NCT03031782

Brief 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

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2017

Typical duration for phase_3

Geographic Reach
10 countries

31 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

May 23, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2020

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

August 15, 2022

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

3.4 years

First QC Date

November 2, 2016

Results QC Date

May 6, 2021

Last Update Submit

August 12, 2022

Conditions

Juvenile Psoriatic ArthritisEnthesitis-related Arthritis

Keywords

JIAJPsAERASecukinumabILARArthritis

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Experiencing a Flare During Treatment Period 2

    Survival analysis of time to flare in treatment period 2 (TP2) FAS2 Subjects are either ERA or JPsA

    From Week 12 until max Week 104

Secondary Outcomes (10)

  • Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - by JIA Category

    baseline, week 12

  • Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - Total

    baseline, week 12

  • Percent Change From Baseline for JIA ACR Core Components in TP1

    baseline, week 12

  • Percent Change in C-reactive Protein Standardized Value (mg/L)

    baseline, week 12

  • Change From Baseline Juvenile Arthritis Disease Activity Score (JADAS) Score

    12 weeks

  • +5 more secondary outcomes

Study Arms (2)

Treatment Period 2 - active

EXPERIMENTAL

secukinumab (AIN457 - pre-filled syringe) for patients with a minimum American college of Rheumatology (ACR) 30 response in Treatment Period 1

Drug: secukinumab

Treatment Period 2 - placebo

PLACEBO COMPARATOR

placebo comparator (matched to secukinumab treatment) for patients with a minimum American college of Rheumatology (ACR) 30 response in Treatment Period 1

Other: placebo

Interventions

secukinumabDRUG

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

Also known as: AIN457
Treatment Period 2 - active
placeboOTHER

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

Treatment Period 2 - placebo

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Novartis Investigative Site

Los Angeles, California, 90027, United States

Location

Novartis Investigative Site

Boise, Idaho, 83702, United States

Location

Novartis Investigative Site

Cincinnati, Ohio, 45229, United States

Location

Novartis Investigative Site

Portland, Oregon, 97232, United States

Location

Novartis Investigative Site

Brussels, 1200, Belgium

Location

Novartis Investigative Site

Ghent, 9000, Belgium

Location

Novartis Investigative Site

Laken, 1020, Belgium

Location

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Freiburg im Breisgau, 79106, Germany

Location

Novartis Investigative Site

Hamburg, 22081, Germany

Location

Novartis Investigative Site

Saint Augustin, 53757, Germany

Location

Novartis Investigative Site

Genova, GE, 16147, Italy

Location

Novartis Investigative Site

Napoli, 80131, Italy

Location

Novartis Investigative Site

Krakow, 31503, Poland

Location

Novartis Investigative Site

Moscow, 119991, Russia

Location

Novartis Investigative Site

Saint Petersburg, 194100, Russia

Location

Novartis Investigative Site

Voronezh, 394036, Russia

Location

Novartis Investigative Site

Yekaterinburg, 620149, Russia

Location

Novartis Investigative Site

Cape Town, 7925, South Africa

Location

Novartis Investigative Site

Panorama, 7500, South Africa

Location

Novartis Investigative Site

Santiago de Compostela, Galicia, 15706, Spain

Location

Novartis Investigative Site

Valencia, 46026, Spain

Location

Novartis Investigative Site

Istanbul, Halkali, 34303, Turkey (Türkiye)

Location

Novartis Investigative Site

Istanbul, TUR, 34098, Turkey (Türkiye)

Location

Novartis Investigative Site

Ankara, 06100, Turkey (Türkiye)

Location

Novartis Investigative Site

Istanbul, 34766, Turkey (Türkiye)

Location

Novartis Investigative Site

Bristol, BS2 8BJ, United Kingdom

Location

Novartis Investigative Site

Glasgow, G51 4TF, United Kingdom

Location

Novartis Investigative Site

Liverpool, L12 2AP, United Kingdom

Location

Novartis Investigative Site

London, WC1N 3JH, United Kingdom

Location

Novartis Investigative Site

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (2)

  • Weiss PF, Ruperto N, Quebe-Fehling E, Shew A, Pricop L, Pieterse CC, Brunner HI; Paediatric Rheumatology International Trials Organisation (PRINTO) and Pediatric Rheumatology Collaborative Study Group (PRCSG) Investigative Sites. Juvenile Spondyloarthritis Disease Activity Index Validation in Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis in a Prospective Clinical Trial Setting. J Rheumatol. 2026 Jan 1;53(1):85-94. doi: 10.3899/jrheum.2025-0294.

    PMID: 40953957DERIVED

  • Brunner HI, Foeldvari I, Alexeeva E, Ayaz NA, Calvo Penades I, Kasapcopur O, Chasnyk VG, Hufnagel M, Zuber Z, Schulert G, Ozen S, Rakhimyanova A, Ramanan A, Scott C, Sozeri B, Zholobova E, Martin R, Zhu X, Whelan S, Pricop L, Martini A, Lovell D, Ruperto N; Paediatric Rheumatology INternational Trials Organization (PRINTO) and Pediatric Rheumatology Collaborative Study Group (PRCSG). Secukinumab in enthesitis-related arthritis and juvenile psoriatic arthritis: a randomised, double-blind, placebo-controlled, treatment withdrawal, phase 3 trial. Ann Rheum Dis. 2023 Jan;82(1):154-160. doi: 10.1136/ard-2022-222849. Epub 2022 Aug 12.

    PMID: 35961761DERIVED

MeSH Terms

Conditions

Arthritis, JuvenileArthritis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
novartis.email@novartis.com
(862) 778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2016

First Posted

January 26, 2017

Study Start

May 23, 2017

Primary Completion

October 7, 2020

Study Completion

November 9, 2020

Last Updated

August 15, 2022

Results First Posted

August 15, 2022

Record last verified: 2022-08

Locations

PL(1)RU(4)TU(4)US(4)BE(3)ZA(2)GB(5)IT(2)ES(2)DE(4)