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Monoclonal Antibodies

Secukinumab for Juvenile Arthritis

Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must not have
Plans for administration of live vaccines during the extension study period.
Any patient taking other concomitant biologic immunomodulating agent(s) except secukinumab.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 308 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is investigating whether secukinumab is effective and safe in treating two subtypes of Juvenile Idiopathic Arthritis: Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis.

Who is the study for?
This trial is for young patients with Juvenile Psoriatic Arthritis (JPsA) or Enthesitis Related Arthritis (ERA) who completed a previous secukinumab study. They should be seeing benefits from the treatment to qualify, and can't be on other biologic immunomodulators or planning to receive live vaccines.
What is being tested?
The trial is an extension study testing the long-term effects and safety of secukinumab, known as AIN457, in children with JPsA and ERA. It's open label, meaning everyone knows they're getting the actual drug, not a placebo.
What are the potential side effects?
Secukinumab may cause side effects like infections due to immune system suppression, allergic reactions at injection sites, diarrhea, upper respiratory tract infections, and possibly others that are less common.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I plan to get live vaccines during the study.
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I am not taking any immune-modifying drugs except secukinumab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~308 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 308 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with JIA ACR30 response
Secondary study objectives
Number of participants with JIA ACR 50/70/90/100 response
Number of participants with Juvenile Arthritis Disease Activity Score (JADAS)
Number of participants with inactive disease status
+3 more

Side effects data

From 2019 Phase 3 trial • 383 Patients • NCT03136861
4%
Headache
3%
Oropharyngeal pain
2%
Fatigue
2%
Diarrhoea
2%
Pain in extremity
2%
Nasopharyngitis
1%
Proteinuria
1%
Pharyngitis
1%
Upper respiratory tract infection
1%
Arthralgia
1%
Cough
1%
Blood creatinine increased
1%
Pruritus
1%
Hypertension
1%
Abdominal pain
1%
Injection site pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Secukinumab 150 mg (Group A)
Placebo (Group B)
Arm A2
Arm A3
Arm B1
Arm B2
Arm A1

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group 2 - Secukinumab 150 mgExperimental Treatment1 Intervention
Group 2 - Secukinumab (AIN457) 150 mg/1.0mL
Group II: Group 1 - Secukinumab 75 mgExperimental Treatment1 Intervention
Group 1 - Secukinumab (AIN457) 75 mg/0.5mL
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AIN457
2017
Completed Phase 3
~2590

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,907 Previous Clinical Trials
4,209,581 Total Patients Enrolled

Media Library

AIN457 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03769168 — Phase 3
Enthesitis Related Arthritis Research Study Groups: Group 2 - Secukinumab 150 mg, Group 1 - Secukinumab 75 mg
Enthesitis Related Arthritis Clinical Trial 2023: AIN457 Highlights & Side Effects. Trial Name: NCT03769168 — Phase 3
AIN457 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03769168 — Phase 3
~9 spots leftby Nov 2025
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