamine (cetirizine or equivalent);Drug: Prednisone/Prednisolone | GlaxoSmithKline | NULL | Terminated | N/A | N/A | All | 1 | Phase 3 | United States |
| 58 | EUCTR2013-001370-20-PL (EUCTR) | 03/07/2015 | 23/04/2015 | Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris | OPV116910: 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 59 | NCT02383589 (ClinicalTrials.gov) | May 26, 2015 | 4/3/2015 | A 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 Vulgaris | Pemphigus Vulgaris | Drug: Mycophenolate Mofetil Placebo;Drug: Mycophenolate Mofetil;Drug: Rituximab;Drug: Rituximab Placebo | Hoffmann-La Roche | Genentech, Inc. | Completed | 18 Years | 75 Years | All | 135 | Phase 3 | United States;Argentina;Australia;Brazil;Canada;France;Germany;Israel;Italy;Spain;Turkey;Ukraine |
| 60 | EUCTR2013-001370-20-FR (EUCTR) | 20/04/2015 | 13/07/2015 | Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris | OPV116910: 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | United States;France;Poland;Ukraine;Croatia;Australia;Russian Federation;Israel;Italy;Japan;China;Korea, Republic of | |||
| 61 | EUCTR2014-000382-41-FR (EUCTR) | 02/04/2015 | 24/06/2015 | A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris | A 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] | 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 124 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy | ||
| 62 | EUCTR2014-000382-41-IT (EUCTR) | 12/03/2015 | 02/02/2015 | A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 124 | Phase 3 | United States;France;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy | ||
| 63 | EUCTR2014-000382-41-ES (EUCTR) | 09/03/2015 | 22/12/2014 | A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 124 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy | ||
| 64 | EUCTR2014-000382-41-DE (EUCTR) | 06/03/2015 | 09/12/2014 | A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Patients With Pemphigus Vulgaris | A 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] | 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy | ||
| 65 | EUCTR2013-001370-20-GR (EUCTR) | 12/12/2014 | 11/12/2014 | Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris | OPV116910: 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 66 | EUCTR2013-001370-20-IT (EUCTR) | 26/11/2014 | 25/08/2014 | Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris | OPV116910: 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 67 | EUCTR2013-001370-20-HR (EUCTR) | 17/11/2014 | 02/12/2014 | Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris | OPV116910: 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 68 | JPRN-UMIN000015451 | 2014/11/13 | 25/10/2014 | Exploratory 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 | Exploratory 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 - Rtx-BD Trial 2 | Pemphigus, Pemphigoid | Rituximab 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 Medicine | Hokkaido University, Kurume University, Okayama University, Kawasaki Medical School | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 20 | Phase 1,2 | Japan |
| 69 | JPRN-jRCTs031180220 | 01/05/2014 | 15/03/2019 | Rituximab treatment of blistering disease | Treatment of refractory autoimmuno blistering disease with rituximab | Pemphigus vulgaris, paraneoplastic pemphigus, bullous pemphigoid | Infusion of rituximab (1000mg) intravenously. Approximately two weeks after the first dose, a second dose of rituximab is administered in a similar manner. | Kanaoka Miwa | Michiko Aihara | Complete | >= 20age old | < 80age old | Both | 10 | N/A | Japan |
| 70 | NCT01930175 (ClinicalTrials.gov) | December 18, 2013 | 23/8/2013 | Study of Efficacy and Safety of VAY736 in Patients With Pemphigus Vulgaris | A 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 | Drug: VAY736;Drug: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 20 Years | 70 Years | All | 13 | Phase 2 | United States;Austria;Bulgaria;Taiwan;Germany;Israel;Italy;United Kingdom |
| 71 | EUCTR2013-001217-33-AT (EUCTR) | 25/11/2013 | 03/10/2013 | Study of efficacy and safety of VAY736 in patients with Pemphigus vulgaris | A 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] | Product Code: VAY736 INN or Proposed INN: ianalumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 32 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Taiwan;Austria;Bulgaria | ||
| 72 | NCT01974518 (ClinicalTrials.gov) | November 2013 | 4/10/2013 | Comparative Study of Rituximab Versus Combination of Rituximab and Intravenous Cyclophosphamide in Severe Pemphigus | A PILOT STUDY TO ASSESS THE EFFICACY OF RITUXIMAB VERSUS COMBINATION OF RITUXIMAB AND INTRAVENOUS CYCLOPHOSPHAMIDE IN THE TREATMENT OF REFRACTORY PEMPHIGUS | Pemphigus | Drug: Rituximab and Cyclophosphamide IV | Uprety Shraddha | Postgraduate Institute of Medical Education and Research | Active, not recruiting | 18 Years | N/A | Both | 20 | Phase 3 | India |
| 73 | EUCTR2013-000211-24-DE (EUCTR) | 01/10/2013 | 08/07/2013 | immunoglobulin infusion as adjuvant therapy in patients with Pemphigus Vulgaris | A 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] | Trade Name: Intratect 5% Product Name: Intratect Other descriptive name: WATER FOR INJECTION Other descriptive name: GLYCINE | Ruprecht-Karls-University Heidelberg | NULL | Not Recruiting | Female: yes Male: yes | 10 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Germany | ||
| 74 | NCT01920477 (ClinicalTrials.gov) | August 13, 2013 | 3/7/2013 | Efficacy and Safety of Ofatumumab in Treatment of Pemphigus Vulgaris | OPV116910: 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 | Biological: Ofatumumab;Biological: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 70 Years | All | 35 | Phase 3 | United States;Australia;Greece;Israel;Italy;Japan;Poland;Romania;Croatia;France;Korea, Republic of;Russian Federation;Ukraine |
| 75 | ChiCTR-TRC-12003540 | 2011-08-01 | 2012-12-19 | Use of intravenous Methotrexate plus Glucocorticoid for the Treatment of Pemphigus:A multicenter,randomized and controlled clinical trial | Guideline-oriented Research in the Management of Some Common and Severe Skin Diseases | Pemphigus | Glucocorticoid 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 Sciences | NULL | Completed | 18 | 75 | Both | Glucocorticoid group:90;Glucocorticoid plus MTX group:90; | China | |
| 76 | ChiCTR-TRC-12003539 | 2011-08-01 | 2012-12-27 | Use of Oral Methotrexate plus Glucocorticoid for the Treatment of Pemphigus:A multicenter,randomized and controlled clinincal trial | Guideline-oriented Research in the Management of Some Common and Severe Skin Diseases | Pemphigus | Glucocorticoid 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 Sciences | NULL | Completed | 18 | 75 | Both | Glucocorticoid hormone group:90;Glucocorticoids joint methotrexate (MTX) group:90; | China | |
| 77 | NCT01299857 (ClinicalTrials.gov) | June 2011 | 17/2/2011 | Long-term Clinical and Biological Evaluation of Patients With Severe Forms of Pemphigus Treated by Rituximab | EVALUATION CLINIQUE ET BIOLOGIQUE A LONG TERME DES PATIENTS ATTEINTS DE FORMES SEVERES DE PEMPHIGUS TRAITES PAR LE RITUXIMAB | Pemphigus | Drug: Rituximab | University Hospital, Rouen | NULL | Completed | 18 Years | N/A | Both | 22 | Phase 3 | France |
| 78 | NCT01313923 (ClinicalTrials.gov) | February 2011 | 10/3/2011 | Evaluating Sirolimus to Treat Autoimmune Blistering Dermatosis Pemphigus | Evaluation of Sirolimus for the Treatment of the Autoimmune Blistering Dermatosis Pemphigus | Pemphigus | Drug: Sirolimus (formerly known as Rapamycin) | University of California, Irvine | NULL | Terminated | 18 Years | N/A | All | 3 | Early Phase 1 | United States |
| 79 | JPRN-UMIN000004428 | 2010/11/01 | 01/11/2010 | Exploratory research on effectiveness and safety of Rituximab treatment for steroid intractable pemphygus, bullous pemphigoid and epidermolysis bullosa acquisita. | Exploratory research on effectiveness and safety of Rituximab treatment for steroid intractable pemphygus, bullous pemphigoid and epidermolysis bullosa acquisita. - Rtx-BD Trial | pemphigus, bullous pemphigoid, epidermolysis bullosa acquisita | Rituximab | Research group of rare intractable dermatologial disorder | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 20 | Phase 2 | Japan |
| 80 | NCT01338103 (ClinicalTrials.gov) | January 2010 | 17/4/2011 | Treatment of Pemphigus Patients With Rituximab 1000mgX2 and Assessment of Immune Status Via Cylex | Treatment 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 Test | Pemphigus | Drug: Rituximab | Rabin Medical Center | Leumit Health Services | Recruiting | 18 Years | 70 Years | Both | 10 | N/A | Israel |
| 81 | NCT00784589 (ClinicalTrials.gov) | July 2009 | 3/11/2008 | Comparison Between Rituximab Treatment and General Corticotherapy Treatment in Patients With Pemphigus | Comparison Between Monoclonal Antibody CD20 Treatment (Rituximab (mabthéra))and General Corticotherapy Treatment in Patients With Pemphigus | Pemphigus Disease | Drug: General Corticotherapy;Drug: Rituximab | University Hospital, Rouen | NULL | Completed | 18 Years | 80 Years | All | 90 | Phase 3 | France |
| 82 | NCT00960713 (ClinicalTrials.gov) | June 2009 | 16/7/2009 | The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders | The RITAI Cohort. An Observational Study on Serious Adverse Events Occuring After Rituximab Off-label Use for Auto-immune Disorders | Pemphigus;Auto-immune Thrombocytopenic Purpura;Hemolytic Auto-immune Anaemia;Cold Agglutinin Disease;Cryoglobulinemia | Drug: Rituximab (MABTHERA® or RITUXAN®). | University Hospital, Toulouse | NULL | Completed | 18 Years | N/A | Both | 35 | N/A | France |
| 83 | EUCTR2008-005266-31-FR (EUCTR) | 06/02/2009 | 13/03/2009 | COMPARAISON 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 | COMPARAISON 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 Rouen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 84 | NCT00626678 (ClinicalTrials.gov) | January 2008 | 21/2/2008 | Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone | A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Adjuvant Azathioprine Therapy in New Cases of Pemphigus Vulgaris Receiving Prednisone | Pemphigus Vulgaris | Drug: Azathioprine;Drug: Prednisone;Drug: Placebo | Tehran University of Medical Sciences | NULL | Completed | 10 Years | 75 Years | Both | 48 | Phase 2 | Iran, Islamic Republic of |
| 85 | NCT00656656 (ClinicalTrials.gov) | January 2008 | 7/4/2008 | Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus | Combined Treatment of Autoimmune Bullous Diseases With Protein A Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab | Pemphigus | Drug: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine | University of Luebeck | NULL | Completed | 18 Years | N/A | All | 23 | Phase 2 | Germany |
| 86 | EUCTR2007-005711-26-IT (EUCTR) | 15/11/2007 | 05/02/2008 | An 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 | An 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 IMMACOLATA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 87 | NCT00606749 (ClinicalTrials.gov) | November 2007 | 22/1/2008 | Use of KC706 for the Treatment of Pemphigus Vulgaris | A Phase 2 Open-Label Uncontrolled Pilot Study of KC706 in Patients With Stable, Active Pemphigus Vulgaris | Pemphigus Vulgaris | Drug: KC706 | Kemia, Inc | NULL | Completed | 18 Years | N/A | Both | 20 | Phase 2 | United States |
| 88 | NCT00483119 (ClinicalTrials.gov) | April 2007 | 5/6/2007 | Randomized Trial of IVIg With or Without Cyclophosphamide in Pemphigus | Phase 2 Randomized Trial of IVIg With or Without Cyclophosphamide in Pemphigus | Pemphigus Vulgaris | Drug: intravenous immunoglobulin;Drug: cyclophosphamide | New York University School of Medicine | NULL | Terminated | 18 Years | 85 Years | All | 9 | Phase 2 | United States |
| 89 | NCT00283712 (ClinicalTrials.gov) | March 2006 | 26/1/2006 | Use of Infliximab for the Treatment of Pemphigus Vulgaris | A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Infliximab in Subjects With Pemphigus Vulgaris Receiving Prednisone | Pemphigus | Drug: Infliximab;Other: Placebo Comparator | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence | Completed | 18 Years | N/A | All | 20 | Phase 2 | United States |
| 90 | EUCTR2004-000526-75-ES (EUCTR) | 06/02/2006 | 12/12/2005 | Estudio 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 | Estudio 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 72 | Phase 3 | Spain | ||
| 91 | NCT00135720 (ClinicalTrials.gov) | June 2004 | 24/8/2005 | Study of Etanercept (Enbrel) in the Treatment of Pemphigus Vulgaris | A Double-Blinded, Placebo-Controlled Study of Etanercept (Enbrel) in the Treatment of Pemphigus Vulgaris | Pemphigus Vulgaris | Drug: Enbrel (Etanercept) | Massachusetts General Hospital | Brigham and Women's Hospital;Stanford University | Completed | 18 Years | 65 Years | Both | 12 | Phase 2 | United States |
| 92 | NCT00683930 (ClinicalTrials.gov) | May 2004 | 19/5/2008 | A 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 Vulgaris | Pemphigus Vulgaris (PV) | Drug: Mycophenolate Mofetil 2 g/Day;Drug: Mycophenolate Mofetil (MMF) 3 g/Day;Drug: Placebo | Hoffmann-La Roche | Aspreva Pharmaceuticals | Completed | 18 Years | 70 Years | All | 96 | Phase 3 | United States;Canada;Germany;Israel;Switzerland;Turkey;Ukraine;United Kingdom;India |
| 93 | NCT00063752 (ClinicalTrials.gov) | July 2003 | 3/7/2003 | Safety Study of PI-0824 to Treat Pemphigus Vulgaris | An Open-Label, Dose-Escalation, Phase I Clinical Study to Assess the Safety of PI-0824 in Patient With Pemphigus Vulgaris Requiring Daily Corticosteroid Therapy | Pemphigus Vulgaris | Drug: PI-0824 | Peptimmune | NULL | Completed | 18 Years | N/A | Both | 15 | Phase 1 | United States |
| 94 | NCT00213512 (ClinicalTrials.gov) | June 2003 | 13/9/2005 | Effect of Anti CD20 in Pemphigus Desease | Traitment of Patients Presenting Pemphigus With Anti CD20 (Mabthera). | Pemphigus | Drug: Mabthera | University Hospital, Rouen | NULL | Completed | 18 Years | N/A | Both | 22 | Phase 2/Phase 3 | France |
| 95 | NCT00278642 (ClinicalTrials.gov) | September 2002 | 16/1/2006 | Hematopoietic Stem Cell Support in Patients With Autoimmune Bullous Skin Disorders | High Dose Cyclophosphamide & ATG With Hematopoietic Stem Cell Support in Patients With Autoimmune Bullous Skin Disorders: A Phase I Trial | Pemphigus | Biological: Hematopoietic stem cell transplantation | Richard Burt, MD | NULL | Terminated | 18 Years | 60 Years | Both | 1 | Phase 1 | United States |
| 96 | NCT00213421 (ClinicalTrials.gov) | August 2001 | 13/9/2005 | Comparison of Two Therapeutic Strategies of Dermoval in Treatment of Bullous Pemphigus | Bullous Pemphigoid | Drug: Dermoval | University Hospital, Rouen | NULL | Completed | 18 Years | N/A | Both | 330 | France | ||
| 97 | NCT00127764 (ClinicalTrials.gov) | January 2001 | 4/8/2005 | European Trial of Adjuvant Oral Glucocorticoid Pulse Therapy in Pemphigus | European Randomised Placebo-Controlled Trial of Adjuvant Oral Glucocorticoid Pulse Therapy in Pemphigus (Pempuls Trial) | Pemphigus | Drug: dexamethasone (50mg 1dd6, 3 consecutive days/month) | University Medical Centre Groningen | NULL | Completed | 18 Years | N/A | Both | 60 | Phase 2/Phase 3 | Netherlands |
| 98 | NCT00010413 (ClinicalTrials.gov) | April 1999 | 2/2/2001 | Phase II Study of High-Dose Cyclophosphamide in Patients With Refractory Pemphigus | Pemphigus | Drug: cyclophosphamide;Drug: filgrastim | Johns Hopkins University | NULL | Completed | 18 Years | 70 Years | Both | 35 | Phase 2 | United States | |
| 99 | NCT00429533 (ClinicalTrials.gov) | November 1996 | 29/1/2007 | Efficacy of Dapsone as a Steroid Sparing Agent in Pemphigus Vulgaris | A Prospective Randomized Placebo-Controlled Clinical Trial of Dapsone as a Glucocorticoid-Sparing Agent in Maintenance Phase Pemphigus Vulgaris | Pemphigus Vulgaris | Drug: Dapsone | Jacobus Pharmaceutical | NULL | Terminated | 18 Years | 80 Years | Both | 48 | Phase 2 | United States |