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
53	シェーグレン症候群	2

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	NCT03239600 (ClinicalTrials.gov)	September 19, 2017	19/6/2017	A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Proof of Mechanism of GSK2618960 in Primary Sjögren's Syndrome (pSS)	A Two Part Phase IIa Study, to Evaluate the Safety and Tolerability, Pharmacokinetics, Proof of Mechanism and Potential for Efficacy of an Anti-IL-7 Receptor-a Monoclonal Antibody (GSK2618960) in the Treatment of Primary Sjögren's Syndrome	Autoimmune Diseases	Drug: GSK2618960 2 mg/kg;Drug: Placebo;Drug: Methotrexate	GlaxoSmithKline	NULL	Withdrawn	18 Years	70 Years	All	0	Phase 2	United Kingdom
2	EUCTR2016-004258-14-GB (EUCTR)	21/02/2017	21/12/2016	A two part Phase IIa Study, to Evaluate the Safety and Tolerability, Pharmacokinetics, Proof of Mechanism and Potential for Efficacy of an Anti-IL-7 Receptor-a Monoclonal Antibody (GSK2618960) in the Treatment of Primary Sjögren’s Syndrome.	A two part Phase IIa Study, to Evaluate the Safety and Tolerability, Pharmacokinetics, Proof of Mechanism and Potential for Efficacy of an Anti-IL-7 Receptor-a Monoclonal Antibody (GSK2618960) in the Treatment of Primary Sjögren’s Syndrome. - GSK2618960, PH2a, 2-part, repeat IV dose, Immunogenecity, Safety and PK/PD Study in pSS pts	Primary Sjögren’s Syndrome MedDRA version: 19.0;Level: LLT;Classification code 10021295;Term: IL-7 therapy;System Organ Class: 100000004865 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	22	Phase 2	United Kingdom

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

NCT03239600
(ClinicalTrials.gov)

September 19, 2017

19/6/2017

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Proof of Mechanism of GSK2618960 in Primary Sjögren's Syndrome (pSS)

A Two Part Phase IIa Study, to Evaluate the Safety and Tolerability, Pharmacokinetics, Proof of Mechanism and Potential for Efficacy of an Anti-IL-7 Receptor-a Monoclonal Antibody (GSK2618960) in the Treatment of Primary Sjögren's Syndrome

Autoimmune Diseases

Drug: GSK2618960 2 mg/kg;Drug: Placebo;Drug: Methotrexate

GlaxoSmithKline

NULL

Withdrawn

18 Years

70 Years

All

Phase 2

United Kingdom

EUCTR2016-004258-14-GB
(EUCTR)

21/02/2017

21/12/2016

A two part Phase IIa Study, to Evaluate the Safety and Tolerability, Pharmacokinetics, Proof of Mechanism and Potential for Efficacy of an Anti-IL-7 Receptor-a Monoclonal Antibody (GSK2618960) in the Treatment of Primary Sjögren’s Syndrome.

Primary Sjögren’s Syndrome
MedDRA version: 19.0;Level: LLT;Classification code 10021295;Term: IL-7 therapy;System Organ Class: 100000004865 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United Kingdom