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
50	皮膚筋炎／多発性筋炎	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	EUCTR2012-002859-42-BE (EUCTR)	16/10/2014	25/08/2014	Study of efficacy and tolerability for BAF312 compared to placebo in patients with polymyositis	A multi-centre, double-blind, placebo controlled, proof of concept study to evaluate the efficacy and tolerability of BAF312 in patients with polymyositis	Polymyositis MedDRA version: 18.0;Level: PT;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: BAF312 0.25 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimid Other descriptive name: BAF312 hemifumarate Product Name: BAF312 1 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: BAF312 2 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: BAF312 0,5 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	45	Phase 2	United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Belgium

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

EUCTR2012-002859-42-BE
(EUCTR)

16/10/2014

25/08/2014

Study of efficacy and tolerability for BAF312 compared to placebo in patients with polymyositis

A multi-centre, double-blind, placebo controlled, proof of concept study to evaluate the efficacy and tolerability of BAF312 in patients with polymyositis

Polymyositis
MedDRA version: 18.0;Level: PT;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: BAF312 0.25 mg tablet
Product Code: BAF312X
INN or Proposed INN: Siponimid
Other descriptive name: BAF312 hemifumarate
Product Name: BAF312 1 mg tablet
Product Code: BAF312X
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Product Name: BAF312 2 mg tablet
Product Code: BAF312X
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Product Name: BAF312 0,5 mg tablet
Product Code: BAF312X
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Belgium