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secukinumab low dose

Phase 3

Moderate to Severe Chronic Plaque-type Psoriasis | Small molecule | Immunology |Novartis AG|Last Updated: May 16, 2025

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-BlindCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment415
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03668613Study to Assess the Long-term Safety, Tolerability, Efficacy of Secukinumab in Pediatric Patients of Age 6 to <18 Years, With Moderate to Severe Plaque PsoriasisPHASE3 COMPLETED 84Aug 29, 2018Sep 12, 2023May 16, 202523 United States, Belgium +7
NCT03504852Efficacy and Safety of 2 Secukinumab Regimens in 90kg or More Weight Group With Moderate/Severe Chronic Plaque PsoriasisPHASE3 COMPLETED 331Jun 25, 2018Jul 15, 2020Oct 11, 202167 United States, Canada +5
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Study Endpoints
Primary Endpoints
Number and Percentage of Participants With PASI 75 Response
Week 12

Psoriasis Area and Severity Index (PASI):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, trunk, upper limbs and lower limbs); 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,Thickening (plaque elevation, induration) \& Scaling(desquamation). Scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section(head: 0.1, upper limbs: 0.2 body: 0.3 lower limbs: 0.4). Psoriasis Area and Severity Index (PASI) will be assessed/calculated as per standard procedure. PASI 75 represents the percentage (or number)of patients who have achieved a 75% or more reduction in their PASI score from baseline. PASI 100 indicates patients who have achieved a complete resolution of all disease.

Number and Percentage of Participants With IGA Mod 2011 0 or 1 Response
Week 12

Investigator will assess the disease using the validated Investigator Global Assessment (IGA) mod 2011 and rate the disease from a score of 0 (clear skin) to 4 (severe disease)

Percentage of Subjects Who Achieve 90% or Greater Reduction in Psoriasis Area and Severity Index (PASI) Score - Week 16 (Full Analysis Set)
16 weeks

A subject was considered as a PASI 90 responder if s/he achieved a reduction of 90% or more of the PASI score, compared to baseline, at a given time point.The head, trunk, upper limbs and lower limbs were assessed separately for erythema, thickening, and scaling. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0, i.e., higher scores represent more severity.

Secondary Endpoints
Number and Percentage of Participants With PASI 90 Response
Week 12
Secukinumab Concentration in Serum
Baleine, Weeks 4, 12, 13, 14, 15, 16, 24, 52, 104, 156, 208
Summary Table of Adverse Events
Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
secukinumab low doseEXPERIMENTALsecukinumab low dose
secukinumab high doseEXPERIMENTALsecukinumab high dose
Secukinumab 300 mg every 2 weeks (Q2W)EXPERIMENTAL2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects remained on secukinumab 300 mg every 2 weeks until the end of treatment.
Secukinumab 300 mg every 4 weeks (Q4W)ACTIVE_COMPARATOR2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter Q4W. Includes both subjects randomized to remain on Q4W the entire treatment period, and subjects that were Psoriasis Area and Severity Index (PASI) 90 responders at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group.
Secukinumab 300 mg every 4 weeks non-responders up-titration (Q4W NR up)ACTIVE_COMPARATOR2 injections of secukinumab 150 mg once weekly up to week 4, then Q4W up to Week 16 and thereafter Q2W. Includes Psoriasis Area and Severity Index (PASI) 90 non-responders (NR) at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group (subjects randomized to switch to Q2W if PASI 90 non-responder at Week 16).
Interventions
NameTypeDescription
secukinumab low doseDRUGdose depends on the weight group
secukinumab high doseDRUGdose depends on the weight group
secukinumab 150 mgDRUGsub-cutaneous secukinumab prefilled syringe 150 mg
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Eligibility Criteria
Age Range6 Years — 17 Years
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: 1. Written informed assent and parental permission (age as per local law) obtained at screening before any assessment is performed. 2. Must be 6 to less than 18 years of age at the time of randomization 3. Moderate to Severe plaque psoriasis, defined as a PASI score ≥ 12, and IG...

Countries:United StatesBelgiumCzechiaEstoniaGermanyPeruPolandRussiaSpainCanadaHungaryItaly
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