Argx-113    (DrugBank: -)

4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
11重症筋無力症20
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18
35天疱瘡7
63特発性血小板減少性紫斑病26

11. 重症筋無力症 [臨床試験数:226,薬物数:172(DrugBank:45),標的遺伝子数:43,標的パスウェイ数:118
Searched query = "Myasthenia", "MG"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
20 / 226 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-002133-37-NL06/06/201926/09/2018A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 20.0 Level: PT Classification code 10028417 Term: Myasthenia gravis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: LLT Classification code 10028423 Term: Myasthenia gravis-like syndrome System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: HLT Classification code 10071942 Term: Myasthenia gravis and related conditions System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
argenx BVBANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Japan;Sweden
2EUCTR2018-002132-25-NL30/04/201926/09/2018An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 20.0Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: LLTClassification code 10028423Term: Myasthenia gravis-like syndromeSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: HLTClassification code 10071942Term: Myasthenia gravis and related conditionsSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Japan;Sweden
3NCT03770403March 1, 201916/11/2018A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle WeaknessGeneralized Myasthenia GravisBiological: ARGX-113argenxNULLActive, not recruiting18 YearsN/AAll151Phase 3United States;Belgium;Canada;Czechia;Denmark;France;Georgia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Russian Federation;Serbia
4EUCTR2018-002133-37-DK26/02/201913/11/2018A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 21.1Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: LLTClassification code 10028423Term: Myasthenia gravis-like syndromeSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: HLTClassification code 10071942Term: Myasthenia gravis and related conditionsSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3Serbia;United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Netherlands;Germany;Japan;Sweden
5EUCTR2018-002132-25-CZ25/02/201901/11/2018An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 21.1Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: LLTClassification code 10028423Term: Myasthenia gravis-like syndromeSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: HLTClassification code 10071942Term: Myasthenia gravis and related conditionsSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2018-002133-37-CZ25/02/201902/11/2018A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 21.1 Level: PT Classification code 10028417 Term: Myasthenia gravis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1 Level: LLT Classification code 10028423 Term: Myasthenia gravis-like syndrome System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: HLT Classification code 10071942 Term: Myasthenia gravis and related conditions System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
argenx BVBANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;Netherlands;Japan
7EUCTR2018-002132-25-DE22/02/201912/11/2018An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 21.1Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: LLTClassification code 10028423Term: Myasthenia gravis-like syndromeSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: HLTClassification code 10071942Term: Myasthenia gravis and related conditionsSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden
8EUCTR2018-002133-37-DE22/02/201912/11/2018A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 21.1 Level: PT Classification code 10028417 Term: Myasthenia gravis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1 Level: LLT Classification code 10028423 Term: Myasthenia gravis-like syndrome System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: HLT Classification code 10071942 Term: Myasthenia gravis and related conditions System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
argenx BVBANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;United States;Russian Federation;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan
9EUCTR2018-002132-25-HU28/01/201916/11/2018An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 20.0Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: LLTClassification code 10028423Term: Myasthenia gravis-like syndromeSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: HLTClassification code 10071942Term: Myasthenia gravis and related conditionsSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Japan;Sweden
10EUCTR2018-002133-37-HU28/01/201922/11/2018A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 20.0 Level: PT Classification code 10028417 Term: Myasthenia gravis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: LLT Classification code 10028423 Term: Myasthenia gravis-like syndrome System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: HLT Classification code 10071942 Term: Myasthenia gravis and related conditions System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
argenx BVBANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2018-002132-25-BE21/01/201916/11/2018An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 21.1Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: LLTClassification code 10028423Term: Myasthenia gravis-like syndromeSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: HLTClassification code 10071942Term: Myasthenia gravis and related conditionsSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden
12EUCTR2018-002133-37-BE21/01/201919/11/2018A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 21.1Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: LLTClassification code 10028423Term: Myasthenia gravis-like syndromeSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: HLTClassification code 10071942Term: Myasthenia gravis and related conditionsSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3Japan;United States;Serbia;Russian Federation;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands
13EUCTR2018-002132-25-FR15/01/201929/10/2018An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 20.0Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: LLTClassification code 10028423Term: Myasthenia gravis-like syndromeSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: HLTClassification code 10071942Term: Myasthenia gravis and related conditionsSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan;Sweden
14EUCTR2018-002132-25-DK13/12/201828/09/2018An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 21.1Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: LLTClassification code 10028423Term: Myasthenia gravis-like syndromeSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: HLTClassification code 10071942Term: Myasthenia gravis and related conditionsSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
Argenx BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden
15NCT03669588September 5, 20186/9/2018An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle WeaknessA Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle WeaknessGeneralized Myasthenia GravisBiological: ARGX-113;Biological: PlaceboargenxNULLCompleted18 YearsN/AAll167Phase 3United States;Belgium;Canada;Czechia;Denmark;France;Georgia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Russian Federation;Serbia;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT02965573December 30, 201620/10/2016A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle WeaknessA Randomized, Double-blind, Placebo-Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle WeaknessMyasthenia GravisBiological: ARGX-113;Drug: PlaceboargenxQuintiles, Inc.Completed18 YearsN/AAll24Phase 2United States;Belgium;Canada;Italy;Netherlands;Poland;Spain;Sweden
17EUCTR2016-002938-73-NL08/12/201603/10/2016A Study of the safety and effectiveness of ARGX-113 in Patients with Myasthenia Gravis who have Generalized Muscle WeaknessA Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness Myasthenia Gravis who have Generalized Muscle Weakness
MedDRA version: 20.0Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ARGX-113
Product Code: ARGX-113
INN or Proposed INN: N/A
Other descriptive name: ARGX-113
Argenx BVBANULLNot RecruitingFemale: yes
Male: yes
24Phase 2United States;Canada;Poland;Belgium;Spain;Netherlands;Italy;Sweden
18EUCTR2016-002938-73-IT01/12/201622/02/2018A Study of the safety and effectiveness of ARGX-113 in Patients with Myasthenia Gravis who have Generalized Muscle WeaknessA Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness. - NA Myasthenia Gravis who have Generalized Muscle Weakness
MedDRA version: 20.0Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ARGX-113
Product Code: ARGX-113
Other descriptive name: ARGX-113
ARGEN-X BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 2United States;Canada;Poland;Belgium;Spain;Netherlands;Italy;Sweden
19EUCTR2016-002938-73-ES08/11/201626/09/2016A Study of the safety and effectiveness of ARGX-113 in Patients with Myasthenia Gravis who have Generalized Muscle WeaknessA Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness Myasthenia Gravis who have Generalized Muscle Weakness
MedDRA version: 19.0Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ARGX-113
Product Code: ARGX-113
INN or Proposed INN: N/A
Other descriptive name: ARGX-113
Argenx BVBANULLNot RecruitingFemale: yes
Male: yes
24Phase 2United States;Canada;Poland;Belgium;Spain;Netherlands;Italy;Sweden
20EUCTR2016-002938-73-BE31/10/201613/09/2016A Study of the safety and effectiveness of ARGX-113 in Patients with Myasthenia Gravis who have Generalized Muscle WeaknessA Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness Myasthenia Gravis who have Generalized Muscle Weakness
MedDRA version: 19.0Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ARGX-113
Product Code: ARGX-113
INN or Proposed INN: N/A
Other descriptive name: ARGX-113
Argenx BVBANULLNot RecruitingFemale: yes
Male: yes
24Phase 2United States;Canada;Poland;Spain;Belgium;Netherlands;Italy;Sweden

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 [臨床試験数:145,薬物数:139(DrugBank:23),標的遺伝子数:12,標的パスウェイ数:21
Searched query = "Chronic inflammatory demyelinating polyneuropathy", "Chronic inflammatory demyelinating poly (radiculo) neuropathy", "Multifocal motor neuropathy", "CIDP"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
18 / 145 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-NL25/09/202001/05/2020A 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: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem 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;Latvia;Germany;Netherlands;Japan
2EUCTR2019-003107-35-DK22/09/202012/08/2020A 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: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem 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;Germany;Latvia;Japan
3NCT04280718September 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 2Georgia
4EUCTR2019-003107-35-BG04/09/202011/06/2020A 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 with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE+ Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem 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;Germany;Latvia;Japan
5EUCTR2019-003076-39-DK19/08/202023/06/2020A 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: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem 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;Latvia;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-003107-35-BE04/08/202020/03/2020A 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: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem 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;Germany;Latvia;Japan
7EUCTR2019-003107-35-DE15/07/202024/02/2020A 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: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem 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;Germany;Japan
8EUCTR2019-003107-35-PL09/07/202006/04/2020A 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: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem 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
9EUCTR2019-003076-39-NL03/07/202025/03/2020A 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: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem 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;Czechia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Latvia;Netherlands;Germany;Japan
10EUCTR2019-003076-39-DE25/06/202003/02/2020A 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: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem 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;Germany;Netherlands;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2019-003076-39-BG17/06/202024/04/2020A 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: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem 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 2Serbia;United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Japan
12EUCTR2019-003107-35-GB11/06/202016/04/2020A 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: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem 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
13EUCTR2019-003076-39-BE29/05/202012/03/2020A 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: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem 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;Latvia;Japan
14EUCTR2019-003076-39-ES25/05/202028/02/2020A 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: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem 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
15EUCTR2019-003107-35-HU15/05/202025/03/2020A 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: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem 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;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Latvia;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2019-003076-39-GB07/05/202006/03/2020A 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: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem 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
17EUCTR2019-003076-39-PL04/05/202020/02/2020A 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: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem 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
18EUCTR2019-003076-39-HU27/04/202020/02/2020A 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: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem 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;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Latvia;Japan

35. 天疱瘡 [臨床試験数:87,薬物数:114(DrugBank:37),標的遺伝子数:17,標的パスウェイ数:158
Searched query = "Pemphigus"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
7 / 87 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-002917-16-GR03/12/202015/10/2020A 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: 20.0Level: LLTClassification code 10052802Term: Pemphigus vulgarisSystem Organ Class: 100000004858
MedDRA version: 20.0Level: LLTClassification code 10057069Term: Pemphigus foliaceusSystem 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 BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Japan
2EUCTR2020-002915-23-FR02/12/202009/09/2020A 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: 20.0Level: LLTClassification code 10052802Term: Pemphigus vulgarisSystem Organ Class: 100000004858
MedDRA version: 20.0Level: LLTClassification code 10057069Term: Pemphigus foliaceusSystem 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 BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Japan
3EUCTR2020-002917-16-HU17/11/202028/09/2020A 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: 20.0Level: LLTClassification code 10052802Term: Pemphigus vulgarisSystem Organ Class: 100000004858
MedDRA version: 20.0Level: LLTClassification code 10057069Term: Pemphigus foliaceusSystem 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 BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Japan
4NCT04598477October 25, 20208/10/2020A 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 PemphigusPemphigus Vulgaris;Pemphigus FoliaceusBiological: efgartigimod PH20 SC;Drug: prednisoneargenxNULLNot yet recruiting18 Years80 YearsAll150Phase 3NULL
5EUCTR2017-002333-40-DE31/01/201814/07/2017A 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: 20.0Level: LLTClassification code 10052802Term: Pemphigus vulgarisSystem Organ Class: 100000004858
MedDRA version: 20.0Level: LLTClassification code 10057069Term: Pemphigus foliaceusSystem 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 BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
22Phase 2Hungary;Ukraine;Romania;Israel;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03334058October 18, 201723/10/2017A Study to Evaluate the Safety, PD, PK and Efficacy of ARGX-113 in Patients With PemphigusAn 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 FoliaceusDrug: ARGX-113argenxNULLCompleted18 YearsN/AAll34Phase 2Germany;Hungary;Israel;Italy;Ukraine
7EUCTR2017-002333-40-HU20/09/201720/07/2017A 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: 20.0Level: LLTClassification code 10052802Term: Pemphigus vulgarisSystem Organ Class: 100000004858
MedDRA version: 20.0Level: LLTClassification code 10057069Term: Pemphigus foliaceusSystem 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 BVBANULLNot RecruitingFemale: yes
Male: yes
12Phase 2Hungary;Ukraine;Romania;Israel;Germany;Italy

63. 特発性血小板減少性紫斑病 [臨床試験数:311,薬物数:185(DrugBank:39),標的遺伝子数:43,標的パスウェイ数:132
Searched query = "Idiopathic thrombocytopenic purpura", "Primary immune thrombocytopenia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
26 / 311 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-002101-21-GB16/12/202029/10/2020A 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: 23.0Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan
2EUCTR2019-002101-21-DE15/12/202026/10/2020A 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: 23.0Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan
3EUCTR2019-002101-21-NL25/05/202007/01/2020A 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: 20.1Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem 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;Netherlands;Germany;Japan
4EUCTR2019-002101-21-BG08/05/202024/04/2020A 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: 23.0Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan
5EUCTR2019-002101-21-CZ06/05/202010/03/2020A 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: 23.0Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-002100-41-AT30/04/202025/11/2019A 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: 23.0Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan
7EUCTR2019-002101-21-BE28/04/202003/03/2020A 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: 23.0Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan
8EUCTR2019-002101-21-FR22/04/202020/02/2020A 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: 20.1Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem 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
9EUCTR2019-002100-41-DE14/04/202025/11/2019A 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: 23.0Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan
10EUCTR2019-002101-21-ES09/04/202023/01/2020A 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: 20.1Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2019-002101-21-HU07/04/202031/01/2020A 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: 23.0Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan
12EUCTR2019-002100-41-PL10/02/202013/11/2019A 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]
argenx BVBANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
156 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany;Japan
13EUCTR2019-002100-41-GB10/01/202005/08/2020A 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: 23.0Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan
14EUCTR2019-002100-41-BE10/01/202021/11/2019A 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: 23.0Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan
15EUCTR2019-002100-41-HU17/12/201930/10/2019A 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: 20.1 Level: LLT Classification code 10050245 Term: Autoimmune thrombocytopenia System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
argenx BVBANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
156 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2019-002100-41-ES16/12/201911/11/2019A 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]
argenx BVBANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
156 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany;Japan
17EUCTR2019-002100-41-NL01/11/201907/08/2019A 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 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]
argenx BVBANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
156 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Ukraine;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany;Japan
18EUCTR2019-000361-21-GB30/04/201906/02/2020A Multicenter, Open-Label, Phase 2 Trial to Evaluate the Safety and Activity of Efgartigimod (ARGX-113) in Adult Patients with Primary Immune Thrombocytopenia - ARGX-113-1804A Multicenter, Open-Label, Phase 2 Trial to Evaluate the Safety and Activity of Efgartigimod (ARGX-113) in Adult Patients with Primary Immune Thrombocytopenia - ARGX-113-1804 Primary Immune Thrombocytopenia
