DDrare: Database of Drug Development for Rare Diseases

Tildrakizumab 200 mg (two 1-ml injections of 100 mg/ml) (DrugBank: Tildrakizumab)

告示番号	疾患名（ページ内リンク）	臨床試験数
271	強直性脊椎炎	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	NCT03552276 (ClinicalTrials.gov)	July 11, 2018	4/5/2018	A Long Term Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects With Psoriatic Arthritis and Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis.	A Multiple-Dose, Long-Term Extension Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects With Psoriatic Arthritis and Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis Who Have Previously Completed Studies With Tildrakizumab.	Psoriatic Arthritis;Ankylosing Spondylitis;Non-Radiographic Axial Spondyloarthritis	Drug: tildrakizumab 200 mg (two 1-mL injections of 100 mg/mL);Drug: tildrakizumab 100 mg (one 1-mL injection of 100 mg/mL + 1 mL placebo)	Sun Pharma Global FZE	NULL	Active, not recruiting	18 Years	N/A	All	540	Phase 2;Phase 3	United States;Argentina;Hungary;Mexico;Poland;Russian Federation;Spain;Ukraine

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

NCT03552276
(ClinicalTrials.gov)

July 11, 2018

4/5/2018

A Long Term Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects With Psoriatic Arthritis and Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis.

A Multiple-Dose, Long-Term Extension Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects With Psoriatic Arthritis and Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis Who Have Previously Completed Studies With Tildrakizumab.

Psoriatic Arthritis;Ankylosing Spondylitis;Non-Radiographic Axial Spondyloarthritis

Drug: tildrakizumab 200 mg (two 1-mL injections of 100 mg/mL);Drug: tildrakizumab 100 mg (one 1-mL injection of 100 mg/mL + 1 mL placebo)

Sun Pharma Global FZE

NULL

Active, not recruiting

18 Years

N/A

All

540

Phase 2;Phase 3

United States;Argentina;Hungary;Mexico;Poland;Russian Federation;Spain;Ukraine