35. 天疱瘡 Pemphigus Clinical trials / Disease details
臨床試験数 : 98 / 薬物数 : 126 - (DrugBank : 41) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 168
| 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 | 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;Systemic Lupus Erythematosus (SLE);Pemphigus Vulgaris;Multiple Sclerosis;Systemic Sclerosis (SSc) | Biological: Moderna mRNA-1273;Biological: BNT162b2;Biological: Ad26.COV2.S;Drug: IS (MMF or MPA);Drug: IS (MTX);Biological: IS (B cell depletion therapy) | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc. | Recruiting | 18 Years | N/A | All | 600 | Phase 2 | United States |
| 2 | 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 | 150 | 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 |
| 3 | 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 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;Georgia;Bulgaria;Germany;Japan | ||
| 4 | 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;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Georgia;Bulgaria;Germany;Japan | ||
| 5 | 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 | ||
| 6 | 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 | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States |
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 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 | EUCTR2020-002915-23-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 | ||
| 12 | 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 | Recruiting | 18 Years | N/A | All | 150 | 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 |
| 13 | 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 | 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 | ||
| 14 | 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 | ||
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | 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 | 30 | Phase 1 | United States |
| 18 | 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 |
| 19 | 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 |
| 20 | 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 |
| 21 | 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 | ||
| 22 | 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 | ||
| 23 | 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 | ||
| 24 | 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 | 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;United Kingdom;Italy;France;Canada;Argentina;Poland;Brazil;Croatia;Australia;Bulgaria;Germany | ||
| 25 | 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 | ||
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | 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 | ||
| 29 | 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 |
| 30 | 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 | ||
| 31 | 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 | |
| 32 | 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 | ||
| 33 | 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 |
| 34 | 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 | |
| 35 | 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 | ||
| 36 | 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 | ||
| 37 | 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 | |||
| 38 | 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 | |||
| 39 | 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 | Recruiting | >= 20age old | < 100age old | Both | 20 | Japan | |
| 40 | 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 | Italy;Germany;Israel;Romania;Ukraine;Hungary | ||
| 41 | 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 | ||
| 42 | 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 |
| 43 | 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 | 4 | Phase 1 | United States |
| 44 | 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 | ||
| 45 | 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 |
| 46 | 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 |
| 47 | 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 |
| 48 | 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 |
| 49 | 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 |
| 50 | 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 |
| 51 | 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 | ||
| 52 | 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 | ||
| 53 | 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 |
| 54 | 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 |
| 55 | 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 |
| 56 | 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 | ||
| 57 | 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 |
| 58 | 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 | |||
| 59 | 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 | ||
| 60 | 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 | ||
| 61 | 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 | ||
| 62 | 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 | ||
| 63 | NCT02365675 (ClinicalTrials.gov) | January 2015 | 11/2/2015 | Wound Dressings for Pemphigus and Pemphigoid | An Open Randomized Comparative Trial of Four Different Dressings for Cutaneous Coverage in Pemphigus and Pemphigoid | Pemphigus;Pemphigoid | Device: 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 Zubiran | Recruiting | 18 Years | N/A | Both | 12 | N/A | Mexico |
| 64 | 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 | ||
| 65 | 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 | ||
| 66 | 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 | ||
| 67 | 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 | 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 | |
| 68 | 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 | Not Recruiting | >= 20age old | < 80age old | Both | 10 | N/A | Japan |
| 69 | 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 |
| 70 | 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 | ||
| 71 | 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 |
| 72 | 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 | ||
| 73 | 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 |
| 74 | 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 | |
| 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 | 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 |
| 77 | 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 |
| 78 | 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. | 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 | |
| 79 | 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 |
| 80 | 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 |
| 81 | 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 |
| 82 | 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 | ||||
| 83 | 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 |
| 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 | 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 | ||||
| 86 | 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 |
| 87 | 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 |
| 88 | 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 |
| 89 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Spain | |||
| 90 | 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 |
| 91 | 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 |
| 92 | 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 |
| 93 | 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 |
| 94 | 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 |
| 95 | 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 | ||
| 96 | 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 |
| 97 | 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 | |
| 98 | 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 |