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Canakinumab in prefilled syringe

Phase 3

Acute Gouty Arthritis | Small molecule | Metabolic |Novartis AG|Last Updated: Jul 19, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment397

FDA Designations

No designations recorded

Clinical trial landscape

Canakinumab in prefilled syringe · 1 trial · 1 indication

Phase 3 1
NCT01431638Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis PatientsAcute Gouty Arthritis
COMPLETED397 Analytics
PHASE3COMPLETED
Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
Acute Gouty Arthritis
NCT01431638397
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Study Endpoints

Primary Endpoints

Number of Participants Who Reported Adverse Events
From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)

Secondary Endpoints

Probability of New Gout Flares at End of Study
Up to Day 337
Number of Participant With New Flares
up to 36 weeks
Change From Baseline in Pain Intensity on a 5-point Likert Scale
Baseline, upto 14 days post-dose
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Canakinumab 150mgEXPERIMENTALCanakinumab 150mg in prefilled syringe subcutaneously

Interventions

NameTypeDescription
Canakinumab 150mg in prefilled syringeDRUGCanakinumab 150mg in prefilled syringe will be given in a single dose subcutaneously upon demand for gouty arthritis flares
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Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites68

Inclusion criteria: * Compliance and completion of the canakinumab PFS core study * Unchanged significant clinical medical history from entry into core study Exclusion criteria: * Physician judgment of unsuitability for the study * Pregnant or nursing women Other protocol-defined inclusion/exclus...

Countries:United StatesCanadaGermanyLithuania
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Frequently asked questions about Canakinumab in prefilled syringe

What is Canakinumab used for?

Canakinumab is an investigational drug being studied for gouty arthritis, acute gout, osteoarthritis, hereditary periodic fevers, gout, and mevalonate kinase deficiency. It is developed by Novartis AG and is in Phase 3 clinical development for these metabolic conditions.

What does Canakinumab target?

Canakinumab targets the interleukin-1 beta pathway, a key mediator of inflammation. By inhibiting this cytokine, it aims to reduce inflammatory responses associated with conditions like gout and hereditary periodic fevers.

Who makes Canakinumab?

Canakinumab is developed by Novartis AG, a multinational pharmaceutical company listed on the NYSE under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the drug's efficacy and safety in various inflammatory and metabolic diseases.

What phase is Canakinumab in?

Canakinumab is in Phase 3 clinical development. It has completed three trials with a total enrollment of 10,066 participants, all of which were randomized, double-blind, and active-controlled studies.

What clinical trials is Canakinumab in?

Canakinumab has completed three clinical trials: NCT00891046 in systemic juvenile idiopathic arthritis, NCT01088880 in familial Mediterranean fever, and NCT02059291 in hereditary periodic fevers. All trials are completed, with no active studies currently ongoing.

Is Canakinumab the same as Ilaris?

Canakinumab is also known by the brand name Ilaris. This alternative name is used in clinical and commercial contexts, and patients or healthcare providers may refer to the drug by either name.