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
51	全身性強皮症	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	EUCTR2010-023047-15-DE (EUCTR)	15/03/2012	08/12/2011	A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung disease	A Phase 2 Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease	systemic sclerosis associated with interstitial lung disease MedDRA version: 16.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: Imnovid 1 mg hard capsules INN or Proposed INN: Pomalidomide	Celgene Corporation	NULL	Not Recruiting			Female: yes Male: yes	88	Phase 2	France;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden

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

EUCTR2010-023047-15-DE
(EUCTR)

15/03/2012

08/12/2011

A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung disease

A Phase 2 Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease

systemic sclerosis associated with interstitial lung disease
MedDRA version: 16.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trade Name: Imnovid 1 mg hard capsules
INN or Proposed INN: Pomalidomide

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden