Anti-human interleukin-23 monoclonal antibody (DrugBank: -)
17 diseases告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
2 | 筋萎縮性側索硬化症 | 0 |
13 | 多発性硬化症/視神経脊髄炎 | 0 |
35 | 天疱瘡 | 0 |
46 | 悪性関節リウマチ | 0 |
49 | 全身性エリテマトーデス | 0 |
51 | 全身性強皮症 | 0 |
53 | シェーグレン症候群 | 0 |
55 | 再発性多発軟骨炎 | 0 |
56 | ベーチェット病 | 0 |
60 | 再生不良性貧血 | 0 |
63 | 特発性血小板減少性紫斑病 | 0 |
65 | 原発性免疫不全症候群 | 0 |
95 | 自己免疫性肝炎 | 0 |
96 | クローン病 | 0 |
97 | 潰瘍性大腸炎 | 0 |
162 | 類天疱瘡(後天性表皮水疱症を含む。) | 0 |
271 | 強直性脊椎炎 | 2 |
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 | EUCTR2018-001060-35-ES (EUCTR) | 19/09/2018 | 17/07/2018 | A 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 Tildrakizumab | 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 (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 FZE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 540 | Phase 3 | United States;Hungary;Mexico;Argentina;Poland;Spain;Ukraine;Russian Federation | ||
2 | EUCTR2018-001060-35-HU (EUCTR) | 29/08/2018 | 21/06/2018 | A long-term extension study to investigate the safety of Tildrakizumab in patients with Psoricatic Arthritis who have previously completed other studies with Tildrakizumab | A 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 FZE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 286 | Phase 3 | United States;Hungary;Mexico;Argentina;Poland;Spain;Ukraine;Russian Federation |