DDrare: Database of Drug Development for Rare Diseases

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.

Drug = 0.9% sodium chloride; 10% intravenous immunoglobulin (IVIg); 10% liquid formulation of human immunoglobulin; : immunoglobulina umana normale 10% per somministrazione endovenosa; ARGX-113; Acthar; Albumin (Human) 25%, United States Pharmacopeia (USP); Anti-C5 antibody; Anti-Thymocyte Globulin; BIVV020; Biological : I10E (Human normal Immunoglobulin for intravenous administration 100mg/mL); Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL); CLORFENAMINA MALEATO; Carmustine; Chloride; Clorfenamina; Clorfenamina maleato; Cyclophosphamide; Cytarabine; Device: Vital EMS+; Dexamethasone; Eculizumab; Efgartigimod PH20 SC; Efgartigimod PH20 SC in stage B; Efgartigimod alfa; Etoposide; FAMPRIDINE; FINGOLIMOD HYDROCHLORIDE; FTY720; FTY720I; Fampridine; Fampyra; Fibrinogen; Fibrinogen concentrate; Fingolimod; Freeze-Dried Sulfonated Human Normal Immunoglobulin (GGS); GILENYA 0,5 mg cápsulas duras; Gammanorm; Gilenya; H.P. Acthar® Gel; HIDROCLORURO DE FINGOLIMOD; HUMAN IMMUNOGLOBULIN G; HUMAN NORMAL IMMUNOGLOBULIN; HUMAN NORMAL IMMUNOGLOBULIN (IV); Hematopoietic stem cell transplantation; Hizentra; Hizentra®; Human Immunoglobulin G; Human immunoglobulin G; Human normal 10% immunoglobulin for intravenous administration; Human normal 10% immunoglobulin for intravenous administrationn; Human normal immunoglobulin; Human normal immunoglobulin (SCIg); Human normal immunoglobulin G (IgG > 98% purity); Human normal immunoglobulin for intravenous administration; HyQvia; Hyqvia; I10; I10E; IGIV, 10%; IGVENA*FL 200ML 10G+SET; IMMUNOGLOBULIN G; IMMUNOGLOBULINA UMANA NORMALE per somministrazione endovenosa; IQYMUNE; IVIg; IgPro10; IgPro20; IgPro20 (high dose); IgPro20 (low dose); Immune Globulin 10% Intravenous Solution; Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified; Immune Globulin Intravenous (human), 10%; Immune Globulin Subcutaneous (Human); Immune globulin; Immunoglobulin; Immunoglobulin G; Immunoglobulin perfusion; Immunoglobulina umana normale per somministrazione endovenosa; Immunoglobuline G; Immunoglobulins; Immunoglobulins, normal human, for extravascular adm.; Immunoglobulins, normal human, for intravascular adm.; Intravenous Immunoglobulin; Intravenous immunoglobulin; Intravenous immunoglobulin (IVIg); KIOVIG; KIOVIG 100 mg/ml solution for infusion; Kiovig; Lipoic acid; MABTHERA - 1 FIALA 500 MG 50 ML; MD1003; METILPREDNISOLONE SODIO SUCCINATO; MabThera; Melphalan; Methylprednisolon; Methylprednisolon (Solu-Medrol); Methylprednisolone; Methylprednisolone (Solu-Medrol); Metilprednisolone sodio succinato; NPB-01; NewGam; Other: Fresh Frozen Plasma; Other: Laboratory Biomarker Analysis; PANZYGA; PARACETAMOLO; Paracetamolo; Placebo; Prednisolone; Prednisone; Privigen; Privigen®; Procedure: Autologous Hematopoietic Stem Cell Transplantation; Procedure: Peripheral Blood Stem Cell Transplantation; Procedure: Syngeneic Bone Marrow Transplantation; RHuPH20; RITUXIMAB; ROZANOLIXIZUMAB; RVG 51680; RVG 56083; Rituximab; Rituximab (genetical recombination); Rozanolixizumab; SOLIRIS; SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML; Sodium Chloride 0.9%; Sodium chloride; Sodium chloride 0.9%; Soliris; Standard of Care; Subcutaneous immunoglobulin; Subcuvia; TACHIPIRINA - 1000 MG COMPRESSE 8 COMPRESSE; TRIMETON - 10 MG/1 ML SOLUZIONE INIETTABILE 5 FIALE 1 ML; UCB7665; Vivaglobin; [Clorfenamina maleato]; [Metilprednisolone sodio succinato]; [Paracetamolo]; [Rituximab]

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2019-003107-35-NL (EUCTR)	25/09/2020	01/05/2020	A 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 BVBA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 2	Serbia;United States;Czechia;Spain;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Romania;Denmark;Georgia;Bulgaria;Latvia;Germany;Netherlands;Japan
2	EUCTR2019-003107-35-DK (EUCTR)	22/09/2020	12/08/2020	A 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 BVBA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 2	United 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
3	NCT04280718 (ClinicalTrials.gov)	September 18, 2020	20/2/2020	A 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 SC	argenx	NULL	Recruiting	18 Years	N/A	All	360	Phase 2	Georgia
4	EUCTR2019-003107-35-BG (EUCTR)	04/09/2020	11/06/2020	A 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 BVBA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 2	United 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
5	EUCTR2019-003076-39-DK (EUCTR)	19/08/2020	23/06/2020	A 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 BVBA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 2	United 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.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2019-003107-35-BE (EUCTR)	04/08/2020	20/03/2020	A 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 BVBA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 2	United 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
7	EUCTR2019-003107-35-DE (EUCTR)	15/07/2020	24/02/2020	A 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 BVBA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 2	Serbia;United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Japan
8	EUCTR2019-003107-35-PL (EUCTR)	09/07/2020	06/04/2020	A 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 BVBA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 2	United 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
9	EUCTR2019-003076-39-NL (EUCTR)	03/07/2020	25/03/2020	A 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 BVBA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 2	United States;Serbia;Czechia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Latvia;Netherlands;Germany;Japan
10	EUCTR2019-003076-39-DE (EUCTR)	25/06/2020	03/02/2020	A 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 BVBA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 2	United 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.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2019-003076-39-BG (EUCTR)	17/06/2020	24/04/2020	A 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 BVBA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 2	Serbia;United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Japan
12	EUCTR2019-003107-35-GB (EUCTR)	11/06/2020	16/04/2020	A 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 BVBA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 2	Serbia;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
13	EUCTR2019-003076-39-BE (EUCTR)	29/05/2020	12/03/2020	A 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 BVBA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 2	United 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
14	EUCTR2019-003076-39-ES (EUCTR)	25/05/2020	28/02/2020	A 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 BVBA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 2	United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Japan
15	EUCTR2019-003107-35-HU (EUCTR)	15/05/2020	25/03/2020	A 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 BVBA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 2	United 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.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	EUCTR2019-003076-39-GB (EUCTR)	07/05/2020	06/03/2020	A 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 BVBA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 2	United 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
17	EUCTR2019-003076-39-PL (EUCTR)	04/05/2020	20/02/2020	A 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 BVBA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 2	United 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
18	EUCTR2019-003076-39-HU (EUCTR)	27/04/2020	20/02/2020	A 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 BVBA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 2	United 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
19	NCT04281472 (ClinicalTrials.gov)	April 15, 2020	20/2/2020	A 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 B	argenx	NULL	Recruiting	18 Years	N/A	All	400	Phase 2	United States;Bulgaria;Georgia;Germany;Hungary;Israel;Latvia;Poland;Russian Federation;Spain;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-003107-35-NL
(EUCTR)

25/09/2020

01/05/2020

A 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 BVBA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

Serbia;United States;Czechia;Spain;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Romania;Denmark;Georgia;Bulgaria;Latvia;Germany;Netherlands;Japan

EUCTR2019-003107-35-DK
(EUCTR)

22/09/2020

12/08/2020

Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113

argenx BVBA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

United 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

NCT04280718
(ClinicalTrials.gov)

September 18, 2020

20/2/2020

A 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 SC

argenx

NULL

Recruiting

18 Years

N/A

All

360

Phase 2

Georgia

EUCTR2019-003107-35-BG
(EUCTR)

04/09/2020

11/06/2020

Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113

argenx BVBA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

United 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

EUCTR2019-003076-39-DK
(EUCTR)

19/08/2020

23/06/2020

A 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

Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113

argenx BVBA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

400

Phase 2

United 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.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-003107-35-BE
(EUCTR)

04/08/2020

20/03/2020

Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113

argenx BVBA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

United 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

EUCTR2019-003107-35-DE
(EUCTR)

15/07/2020

24/02/2020

Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113

argenx BVBA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

Serbia;United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Japan

EUCTR2019-003107-35-PL
(EUCTR)

09/07/2020

06/04/2020

Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113

argenx BVBA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

United 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

EUCTR2019-003076-39-NL
(EUCTR)

03/07/2020

25/03/2020

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

Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113

argenx BVBA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

400

Phase 2

United States;Serbia;Czechia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Latvia;Netherlands;Germany;Japan

EUCTR2019-003076-39-DE
(EUCTR)

25/06/2020

03/02/2020

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

Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113

argenx BVBA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

400

Phase 2

United 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.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-003076-39-BG
(EUCTR)

17/06/2020

24/04/2020

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

Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113

argenx BVBA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

400

Phase 2

Serbia;United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Japan

EUCTR2019-003107-35-GB
(EUCTR)

11/06/2020

16/04/2020

Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113

argenx BVBA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

Serbia;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

EUCTR2019-003076-39-BE
(EUCTR)

29/05/2020

12/03/2020

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

Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113

argenx BVBA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

400

Phase 2

United 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

EUCTR2019-003076-39-ES
(EUCTR)

25/05/2020

28/02/2020

A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113

argenx BVBA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

400

Phase 2

United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Japan

EUCTR2019-003107-35-HU
(EUCTR)

15/05/2020

25/03/2020

Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113

argenx BVBA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

United 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.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-003076-39-GB
(EUCTR)

07/05/2020

06/03/2020

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

Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113

argenx BVBA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

400

Phase 2

United 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

EUCTR2019-003076-39-PL
(EUCTR)

04/05/2020

20/02/2020

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

Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113

argenx BVBA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

400

Phase 2

United 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

EUCTR2019-003076-39-HU
(EUCTR)

27/04/2020

20/02/2020

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

Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113

argenx BVBA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

400

Phase 2

United 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

NCT04281472
(ClinicalTrials.gov)

April 15, 2020

20/2/2020

A 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 B

argenx

NULL

Recruiting

18 Years

N/A

All

400

Phase 2

United States;Bulgaria;Georgia;Germany;Hungary;Israel;Latvia;Poland;Russian Federation;Spain;Ukraine