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 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2018-002133-37-NL (EUCTR) | 06/06/2019 | 26/09/2018 | A 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;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Japan;Sweden | |||
| 2 | EUCTR2018-002132-25-NL (EUCTR) | 30/04/2019 | 26/09/2018 | An 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: 20.0;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;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System 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 BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Japan;Sweden | ||
| 3 | NCT03770403 (ClinicalTrials.gov) | March 1, 2019 | 16/11/2018 | A 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 | Generalized Myasthenia Gravis | Biological: ARGX-113 | argenx | NULL | Active, not recruiting | 18 Years | N/A | All | 151 | Phase 3 | United States;Belgium;Canada;Czechia;Denmark;France;Georgia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Russian Federation;Serbia |
| 4 | EUCTR2018-002133-37-DK (EUCTR) | 26/02/2019 | 13/11/2018 | A 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] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Netherlands;Germany;Japan;Sweden | ||
| 5 | EUCTR2018-002132-25-CZ (EUCTR) | 25/02/2019 | 01/11/2018 | An 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: 21.1;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] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden | ||
| 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 | EUCTR2018-002133-37-CZ (EUCTR) | 25/02/2019 | 02/11/2018 | A 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 BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;Netherlands;Japan | |||
| 7 | EUCTR2018-002133-37-DE (EUCTR) | 22/02/2019 | 12/11/2018 | A 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 BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Russian Federation;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan | |||
| 8 | EUCTR2018-002132-25-DE (EUCTR) | 22/02/2019 | 12/11/2018 | An 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: 21.1;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] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden | ||
| 9 | EUCTR2018-002133-37-HU (EUCTR) | 28/01/2019 | 22/11/2018 | A 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;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan;Sweden | |||
| 10 | EUCTR2018-002132-25-HU (EUCTR) | 28/01/2019 | 16/11/2018 | An 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: 20.0;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;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System 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 BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 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 | EUCTR2018-002133-37-BE (EUCTR) | 21/01/2019 | 19/11/2018 | A 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] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Japan;United States;Serbia;Russian Federation;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands | ||
| 12 | EUCTR2018-002132-25-BE (EUCTR) | 21/01/2019 | 16/11/2018 | An 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: 21.1;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] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden | ||
| 13 | EUCTR2018-002132-25-FR (EUCTR) | 15/01/2019 | 29/10/2018 | An 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: 20.0;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;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System 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 BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 14 | EUCTR2018-002132-25-DK (EUCTR) | 13/12/2018 | 28/09/2018 | An 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: 21.1;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] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | Argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden | ||
| 15 | NCT03669588 (ClinicalTrials.gov) | September 5, 2018 | 6/9/2018 | An 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 | Generalized Myasthenia Gravis | Biological: ARGX-113;Biological: Placebo | argenx | NULL | Completed | 18 Years | N/A | All | 167 | Phase 3 | United States;Belgium;Canada;Czechia;Denmark;France;Georgia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Russian Federation;Serbia;United Kingdom |
| 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 | NCT02965573 (ClinicalTrials.gov) | December 30, 2016 | 20/10/2016 | A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness | A 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 | Biological: ARGX-113;Drug: Placebo | argenx | Quintiles, Inc. | Completed | 18 Years | N/A | All | 24 | Phase 2 | United States;Belgium;Canada;Italy;Netherlands;Poland;Spain;Sweden |
| 17 | EUCTR2016-002938-73-NL (EUCTR) | 08/12/2016 | 03/10/2016 | A Study of the safety and effectiveness of ARGX-113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness | A 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: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System 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 BVBA | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United States;Canada;Poland;Belgium;Spain;Netherlands;Italy;Sweden | ||
| 18 | EUCTR2016-002938-73-IT (EUCTR) | 01/12/2016 | 22/02/2018 | A Study of the safety and effectiveness of ARGX-113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness | A 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: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System 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 BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | United States;Canada;Poland;Belgium;Spain;Netherlands;Italy;Sweden | ||
| 19 | EUCTR2016-002938-73-ES (EUCTR) | 08/11/2016 | 26/09/2016 | A Study of the safety and effectiveness of ARGX-113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness | A 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: 19.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System 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 BVBA | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United States;Canada;Poland;Belgium;Spain;Netherlands;Italy;Sweden | ||
| 20 | EUCTR2016-002938-73-BE (EUCTR) | 31/10/2016 | 13/09/2016 | A Study of the safety and effectiveness of ARGX-113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness | A 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: 19.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System 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 BVBA | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United States;Canada;Poland;Spain;Belgium;Netherlands;Italy;Sweden |
| 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 |
| 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 | EUCTR2020-002917-16-GR (EUCTR) | 03/12/2020 | 15/10/2020 | A 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: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10057069;Term: Pemphigus foliaceus;System 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 BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Japan | ||
| 2 | EUCTR2020-002915-23-FR (EUCTR) | 02/12/2020 | 09/09/2020 | A 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: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10057069;Term: Pemphigus foliaceus;System 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 BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Japan | ||
| 3 | EUCTR2020-002917-16-HU (EUCTR) | 17/11/2020 | 28/09/2020 | A 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: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10057069;Term: Pemphigus foliaceus;System 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 BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Japan | ||
| 4 | NCT04598477 (ClinicalTrials.gov) | October 25, 2020 | 8/10/2020 | A 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 Pemphigus | Pemphigus Vulgaris;Pemphigus Foliaceus | Biological: efgartigimod PH20 SC;Drug: prednisone | argenx | NULL | Not yet recruiting | 18 Years | 80 Years | All | 150 | Phase 3 | NULL |
| 5 | EUCTR2017-002333-40-DE (EUCTR) | 31/01/2018 | 14/07/2017 | A 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: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10057069;Term: Pemphigus foliaceus;System 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 BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 22 | Phase 2 | Hungary;Ukraine;Romania;Israel;Germany;Italy | ||
| 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 | NCT03334058 (ClinicalTrials.gov) | October 18, 2017 | 23/10/2017 | A Study to Evaluate the Safety, PD, PK and Efficacy of ARGX-113 in Patients With Pemphigus | 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 and Foliaceus) | Pemphigus Vulgaris;Pemphigus Foliaceus | Drug: ARGX-113 | argenx | NULL | Completed | 18 Years | N/A | All | 34 | Phase 2 | Germany;Hungary;Israel;Italy;Ukraine |
| 7 | EUCTR2017-002333-40-HU (EUCTR) | 20/09/2017 | 20/07/2017 | A 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: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10057069;Term: Pemphigus foliaceus;System 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 BVBA | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Hungary;Ukraine;Romania;Israel;Germany;Italy |
| 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 | EUCTR2019-002101-21-GB (EUCTR) | 16/12/2020 | 29/10/2020 | A 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: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan | ||
| 2 | EUCTR2019-002101-21-DE (EUCTR) | 15/12/2020 | 26/10/2020 | A 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: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan | ||
| 3 | EUCTR2019-002101-21-NL (EUCTR) | 25/05/2020 | 07/01/2020 | A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia - ADVANCE+ | Primary immune thrombocytopenia MedDRA version: 20.1;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod alfa Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Netherlands;Germany;Japan | ||
| 4 | EUCTR2019-002101-21-BG (EUCTR) | 08/05/2020 | 24/04/2020 | A 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: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan | ||
| 5 | EUCTR2019-002101-21-CZ (EUCTR) | 06/05/2020 | 10/03/2020 | A 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: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;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 |
| 6 | EUCTR2019-002100-41-AT (EUCTR) | 30/04/2020 | 25/11/2019 | A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan | ||
| 7 | EUCTR2019-002101-21-BE (EUCTR) | 28/04/2020 | 03/03/2020 | A 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: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan | ||
| 8 | EUCTR2019-002101-21-FR (EUCTR) | 22/04/2020 | 20/02/2020 | A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia - ADVANCE+ | Primary immune thrombocytopenia MedDRA version: 20.1;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod alfa Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands;Japan | ||
| 9 | EUCTR2019-002100-41-DE (EUCTR) | 14/04/2020 | 25/11/2019 | A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan | ||
| 10 | EUCTR2019-002101-21-ES (EUCTR) | 09/04/2020 | 23/01/2020 | A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia - ADVANCE+ | Primary immune thrombocytopenia MedDRA version: 20.1;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod alfa Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;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 | EUCTR2019-002101-21-HU (EUCTR) | 07/04/2020 | 31/01/2020 | A 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: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan | ||
| 12 | EUCTR2019-002100-41-PL (EUCTR) | 10/02/2020 | 13/11/2019 | A 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 BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany;Japan | |||
| 13 | EUCTR2019-002100-41-BE (EUCTR) | 10/01/2020 | 21/11/2019 | A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan | ||
| 14 | EUCTR2019-002100-41-GB (EUCTR) | 10/01/2020 | 05/08/2020 | A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan | ||
| 15 | EUCTR2019-002100-41-HU (EUCTR) | 17/12/2019 | 30/10/2019 | A 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 BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany;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 | EUCTR2019-002100-41-ES (EUCTR) | 16/12/2019 | 11/11/2019 | A 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 BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany;Japan | |||
| 17 | EUCTR2019-002100-41-NL (EUCTR) | 01/11/2019 | 07/08/2019 | A 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 BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany;Japan | |||
| 18 | EUCTR2019-000361-21-GB (EUCTR) | 30/04/2019 | 06/02/2020 | A 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 | A 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: 20.1;Level: LLT;Classification code 10074678;Term: Primary immune thrombocytopenic purpura;System 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 BVBA | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | Hungary;Spain;Ukraine;United Kingdom | ||
| 19 | EUCTR2016-003038-26-DE (EUCTR) | 27/04/2017 | 08/12/2016 | A Study of the safety and effectiveness of ARGX-113 in Patients with Primary Immune Thrombocytopenia | A 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 BVBA | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | France;Hungary;Czech Republic;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom | |||
| 20 | NCT03102593 (ClinicalTrials.gov) | March 13, 2017 | 14/3/2017 | A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With ITP | A 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 | Drug: ARGX-113;Other: Placebo | argenx | Quintiles, Inc. | Completed | 18 Years | 85 Years | All | 38 | Phase 2 | Austria;Belgium;Czechia;France;Germany;Hungary;Poland;Spain;Ukraine;United Kingdom;Czech Republic |
| 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 |
| 21 | EUCTR2016-003038-26-CZ (EUCTR) | 10/02/2017 | 02/12/2016 | A Study of the safety and effectiveness of ARGX-113 in Patients with Primary Immune Thrombocytopenia | A 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 BVBA | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | France;Hungary;Czech Republic;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom | |||
| 22 | EUCTR2016-003038-26-GB (EUCTR) | 08/02/2017 | 16/11/2016 | A Study of the safety and effectiveness of ARGX-113 in Patients with Primary Immune Thrombocytopenia | A 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: 20.1;Level: LLT;Classification code 10074678;Term: Primary immune thrombocytopenic purpura;System 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 BVBA | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | France;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Austria;Germany;United Kingdom | ||
| 23 | EUCTR2016-003038-26-ES (EUCTR) | 07/02/2017 | 27/12/2016 | A Study of the safety and effectiveness of ARGX-113 in Patients with Primary Immune Thrombocytopenia | A 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 BVBA | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | France;Hungary;Czech Republic;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom | |||
| 24 | EUCTR2016-003038-26-AT (EUCTR) | 06/02/2017 | 14/12/2016 | A Study of the safety and effectiveness of ARGX-113 in Patients with Primary Immune Thrombocytopenia | A 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 BVBA | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | France;Hungary;Czech Republic;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom | |||
| 25 | EUCTR2016-003038-26-BE (EUCTR) | 27/01/2017 | 08/12/2016 | A Study of the safety and effectiveness of ARGX-113 in Patients with Primary Immune Thrombocytopenia | A 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] | Product Name: ARGX-113 Product Code: ARGX-113 INN or Proposed INN: N/A Other descriptive name: ARGX-113 | Argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | France;Hungary;Czech Republic;Poland;Spain;Belgium;Ukraine;Austria;Germany;United Kingdom | ||
| 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 |
| 26 | EUCTR2016-003038-26-HU (EUCTR) | 19/01/2017 | 30/11/2016 | A Study of the safety and effectiveness of ARGX-113 in Patients with Primary Immune Thrombocytopenia | A 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 BVBA | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | France;Czech Republic;Hungary;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom |