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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 |
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 |