MOR202 ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
66IgA腎症6
222一次性ネフローゼ症候群11

66. IgA腎症


臨床試験数 : 275 薬物数 : 258 - (DrugBank : 82) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 140
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05065970
(ClinicalTrials.gov)
August 31, 202114/9/2021Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA NephropathyA Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA NephropathyImmunoglobulin A (IgA) NephropathyDrug: Felzartamab;Other: PlaceboMorphoSys AGNULLRecruiting18 Years80 YearsAll48Phase 2United States;Australia;Belgium;Bulgaria;Czechia;Georgia;Germany;Japan;Korea, Republic of;Malaysia;Philippines;Serbia;Spain;Taiwan;Ukraine;United Kingdom
2EUCTR2020-005054-19-DE
(EUCTR)
16/08/202101/04/2021A clinical study to assess efficacy and safety of the human Anti-CD38 Antibody Felzartamab in IgA NephropathyA Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ IgA Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Felzartamab
Product Code: MOR202
INN or Proposed INN: Felzartamab
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 2Serbia;United States;Czechia;Philippines;Taiwan;Spain;Ukraine;United Kingdom;Czech Republic;Canada;Malaysia;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Korea, Republic of
3EUCTR2020-005054-19-CZ
(EUCTR)
28/07/202109/03/2021A clinical study to assess efficacy and safety of the human Anti-CD38 Antibody Felzartamab in IgA NephropathyA Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ IgA Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Felzartamab
Product Code: MOR202
INN or Proposed INN: Felzartamab
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 2Serbia;United States;Czechia;Philippines;Taiwan;Spain;Ukraine;United Kingdom;Czech Republic;Canada;Malaysia;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Korea, Republic of
4EUCTR2020-005054-19-ES
(EUCTR)
08/07/202109/07/2021A clinical study to assess efficacy and safety of the human Anti-CD38 Antibody Felzartamab in IgA NephropathyA Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ IgA Nephropathy (IgAN)
MedDRA version: 23.1;Level: PT;Classification code 10084204;Term: Sickle cell nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Felzartamab
Product Code: MOR202
INN or Proposed INN: Felzartamab
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
44Phase 2Serbia;United States;Czechia;Philippines;Taiwan;Spain;Ukraine;United Kingdom;Canada;Malaysia;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Korea, Republic of
5EUCTR2020-005054-19-BG
(EUCTR)
30/06/202118/03/2021A clinical study to assess efficacy and safety of the human Anti-CD38 Antibody Felzartamab in IgA NephropathyA Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ IgA Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Felzartamab
Product Code: MOR202
INN or Proposed INN: Felzartamab
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 2Serbia;United States;Czechia;Philippines;Taiwan;Spain;Ukraine;United Kingdom;Czech Republic;Canada;Malaysia;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Korea, Republic of
6EUCTR2020-005054-19-BE
(EUCTR)
30/06/202107/05/2021A clinical study to assess efficacy and safety of the human Anti-CD38 Antibody Felzartamab in IgA NephropathyA Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ IgA Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Felzartamab
Product Code: MOR202
INN or Proposed INN: Felzartamab
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 2United States;Serbia;Philippines;Czechia;Taiwan;Spain;Ukraine;United Kingdom;Czech Republic;Canada;Belgium;Malaysia;Australia;Georgia;Bulgaria;Germany;Japan;Korea, Republic of

222. 一次性ネフローゼ症候群


臨床試験数 : 310 薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04893096
(ClinicalTrials.gov)
October 22, 202111/5/2021Rescue Therapy With the Human Anti-CD38 Antibody MOR202 (Felzartamab) in Patients With Membranous Nephropathy Who Failed Anti-CD20 Target TherapyRescue Therapy With the Human Anti-CD38 Antibody MOR202 (Felzartamab) in Patients With Membranous Nephropathy Who Failed Anti-CD20 Target TherapyMembranous NephropathyDrug: MOR202Mario Negri Institute for Pharmacological ResearchMorphoSys AGActive, not recruiting18 YearsN/AAll10Phase 2Italy
2EUCTR2021-000835-30-IT
(EUCTR)
12/10/202130/08/2021MOR202 for refractory MNRESCUE THERAPY WITH THE HUMAN ANTI-CD38 ANTIBODY MOR202 (FELZARTAMAB) IN PATIENTS WITH MEMBRANOUS NEPHROPATHY WHO FAILED ANTI-CD20 TARGETED THERAPY: A PILOT, PROOF-OF-CONCEPT STUDY - MOR202 for refractory MN Membranous Nephropathy who Failed Anti-CD20 Target Therapy.
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: MOR202
Product Code: [MOR202]
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
10Phase 2Italy
3EUCTR2019-000780-24-PL
(EUCTR)
07/01/202114/09/2020Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous NephropathyA Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE Primary (anti-PLA2R antibody positive) Membranous Nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MOR202
Product Code: MOR202
INN or Proposed INN: felzartamab
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 1;Phase 2France;United States;European Union;Belgium;Spain;Poland;Australia;Netherlands;Italy;Korea, Republic of
4EUCTR2020-002985-15-DE
(EUCTR)
21/12/202031/08/2020Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN)A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) - NewPLACE Anti-PLA2R antibody positive membranous nephropathy (aMN)
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: MOR202
INN or Proposed INN: not yet assigned
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
22Phase 2France;Taiwan;Hong Kong;Greece;Russian Federation;Georgia;Germany;United Kingdom;Korea, Republic of
5EUCTR2020-002985-15-GR
(EUCTR)
22/10/202011/09/2020Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN)A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) - NewPLACE Anti-PLA2R antibody positive membranous nephropathy (aMN)
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: MOR202
INN or Proposed INN: not yet assigned
Other descriptive name: MOR03087
Human Immunology Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
22Phase 2Greece;Russian Federation;Georgia;Germany;United Kingdom;Korea, Republic of
6EUCTR2020-002985-15-GB
(EUCTR)
12/10/202025/08/2020Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN)A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) - NewPLACE Anti-PLA2R antibody positive membranous nephropathy (aMN)
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: MOR202
INN or Proposed INN: not yet assigned
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
22Phase 2Taiwan;Greece;Australia;Russian Federation;Georgia;Germany;United Kingdom;Korea, Republic of
7EUCTR2019-000780-24-ES
(EUCTR)
25/10/201926/07/2019Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous NephropathyA Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE Primary (anti-PLA2R antibody positive) Membranous Nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MOR202
Product Code: MOR202
INN or Proposed INN: No INN assigned yet
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 1;Phase 2France;United States;European Union;Spain;Netherlands
8NCT04145440
(ClinicalTrials.gov)
October 15, 201918/10/2019Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN)A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (aMN)Glomerulonephritis, Membranous;antiPLA2R PositiveDrug: MOR202MorphoSys AGNULLCompleted18 Years80 YearsAll31Phase 1/Phase 2United States;Australia;Belgium;France;Italy;Korea, Republic of;Netherlands;Poland;Spain
9EUCTR2019-000780-24-IT
(EUCTR)
08/10/201922/01/2020Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous NephropathyA Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE Primary (anti-PLA2R antibody positive) Membranous Nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MOR202
Product Code: MOR202
INN or Proposed INN: No INN assigned yet
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 1;Phase 2France;United States;European Union;Spain;Netherlands;Italy
10EUCTR2019-000780-24-NL
(EUCTR)
24/09/201903/07/2019Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous NephropathyA Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE - M-PLACE Primary (anti-PLA2R antibody positive) Membranous Nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MOR202
Product Code: MOR202
INN or Proposed INN: No INN assigned yet
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 1;Phase 2France;United States;European Union;Poland;Spain;Australia;Netherlands;Italy;Korea, Republic of
11EUCTR2019-000780-24-FR
(EUCTR)
23/09/201915/10/2019Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous NephropathyA Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE Primary (anti-PLA2R antibody positive) Membranous Nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MOR202
Product Code: MOR202
INN or Proposed INN: No INN assigned yet
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
30 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;France;European Union;Spain;Netherlands