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
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.
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
Juvenile Psoriatic Arthritis
Active, not recruiting
Oct 09, 2020
May 23, 2017
Nov 09, 2020
2 Years - 17 Years (Child)
Secukinumab (AIN457) is a high-affinity fully human monoclonal anti-human antibody that targets IL-17A and neutralizes activity.
Matched placebo to AIN457 for use in the double blind Treatment Period 2
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.
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.