Tildrakizumab ( DrugBank: Tildrakizumab )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
162類天疱瘡(後天性表皮水疱症を含む。)1
271強直性脊椎炎5

162. 類天疱瘡(後天性表皮水疱症を含む。)


臨床試験数 : 83 薬物数 : 128 - (DrugBank : 51) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 142
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04465292
(ClinicalTrials.gov)
September 1, 202014/5/2020The Effects of Tildrakizumab in Treatment of Bullous PemphigoidThe Effects of Tildrakizumab in Treatment of Bullous PemphigoidPemphigoid, BullousDrug: Tildrakizumab Prefilled SyringeBrigham and Women's HospitalJoseph MerolaNot yet recruiting18 YearsN/AAll16Early Phase 1NULL

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_
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
3NCT02980705
(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 Pharmaceutical Industries LimitedNULLTerminated18 YearsN/AAll180Phase 2United States;Hungary;Poland;Spain
4EUCTR2016-003936-19-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]Product Name: Tildrakizumab
Product Code: MK-3222
INN or Proposed INN: Tildrakizumab
Other descriptive name: Anti-Human Interleukin-23 Monoclonal Antibody
SUN Pharmaceuticals Global FZENULLNot 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): noUnited States;Hungary;Mexico;Poland;Spain;Germany;United Kingdom
5EUCTR2016-003936-19-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]Product Name: Tildrakizumab
Product Code: MK-3222
INN or Proposed INN: Tildrakizumab
Other descriptive name: Anti-Human Interleukin-23 Monoclonal Antibody
SUN Pharmaceuticals Global FZENULLNot 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): noUnited States;Hungary;Mexico;Poland;Spain;Germany;United Kingdom