ALXN1830 ( DrugBank: - )


3 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1
35天疱瘡1
61自己免疫性溶血性貧血6

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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04982289
(ClinicalTrials.gov)
January 1, 202221/6/2021Study of ALXN1830 Administered Subcutaneously in Adults With Generalized Myasthenia GravisA Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel Groups, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALXN1830 Administered Subcutaneously in Adult Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: ALXN1830;Other: PlaceboAlexion PharmaceuticalsNULLWithdrawn18 YearsN/AAll0Phase 2United States

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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03075904
(ClinicalTrials.gov)
July 18, 20176/3/2017A Safety and Dose-Finding Study of SYNT001 in Subjects With Pemphigus (Vulgaris or Foliaceus)A Phase 1B/2, Multicenter, Open-Label, Safety, and Dose-Finding Study of SYNT001 in Subjects With Pemphigus (Vulgaris or Foliaceus)Pemphigus;Pemphigus Vulgaris;Pemphigus FoliaceusDrug: ALXN1830Alexion PharmaceuticalsNULLTerminated18 YearsN/AAll8Phase 1/Phase 2United States

61. 自己免疫性溶血性貧血


臨床試験数 : 146 薬物数 : 131 - (DrugBank : 59) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 158
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04956276
(ClinicalTrials.gov)
January 1, 202230/6/2021Subcutaneous ALXN1830 in Adult Participants With Warm Autoimmune Hemolytic AnemiaA Phase 2, Multiple Ascending Dose, Randomized, Double-Blind, Placebo-Controlled Study of ALXN1830 Administered Subcutaneously in Patients With Warm Autoimmune Hemolytic Anemia (WAIHA)Warm Autoimmune Hemolytic AnemiaDrug: ALXN1830;Drug: PlaceboAlexion PharmaceuticalsNULLWithdrawn18 YearsN/AAll0Phase 2United States
2EUCTR2021-001211-90-IT
(EUCTR)
26/08/202122/10/2021ALXN1830 in Patients with Warm Autoimmune Hemolytic AnemiaA Phase 2, Multiple Ascending Dose, Randomized, Double-Blind, Placebo- Controlled Study of ALXN1830 Administered Subcutaneously in Patients with Warm Autoimmune Hemolytic Anemia (WAIHA) - N/A Warm Autoimmune Hemolytic Anemia (WAIHA)
MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ALXN1830
Product Code: [N/A]
INN or Proposed INN: ORILANOLIMAB
ALEXION PHARMACEUTICALS INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
36Phase 2France;United States;Spain;Germany;United Kingdom;Italy;Korea, Republic of
3EUCTR2021-001211-90-ES
(EUCTR)
11/08/202102/07/2021ALXN1830 in Patients with Warm Autoimmune Hemolytic AnemiaA Phase 2, Multiple Ascending Dose, Randomized, Double-Blind, Placebo-Controlled Study of ALXN1830 Administered Subcutaneously in Patients with Warm Autoimmune Hemolytic Anemia (WAIHA) Warm Autoimmune Hemolytic Anemia (WAIHA)
MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ALXN1830
INN or Proposed INN: ORILANOLIMAB
Other descriptive name: SYNT001
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
36Phase 2France;United States;Spain;Germany;United Kingdom;Italy;Korea, Republic of
4NCT04256148
(ClinicalTrials.gov)
July 202127/1/2020ALXN1830 in Patients With Warm Autoimmune Hemolytic AnemiaA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study of ALXN1830 in Patients With Warm Autoimmune Hemolytic AnemiaWarm Autoimmune Hemolytic AnemiaBiological: ALXN1830;Other: PlaceboAlexion PharmaceuticalsNULLWithdrawn18 YearsN/AAll0Phase 2United States
5EUCTR2019-004055-37-ES
(EUCTR)
06/05/202010/05/2020ALXN1830 in Patients with Warm Autoimmune Hemolytic AnemiaA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study of ALXN1830 in Patients with Warm Autoimmune Hemolytic Anemia WAIHA
MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: ALXN1830
INN or Proposed INN: ORILANOLIMAB
Other descriptive name: SYNT001
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
32Phase 2United States;Taiwan;Spain;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Korea, Republic of
6NCT03075878
(ClinicalTrials.gov)
January 10, 20183/3/2017A Safety Study of SYNT001 in Participants With Warm Autoimmune Hemolytic Anemia (WAIHA)A Phase 1B/2, Multicenter, Open-Label, Safety, Tolerability, and Activity Study of SYNT001 in Patients With Warm Autoimmune Hemolytic Anemia (WAIHA)Warm Autoimmune Hemolytic AnemiaDrug: ALXN1830Alexion PharmaceuticalsNULLTerminated18 YearsN/AAll8Phase 1/Phase 2United States;Jordan