CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 55 enrolled
Drug / intervention
Secukinumabdrug
Likely dose
Secukinumab 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03769168
NCT03769168Phase 3Completed

An Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Efficacy, Safety and Tolerability up to 4 Years in Patients With Juvenile Idiopathic Arthritis Subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis

Novartis Pharmaceuticals·interventional·Posted Dec 7, 2018·Updated Oct 16, 2025

In Brief

A Phase 3 clinical trial evaluating Secukinumab for Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis. Completed, enrolled 55 participants across 23 sites in 9 countries.

Detailed Summary

Optional open label, roll over extension study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic Arthritis (JIA) subtypes of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Germany, Italy, Poland, Russia, South Africa, Spain, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedDec 7, 2018
Enrollment StartJun 7, 2019
Primary CompletionNov 7, 2024
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 7.6 years ago

Interventions

Secukinumabdrug

Secukinumab solution for subcutaneous injections was provided in PFS. Initially, participants continued to receive secukinumab at either 75 mg (in 0.5mL) or 150 mg (in 1mL) every 4 weeks, consistent with their dosage at the Week 100 visit of the core study. The dose could be escalated from 75 mg to 150 mg for patients whose signs and symptoms were not fully controlled, as judged by the investigator, with the current 75 mg dose. Furthermore, the dose could also be escalated to 300 mg every 4 weeks for patients weighing 50kg and over who were currently on the 150 mg dose and whose signs and symptoms were not well-controlled, as judged by the investigator. The dose escalation from secukinumab 75 mg to 300 mg was to be implemented in two steps (first 150 mg and then 300 mg based on the investigator's judgment). At each study treatment time point, one or two subcutaneous injections in the form of PFS were administered.