Efgartigimod PH20 SC ( DrugBank: - )
5 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 | 12 |
| 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 | 25 |
| 35 | 天疱瘡 | 14 |
| 63 | 特発性血小板減少性紫斑病 | 18 |
| 162 | 類天疱瘡（後天性表皮水疱症を含む。） | 5 |
11. 重症筋無力症
臨床試験数 : 332 / 薬物数 : 234 - (DrugBank : 81) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 127
| 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 | EUCTR2020-004086-38-DE (EUCTR) | 06/08/2021 | 12/02/2021 | Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis | A Long-Term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia Gravis - ADAPT SC+ | Generalized Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 201 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Canada;Poland;Belgium;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina | ||
| 2 | EUCTR2020-004086-38-NL (EUCTR) | 02/06/2021 | 12/04/2021 | Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis | A Long-Term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia Gravis - ADAPT SC+ | Generalized Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 201 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Georgia;Netherlands;Germany;Japan;Bosnia and Herzegovina | ||
| 3 | EUCTR2020-004085-19-DE (EUCTR) | 31/05/2021 | 29/01/2021 | Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis | A Phase 3, Randomized, Open-label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis (ADAPT) - ADAPT SC | Generalized Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA Product Name: Efgartigimod IV INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Belgium;Poland;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina | ||
| 4 | EUCTR2020-004086-38-ES (EUCTR) | 07/05/2021 | 01/09/2021 | Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis | A Long-Term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia Gravis - ADAPT SC+ | Generalized Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 201 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Canada;Poland;Belgium;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina | ||
| 5 | EUCTR2020-004086-38-BE (EUCTR) | 04/05/2021 | 04/03/2021 | Evaluating the Long-term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis | A Long-term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia Gravis - ADAPT SC+ | Generalized Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 201 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina | ||
| 6 | EUCTR2020-004086-38-IT (EUCTR) | 27/04/2021 | 08/06/2021 | Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis | A Long-Term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia Gravis - ADAPT SC+ | Generalized Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC Product Code: [.] INN or Proposed INN: EFGARTIGIMOD ALFA | ARGENX BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 201 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina | ||
| 7 | EUCTR2020-004085-19-IT (EUCTR) | 26/04/2021 | 07/06/2021 | Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis | A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis - ADAPT SC | Generalized Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC Product Code: [NA] INN or Proposed INN: EFGARTIGIMOD ALFA Product Name: Efgartigimod IV Product Code: [NA] INN or Proposed INN: EFGARTIGIMOD ALFA | ARGENX BV | NULL | Not Recruiting | Female: yes Male: yes | 76 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Belgium;Poland;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina | ||
| 8 | EUCTR2020-004086-38-HU (EUCTR) | 22/04/2021 | 18/02/2021 | Evaluating the Long-term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis | A Long-term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia Gravis - ADAPT SC+ | Generalized Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 201 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina | ||
| 9 | EUCTR2020-004085-19-NL (EUCTR) | 19/03/2021 | 05/01/2021 | Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis | A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis (ADAPT) - ADAPT SC | Generalized Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA Product Name: Efgartigimod IV INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Not Recruiting | Female: yes Male: yes | 76 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Belgium;Poland;Georgia;Netherlands;Germany;Japan;Bosnia and Herzegovina | ||
| 10 | EUCTR2020-004085-19-BE (EUCTR) | 16/03/2021 | 12/01/2021 | Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis | A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis (ADAPT) - ADAPT SC | Generalized Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA Product Name: Efgartigimod IV INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 76 | Phase 3 | Georgia;Germany;Netherlands;Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Belgium;Poland;Japan;Bosnia and Herzegovina | ||
| 11 | EUCTR2020-004085-19-HU (EUCTR) | 24/02/2021 | 29/12/2020 | Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis | A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis (ADAPT) - ADAPT SC | Generalized Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA Product Name: Efgartigimod IV INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Belgium;Poland;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina | ||
| 12 | NCT04735432 (ClinicalTrials.gov) | February 5, 2021 | 26/1/2021 | Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis | A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC With Multiple Intravenous Infusions of Efgartigimod in Patients With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Biological: efgartigimod PH20 SC;Biological: efgartigimod IV | argenx | NULL | Completed | 18 Years | N/A | All | 111 | Phase 3 | United States;Belgium;Georgia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Russian Federation;Spain |
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 : 175 / 薬物数 : 161 - (DrugBank : 41) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 24
| 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-CZ (EUCTR) | 18/10/2021 | 05/03/2020 | 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;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Georgia;Bulgaria;Netherlands;Latvia;Germany;Japan | ||
| 2 | EUCTR2019-003107-35-AT (EUCTR) | 27/07/2021 | 21/08/2020 | 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 Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 2 | Serbia;United States;Czechia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Georgia;Bulgaria;Netherlands;Latvia;Germany;Japan | ||
| 3 | EUCTR2019-003076-39-AT (EUCTR) | 21/04/2021 | 01/10/2020 | 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 Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 2 | Serbia;United States;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Germany;Japan | ||
| 4 | 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;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Georgia;Bulgaria;Latvia;Germany;Netherlands;Japan | ||
| 5 | 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 Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | 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;Netherlands;Latvia;Germany;Japan | ||
| 6 | 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 | United States;Austria;Belgium;Bulgaria;China;Czechia;Denmark;France;Georgia;Germany;Israel;Italy;Japan;Latvia;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom |
| 7 | 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 Wth Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE+ | Chronic Inflammatory Demyelinating Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx 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;Bulgaria;Georgia;Netherlands;Latvia;Germany;Japan | ||
| 8 | 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 Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 2 | Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Denmark;Georgia;Bulgaria;Netherlands;Latvia;Germany;Japan | ||
| 9 | EUCTR2019-003076-39-CZ (EUCTR) | 12/08/2020 | 05/03/2020 | 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 | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Serbia;Czechia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Latvia;Germany;Japan | ||
| 10 | 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 Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 2 | United States;Serbia;Taiwan;Spain;Ukraine;Russian Federation;Israel;Italy;France;Denmark;Latvia;Netherlands;China;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 11 | 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 Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 2 | United States;Serbia;Taiwan;Spain;Ukraine;Russian Federation;Israel;Italy;France;Denmark;Latvia;Netherlands;China;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 12 | 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 | ||
| 13 | 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 Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 2 | Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Georgia;Bulgaria;Germany;Japan;United States;Serbia;Taiwan;Spain;Ukraine;Russian Federation;Israel;Italy;France;Denmark;Netherlands;Latvia;China;Czechia | ||
| 14 | 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 Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 2 | United States;Serbia;Taiwan;Spain;Ukraine;Russian Federation;Israel;Italy;France;Denmark;Netherlands;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 15 | 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 Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 2 | Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Germany;Japan;United Kingdom;Czech Republic;Hungary;Serbia;United States;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria | ||
| 16 | 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 | ||
| 17 | EUCTR2019-003107-35-IT (EUCTR) | 01/06/2020 | 17/06/2021 | 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 Product Code: [NA] 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 | 360 | Phase 2 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Romania;Denmark;Georgia;Bulgaria;Netherlands;Latvia;Germany;Japan | ||
| 18 | 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 Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 2 | United States;Serbia;Taiwan;Spain;Ukraine;Russian Federation;Israel;Italy;France;Denmark;Latvia;Netherlands;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 19 | 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 | ||
| 20 | EUCTR2019-003076-39-IT (EUCTR) | 18/05/2020 | 17/06/2021 | 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 Product Code: [NA] 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 | 400 | Phase 2 | Serbia;United States;Czechia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Georgia;Bulgaria;Netherlands;Latvia;Germany;Japan | ||
| 21 | 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 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Romania;Denmark;Georgia;Bulgaria;Netherlands;Latvia;Germany;Japan | ||
| 22 | 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 | ||
| 23 | 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 Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 2 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Georgia;Bulgaria;Netherlands;Latvia;Germany;Japan | ||
| 24 | 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 | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;United States;Czechia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Georgia;Bulgaria;Netherlands;Latvia;Germany;Japan | ||
| 25 | 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 | Active, not recruiting | 18 Years | N/A | All | 360 | Phase 2 | United States;Austria;Belgium;Bulgaria;China;Czechia;Denmark;France;Georgia;Germany;Hungary;Israel;Italy;Japan;Latvia;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Taiwan;Turkey;Ukraine;United Kingdom |
35. 天疱瘡
臨床試験数 : 99 / 薬物数 : 124 - (DrugBank : 36) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 169
| 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 | NCT04598477 (ClinicalTrials.gov) | July 15, 2021 | 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 | Recruiting | 18 Years | N/A | All | 213 | Phase 3 | United States;Australia;Bulgaria;China;France;Georgia;Germany;Greece;Hungary;India;Israel;Italy;Japan;Poland;Romania;Russian Federation;Serbia;Spain;Turkey;Ukraine;United Kingdom |
| 2 | EUCTR2020-002915-23-DE (EUCTR) | 25/01/2021 | 27/08/2020 | 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 Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Georgia;Bulgaria;Germany;Japan | ||
| 3 | EUCTR2020-002917-16-DE (EUCTR) | 25/01/2021 | 31/08/2020 | 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+) - 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 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 | Serbia;United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Georgia;Bulgaria;Germany;Japan | ||
| 4 | EUCTR2020-002917-16-FR (EUCTR) | 21/01/2021 | 10/11/2020 | 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 | ||
| 5 | EUCTR2020-002917-16-IT (EUCTR) | 17/12/2020 | 24/05/2021 | 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 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC Product Code: [na] INN or Proposed INN: EFGARTIGIMOD ALFA Other descriptive name: ARGX-113 Trade Name: Prednison 5 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Prednison 10 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Prednison20 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Prednison 50 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | ARGENX BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Georgia;Bulgaria;Germany;Japan | ||
| 6 | EUCTR2020-002915-23-IT (EUCTR) | 11/12/2020 | 24/05/2021 | 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 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Prednison 50 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Prednison 5 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: prednisone Trade Name: Prednison20 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Product Name: Efgartigimod PH20 SC Product Code: [na] INN or Proposed INN: EFGARTIGIMOD ALFA Trade Name: Prednison 10 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | ARGENX BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Georgia;Bulgaria;Germany;Japan | ||
| 7 | EUCTR2020-002915-23-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) | 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 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | NCT04598451 (ClinicalTrials.gov) | December 1, 2020 | 8/10/2020 | A Study to Assess the Efficacy and Safety 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) | Pemphigus Vulgaris;Pemphigus Foliaceus | Biological: efgartigimod PH20 SC;Other: Placebo;Drug: prednisone | argenx | NULL | Active, not recruiting | 18 Years | N/A | All | 222 | Phase 3 | United States;Australia;Bulgaria;China;France;Georgia;Germany;Greece;Hungary;India;Israel;Italy;Japan;Poland;Romania;Russian Federation;Serbia;Spain;Turkey;Ukraine;United Kingdom |
| 11 | EUCTR2020-002917-16-BG (EUCTR) | 30/11/2020 | 03/11/2020 | 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+) - 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 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 | 180 | Phase 3 | Serbia;Portugal;United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Croatia;Romania;Australia;Georgia;Bulgaria;Netherlands;Germany;China;Japan | ||
| 12 | EUCTR2020-002915-23-BG (EUCTR) | 24/11/2020 | 24/09/2020 | 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 Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Japan | ||
| 13 | 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 | ||
| 14 | EUCTR2020-002915-23-HU (EUCTR) | 16/11/2020 | 21/09/2020 | 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 Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Serbia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Georgia;Bulgaria;Germany;Japan |
63. 特発性血小板減少性紫斑病
臨床試験数 : 391 / 薬物数 : 235 - (DrugBank : 50) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 139
| 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 | EUCTR2020-004032-21-DK (EUCTR) | 11/01/2022 | 16/04/2021 | A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia. | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Australia;Denmark;Peru;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 2 | NCT04812925 (ClinicalTrials.gov) | November 17, 2021 | 15/3/2021 | A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | Primary Immune Thrombocytopenia | Biological: efgartigimod PH20 SC | argenx | NULL | Recruiting | 18 Years | N/A | All | 156 | Phase 3 | United States;Argentina;Australia;Bulgaria;Chile;China;Georgia;Greece;Ireland;Italy;Japan;Jordan;Korea, Republic of;Mexico;New Zealand;Poland;Portugal;Romania;Russian Federation;South Africa;Thailand;Tunisia;Turkey;United Kingdom |
| 3 | EUCTR2020-004033-20-RO (EUCTR) | 06/10/2021 | 20/04/2022 | Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Australia;Peru;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Bulgaria;Georgia;Norway;Germany;New Zealand;Japan | ||
| 4 | EUCTR2020-004033-20-NO (EUCTR) | 08/09/2021 | 20/04/2021 | Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 5 | EUCTR2020-004033-20-GR (EUCTR) | 07/09/2021 | 19/07/2021 | Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 6 | EUCTR2020-004033-20-PT (EUCTR) | 03/09/2021 | 20/05/2021 | Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 7 | EUCTR2020-004033-20-BG (EUCTR) | 03/09/2021 | 26/05/2021 | Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 8 | EUCTR2020-004033-20-ES (EUCTR) | 13/08/2021 | 09/06/2021 | Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 9 | EUCTR2020-004033-20-IT (EUCTR) | 23/07/2021 | 17/08/2021 | Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC Product Code: [ARGX-113] INN or Proposed INN: efgartigimod alfa | ARGENX BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 10 | EUCTR2020-004032-21-PT (EUCTR) | 19/07/2021 | 11/03/2021 | A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia. | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 219 | Phase 3 | Thailand;Serbia;Portugal;United States;Taiwan;Greece;Spain;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Jordan;Denmark;Peru;Australia;South Africa;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 11 | EUCTR2020-004032-21-NO (EUCTR) | 25/06/2021 | 18/03/2021 | A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia. | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Serbia;Portugal;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;France;Jordan;Denmark;Australia;Peru;South Africa;Tunisia;Latvia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 12 | EUCTR2020-004032-21-RO (EUCTR) | 23/06/2021 | 25/05/2022 | A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia. | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Serbia;Portugal;United States;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Jordan;Denmark;Peru;Australia;South Africa;Tunisia;Latvia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 13 | EUCTR2020-004032-21-DE (EUCTR) | 15/06/2021 | 12/03/2021 | A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia. | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 14 | EUCTR2020-004032-21-IT (EUCTR) | 04/06/2021 | 08/06/2021 | A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH20 Subcutaneous in adult patients with primary immune thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC | Primary immune thrombocytopenia (ITP) MedDRA version: 22.1;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC Product Code: [ARGX-113] INN or Proposed INN: efgartigimod alfa | ARGENX BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 15 | EUCTR2020-004032-21-BG (EUCTR) | 17/05/2021 | 15/03/2021 | A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia. | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Australia;Peru;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 16 | EUCTR2020-004032-21-IE (EUCTR) | 07/05/2021 | 17/02/2021 | A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia. | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Australia;Peru;Denmark;South Africa;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Bulgaria;Georgia;Norway;Germany;New Zealand;Japan | ||
| 17 | NCT04687072 (ClinicalTrials.gov) | December 11, 2020 | 18/12/2020 | A Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | Primary Immune Thrombocytopenia | Biological: Efgartigimod PH20 SC;Other: Placebo PH20 SC | argenx | NULL | Recruiting | 18 Years | N/A | All | 219 | Phase 3 | United States;Argentina;Australia;Bulgaria;Chile;China;Denmark;France;Georgia;Germany;Greece;Ireland;Israel;Italy;Japan;Jordan;Korea, Republic of;Mexico;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;South Africa;Spain;Taiwan;Thailand;Tunisia;Turkey;United Kingdom |
| 18 | EUCTR2020-004032-21-GR (EUCTR) | 19/04/2021 | A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia. | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Australia;Peru;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Bulgaria;Georgia;Norway;Germany;New Zealand;Japan |
162. 類天疱瘡（後天性表皮水疱症を含む。）
臨床試験数 : 90 / 薬物数 : 122 - (DrugBank : 47) / 標的遺伝子数 : 34 - 標的パスウェイ数 : 144
| 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 | NCT05267600 (ClinicalTrials.gov) | June 9, 2022 | 14/2/2022 | A Phase 2/3 Study of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid (BALLAD) | A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid | Bullous Pemphigoid | Biological: efgartigimod PH20 SC;Other: placebo;Drug: Prednisone | argenx | NULL | Recruiting | 18 Years | N/A | All | 160 | Phase 2/Phase 3 | United States;Australia;Bulgaria;Croatia;France;Germany;Greece;Hungary;Israel;Italy;Latvia;Netherlands;Poland;Serbia;Spain;United Kingdom |
| 2 | EUCTR2021-003087-27-BG (EUCTR) | 19/05/2022 | 07/03/2022 | A study to assess the efficacy and safety of a subcutaneous formulation of efgartigimod PH20 in adults with bullous pemphigoid. | A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid - A phase 2/3 study of efgartigimod PH20 SC in adult participants with bullous pemphigoid | Bullous Pemphigoid MedDRA version: 21.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2;Phase 3 | Serbia;United States;Czechia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Poland;Croatia;Romania;Australia;Bulgaria;Germany;Latvia;Netherlands;China;Japan | ||
| 3 | EUCTR2021-003087-27-HR (EUCTR) | 29/04/2022 | 16/05/2022 | A study to assess the efficacy and safety of a subcutaneous formulation of efgartigimod PH20 in adults with bullous pemphigoid. | A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid - A phase 2/3 study of efgartigimod PH20 SC in adult participants with bullous pemphigoid | Bullous Pemphigoid MedDRA version: 21.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2;Phase 3 | Germany;China;Japan;Australia;Bulgaria;Serbia;United States;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Poland;Croatia | ||
| 4 | EUCTR2021-003087-27-ES (EUCTR) | 13/04/2022 | 24/02/2022 | A study to assess the efficacy and safety of a subcutaneous formulation of efgartigimod PH20 in adults with bullous pemphigoid. | A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid - A phase 2/3 study of efgartigimod PH20 SC in adult participants with bullous pemphigoid | Bullous Pemphigoid MedDRA version: 21.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2;Phase 3 | United States;Serbia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Poland;Croatia;Australia;Bulgaria;Germany;China;Japan | ||
| 5 | EUCTR2021-003087-27-HU (EUCTR) | 29/03/2022 | 09/02/2022 | A study to assess the efficacy and safety of a subcutaneous formulation of efgartigimod PH20 in adults with bullous pemphigoid. | A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid - A phase 2/3 study of efgartigimod PH20 SC in adult participants with bullous pemphigoid | Bullous Pemphigoid MedDRA version: 21.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2;Phase 3 | United States;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Croatia;Australia;Bulgaria;Germany;China;Japan |