Pediatric Study in Children and Adolescents With Severe Plaque Psoriasis

PHASE3CompletedINTERVENTIONAL
Enrollment

162

Participants

Timeline

Start Date

September 29, 2015

Primary Completion Date

December 13, 2018

Study Completion Date

March 30, 2023

Conditions
Chronic Severe Plaque-type Psoriasis
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.

Trial Locations (46)

1015

Novartis Investigative Site, Guatemala City

1125

Novartis Investigative Site, Budapest

1200

Novartis Investigative Site, Brussels

4000

Novartis Investigative Site, Liège

4032

Novartis Investigative Site, Debrecen

9000

Novartis Investigative Site, Ghent

11341

Novartis Investigative Site, Cairo

21131

Novartis Investigative Site, Alexandria

28046

Novartis Investigative Site, Madrid

43100

Novartis Investigative Site, Parma

44791

Novartis Investigative Site, Bochum

48149

Novartis Investigative Site, Münster

48455

Novartis Investigative Site, Bad Bentheim

51014

Novartis Investigative Site, Tartu

52621

Novartis Investigative Site, Ramat Gan

55131

Novartis Investigative Site, Mainz

75015

Novartis Investigative Site, Paris

78218

Novartis Investigative Site, San Antonio

80054

Novartis Investigative Site, Amiens

80377

Novartis Investigative Site, München

91054

Novartis Investigative Site, Erlangen

110221

Novartis Investigative Site, Bogotá

119296

Novartis Investigative Site, Moscow

191123

Novartis Investigative Site, Saint Petersburg

350020

Novartis Investigative Site, Krasnodar

400006

Novartis Investigative Site, Cluj-Napoca

420012

Novartis Investigative Site, Kazan'

620076

Novartis Investigative Site, Yekaterinburg

1834111

Novartis Investigative Site, Afula

8457108

Novartis Investigative Site, Beersheba

05001000

Novartis Investigative Site, Medellín

06202

Novartis Investigative Site, Nice

01307

Novartis Investigative Site, Dresden

01010

Novartis Investigative Site, Guatemala City

H-1089

Novartis Investigative Site, Budapest

00133

Novartis Investigative Site, Roma

467-8602

Novartis Investigative Site, Nagoya

LV-1001

Novartis Investigative Site, Riga

LV-1004

Novartis Investigative Site, Riga

90-265

Novartis Investigative Site, Lodz

20-079

Novartis Investigative Site, Lublin

03-924

Novartis Investigative Site, Warsaw

08950

Novartis Investigative Site, Esplugues de Llobregat

08041

Novartis Investigative Site, Barcelona

CH - 8032

Novartis Investigative Site, Zurich

DN15 7GB

Novartis Investigative Site, Scunthorpe

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY