Canakinumab

Generic Name: Canakinumab

Brand Names: Ilaris

Drug Type: Biotech

Chemical Formula: -

CAS Number: 914613-48-2

Unique Ingredient Identifier: 37CQ2C7X93

Background: Canakinumab is a recombinant, human anti-human-IL-1β monoclonal antibody that belongs to the IgG1/κ isotype subclass. It is expressed in a murine Sp2/0-Ag14 cell line and comprised of two 447- (or 448-) residue heavy chains and two 214-residue light chains, with a molecular mass of 145157 Daltons when deglycosylated. Both heavy chains of canakinumab contain ...

Indication: Canakinumab is indicated for the treatment of periodic fever syndromes in specific patient populations. In patients ≥4 years of age, canakinumab is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS). In adult and pediatric patients, canakinum...

Associated Conditions: Adult Onset Still's Disease, Cryopyrin-associated Periodic Syndromes (CAPS), Familial Cold Autoinflammatory Syndrome (FCAS), Familial Mediterranean Fever (FMF ), Gout Flares, Mevalonate Kinase Deficiency, Muckle-Wells Syndrome (MWS), Systemic Juvenile Idiopathic Arthritis (SJIA), Tumour necrosis factor receptor-associated periodic syndrome

Associated Therapies: -

Clinical Trials

ACZ885 for the Treatment of Abdominal Aortic Aneurysm

Phase 2

Terminated

Conditions: Abdominal Aortic Aneurysm (AAA)

Interventions: Drug: Placebo
Drug: ACZ885

First Posted Date: 2013-12-10

Last Posted Date: 2021-01-05

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 65

Registration Number: NCT02007252

Locations: 🇬🇧
Novartis Investigative Site, Manchester, United Kingdom

An Open-label, Multi-arm, Non-comparative Safety and Tolerability Study of Canakinumab (ACZ885) in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)

Phase 3

Withdrawn

Conditions: Systemic Juvenile Idiopathic Arthritis

Interventions: Drug: Canakinumab
Drug: ACZ885

First Posted Date: 2012-08-31

Last Posted Date: 2015-10-15

Lead Sponsor: Novartis Pharmaceuticals

Registration Number: NCT01676948

Efficacy Study of Canakinumab to Treat Urticaria

Phase 2

Conditions: Chronic Idiopathic Urticaria

Interventions: Drug: Placebo
Drug: Canakinumab

First Posted Date: 2012-07-06

Last Posted Date: 2016-09-27

Lead Sponsor: University of Zurich

Target Recruit Count: 20

Registration Number: NCT01635127

Locations: 🇨🇭
University Hospital Zurich, Division of Dermatology, Zurich, Switzerland

Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease

Phase 3

Withdrawn

Conditions: Acute Gouty Arthritis

Interventions: Drug: ACZ885
Drug: Triamcinelone acetonide

First Posted Date: 2012-05-08

Last Posted Date: 2017-04-20

Lead Sponsor: Novartis Pharmaceuticals

Registration Number: NCT01593527

β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3)

Phase 3

Completed

Conditions: Acute Gouty Arthritis Flares

Interventions: Drug: ACZ885
Drug: Triamcinolone acetonide 40 mg

First Posted Date: 2011-11-11

Last Posted Date: 2021-07-09

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 136

Registration Number: NCT01470989

Locations: 🇺🇦
Novartis Investigative Site, Zaporizhzhya, Ukraine

Ilaris® Effects in Schnitzler Syndrome (ILESCH)

Phase 2

Completed

Conditions: Schnitzler Syndrome

Interventions: Drug: Placebo
Drug: Canakinumab

First Posted Date: 2011-07-11

Last Posted Date: 2018-07-17

Lead Sponsor: Charite University, Berlin, Germany

Target Recruit Count: 20

Registration Number: NCT01390350

Locations: 🇩🇪
Dept. of Dermatology, University Heidelberg, Heidelberg, Germany
🇩🇪
Dept. of Dermatology, University Münster, Münster, Germany
🇩🇪
Dept. of Dermatology, University Tübingen, Tübingen, Germany

and more 2 locations

A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica

Phase 2

Terminated

Conditions: Polymyalgia Rheumatica
Inflammatory Diseases

Interventions: Drug: AIN457
Drug: ACZ885
Drug: Prednisone
Drug: Placebo

First Posted Date: 2011-06-02

Last Posted Date: 2021-09-17

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 16

Registration Number: NCT01364389

Locations: 🇬🇧
Novartis Investigative Site, Westcliff-on-Sea, Essex, United Kingdom

Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)

Phase 3

Completed

Conditions: Atherosclerosis

Interventions: Drug: Placebo
Drug: Canakinumab
Drug: Standard of care

First Posted Date: 2011-04-04

Last Posted Date: 2020-01-22

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 10066

Registration Number: NCT01327846

Locations: 🇬🇧
Novartis Investigative Site, York, United Kingdom

ACZ885 in Type 1 Diabetes Mellitus

Phase 2

Withdrawn

Conditions: Diabetes Mellitus
Diabetes Type 1

Interventions: Drug: ACZ885
Drug: Placebo

First Posted Date: 2011-03-24

Last Posted Date: 2012-09-05

Lead Sponsor: Novartis Pharmaceuticals

Registration Number: NCT01322321

Locations: 🇨🇦
LMC Endocrinology Centres (Barrie) Ltd, Barrie, Ontario, Canada
🇬🇧
Novartis Investigative Site, Liverpool, United Kingdom
🇨🇦
LMC Endocrinology Centres (Bayview) Ltd, Toronto, Ontario, Canada

and more 1 locations

Canakinumab in Patients With Active Hyper-IgD Syndrome

Phase 2

Completed

Conditions: Mevalonate Kinase Deficiency

Interventions: Drug: Canakinumab

First Posted Date: 2011-02-24

Last Posted Date: 2015-11-05

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 9

Registration Number: NCT01303380

Locations: 🇪🇸
Novartis Investigative Site, Madrid, Spain

Drug Development Updates

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