Tildrakizumab 100 mg/ml ( DrugBank: Tildrakizumab )


1 disease
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2

271. 強直性脊椎炎


臨床試験数 : 563 薬物数 : 372 - (DrugBank : 72) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 145
No.TrialIDDate_
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agemin
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agemax
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PhaseCountries
1EUCTR2018-001060-35-ES
(EUCTR)
19/09/201817/07/2018A long-term extension study to investigate the safety and effectiveness of Tildrakizumab in patients with Psoriatic Arthritis and Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis who have previously completed other studies with TildrakizumabA 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 (PsA), Ankylosing Spondylitis (AS) and Non-Radiographic Axial Spondyloarthritis (nr-axSpA)
MedDRA version: 20.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tildrakizumab 100 mg/ml
Product Code: MK-3222
INN or Proposed INN: Tildrakizumab
Other descriptive name: Anti-Human Interleukin-23 Monoclonal Antibody
Sun Pharma Global FZENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
540Phase 3United States;Hungary;Mexico;Argentina;Poland;Spain;Ukraine;Russian Federation
2EUCTR2018-001060-35-HU
(EUCTR)
29/08/201821/06/2018A long-term extension study to investigate the safety of Tildrakizumab in patients with Psoricatic Arthritis who have previously completed other studies with TildrakizumabA Long-Term Extension Study to Demonstrate Safety of Tildrakizumab in Subjects with Psoriatic Arthritis who Have Previously Completed Study with Tildrakizumab Psoriatic Arthritis (PsA)
MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Ilumetri
Product Name: Tildrakizumab 100 mg/ml
Product Code: MK-3222
INN or Proposed INN: Tildrakizumab
Other descriptive name: Anti-Human Interleukin-23 Monoclonal Antibody
Sun Pharma Global FZENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
286Phase 3United States;Hungary;Mexico;Argentina;Poland;Spain;Ukraine;Russian Federation