Atacicept 150 mg ( DrugBank: Atacicept )


2 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
49全身性エリテマトーデス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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00853762
(ClinicalTrials.gov)
March 200926/2/2009Atacicept in Multiple Sclerosis Extension Study, Phase IIAn Open-label, Multicenter Phase II Extension of Study 28063 (ATAMS) to Obtain Long-term Follow-up Data in Subjects With Relapsing Multiple Sclerosis Treated With Atacicept for up to 5 Years (ATAMS-Extension)Relapsing Multiple SclerosisDrug: Atacicept 25 mg;Drug: Atacicept 75 mg;Drug: Atacicept 150 mgEMD SeronoMerck KGaATerminated18 Years60 YearsAll74Phase 2United States;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom

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
1NCT02070978
(ClinicalTrials.gov)
July 29, 201421/2/2014Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed Protocol EMR-700461-023 (ADDRESS II)Lupus Erythematosus, SystemicDrug: Atacicept 75 mg;Drug: Atacicept 150 mgEMD SeronoNULLTerminated18 YearsN/AAll253Phase 2United States;Argentina;Brazil;Bulgaria;Chile;Czechia;Germany;Italy;Korea, Republic of;Mexico;Peru;Philippines;Poland;Russian Federation;South Africa;Spain;United Kingdom
2NCT01972568
(ClinicalTrials.gov)
December 201324/10/2013Efficacy and Safety of Atacicept in Systemic Lupus ErythematosusA Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)Lupus Erythematosus, SystemicDrug: Atacicept 75 milligram (mg);Drug: Atacicept 150 mg;Drug: PlaceboEMD SeronoNULLCompleted18 YearsN/AAll306Phase 2United States;Argentina;Brazil;Bulgaria;Chile;Czechia;Germany;Italy;Japan;Korea, Republic of;Mexico;Peru;Philippines;Poland;Russian Federation;South Africa;Spain;United Kingdom;Czech Republic;Ukraine
3NCT00624338
(ClinicalTrials.gov)
January 200815/2/2008Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)A Randomised, Double-blind, Placebo Controlled, Multicentre Prospective Dose-finding Phase II/III Study With Atacicept Given Subcutaneously to Subjects Having Recently Experienced a Flare of Systemic Lupus Erythematosus (SLE)Lupus Erythematosus, SystemicDrug: Atacicept 75 mg;Drug: Atacicept 150 mg;Other: Placebo ComparatorEMD SeronoMerck KGaACompleted16 YearsN/AAll461Phase 2/Phase 3United States;Argentina;Australia;Austria;Bulgaria;Croatia;Czech Republic;France;Germany;Greece;India;Israel;Korea, Republic of;Latvia;Lebanon;Lithuania;Malaysia;Mexico;Netherlands;Philippines;Poland;Russian Federation;Serbia;South Africa;Spain;Switzerland;Taiwan;Ukraine;United Kingdom