Study of Efficacy and Safety of Secukinumab 2 mL Auto-injector (300 mg) in Subjects With Moderate to Severe Plaque Psoriasis

PHASE3CompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

December 19, 2018

Primary Completion Date

November 19, 2019

Study Completion Date

August 5, 2020

Conditions
Plaque Psoriasis
Interventions
DRUG

Placebo 2 mL auto-injector

"All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8.~PASI 90 responders at week 12: 2 mL auto-injector placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48.~PASI 90 non-responders at week 12: 2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48"

DRUG

Placebo 1 mL prefilled syringe

"All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8.~PASI 90 responders at week 12: 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48.~PASI 90 non-responders at week 12: 2x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48"

DRUG

Secukinumab 2 mL auto-injector

2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15 , 16 and 4-weekly thereafter until week 48

DRUG

Secukinumab 1 mL prefilled syringe

2 x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48

Trial Locations (22)

201

Novartis Investigative Site, Kopavogur

28031

Novartis Investigative Site, Madrid

28041

Novartis Investigative Site, Madrid

30060

Novartis Investigative Site, Marietta

33155

Novartis Investigative Site, Miami

33647

Novartis Investigative Site, Bielefeld

45147

Novartis Investigative Site, Essen

46014

Novartis Investigative Site, Valencia

49377

Novartis Investigative Site, Vechta

58453

Novartis Investigative Site, Witten

64506

Novartis Investigative Site, Saint Joseph

77030

Novartis Investigative Site, Houston

77479

Novartis Investigative Site, Sugar Land

78218

Novartis Investigative Site, San Antonio

97210

Novartis Investigative Site, Portland

07044

Novartis Investigative Site, Verona

T5K 1X3

Novartis Investigative Site, Edmonton

V3R 6A7

Novartis Investigative Site, Surrey

02 495

Novartis Investigative Site, Warsaw

50-566

Novartis Investigative Site, Wroclaw

03010

Novartis Investigative Site, Alicante

08003

Novartis Investigative Site, Barcelona

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY