14. 慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー Chronic inflammatory demyelinating polyneuropathy Clinical trials / Disease details
臨床試験数 : 175 / 薬物数 : 161 - (DrugBank : 41) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 24
| 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 |