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Secukinumab form

Phase 3

Psoriasis | Monoclonal antibody | Dermatology |Novartis AG|Trials Updated: Jul 15, 2019

Secukinumab form target and mechanism

Molecular targetIL17A
Target classInhibitor
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment214

FDA Designations

No designations recorded

Secukinumab form clinical trials

Secukinumab form · 1 trial · 1 indication

Phase 3 1
NCT02748863Study of Secukinumab With 2 mL Pre-filled SyringesPsoriasis
COMPLETED214 Analytics
PHASE3COMPLETED
Study of Secukinumab With 2 mL Pre-filled Syringes
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Participants With Psoriasis Area and Severity Index (PASI) 75 Response After 12 Weeks of Treatment
12 weeks

Number of participants who achieved ≥ 75% reduction in PASI compared to baseline PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).

Participants With IGA Mod 2011 0 or 1 After 12 Weeks of Treatment
12 weeks

The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1. Number of participants who achieved IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline

Secondary Endpoints

Participants With PASI 90 After 12 Weeks of Treatment
12 weeks
Number of Participants With PASI 100 Response After 12 Weeks of Treatment
12 weeks
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
up to week 52
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo, provided in a 2 mL pre-filled syringe Placebo, provided in a 1 mL pre-filled syringe
Secukinumab 2 mL formEXPERIMENTALSecukinumab 300 mg, provided in a 2 mL pre-filled syringe
Secukinumab 1 mL formACTIVE_COMPARATORSecukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg (current approved form)

Interventions

NameTypeDescription
PlaceboDRUG2 mL + 2 x 1 mL Placebo s.c. at randomization, weeks 1, 3, and 4, thereafter 4-weekly until week 48
Secukinumab 2 mL formDRUGSecukinumab 300 mg/2mL + 2 x 1 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48
Secukinumab 1 mL formDRUGSecukinumab 150 mg/1mL x 2 + 2 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites52

Inclusion Criteria: Subjects eligible for inclusion in this study must fulfill all of the following criteria: 1. Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before...

Countries:United StatesBelgiumCanadaGermanyIcelandLatviaPolandRussiaSpainTurkey (Türkiye)United Kingdom
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Frequently asked questions about Secukinumab form

What is Secukinumab form used for?

Secukinumab form is used to treat psoriasis, a chronic inflammatory skin condition. It is a monoclonal antibody developed by Novartis AG under the ticker NVS. The 2 mL form refers to a pre-filled syringe presentation studied in a Phase 3 clinical trial.

What does Secukinumab form target?

Secukinumab form targets IL17A, a pro-inflammatory cytokine. By binding to IL17A, it acts as an inhibitor of the IL17A signaling pathway, which is involved in the inflammatory process underlying psoriasis. This targeted mechanism is the basis for its development in dermatology.

Who makes Secukinumab form?

Secukinumab form is developed by Novartis AG, which trades under the ticker NVS. Novartis is the company responsible for the clinical development of this 2 mL pre-filled syringe formulation of secukinumab.

What phase is Secukinumab form in?

Secukinumab form is in Phase 3 clinical development. The Phase 3 trial for this 2 mL pre-filled syringe formulation has been completed. It is an investigational product and has not been approved by the FDA for any indication.

What clinical trials is Secukinumab form in?

Secukinumab form has been studied in one Phase 3 clinical trial, NCT02748863, titled Study of Secukinumab With 2 mL Pre-filled Syringes. This completed trial enrolled 214 participants with psoriasis across multiple countries including the United States, Belgium, Canada, Germany, and others.