14. 慢性炎症性脱髄性多発神経炎/多巣性運動ニューロパチー Chronic inflammatory demyelinating polyneuropathy Clinical trials / Disease details


臨床試験数 : 175 薬物数 : 161 - (DrugBank : 41) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 24

  
25 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-003107-35-CZ
(EUCTR)
18/10/202105/03/2020A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE+ Chronic Inflammatory Demyelinating Polyneuropathy;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
360Phase 2Serbia;United States;Czechia;Spain;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Georgia;Bulgaria;Netherlands;Latvia;Germany;Japan
2EUCTR2019-003107-35-AT
(EUCTR)
27/07/202121/08/2020A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE+ Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2Serbia;United States;Czechia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Georgia;Bulgaria;Netherlands;Latvia;Germany;Japan
3EUCTR2019-003076-39-AT
(EUCTR)
21/04/202101/10/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 2Serbia;United States;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Germany;Japan
4EUCTR2019-003107-35-NL
(EUCTR)
25/09/202001/05/2020A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE+ Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2Serbia;United States;Czechia;Spain;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Georgia;Bulgaria;Latvia;Germany;Netherlands;Japan
5EUCTR2019-003107-35-DK
(EUCTR)
22/09/202012/08/2020A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE+ Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2Serbia;United States;Czechia;Spain;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Romania;Denmark;Georgia;Bulgaria;Netherlands;Latvia;Germany;Japan
6NCT04280718
(ClinicalTrials.gov)
September 18, 202020/2/2020A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Biological: Efgartigimod PH20 SCargenxNULLRecruiting18 YearsN/AAll360Phase 2United States;Austria;Belgium;Bulgaria;China;Czechia;Denmark;France;Georgia;Germany;Israel;Italy;Japan;Latvia;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom
7EUCTR2019-003107-35-BG
(EUCTR)
04/09/202011/06/2020A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients Wth Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE+ Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2Serbia;United States;Czechia;Spain;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Latvia;Germany;Japan
8EUCTR2019-003076-39-DK
(EUCTR)
19/08/202023/06/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 2Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Denmark;Georgia;Bulgaria;Netherlands;Latvia;Germany;Japan
9EUCTR2019-003076-39-CZ
(EUCTR)
12/08/202005/03/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;Serbia;Czechia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Latvia;Germany;Japan
10EUCTR2019-003107-35-BE
(EUCTR)
04/08/202020/03/2020A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE+ Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Serbia;Taiwan;Spain;Ukraine;Russian Federation;Israel;Italy;France;Denmark;Latvia;Netherlands;China;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Georgia;Bulgaria;Germany;Japan
11EUCTR2019-003107-35-DE
(EUCTR)
15/07/202024/02/2020A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults With chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE+ Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Serbia;Taiwan;Spain;Ukraine;Russian Federation;Israel;Italy;France;Denmark;Latvia;Netherlands;China;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Georgia;Bulgaria;Germany;Japan
12EUCTR2019-003107-35-PL
(EUCTR)
09/07/202006/04/2020A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE+ Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Latvia;Germany;Japan
13EUCTR2019-003076-39-NL
(EUCTR)
03/07/202025/03/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 2Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Georgia;Bulgaria;Germany;Japan;United States;Serbia;Taiwan;Spain;Ukraine;Russian Federation;Israel;Italy;France;Denmark;Netherlands;Latvia;China;Czechia
14EUCTR2019-003076-39-DE
(EUCTR)
25/06/202003/02/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 2United States;Serbia;Taiwan;Spain;Ukraine;Russian Federation;Israel;Italy;France;Denmark;Netherlands;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Georgia;Bulgaria;Germany;Japan
15EUCTR2019-003076-39-BG
(EUCTR)
17/06/202024/04/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 2Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Germany;Japan;United Kingdom;Czech Republic;Hungary;Serbia;United States;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria
16EUCTR2019-003107-35-GB
(EUCTR)
11/06/202016/04/2020A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE+ Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2Serbia;United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Latvia;Germany;Japan
17EUCTR2019-003107-35-IT
(EUCTR)
01/06/202017/06/2021A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE+ Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
Product Code: [NA]
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
ARGENX BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2Serbia;United States;Czechia;Spain;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Romania;Denmark;Georgia;Bulgaria;Netherlands;Latvia;Germany;Japan
18EUCTR2019-003076-39-BE
(EUCTR)
29/05/202012/03/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 2United States;Serbia;Taiwan;Spain;Ukraine;Russian Federation;Israel;Italy;France;Denmark;Latvia;Netherlands;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Georgia;Bulgaria;Germany;Japan
19EUCTR2019-003076-39-ES
(EUCTR)
25/05/202028/02/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 2United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Japan
20EUCTR2019-003076-39-IT
(EUCTR)
18/05/202017/06/2021A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
Product Code: [NA]
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
ARGENX BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 2Serbia;United States;Czechia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Georgia;Bulgaria;Netherlands;Latvia;Germany;Japan
21EUCTR2019-003107-35-HU
(EUCTR)
15/05/202025/03/2020A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE+ Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2Serbia;United States;Czechia;Spain;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Romania;Denmark;Georgia;Bulgaria;Netherlands;Latvia;Germany;Japan
22EUCTR2019-003076-39-GB
(EUCTR)
07/05/202006/03/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 2United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Latvia;Germany;Japan
23EUCTR2019-003076-39-PL
(EUCTR)
04/05/202020/02/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 2Serbia;United States;Czechia;Spain;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Georgia;Bulgaria;Netherlands;Latvia;Germany;Japan
24EUCTR2019-003076-39-HU
(EUCTR)
27/04/202020/02/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
400Phase 2Serbia;United States;Czechia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Georgia;Bulgaria;Netherlands;Latvia;Germany;Japan
25NCT04281472
(ClinicalTrials.gov)
April 15, 202020/2/2020A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Biological: efgartigimod PH20 SC in stage B;Other: placebo in stage BargenxNULLActive, not recruiting18 YearsN/AAll360Phase 2United States;Austria;Belgium;Bulgaria;China;Czechia;Denmark;France;Georgia;Germany;Hungary;Israel;Italy;Japan;Latvia;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Taiwan;Turkey;Ukraine;United Kingdom