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	EUCTR2020-001398-59-HR (EUCTR)	02/12/2020	07/12/2020	Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s)	Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s)	Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: OSE-127 Product Code: OSE-127 INN or Proposed INN: AS INN Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127	OSE Immunotherapeutics	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia

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

EUCTR2020-001398-59-HR
(EUCTR)

02/12/2020

07/12/2020

Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s)

Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s)

Moderate to severe Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: OSE-127
Product Code: OSE-127
INN or Proposed INN: AS INN
Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127

OSE Immunotherapeutics

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia