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

Completed · Phase 3 · Has a placebo group

Conditions studied: Juvenile Psoriatic Arthritis, Enthesitis-related Arthritis

In brief

This was 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 was 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

Key facts

Study ID

NCT03031782

Run by

Novartis Pharmaceuticals

People needed

86

Starts

2017-05-23

Expected to finish

2020-11-09

Last updated by the study team

2022-08-15

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Boise, Idaho, United States
• Novartis Investigative Site — Cincinnati, Ohio, United States
• Novartis Investigative Site — Portland, Oregon, United States
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Laken, Belgium
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Freiburg im Breisgau, Germany
• Novartis Investigative Site — Hamburg, Germany
• Novartis Investigative Site — Saint Augustin, Germany
• Novartis Investigative Site — Genova, GE, Italy
• Novartis Investigative Site — Naples, Italy
• Novartis Investigative Site — Krakow, Poland
• Novartis Investigative Site — Moscow, Russia
• Novartis Investigative Site — Saint Petersburg, Russia
• Novartis Investigative Site — Voronezh, Russia
• Novartis Investigative Site — Yekaterinburg, Russia
• Novartis Investigative Site — Cape Town, South Africa
• Novartis Investigative Site — Panorama, South Africa
• Novartis Investigative Site — Santiago de Compostela, Galicia, Spain
• Novartis Investigative Site — Valencia, Spain
• Novartis Investigative Site — Istanbul, Halkali, Turkey (Türkiye)
• Novartis Investigative Site — Istanbul, TUR, Turkey (Türkiye)
• Novartis Investigative Site — Ankara, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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