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
97	潰瘍性大腸炎	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	EUCTR2016-000509-35-BG (EUCTR)	27/10/2016	03/08/2016	Drug OPRX-106 in Patients with Ulcerative Colitis	An Open Label, Proof of Concept Study to Assess the Safety, PK and Explore Efficacy of OPRX-106 in Patients with Active Mild to Moderate Ulcerative Colitis	Active mild to moderate ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: OPRX-106 (plant cells expressing TNFR-Fc) 8mg Product Code: OPRX-106 Product Name: OPRX-106 (plant cells expressing TNFR-Fc) 2mg Product Code: OPRX-106	Protalix Biotherapeutics Ltd.	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	Serbia;Israel;Bulgaria

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

EUCTR2016-000509-35-BG
(EUCTR)

27/10/2016

03/08/2016

Drug OPRX-106 in Patients with Ulcerative Colitis

An Open Label, Proof of Concept Study to Assess the Safety, PK and Explore Efficacy of OPRX-106 in Patients with Active Mild to Moderate Ulcerative Colitis

Active mild to moderate ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: OPRX-106 (plant cells expressing TNFR-Fc) 8mg
Product Code: OPRX-106
Product Name: OPRX-106 (plant cells expressing TNFR-Fc) 2mg
Product Code: OPRX-106

Protalix Biotherapeutics Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;Israel;Bulgaria