Daratumumab ( DrugBank: Daratumumab )

5 diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
13	多発性硬化症／視神経脊髄炎	1
28	全身性アミロイドーシス	30
48	原発性抗リン脂質抗体症候群	1
49	全身性エリテマトーデス	2
63	特発性血小板減少性紫斑病	3

13. 多発性硬化症／視神経脊髄炎

臨床試験数 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238

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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	NCT05403138 (ClinicalTrials.gov)	November 1, 2022	30/5/2022	Safety and Efficacy of Daratumumabin Patients With Anti-Aquaporin 4 Antibody Positive Neuromyelitis ...	A Multi-center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Effica ...	Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder;NMO Spectrum Disorder	Drug: Daratumumab;Drug: Placebo	Tianjin Medical University General Hospital	NULL	Recruiting	18 Years	N/A	All	72	Phase 2/Phase 3	China

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28. 全身性アミロイドーシス

臨床試験数 : 267 / 薬物数 : 241 - (DrugBank : 77) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 180

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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	NCT05486481 (ClinicalTrials.gov)	April 1, 2023	1/8/2022	Venetoclax, Daratumumab, and Dexamethasone for Systemic Light-Chain Amyloidosis With Translocation ( ...	A Multicenter Phase 1/2 Study of Venetoclax / Daratumumab/ Dexamethasone for Previously Treated Syst ...	AL Amyloidosis;Light Chain (AL) Amyloidosis;Systemic Light Chain Disease	Drug: Venetoclax;Drug: Dexamethasone;Drug: Daratumumab	Sandy Wong, MD	Janssen Pharmaceuticals;AbbVie	Not yet recruiting	18 Years	N/A	All	78	Phase 1/Phase 2	United States
2	NCT05451771 (ClinicalTrials.gov)	October 26, 2022	6/7/2022	Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis	An Open-label Phase I/II Trial of Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Sy ...	AL Amyloidosis	Drug: Venetoclax Oral Tablet, 200 mg;Device: FISH assay;Drug: Venetoclax Oral Tablet, 400 mg;Drug: D ...	Rajshekhar Chakraborty, MD	Genentech, Inc.	Recruiting	18 Years	N/A	All	53	Phase 1/Phase 2	United States
3	EUCTR2021-002639-48-DE (EUCTR)	25/07/2022	15/12/2021	A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain ...	A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain ...	Amyloid Light Chain Amyloidosis MedDRA version: 23.0;Level: LLT;Classification code 10083938;Term: A ...	Trade Name: DAZARLEX Product Name: Daratumumabco-formulated with recombinant human hyaluronidase (rHu ...	Janssen-Cilag International N.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	France;United States;Greece;Canada;Spain;Netherlands;Germany;United Kingdom;Italy
4	EUCTR2021-002639-48-NL (EUCTR)	10/06/2022	09/02/2022	A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain ...	A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain ...	Amyloid Light Chain Amyloidosis MedDRA version: 23.0;Level: LLT;Classification code 10083938;Term: A ...	Trade Name: DAZARLEX Product Name: Daratumumabco-formulated with recombinant human hyaluronidase (rHu ...	Janssen-Cilag International N.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	United States;France;Greece;Canada;Spain;Germany;Netherlands;United Kingdom;Italy
5	EUCTR2021-002639-48-ES (EUCTR)	08/03/2022	28/12/2021	A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain ...	A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain ...	Amyloid Light Chain Amyloidosis MedDRA version: 23.0;Level: LLT;Classification code 10083938;Term: A ...	Trade Name: DAZARLEX Product Name: Daratumumabco-formulated with recombinant human hyaluronidase (rHu ...	Janssen-Cilag International N.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	France;United States;Greece;Canada;Spain;Netherlands;Germany;United Kingdom;Italy
6	NCT04270175 (ClinicalTrials.gov)	April 14, 2021	12/2/2020	Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Pa ...	Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Pa ...	Amyloid;AL Amyloidosis;Refractory AL Amyloidosis	Drug: Daratumumab;Drug: Pomalidomide;Drug: Dexamethasone	Weill Medical College of Cornell University	Janssen Scientific Affairs, LLC	Recruiting	18 Years	N/A	All	21	Phase 2	United States
7	EUCTR2019-001962-13-IT (EUCTR)	13/01/2021	21/10/2020	Daratumumab and Pomalidomide in previously treated patients with AL amyloidosis	A multi-center open label phase II study of daratumumaband pomalidomide in previously treated patien ...	AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System ...	Trade Name: Imnovid Product Name: Pomalidomide Product Code: [Pomalidomide] INN or Proposed INN: pomali ...	FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 2	Italy
8	NCT04304144 (ClinicalTrials.gov)	March 18, 2020	28/2/2020	A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis	CAEL101-203: A Phase 2, Open-label, Multicenter Dose Selection Study to Evaluate the Safety and Tole ...	AL Amyloidosis	Drug: CAEL-101;Drug: SoC: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD);Drug: Daratumumab ...	Alexion Pharmaceuticals	NULL	Active, not recruiting	18 Years	N/A	All	25	Phase 2	United States
9	EUCTR2018-004333-33-FR (EUCTR)	23/01/2020	02/12/2019	Phase 2 study of daratumumabmonotherapy in previously untreated patients with stage 3B light chain ( ...	Phase 2 study of daratumumabmonotherapy in previously untreated patients with stage 3B light chain ( ...	Patients with newly diagnosed stage 3B AL amyloidosis MedDRA version: 20.0;Level: PT;Classification ...	Trade Name: Velcade Product Name: Bortezomib Product Code: 26866138 INN or Proposed INN: BORTEZOMIB Prod ...	European Myeloma Network	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 2	France;Greece;Netherlands;Italy
10	EUCTR2018-004333-33-IT (EUCTR)	01/08/2019	28/04/2020	Phase 2 study of daratumumabmonotherapy in previously untreated patients with stage 3B light chain ( ...	Phase 2 study of daratumumabmonotherapy in previously untreated patients with stage 3B light chain ( ...	Patients with newly diagnosed stage 3B AL amyloidosis MedDRA version: 20.0;Level: PT;Classification ...	Trade Name: Darzalex Product Name: Daratumumab Product Code: JNJ-54767414 INN or Proposed INN: DARATUMU ...	European Myeloma Network	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 2	France;Greece;Netherlands;Italy

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48. 原発性抗リン脂質抗体症候群

臨床試験数 : 5 / 薬物数 : 6 - (DrugBank : 4) / 標的遺伝子数 : 1 - 標的パスウェイ数 : 7

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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	NCT05671757 (ClinicalTrials.gov)	March 12, 2023	20/12/2022	Daratumumab in Primary Antiphospholipid Syndrome	Targeting CD38 With Daratumumabin Primary Antiphospholipid Syndrome: A Phase 1b Dose Escalation Safe ...	Autoimmune Disorders	Biological: Daratumumab	National Institute of Allergy and Infectious Diseases (NIAID)	Immune Tolerance Network (ITN);PPD;Rho Federal Systems Division, Inc.	Not yet recruiting	18 Years	65 Years	All	22	Phase 1/Phase 2	United States

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49. 全身性エリテマトーデス

臨床試験数 : 993 / 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200

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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	EUCTR2021-000962-14-DE (EUCTR)	02/07/2021	19/04/2021	A drug trial to evaluate the safety and efficacy of daratumumab, an agent already approved for other ...	A Monocenter, Open Label Study to Evaluate the Safety and Efficacy of Daratumumabin Combination with ...	Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Syste ...	Trade Name: Darzalex Product Name: Daratumumab Product Code: JNJ-54767414	Charité - Universitätsmedizin Berlin	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	10	Phase 2	Germany
2	NCT04810754 (ClinicalTrials.gov)	June 30, 2021	11/3/2021	An Open Label Study to Evaluate Daratumumabin Participants With Moderate to Severe Systemic Lupus Er ...	A Monocenter, Open Label Study to Evaluate the Safety and Efficacy of Daratumumabin Combination With ...	Systemic Lupus Erythematosus	Drug: Daratumumab Injection	Charite University, Berlin, Germany	Janssen-Cilag G.m.b.H;Labor Berlin-Charité Vivantes G.m.b.H;Deutsches Rheuma-Forschungszentrum Berli ...	Not yet recruiting	18 Years	60 Years	All	10	Phase 2	NULL

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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

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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	NCT05562882 (ClinicalTrials.gov)	October 15, 2022	28/9/2022	A Clinical Trial to Assess Safety and Efficacy of Daratumumabin the Treatment of Primary Immune Thro ...	A Investigator-initiated Clinical Trial to Assess Safety and Efficacy of Daratumumabin the Treatment ...	Immune Thrombocytopenia	Drug: Daratumumab Injection	Institute of Hematology & Blood Diseases Hospital	NULL	Not yet recruiting	18 Years	N/A	All	20	Early Phase 1	NULL
2	EUCTR2019-004683-22-DK (EUCTR)	12/07/2022	17/05/2022	Daratumumab as a treatment for adult immune thrombocytopenia	Daratumumab as a treatment for adult immune thrombocytopenia - The DART-study	Immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10021245;Term: Idiopathi ...	Trade Name: Darzalex Product Name: Daratumumab Product Code: L01FC01 INN or Proposed INN: DARATUMUMAB Ot ...	Ostfold Hospital Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	21	Phase 2	Denmark;Norway
3	EUCTR2019-004683-22-NO (EUCTR)	16/10/2020	29/04/2020	Daratumumab as a treatment for adult immune thrombocytopenia	Daratumumab as a treatment for adult immune thrombocytopenia - The DART-study	Immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10021245;Term: Idiopathi ...	Product Name: daratumumab INN or Proposed INN: DARATUMUMAB Other descriptive name: HUMAX-CD38	Ostfold Hospital Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Phase 2	Norway

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