50. 皮膚筋炎/多発性筋炎 Dermatomyositis Clinical trials / Disease details


臨床試験数 : 194 薬物数 : 244 - (DrugBank : 89) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 151

  
6 trials found
No.TrialIDDate_
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1JPRN-jRCT2031210681
16/03/202218/03/2022Ravulizumab versus Placebo in Adult Participants with DermatomyositisA Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Dermatomyositis DermatomyositisEligible participants will be enrolled into the study and will be randomized in a 2:1 ratio (Part A) or a 1:1 ratio (Part B) to receive intravenous (IV) ravulizumab or placebo.
The study intervention dose for each participant will be based on body weight. The dosing regimen for both Parts A and B consists of a loading dose followed by maintenance doses administered every 8 weeks (q8w). The maintenance dosing will be initiated 2 weeks after the loading dose is administered.
The Randomized Controlled Period for Part A will be 26 weeks in duration. The Randomized Controlled Period for Part B will be 50 weeks in duration. Participants will receive ravulizumab during the OLE Period until ravulizumab is registered or approved (in accordance with country-specific regulations) or for up to 74 weeks (approximately 1.5 years), whichever occurs first. The total study treatment duration for Part A will be approximately 2 years and for Part B approximately 2.5 years.
Ishida HirokazuNULLRecruiting>= 18age oldNot applicableBoth180Phase 2-3USA;Italy;France;Germany;UK;Japan
2NCT04999020
(ClinicalTrials.gov)
December 2, 20214/8/2021Ravulizumab Versus Placebo in Adult Participants With DermatomyositisA Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With DermatomyositisDermatomyositisDrug: Ravulizumab;Drug: PlaceboAlexion PharmaceuticalsNULLRecruiting18 YearsN/AAll150Phase 2/Phase 3United States;France;Germany;Italy;Japan;Korea, Republic of;Spain;United Kingdom
3EUCTR2021-001200-15-DE
(EUCTR)
05/10/202115/06/2021Ravulizumab versus Placebo in Adult Participants with Dermatomyositis.A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Dermatomyositis. - Ravulizumab versus Placebo in Adult Participants with Dermatomyositis. Dermatomyositis
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Other descriptive name: ALXN1210
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Other descriptive name: ALXN1210
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2;Phase 3France;United States;Spain;Germany;United Kingdom;Italy;Japan;Korea, Republic of
4EUCTR2021-001200-15-ES
(EUCTR)
27/09/202116/09/2021Ravulizumab versus Placebo in Adult Participants with Dermatomyositis.A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Dermatomyositis. - Ravulizumab versus Placebo in Adult Participants with Dermatomyositis. Dermatomyositis
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Other descriptive name: ALXN1210
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Other descriptive name: ALXN1210
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2;Phase 3France;United States;Spain;Germany;United Kingdom;Italy;Japan;Korea, Republic of
5EUCTR2021-001200-15-IT
(EUCTR)
16/08/202118/10/2021Ravulizumab versus Placebo in Adult Participants with Dermatomyositis.A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Dermatomyositis. - Ravulizumab versus Placebo in Adult Participants with Dermatomyositis. Dermatomyositis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: [ALXN1210]
INN or Proposed INN: RAVULIZUMAB
Other descriptive name: ALXN1210
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: [ALXN1210]
INN or Proposed INN: RAVULIZUMAB
Other descriptive name: ALXN1210
Trade Name: Nimenrix
Product Name: Nimenrix
Product Code: [NA]
INN or Proposed INN: tetanus protein
Other descriptive name: tetanus protein
INN or Proposed INN: NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED WITH TETANUS TOXOID CARRIER PROTEIN
Other descriptive name: NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED WITH TETANUS TOXOID CARRIER PROTEIN
INN or Proposed INN: NEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
Other descriptive name: NEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETA
ALEXION PHARMACEUTICALS INCORPORATEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2;Phase 3France;United States;Spain;Germany;United Kingdom;Japan;Italy;Korea, Republic of
6EUCTR2021-001200-15-FR
(EUCTR)
10/08/202128/06/2021Ravulizumab versus Placebo in Adult Participants with Dermatomyositis.A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Dermatomyositis. - Ravulizumab versus Placebo in Adult Participants with Dermatomyositis. Dermatomyositis
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Other descriptive name: ALXN1210
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Other descriptive name: ALXN1210
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2;Phase 3United States;France;Spain;Germany;United Kingdom;Italy;Japan;Korea, Republic of