271. 強直性脊椎炎
[臨床試験数:531,薬物数:343(DrugBank:66),標的遺伝子数:41,標的パスウェイ数:141

Searched query = "Ankylosing spondylitis", "Spondylarthritis ankylopoietica"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
6 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
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
3NCT03552276
(ClinicalTrials.gov)
July 11, 20184/5/2018A 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 SpondyloarthritisDrug: 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 FZENULLActive, not recruiting18 YearsN/AAll540Phase 2;Phase 3United States;Argentina;Hungary;Mexico;Poland;Russian Federation;Spain;Ukraine
4NCT02980705
(ClinicalTrials.gov)
November 6, 201730/11/2016Efficacy and Safety Study of SUNPG1622A 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 SpondyloarthritisActive Ankylosing Spondylitis or Non-Radiographic Axial SpondyloarthritisDrug: SUNPG1622 I dose;Drug: Placebo doseSun Pharma Global FZENULLTerminated18 YearsN/AAll180Phase 2United States
5EUCTR2016-003936-19-ES
(EUCTR)
04/04/201710/02/2017A Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Patients with Active Ankylosing Spondylitis or Non-Radiographic Axial SpondyloarthritisA 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]SUN Pharmaceuticals Global FZENULLNot Recruiting Female: yes
Male: yes
180Phase 2United States;Hungary;Mexico;Poland;Spain;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2016-003936-19-HU
(EUCTR)
20/03/201706/01/2017A Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Patients with Active Ankylosing Spondylitis or Non-Radiographic Axial SpondyloarthritisA 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]SUN Pharmaceuticals Global FZENULLNot Recruiting Female: yes
Male: yes
180Phase 2United States;Hungary;Mexico;Poland;Spain;Germany;United Kingdom