63. Idiopathic thrombocytopenic purpura Clinical trials / Disease details


Clinical trials : 363 Drugs : 212 - (DrugBank : 43) / Drug target genes : 47 - Drug target pathways : 138

  
23 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2020-004032-21-DK
(EUCTR)
11/01/202216/04/2021A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia.A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Australia;Denmark;Peru;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan
2EUCTR2020-004033-20-NO
(EUCTR)
08/09/202120/04/2021Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune ThrombocytopeniaA Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan
3EUCTR2020-004033-20-GR
(EUCTR)
07/09/202119/07/2021Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune ThrombocytopeniaA Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan
4EUCTR2020-004033-20-BG
(EUCTR)
03/09/202126/05/2021Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune ThrombocytopeniaA Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan
5EUCTR2020-004033-20-PT
(EUCTR)
03/09/202120/05/2021Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune ThrombocytopeniaA Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan
6EUCTR2020-004033-20-ES
(EUCTR)
13/08/202109/06/2021Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune ThrombocytopeniaA Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan
7EUCTR2020-004033-20-IT
(EUCTR)
23/07/202117/08/2021Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune ThrombocytopeniaA Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
Product Code: [ARGX-113]
INN or Proposed INN: efgartigimod alfa
ARGENX BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan
8EUCTR2020-004032-21-PT
(EUCTR)
19/07/202111/03/2021A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia.A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan
9EUCTR2020-004032-21-NO
(EUCTR)
25/06/202118/03/2021A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia.A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Serbia;Portugal;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;France;Jordan;Denmark;Australia;Peru;South Africa;Tunisia;Latvia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
10EUCTR2020-004032-21-DE
(EUCTR)
15/06/202112/03/2021A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia.A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan
11EUCTR2020-004032-21-IT
(EUCTR)
04/06/202108/06/2021A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH20 Subcutaneous in adult patients with primary immune thrombocytopeniaA Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC Primary immune thrombocytopenia (ITP)
MedDRA version: 22.1;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
Product Code: [ARGX-113]
INN or Proposed INN: efgartigimod alfa
ARGENX BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan
12JPRN-jRCT2071210025
25/05/202124/05/2021A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC Primary Immune ThrombocytopeniaPatients will receive ARGX-113 PH20 SC (1000 mg of Efgartigimod Alfa) or placebo PH20 SC, weekly from visits 1 to 4 and then from visits 5 to 16 either weekly or biweekly, adjusted according to their platelet count. From visits 17 to 24, patients will be fixed on the dosing schedule they were receiving at visit 16 or the last visit at which IMP was administered (i.e. either weekly or biweekly).Gandini DomenicaNULLRecruiting>= 20age oldNot applicableBoth9Phase 3Denmark;France;Georgia;Germany;Greece;Ireland;Israel;Italy;Jordan;Republic of Korea;Latvia;Mexico;New Zealand;Norway;Peru;Poland;Portugal;Romania;Russian Federation;Serbia;South Africa;Spain;Taiwan;Thailand;Tunisia;Turkey;United Kingdom;United State;Japan;Argentina;Australia;Bulgaria;Chile;China;Colombia
13EUCTR2020-004032-21-BG
(EUCTR)
17/05/202115/03/2021A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia.A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Australia;Peru;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan
14EUCTR2020-004032-21-IE
(EUCTR)
07/05/202117/02/2021A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia.A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Portugal;Serbia;Taiwan;Greece;Spain;Thailand;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
15EUCTR2019-002101-21-FR
(EUCTR)
22/04/202020/02/2020A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia - ADVANCE+ A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia - ADVANCE+ Primary immune thrombocytopenia
MedDRA version: 20.1;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands;Japan
16EUCTR2019-002101-21-ES
(EUCTR)
09/04/202023/01/2020A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia - ADVANCE+ Primary immune thrombocytopenia
MedDRA version: 20.1;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands;Japan
17EUCTR2019-002100-41-CZ
(EUCTR)
20/02/202008/11/2019A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia - ADVANCE Primary immune thrombocytopenia
MedDRA version: 20.1;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands;Japan
18EUCTR2019-002100-41-FR
(EUCTR)
04/02/202028/10/2019A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia - ADVANCE Primary immune thrombocytopenia
MedDRA version: 20.1;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands;Japan
19EUCTR2019-002100-41-BE
(EUCTR)
10/01/202021/11/2019A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE Primary immune thrombocytopenia
MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
156Phase 3Japan;Germany;Netherlands;Bulgaria;Georgia;Belgium;Poland;Hungary;Czech Republic;France;Italy;United Kingdom;Russian Federation;Austria;Turkey;Ukraine;Spain;Czechia;United States
20EUCTR2019-002100-41-HU
(EUCTR)
17/12/201930/10/2019A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE Primary immune thrombocytopenia
MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: EFGARTIGIMOD alfa
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
156Phase 3United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Georgia;Bulgaria;Netherlands;Germany;Japan
21EUCTR2019-002100-41-ES
(EUCTR)
16/12/201911/11/2019A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia - ADVANCE Primary immune thrombocytopenia
MedDRA version: 20.1;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
156 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany;Japan
22EUCTR2019-002100-41-NL
(EUCTR)
01/11/201907/08/2019A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE Primary immune thrombocytopenia
MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: EFGARTIGIMOD ALFA
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
156Phase 3United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Georgia;Bulgaria;Netherlands;Germany;Japan
23EUCTR2020-004032-21-GR
(EUCTR)
19/04/2021A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia.A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan