DDrare: Database of Drug Development for Rare 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

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT01972568 (ClinicalTrials.gov)	December 2013	24/10/2013	Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus	A 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, Systemic	Drug: Atacicept 75 milligram (mg);Drug: Atacicept 150 mg;Drug: Placebo	EMD Serono	NULL	Completed	18 Years	N/A	All	306	Phase 2	United 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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT01972568
(ClinicalTrials.gov)

December 2013

24/10/2013

Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus

A 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, Systemic

Drug: Atacicept 75 milligram (mg);Drug: Atacicept 150 mg;Drug: Placebo

EMD Serono

NULL

Completed

18 Years

N/A

All

306

Phase 2

United 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