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Cosentyx : clinical trails roadmap

药怪站住  · 公众号  ·  · 2024-05-17 08:28

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文|小药怪

Cosentyx(司库奇尤单抗)是由诺华开发的靶向IL-17A的单抗,最早于2014/12/26在日本获批,用于治疗中重度斑块状银屑病、银屑病关节炎、强制性脊柱炎、活动性附着点炎相关关节炎、活动性非放射学轴性脊柱关节炎和化脓性汗腺炎。

2019年-2023年全球销售额分别为35.51、39.95、47.18、47.88、49.80亿美元,2024年Q1双位数25%同比增长,销售额达13.26亿美元。
Cosentyx分为静脉和皮下注射剂。
静脉注射剂全球共布局过33项临床研究(含学术机构),临床IV期2项,临床III期9项,临床II期18项,临床I/II期3项,临床I期1项。
静脉注射剂:临床IV期&III期


研究编号

研究题目

人群

研究阶段

状态

TrialTroveID-384916

Secukinumab Therapy Does Not Affect Neutrophil Host Defence In Psoriatic Arthritis

PsA

临床四期

完成

TrialTroveID-368633

Effectiveness and Retention Rate of Secukinumab for Psoriatic Arthritis and Axial Spondyloarthritis: Real-life Data from the Italian LORHEN Registry

PsA&AS

临床四期

完成


INVIGORATE 2
NCT04209205

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Multicenter Study of Intravenous Secukinumab to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tolerability up to 52 Weeks in Subjects With Active Psoriatic Arthritis

PsA

临床 III

完成


INVIGORATE-1
NCT04156620

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Multicenter Study of Intravenous Secukinumab to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tolerability up to 52 Weeks in Subjects With Active Ankylosing Spondylitis or Non-radiographic Axial SpondyloArthritis

AS

临床 III

完成


MEASURE 3
NCT02008916

A Randomized, Double-blind, Placebo-controlled Phase III Study of Secukinumab to Demonstrate the Efficacy at 16 weeks and to Assess the Long-term Safety, Tolerability and Efficacy up to 3 Years in Subjects with Active Ankylosing Spondylitis.

AS

临床 III

完成


FUTURE 1 ext
NCT01892436

A Three-year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients with Active Psoriatic Arthritis

PsA

临床 III

完成


NCT01640938

A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients with Active Rheumatoid Arthritis

RA

临床 III

终止


NCT01412944
STATURE

A Randomized, Double-blind, Double Dummy, Multicenter Study to Assess the Safety, Tolerability and Long-term Efficacy of Intravenous (10mg/kg) and Subcutaneous (300mg) Secukinumab in Subjects with Moderate to Severe Chronic Plaque-type Psoriasis who Are Partial Responders to Secukinumab

PsO

临床 III

完成


FUTURE 1
NCT01392326

A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients with Active Psoriatic Arthritis

PsA

临床 III

完成


MEASURE 1
NCT01358175

A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the Efficacy at 16 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients with Active Ankylosing Spondylitis.

AS

临床 III

完成


NCT01350804
NURTURE 1

A Randomized, Double-blind, Placebo- and Active-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 1 Year in Patients with Active Rheumatoid Arthritis who have an Inadequate Response to Anti-TNFalpha Agents

RA

临床 III

完成

静脉注射剂:临床II期&I/II


研究编号

研究题目

人群

研究阶段

状态


CAIN457A2103

A Randomized Multiple–dose, Open Label Study to Determine the Absolute Bioavailability of a Subcutaneous Administration of AIN457 in Patients with Chronic Plaque Type Psoriasis

PsO

临床 II

完成


NCT01364389

A 2-week Single-blind, Randomized, 3-arm Proof of Concept Study of the Effects of AIN457 (Anti-IL17 Antibody), ACZ885 (Canakinumab, Anti-IL1b Antibody), or Corticosteroids in Patients With Polymyalgia Rheumatica, Followed by an Open Label Phase to Assess Safety and Long Term Efficacy

风湿性多肌痛

临床 II

终止

TrialTroveID-195065

Association Of HLA-DRB1 Alleles With Clinical Responses To The Anti-Interleukin-17A Monoclonal Antibody Secukinumab In a Cohort Of Patients With Active Rheumatoid Arthritis:  An Exploratory Phase II Biomarker Study

RA

临床 II

完成


NCT01874340
REec-2013-0265

A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients with Relapsing Multiple Sclerosis

MS

临床 II

终止


NCT01478360

A Randomized, Double-blind, Placebo Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous Administration of Secukinumab (AIN457) in Patients with Asthma Not Adequately Controlled with Inhaled Corticosteroids and Long Acting Beta-agonists

哮喘

临床 II

终止


NCT01433250

An Open Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis.

