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

NCT03031782 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2022-08-15

Study results available
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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

Conditions

  • Juvenile Psoriatic Arthritis
  • Enthesitis-related Arthritis

Interventions

DRUG

secukinumab

secukinumab is a high-affinity fully human monoclonal anti-human antibody that targets IL-17A and neutralizes activity.

OTHER

placebo

Matched placebo to AIN457 for use in the double blind Treatment Period 2

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-23
Primary Completion
2020-10-07
Completion
2020-11-09
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Germany
  • Italy
  • Poland
  • Russia
  • South Africa
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03031782 on ClinicalTrials.gov