Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA)

A Three-part Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Secukinumab Treatment in Juvenile Idiopathic Arthritis Subtypes of Psoriatic and Enthesitis-related Arthritis

ClinicalTrials.gov Identifier: NCT03031782

Novartis Reference Number: CAIN457F2304

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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 double-blind, placebo-controlled, event-driven randomized withdrawal study to investigate the efficacy and safety of secukinumab treatment in the Juvenile Idiopathic Arthritis (JIA) categories of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA). The study is divided into 3 parts (plus a post-treatment follow-up period) consisting of open-label, single-arm active treatment in Treatment Periods 1 and 3 and a randomized, double-blind, placebo controlled, event-driven withdrawal design in Treatment Period 2

Condition 
Juvenile Psoriatic Arthritis
Enthesitis-related Arthritis
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
86 participants
Start date 
May 23, 2017
Completion date 
Nov 09, 2020
Gender 
All
Age(s)
2 Years - 17 Years (Child)

Interventions

Drug
AIN457
Secukinumab (AIN457) is a high-affinity fully human monoclonal anti-human antibody that targets IL-17A and neutralizes activity.
Other
Matched placebo
Matched placebo to AIN457 for use in the double blind Treatment Period 2

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of Enthesitis-related arthritis (ERA) or Juvenile psoriatic arthritis (JPsA) according to the International League of Associations for Rheumatology (ILAR) classification criteria of at least 6 months duration.

Active disease (ERA or JPsA) defined as having both:

at least 3 active joints
at least 1 site of active enthesitis at baseline or documented by history.
Inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal anti-inflammatory drugs(NSAID)
Inadequate response (at least 2 months) or intolerance to at least 1 Disease-modifying antirheumatic drugs (DMARD)
No concomitant use of second line agents such as disease-modifying and/or immunosuppressive drugs.

Exclusion Criteria:

Patients fulfilling any ILAR diagnostic JIA category other than ERA or JPsA.
Patients who have ever received biologic immunomodulating agents
Patients taking any non-biologic DMARD except for MTX (or sulfasalazine for ERA patients only).
Patients with active uncontrolled inflammatory bowel disease or active uncontrolled uveitis.

Other protocol-defined inclusion/exclusion criteria apply.

Study Locations

United States
Novartis Investigative Site
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Los Angeles, 90027
California
United States
Novartis Investigative Site
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Boise, 83702
Idaho
United States
Novartis Investigative Site
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Cincinnati, 45229
Ohio
United States
Novartis Investigative Site
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Portland, 97232
Oregon
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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Laeken, 1020
-
Belgium
Germany
Novartis Investigative Site
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Berlin, 13353
-
Germany
Novartis Investigative Site
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Freiburg, 79106
-
Germany
Novartis Investigative Site
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Hamburg, 22081
-
Germany
Novartis Investigative Site
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Saint Augustin, 53757
-
Germany
Italy
Novartis Investigative Site
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Genova, 16147
GE
Italy
Novartis Investigative Site
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Napoli, 80131
-
Italy
Poland
Novartis Investigative Site
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Krakow, 31503
-
Poland
Russian Federation
Novartis Investigative Site
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Moscow, 119991
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Russian Federation
Novartis Investigative Site
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Saint-Petersburg, 194100
-
Russian Federation
Novartis Investigative Site
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Voronezh, 394036
-
Russian Federation
Novartis Investigative Site
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Yekaterinburg, 620149
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Russian Federation
South Africa
Novartis Investigative Site
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Cape Town, 7925
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South Africa
Novartis Investigative Site
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Panorama, 7500
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South Africa
Spain
Novartis Investigative Site
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Santiago de Compostela, 15706
Galicia
Spain
Novartis Investigative Site
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Valencia, 46026
-
Spain
Turkey
Novartis Investigative Site
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Istanbul, 34303
Halkali
Turkey
Novartis Investigative Site
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Istanbul, 34098
TUR
Turkey
Novartis Investigative Site
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Ankara, 06100
-
Turkey
Novartis Investigative Site
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Istanbul, 34390
-
Turkey
Novartis Investigative Site
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Istanbul, 34766
-
Turkey
United Kingdom
Novartis Investigative Site
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Bristol, BS2 8BJ
-
United Kingdom
Novartis Investigative Site
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Glasgow, G51 4TF
-
United Kingdom
Novartis Investigative Site
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Liverpool, L12 2AP
-
United Kingdom
Novartis Investigative Site
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London, WC1N 3JH
-
United Kingdom
Novartis Investigative Site
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Nottingham, NG7 2UH
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United Kingdom

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Call 1-999-669-6682 or email [email protected]