INCB050465 ( DrugBank: INCB050465 )
2 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 35 | 天疱瘡 | 3 |
| 61 | 自己免疫性溶血性貧血 | 8 |
35. 天疱瘡
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 | EUCTR2018-002146-37-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 | ||
| 2 | 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in Participants With Pemphigus Vulgaris | Pemphigus Vulgaris | Drug: Parsaclisib | Incyte Corporation | NULL | Withdrawn | 18 Years | 80 Years | All | 0 | Phase 2 | NULL |
| 3 | 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 |
61. 自己免疫性溶血性貧血
臨床試験数 : 146 / 薬物数 : 131 - (DrugBank : 59) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 158
| 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 | EUCTR2021-002844-66-DE (EUCTR) | 30/05/2022 | 20/09/2021 | Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia (PATHWAY) - PATHWAY | Primary Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Parsaclisib (1 mg) Product Code: INCB050465 INN or Proposed INN: Paraclisib Other descriptive name: INCB050465 HYDROCHLORIDE Product Name: Parsaclisib (2.5 mg) Product Code: INCB050465 INN or Proposed INN: Paraclisib Other descriptive name: INCB050465 HYDROCHLORIDE | Incyte Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Japan;Ukraine;United Kingdom;Spain;Canada;Austria;Netherlands;Belgium;Poland;Italy;Israel;France;Germany | ||
| 2 | EUCTR2021-002844-66-NL (EUCTR) | 10/03/2022 | 29/11/2021 | Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia | Primary Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Parsaclisib (1 mg) Product Code: INCB050465 INN or Proposed INN: not yet assigned Other descriptive name: INCB050465 HYDROCHLORIDE Product Name: Parsaclisib (2.5 mg) Product Code: INCB050465 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 | 100 | Phase 3 | United States;Spain;Ukraine;Austria;Israel;Italy;United Kingdom;France;Canada;Belgium;Poland;Netherlands;Germany;Japan | ||
| 3 | EUCTR2021-002844-66-ES (EUCTR) | 03/02/2022 | 15/10/2021 | Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia | Primary Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Parsaclisib (1 mg) Product Code: INCB050465 INN or Proposed INN: Parsaclisib Other descriptive name: INCB050465 HYDROCHLORIDE Product Name: Parsaclisib (2.5 mg) Product Code: INCB050465 INN or Proposed INN: Parsaclisib Other descriptive name: INCB050465 HYDROCHLORIDE | Incyte Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Germany;Netherlands;Japan | ||
| 4 | JPRN-jRCT2051210140 | 30/12/2021 | 24/12/2021 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia - PATHWAY | Warm Autoimmune Hemolytic Anemia (wAIHA) | Group A: Parsaclisib (INCB050465) will be administered QD orally. Group B: Placebo will be administered QD orally. | Ueda Eiji | NULL | Recruiting | >= 18age old | <= 99age old | Both | 100 | Phase 3 | U.S.A;Japan |
| 5 | EUCTR2021-002844-66-IT (EUCTR) | 23/11/2021 | 23/09/2021 | Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia - NA | Primary Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Parsaclisib (1 mg) Product Code: [INCB050465] Other descriptive name: INCB050465 HYDROCHLORIDE Product Name: Parsaclisib (2.5 mg) Product Code: [INCB050465] Other descriptive name: INCB050465 HYDROCHLORIDE Product Name: trimethoprim-sulfamethoxazole Product Code: [trimethoprim-sulfamethoxazole] INN or Proposed INN: TRIMETOPRIM + SULFAMETOSSAZOLO * Product Name: pentamidine Product Code: [pentamidine] INN or Proposed INN: PENTAMIDINA ISETIONATO Product Name: atovaquone Product Code: [atovaquone] INN or Proposed INN: ATOVAQUONE | INCYTE CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Germany;Netherlands;Japan | ||
| 6 | NCT03538041 (ClinicalTrials.gov) | November 21, 2018 | 15/5/2018 | A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia | A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia | Autoimmune Hemolytic Anemia | Drug: Parsaclisib | Incyte Corporation | NULL | Active, not recruiting | 18 Years | N/A | All | 25 | Phase 2 | United States;Austria;France;Italy |
| 7 | EUCTR2017-003652-22-IT (EUCTR) | 18/09/2018 | 15/01/2021 | A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia (AIHA) | A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia - A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia (AIHA) | Autoimmune Hemolytic Anemia (AIHA), immunohemolytic anemia, autoimmune hemolytic anemia, immune complex hemolytic anemia.Warm AIHA, Cold AIHA MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: INCB050465 2.5 mg Product Code: [INCB050465 2.5 mg] Product Name: INCB050465 1 mg Product Code: [INCB050465 1 mg] | INCYTE CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 25 | Phase 2 | France;United States;Austria;Italy | ||
| 8 | EUCTR2017-003652-22-AT (EUCTR) | 18/07/2018 | 29/03/2018 | A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia (AIHA) | A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia | Autoimmune Hemolytic Anemia (AIHA), immunohemolytic anemia, autoimmune hemolytic anemia, immune complex hemolytic anemia.Warm AIHA, Cold AIHA MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: INCB050465 1 mg INN or Proposed INN: not yet assigned Other descriptive name: INCB050465 HYDROCHLORIDE Product Code: INCB050465 2.5 mg INN or Proposed INN: not yet assigned Other descriptive name: INCB050465 HYDROCHLORIDE | Incyte Coorporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 25 | Phase 2 | France;United States;Austria;Italy |