Pediatric Study in Children and Adolescents With Severe Plaque Psoriasis

A Randomized, Double-blind, Placebo- and Active Controlled Multicenter Trial to Demonstrate Efficacy of Subcutaneous Secukinumab Compared to Placebo and Etanercept (in a Single-blinded Arm) After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, and Long-term Efficacy in Subjects From 6 to Less Than 18 Years of Age With Severe Chronic Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT02471144

Novartis Reference Number: CAIN457A2310

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This is a multicenter, randomized, double-blind, placebo- and active-controlled (etanercept in single blinded arm) study in pediatric subjects aged 6 years to less than 18 years with severe chronic plaque psoriasis. Approximately 160 subjects aged 6 years to <18 years will be enrolled, of which at least 30 will be 6 years to <12 years old. It is expected that subjects will be enrolled at approximately 70 study sites worldwide

Condition 
Chronic Severe Plaque-type Psoriasis
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
162 participants
Start date 
Sep 29, 2015
Completion date 
Jul 19, 2023
Gender 
All
Age(s)
6 Years - 17 Years (Child)

Interventions

Biological
Experimental : Secukinumab low dose
Depending on weight group subject will receive per dose a) 75 mg if weighing less than 50 kg b) 150 mg if weighing 50 kg or more. Secukinumab injections (one or two per dose, depending on the weight group) will be administered subcutaneously at Randomization, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48, and Placebo secukinumab at Weeks 13, 14 and 15 during the blinded phase of the study; thereafter at Week 52 and every 4 weeks during the extension treatment period until Week 232.
Biological
Experimental: Secukinumab high dose
Depending on weight group subject will receive per dose a) 75 mg if weighing less than 25 kg b) 150 mg if weighing between 25 and less than 50 kg c) 300 mg if weighing more than 50 kg. Secukinumab injections (one or two per dose, depending on the weight group) will be administered subcutaneously at Randomization, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48, and Placebo secukinumab at Weeks 13, 14 and 15 during the blinded phase of the study; thereafter at Week 52 and every 4 weeks during the extension treatment period until Week 232.
Biological
Placebo Comparator: Secukinumab Placebo
Placebo secukinumab (one or two subcutaneous injections per dose, depending on weight group) at Randomization and Weeks 1, 2, 3 4 and 8. At Week 12, subjects in the placebo group based on their PASI 75 response status at Week 12 will proceed as follows: • PASI 75 responders will discontinue study treatment at Week 12 and enter the treatment-free follow-up period • PASI 75 non-responders will receive high dose or low dose secukinumab, according to the pre-assignment at the Randomization visit. They will receive their treatment based on the weight category(<25 kg, 25- <50kg, ≥50 kg), on Weeks 12, 13, 14, 15, and then every four weeks starting at Week 16 until Week 48 during the maintenance period; thereafter at week 52 and every 4 weeks during the extension treatment period until Week 232.
Biological
Active Comparator: Etanercept
Etanercept 0.8 mg/kg of subject weight and up to a maximum of 50 mg per dose. Subcutaneous etanercept 0.8 mg/kg (one or two injections per dose) once per week, for 51 weeks administered at home (self-injected or by caregiver) or at the study site. At Wk 52 subjects in the etanercept group will move into the treatment-free follow up period and terminate the study.

Eligibility Criteria

Inclusion criteria:

Must be 6 to less than 18 years of age at the time of randomization
Plaque-type psoriasis history for at least 3 months.

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.

Patient being regarded by the investigator to be a candidate for systemic therapy because of:

inadequate control of symptoms with topical treatment, or
failure to respond to or tolerate previous systemic treatment and/or UV therapy

Exclusion criteria:

Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate) at randomization.
Current drug-induced psoriasis.
Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
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
History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
Pregnant or nursing (lactating) women.
Other protocol-defined inclusion/exclusion criteria may apply.

Study Locations

United States
Novartis Investigative Site
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San Antonio, 78218
Texas
United States
Belgium
Novartis Investigative Site
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Bruxelles, 1200
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Belgium
Novartis Investigative Site
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Gent, 9000
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Belgium
Novartis Investigative Site
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Liege, 4000
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Belgium
Colombia
Novartis Investigative Site
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Medellin, 05001000
Antioquia
Colombia
Novartis Investigative Site
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Bogota, 110221
-
Colombia
Egypt
Novartis Investigative Site
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Alexandria, 21131
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Egypt
Novartis Investigative Site
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Cairo, 11341
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Egypt
Estonia
Novartis Investigative Site
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Tartu, 51014
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Estonia
France
Novartis Investigative Site
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Amiens Cedex 1, 80054
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France
Novartis Investigative Site
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Nice, 06202
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France
Novartis Investigative Site
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Paris, 75015
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France
Germany
Novartis Investigative Site
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Bad Bentheim, 48455
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Germany
Novartis Investigative Site
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Bochum, 44791
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Germany
Novartis Investigative Site
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Dresden, 01307
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Germany
Novartis Investigative Site
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Erlangen, 91054
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Germany
Novartis Investigative Site
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Mainz, 55131
-
Germany
Novartis Investigative Site
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Muenchen, 81675
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Germany
Novartis Investigative Site
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Muenster, 48149
-
Germany
Guatemala
Novartis Investigative Site
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Guatemala city, 01010
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Guatemala
Novartis Investigative Site
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Guatemala City, 01015
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Guatemala
Hungary
Novartis Investigative Site
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Budapest, 1125
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Hungary
Novartis Investigative Site
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Budapest, H-1089
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Hungary
Novartis Investigative Site
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Debrecen, 4032
-
Hungary
Israel
Novartis Investigative Site
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Afula, 1834111
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Israel
Novartis Investigative Site
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Be'er Sheva, 84101
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Israel
Novartis Investigative Site
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Ramat Gan, 52621
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Israel
Italy
Novartis Investigative Site
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Parma, 43100
PR
Italy
Novartis Investigative Site
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Roma, 00133
RM
Italy
Japan
Novartis Investigative Site
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Nagoya-city, 467-8602
Aichi
Japan
Latvia
Novartis Investigative Site
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Riga, LV-1001
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Latvia
Novartis Investigative Site
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Riga, LV-1004
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Latvia
Poland
Novartis Investigative Site
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Lodz, 90-265
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Poland
Novartis Investigative Site
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Lublin, 20-079
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Poland
Novartis Investigative Site
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Warszawa, 03-924
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Poland
Romania
Novartis Investigative Site
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Cluj Napoca, 400006
Cluj
Romania
Russian Federation
Novartis Investigative Site
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Kazan, 420012
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Russian Federation
Novartis Investigative Site
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Krasnodar, 350020
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Russian Federation
Novartis Investigative Site
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Moscow, 119296
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Russian Federation
Novartis Investigative Site
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Saint Petersburg, 191123
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Russian Federation
Novartis Investigative Site
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Yekaterinburg, 620076
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Russian Federation
Spain
Novartis Investigative Site
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Esplugues de Llobregat, 08950
Barcelona
Spain
Novartis Investigative Site
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Barcelona, 08041
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Spain
Novartis Investigative Site
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Madrid, 28046
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Spain
Switzerland
Novartis Investigative Site
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Zuerich, CH - 8032
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Switzerland
United Kingdom
Novartis Investigative Site
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Scunthorpe, DN15 7GB
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United Kingdom

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