Plaque Psoriasis MedDRA version: 20.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Cosentyx
Product Name: secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Secukinumab
CAS Number: 1229022-83-6
Current
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Must be 6 to less than 18 years of age at the time of randomization 2) Severe plaque-type psoriasis meeting all of the following three criteria: PASI score of 20 or greater, Investigator's Global Assessment (IGA) score of 4 Total body surface area (BSA) affected of 10% or greater. 3) Patients being regarded by the investigator to be a candidate for systemic therapy because of: 1) inadequate control of symptoms with topical treatment 2) failure to respond to or tolerate previous systemic treatment and/or UV therapy Other protocol-defined inclusion criteria may apply Are the trial subjects under 18? yes Number of subjects for this age range: 160 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate) active at randomization. 2) Current drug-induced psoriasis. 3) Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor. 4) Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis. 5) History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years. 6) Pregnant or nursing (lactating) women. Other protocol-defined inclusion/exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate superior efficacy of secukinumab versus placebo at Week 12, based on both PASI 75 and IGA mod 2011 0 or 1 response rates in children and adolescents aged 6 to less than 18 years with severe chronic plaque psoriasis who had inadequate control of symptoms with topical treatment or failure to respond to or tolerate previous systemic treatment and/or UV therapy;Secondary Objective: To assess the long term safety and tolerability of secukinumab in this pediatric age group and will describe the efficacy and safety of secukinumab compared to etanercept. To provide efficacy and safety data to support the extension of label of secukinumab to include children and adolescents (6 years to <18 years) with severe chronic plaque psoriasis. Other protocol-defined secondary objectives may apply.;Primary end point(s): The percentage of Participants achieving a 75% Improvement from Baseline in PASI Score. The percentage of Participants who showed Investgator's Global Assessment (IGA) mod 2011 response of 0 or 1;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percentage of Participants achieving a 90% Improvement from baseline in PASI score 2. Percentage of Participants achieving a 50%, 100% Improvement from baseline in PASI score 3. Percentage of Participants achieving a 50%, 75%, 90% or 100% Improvement from baseline in (PASI ) Score and an IGA mod 2011 score of 0 or 1 4. Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) score and IGA mod 2011 0 or 1 score 5. Change from Baseline in Children's Dermatology Life Quality Index (cDLQI) score. 6. Percentage of participants achieving a Childrens' DLQI score of 0 or 1 7. To evaluate the effects of treatment of secukinumab on disability at Week 12 and over time up to Week 52 by use of the Childhood Health Assessment Questionnaire (CHAQ©) for subjects with history of psoriatic arthritis. 8. Patients' safety. Clinical safety and tolerability as assessed by growth, weight gain, tolerability of s.c. injections, vital signs, clinical laboratory variables, ECGs, and adverse events monitoring Other protocol-defined endpoints may apply.;Timepoint(s) of evaluation of this end point: 1. 12 weeks 2. 12 weeks 3. Weeks 1, 2, 3, 4, 6, 8, 12, 13, 14, 15, 16, 20, 24, 28, 32,36, 40, 44, 48 and 52 4. Baseline, week 1, 2, 3 ,4, 6, 8, 12, 13, 14, 15, 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52 5. Baseline, Weeks 4, 8, 12, 24, 36, 52 6. Baseline, Weeks 4, 8, 12, 24, 36, 52 7. Baseline, Weeks 4, 8, 12, 24, 36, 52 8. from screening to Week 252 | — |
Countries
Argentina, Belgium, Brazil, Colombia, Egypt, Estonia, France, Germany, Guatemala, Hungary, Israel, Italy, Japan, Latvia, Poland, Romania, Spain, United Kingdom
Contacts
Public ContactFlorent Hartmann
Novartis Pharma Services AG
Outcome results
None listed