271. 強直性脊椎炎 Ankylosing spondylitis Clinical trials / Disease details
臨床試験数 : 574 / 薬物数 : 359 - (DrugBank : 68) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 146
| 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 | ||
| 3 | NCT02980705 (ClinicalTrials.gov) | November 6, 2017 | 30/11/2016 | Efficacy and Safety Study of SUNPG1622 | A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Subjects With Active Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis | Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis | Drug: SUNPG1622 I dose;Drug: Placebo dose | Sun Pharmaceutical Industries Limited | NULL | Terminated | 18 Years | N/A | All | 180 | Phase 2 | United States;Hungary;Poland;Spain |
| 4 | EUCTR2016-003936-19-ES (EUCTR) | 04/04/2017 | 10/02/2017 | A Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Patients with Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis | A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Subjects with Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis | Ankylosing spondylitis (AS) and Non-Radiographic Axial Spondyloarthritis (nr-axSpA);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tildrakizumab Product Code: MK-3222 INN or Proposed INN: Tildrakizumab Other descriptive name: Anti-Human Interleukin-23 Monoclonal Antibody | SUN Pharmaceuticals Global FZE | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Mexico;Poland;Spain;Germany;United Kingdom | ||
| 5 | EUCTR2016-003936-19-HU (EUCTR) | 20/03/2017 | 06/01/2017 | A Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Patients with Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis | A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Subjects with Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis | Ankylosing spondylitis (AS) and Non-Radiographic Axial Spondyloarthritis (nr-axSpA);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tildrakizumab Product Code: MK-3222 INN or Proposed INN: Tildrakizumab Other descriptive name: Anti-Human Interleukin-23 Monoclonal Antibody | SUN Pharmaceuticals Global FZE | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Mexico;Poland;Spain;Germany;United Kingdom |