Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA)
Condition: Juvenile Psoriatic Arthritis; Enthesitis-related Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic; Enthesopathy; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      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
    

Detailed description: 
      TP1: All eligible subjects entered TP1 to receive 12-weeks of open-label secukinumab at a
      dose predicted to achieve secukinumab serum levels equivalent to adults administered a 150 mg
      dose regimen. Secukinumab was administered s.c. weekly for the first 4 weeks (Baseline, Weeks
      1, 2, 3, 4) and then every 4 weeks thereafter. Clinical response (JIA ACR 30) was assessed at
      Week 12. Responders advanced to TP2 and non-responders exited the trial (early termination
      visit and entered into the Post-treatment follow-up period).

      TP2: Subjects who were a responder (JIA ACR 30) at Week 12 entered the double-blind
      withdrawal TP2 and were randomized 1:1 to either secukinumab or placebo on that visit and
      then every 4 weeks, until either experiencing a disease flare or completion of TP2. TP2 was
      event driven and was planned to be closed when 33 subjects experienced a disease flare as per
      JIA definition. Alternatively, the study could be closed when all subjects reached the total
      study duration of 104 Weeks and therefore subjects who did not experience a disease flare
      remained in TP2 for the duration of the study and completed the study without entering into
      TP3

      TP3: Subjects experiencing a disease flare in TP2 immediately entered TP3 to receive
      openlabel secukinumab every 4 weeks until total study duration of 104 weeks for that subject
      was achieved.

      Post-treatment follow-up: The post-treatment follow-up period (lasting 12 weeks from the last
      study drug administration) was required for all subjects, unless they qualified and entered
      the secukinumab extension trial. All subjects were expected to participate in the
      post-treatment follow up period, except for those entering the extension study.
    

Intervention name(s): secukinumab; placebo
Intervention type(s): Drug; Other
Intervention description(s): secukinumab 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
Other intervention name(s): AIN457
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: JIA; JPsA; ERA; Secukinumab; ILAR; Arthritis