MS

临床 II

终止

CAIN457F2208
NCT01426789

A Multicenter, 12 Week, Randomized, Double-blind, Placebo-controlled Biomarker Study of Secukinumab (AIN457) in Rheumatoid Arthritis Patients Followed by an Open Label Extension

RA

临床 II

完成

CAIN457F2206
EudraCT Number: 2010-024516-34
NCT01359943

A Randomized, Double-blind, Placebo-controlled Study of Efficacy, Safety and Tolerability of Secukinumab at 12 Weeks Administered with an i.v. or s.c. Loading Regimen Compared to Placebo in Patients with Active Rheumatoid Arthritis Despite Treatment with Methotrexate

RA

临床 II

完成

CPJMR0092202
NCT01250171

A Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study of Intravenous ACZ885 or AIN457 in Dry Eye Syndrome

干眼

临床 II

完成


EudraCT Number: 2009-011622-34
NCT01169844

An Open Label Non-randomized Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti Interleukin-17 Monoclonal Antibody) in Patients with Psoriatic Arthritis

PsA

临床 II

完成


CAIN457A2209-EXT
NCT01109940

An Open Label, Non-randomized Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti Interleukin-17 Monoclonal Antibody) in Patients with Moderate to Severe Ankylosing Spondylitis

AS

临床 II

完成


CAIN457A2202E1
NCT01009281

A 52 Week Open Label Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti IL-17 Monoclonal Antibody) in Patients with Moderate to Severe Crohn's Disease

CD

临床 II

终止

B2201
CAIN457B2201
EudraCT number: 2009-011626-34
NCT01051817
TrialTroveID-117251

A Randomized, Multi-center, Double-blind, Proof-of-concept Study to Assess the Effect of Multiple Infusions of AIN457 (10 mg/kg) Versus Placebo on Disease Activity (MRI Scans) in Patients With Relapsing-remitting Multiple Sclerosis

MS

临床 II

完成

09-I-0175
090175
NCT00936585
TrialTroveID-111976

NIH SUBSTUDY:Randomized, Double-blind, Placebo-controlled, Parallel-group Proof-of-concept Study to Assess the Efficacy, Safety and Tolerability of Two Single Infusions of AIN457 in Patients With Moderate to Severe Active Crohn's Disease

CD

临床 II

终止


CAIN457A2212
NCT00805480

Phase II Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled Multiple-Loading Dose Regimen Study to Assess the Safety, Efficacy and Duration of Response of AIN457 in Patients with Chronic Plaque-Type Psoriasis.

PsO

临床 II

完成


EudraCT Number: 2008-002631-33
NCT00809159

Randomized, Placebo Controlled Double Blind, Multi-center Phase II Proof-of-concept Study to Assess the Efficacy of AIN457 in Patients With Moderate to Severe Ankylosing Spondylitis

AS

临床 II

完成

CAIN457A2104
NCT00920933

Double Blind, Placebo Controlled, Parallel Group Study with an Open Label Reference Arm to Assess the Effects of Intravenously Administered AIN457 on Ozone Induced Neutrophilia Compared to Placebo & Oral Corticosteroid in Healthy Volunteers

Ozone Induced Neutrophilia

临床 I/II

完成


CAIN457A2204
NCT00770965

Phase II Single Dose, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled Study to Assess the Efficacy of Three Dose Levels of AIN457 in Patients with Chronic Plaque-Type Psoriasis

PsO

临床 II

完成


HUM00017810
NCT00584740

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Two Single IV Infusions of AIN457 10 mg/kg (Anti IL-17 Monoclonal Antibody) in Patients with Moderate to Severe Active Crohn's Disease

CD

临床 II

终止


CAIN457A2102
NCT00669916

Phase 2a Single-Dose, Randomized, Double Blind, Multi-Center, Parallel-Group, Placebo-Controlled Proof of Concept Study to Assess the Efficacy, Safety, Tolerability, and Population Pharmacokinetics of AIN457 in Patients with Stable Plaque-Type Psoriasis

PsO

临床 I/II

完成

CAIN457A2101
NCT00669942

A Randomized, Double Blind, Placebo-Controlled, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients with Pharmacodynamics Assessed in an Expanded Cohort at the Maximum Tolerated Dose

RA

临床 I/II

完成







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