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	NCT04643067 (ClinicalTrials.gov)	December 1, 2020	12/11/2020	A Study to Assess the Safety and Tolerability, PK and Efficacy of KPG-818 in Mild to Moderate SLE Patients	A Phase 1b/2a Multicenter, Randomized, Double-Blind, Placebo- Controlled Study to Assess the Safety and Tolerability, Pharmacokinetics and Preliminary Efficacy of KPG-818 in Patients With Mild to Moderate Systemic Lupus Erythematosus	SLE; Drug	Drug: 0.15mg KPG-818 dose;Drug: 0.6mg KPG-818 dose;Drug: 2mg KPG-818 dose;Drug: Placebo	Kangpu Biopharmaceuticals, Ltd.	NULL	Not yet recruiting	18 Years	N/A	All	64	Phase 1;Phase 2	NULL

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

NCT04643067
(ClinicalTrials.gov)

December 1, 2020

12/11/2020

A Study to Assess the Safety and Tolerability, PK and Efficacy of KPG-818 in Mild to Moderate SLE Patients

A Phase 1b/2a Multicenter, Randomized, Double-Blind, Placebo- Controlled Study to Assess the Safety and Tolerability, Pharmacokinetics and Preliminary Efficacy of KPG-818 in Patients With Mild to Moderate Systemic Lupus Erythematosus

SLE; Drug

Drug: 0.15mg KPG-818 dose;Drug: 0.6mg KPG-818 dose;Drug: 2mg KPG-818 dose;Drug: Placebo

Kangpu Biopharmaceuticals, Ltd.

NULL

Not yet recruiting

18 Years

N/A

All

Phase 1;Phase 2

NULL