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Secukinumab s.c.

Phase 3

Plaque Psoriasis | Small molecule | Immunology |Novartis AG|Last Updated: Dec 30, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment543
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03066609Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type PsoriasisPHASE3 COMPLETED 543Feb 28, 2017Nov 20, 2018Dec 30, 201932 China, Hungary +4
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Study Endpoints
Primary Endpoints
Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation)
Week 12

Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. 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).

Investigator's Global Assessment (IGA) Mod 2011 0/1 (Multiple Imputation)
Week 12

Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease). result given in terms of count of participants with response in 100 imputations. 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.

Secondary Endpoints
Psoriasis Area and Severity Index (PASI) 90 (Multiple Imputation)
Week 12
Efficacy of Secukinumab in Maintaining PASI 75 Response at Week 52 in Subjects Who Were PASI 75 Responders at Week 12 (Multiple Imputation)
Week 52
Efficacy of Secukinumab in Maintaining IGA Mod 2011 0 or 1 Response at Week 52 in Subjects Who Were IGA Mod 2011 0 or 1 Responders at Week 12 (Multiple Imputation)
Week 52
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Secukinumab 150mgEXPERIMENTALSecukinumab 150mg s.c.
Secukinumab 300mgEXPERIMENTALSecukinumab 300mg s.c.
PlaceboPLACEBO_COMPARATORPlacebo to secukinumab s.c
Interventions
NameTypeDescription
Secukinumab 150 mg s.c.DRUG150 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48
Secukinumab 300 mg s.c.DRUG300 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48
PlaceboDRUGPlacebo 150 or 300 mg s.c at randomization, Weeks 1, 2, 3, 4, and 8. PASI responders at week 12 continued to receive placebo till Week 48. PASI non-responders at Week 12 received Secukinumab 300mg at Weeks 12, 13, 14, 15, 16 and every 4 weeks till Week 48
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites32

Inclusion Criteria: 1. Subjects must give a written, signed and dated informed consent. 2. Men or women at least 18 years of age at time of screening. 3. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Baseline. 4. Moderate to severe psoriasis as defined at Baseline...

Countries:ChinaHungaryMalaysiaPhilippinesThailandTurkey (Türkiye)
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