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Secukinumab/kg

Phase 2

Dry Eye | Monoclonal antibody | Ophthalmology |Novartis AG|Last Updated: Jan 7, 2013

Target and mechanism

Molecular targetIL17A
Target classInhibitor
ModalityMonoclonal antibody

Also known as Secukinumab

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

Secukinumab/kg · 1 trial · 1 indication

Phase 2 1
NCT01250171The Effects of a Single Intravenous Administration of Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye PatientsDry Eye
COMPLETED72 Analytics
PHASE2COMPLETED
The Effects of a Single Intravenous Administration of Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Patients
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Study Endpoints

Primary Endpoints

Change From Baseline on the National Eye Institute Corneal Staining Scale (NEI-CSS) at Week 4
Baseline to Week 4

Corneal staining was done with 2% sodium fluorescein instilled into the lower palpebral conjunctiva of each eye. Staining was assessed in 5 zones of the cornea (central plus 4 quadrants) and rated on a scale of 0 (no staining) to 3 (severe, confluent staining). A mean of the 5 zones for the study eye was calculated. A higher score indicates a drier eye. A negative change score indicates improvement in dryness.

Secondary Endpoints

Change From Baseline on the Ora Corneal Staining Scale at Weeks 1, 4, and 8
Baseline to Weeks 1, 4, and 8
Change From Baseline on the Schirmer Test at Weeks 1, 4, and 8
Baseline to Weeks 1, 4, and 8
Change From Baseline in Tear Film Breakup Time at Weeks 1, 4, and 8
Baseline to Weeks 1, 4, and 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Secukinumab 10 mg/kgEXPERIMENTALPatients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
Canakinumab 10 mg/kgEXPERIMENTALPatients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
PlaceboPLACEBO_COMPARATORPatients received a single placebo infusion intravenously over a 2 hour period.

Interventions

NameTypeDescription
Secukinumab 10 mg/kgBIOLOGICALSecukinumab was prepared in a sterile water solution.
Canakinumab 10 mg/kgBIOLOGICALCanakinumab was prepared in a sterile water solution.
PlaceboBIOLOGICALThe placebo solution for infusion contained 5% glucose.
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Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male and female patients age 18-85 with a diagnosis of moderate to severe dry eye. * Schirmer test without anesthesia ≥ 1 and \< 10 mm wetting over 5 minutes in at least 1 eye. * Tear break up time \< 7 seconds in at least 1 eye. * Corneal staining score ≥ 3 (National Eye Inst...

Countries:United States
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Frequently asked questions about Secukinumab/kg

What is Secukinumab used for?

Secukinumab is used for chronic plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, ankylosing spondylitis, and moderate to severe chronic plaque-type psoriasis. It is being studied in clinical trials for these conditions, including active psoriatic arthritis with axial skeleton involvement.

What does Secukinumab target?

Secukinumab is a monoclonal antibody, indicated by its -mab suffix. It is being developed for immunology indications, including psoriatic arthritis and giant cell arteritis, and is in Phase 3 clinical trials for several of these conditions.

Who makes Secukinumab?

Secukinumab is developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. The company is conducting clinical trials of Secukinumab across multiple countries, including the United States, Germany, and the United Kingdom.

What phase is Secukinumab in?

Secukinumab is in Phase 3 clinical development for conditions such as axial psoriatic arthritis and giant cell arteritis. It has also completed Phase 1 and Phase 2 trials. Secukinumab is an investigational drug and is not approved for the indications being studied.

What clinical trials is Secukinumab in?

Secukinumab has been studied in clinical trials including NCT02721966 for active psoriatic arthritis with axial skeleton involvement, NCT03765788 for giant cell arteritis, NCT05380453 for new onset giant cell arteritis, and NCT06130540 for giant cell arteritis or polymyalgia rheumatica.

Is Secukinumab the same as Cosentyx?

Secukinumab is the generic name for the drug also known as Cosentyx. It is a monoclonal antibody developed by Novartis AG for immunology indications such as psoriasis and psoriatic arthritis.