MedDRA version: 20.1Level: LLTClassification code 10074678Term: Primary immune thrombocytopenic purpuraSystem Organ Class: 100000004851;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: efgartigimod
Product Code: ARGX-113
Other descriptive name: ARGX-113
Product Name: efgartigimod
Product Code: ARGX-113
Other descriptive name: ARGX-113
Argenx BVBANULLNot RecruitingFemale: yes
Male: yes
15Phase 2Hungary;Spain;Ukraine;United Kingdom
19EUCTR2016-003038-26-DE27/04/201708/12/2016A Study of the safety and effectiveness of ARGX-113 in Patients with Primary Immune ThrombocytopeniaA Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia Primary Immune Thrombocytopenia
MedDRA version: 20.1 Level: LLT Classification code 10074678 Term: Primary immune thrombocytopenic purpura System Organ Class: 100000004851 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Argenx BVBANULLNot Recruiting Female: yes
Male: yes
36 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;Hungary;Czech Republic;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom
20NCT03102593March 13, 201714/3/2017A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With ITPA Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Primary Immune ThrombocytopeniaPrimary Immune ThrombocytopeniaDrug: ARGX-113;Other: PlaceboargenxQuintiles, Inc.Completed18 Years85 YearsAll38Phase 2Austria;Belgium;Czechia;France;Germany;Hungary;Poland;Spain;Ukraine;United Kingdom;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2016-003038-26-CZ10/02/201702/12/2016A Study of the safety and effectiveness of ARGX-113 in Patients with Primary Immune ThrombocytopeniaA Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia, followed by an Open-Label Treatment Period Primary Immune Thrombocytopenia
MedDRA version: 20.1 Level: LLT Classification code 10074678 Term: Primary immune thrombocytopenic purpura System Organ Class: 100000004851 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Argenx BVBANULLNot Recruiting Female: yes
Male: yes
36 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;Hungary;Czech Republic;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom
22EUCTR2016-003038-26-GB08/02/201716/11/2016A Study of the safety and effectiveness of ARGX-113 in Patients with Primary Immune ThrombocytopeniaA Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia, followed by an Open-Label Treatment Period - ARGX-113-1603_Argenx BVBA Primary Immune Thrombocytopenia
MedDRA version: 20.1Level: LLTClassification code 10074678Term: Primary immune thrombocytopenic purpuraSystem Organ Class: 100000004851;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ARGX-113
Product Code: ARGX-113
INN or Proposed INN: N/A
Other descriptive name: ARGX-113
Argenx BVBANULLNot RecruitingFemale: yes
Male: yes
36Phase 2France;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Austria;Germany;United Kingdom
23EUCTR2016-003038-26-ES07/02/201727/12/2016A Study of the safety and effectiveness of ARGX-113 in Patients with Primary Immune ThrombocytopeniaA Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia Primary Immune Thrombocytopenia
MedDRA version: 19.0 Level: LLT Classification code 10074678 Term: Primary immune thrombocytopenic purpura System Organ Class: 100000004851 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Argenx BVBANULLNot Recruiting Female: yes
Male: yes
36 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;Hungary;Czech Republic;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom
24EUCTR2016-003038-26-AT06/02/201714/12/2016A Study of the safety and effectiveness of ARGX-113 in Patients with Primary Immune ThrombocytopeniaA Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia Primary Immune Thrombocytopenia
MedDRA version: 20.1 Level: LLT Classification code 10074678 Term: Primary immune thrombocytopenic purpura System Organ Class: 100000004851 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Argenx BVBANULLNot Recruiting Female: yes
Male: yes
36 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;Hungary;Czech Republic;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom
25EUCTR2016-003038-26-BE27/01/201708/12/2016A Study of the safety and effectiveness of ARGX-113 in Patients with Primary Immune ThrombocytopeniaA Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia followed by an Open-Label Treatment Period. Primary Immune Thrombocytopenia
MedDRA version: 20.1Level: LLTClassification code 10074678Term: Primary immune thrombocytopenic purpuraSystem Organ Class: 100000004851;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ARGX-113
Product Code: ARGX-113
INN or Proposed INN: N/A
Other descriptive name: ARGX-113
Argenx BVBANULLNot RecruitingFemale: yes
Male: yes
36Phase 2France;Hungary;Czech Republic;Poland;Spain;Belgium;Ukraine;Austria;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2016-003038-26-HU19/01/201730/11/2016A Study of the safety and effectiveness of ARGX-113 in Patients with Primary Immune ThrombocytopeniaA Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia Primary Immune Thrombocytopenia
MedDRA version: 19.0 Level: LLT Classification code 10074678 Term: Primary immune thrombocytopenic purpura System Organ Class: 100000004851 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Argenx BVBANULLNot Recruiting Female: yes
Male: yes
36 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;Czech Republic;Hungary;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom