M5049 high dose ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
49全身性エリテマトーデス1
50皮膚筋炎/多発性筋炎1

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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05540327
(ClinicalTrials.gov)
September 16, 202212/9/2022The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)A Phase II, Double-blind, Dose-Ranging, Parallel, Long-term Extension Study to Evaluate the Safety and Efficacy of Enpatoran in Participants With Subacute Cutaneous Lupus Erythematosus, Discoid Lupus Erythematosus and/or Systemic Lupus Erythematosus Having Completed the WILLOW (MS200569_0003) Study Treatment (WILLOW LTE)Systemic Lupus ErythematosusDrug: M5049 low dose;Drug: M5049 medium dose;Drug: M5049 high dose;Drug: PlaceboMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyNULLRecruiting18 Years76 YearsAll440Phase 2United States;Bulgaria;Japan;Moldova, Republic of;Poland;Argentina;Australia;Brazil;Chile;China;Colombia;Greece;Israel;Korea, Republic of;Mauritius;Mexico;Philippines;Serbia;South Africa;Spain;Taiwan

50. 皮膚筋炎/多発性筋炎


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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05650567
(ClinicalTrials.gov)
January 19, 20236/12/2022Study of M5049 in DM and PM Participants (NEPTUNIA)A Phase IIa, Randomized, Parallel, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Enpatoran in Dermatomyositis and Polymyositis Participants Receiving Standard of Care (NEPTUNIA)Dermatomyositis;PolymyositisDrug: M5049 high dose;Drug: PlaceboEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyRecruiting18 Years75 YearsAll40Phase 2United States;Germany