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Secukinumab Safety and Efficacy in JPsA and ERA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03031782
Recruitment Status : Active, not recruiting
First Posted : January 26, 2017
Last Update Posted : June 11, 2019
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This is 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 is 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.

Condition or disease Intervention/treatment Phase
Juvenile Psoriatic Arthritis Enthesitis-related Arthritis Drug: AIN457 Other: Matched placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Three-part Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Secukinumab Treatment in Juvenile Idiopathic Arthritis Subtypes of Psoriatic and Enthesitis-related Arthritis
Actual Study Start Date : May 23, 2017
Estimated Primary Completion Date : October 22, 2019
Estimated Study Completion Date : December 29, 2020

Arm Intervention/treatment
Experimental: Treatment Period 2 - active
secukinumab (AIN457 - pre-filled syringe) for patients with a minimum American college of Rheumatology (ACR) 30 response in Treatment Period 1
Drug: AIN457
Secukinumab (AIN457) is a high-affinity fully human monoclonal anti-human antibody that targets IL-17A and neutralizes activity.

Placebo Comparator: Treatment Period 2 - placebo
Placebo comparator (matched to secukinumab treatment) for patients with a minimum American college of Rheumatology (ACR) 30 response in Treatment Period 1
Other: Matched placebo
Matched placebo to AIN457 for use in the double blind Treatment Period 2

Primary Outcome Measures :
  1. Time to flare in Treatment Period 2 [ Time Frame: From Week 12 until max Week 104 ]
    Patients will be randomised 1:1 secukinumab:Placebo at beginning of event-driven Treatment Period 2 at Week 12.

Secondary Outcome Measures :
  1. Change from baseline for Juvenile idiopathic arthritis (JIA) American college of rheumatology (ACR) 30/50/70/90/100 response [ Time Frame: 12 weeks ]
  2. Change from baseline for JIA ACR core components [ Time Frame: 12 weeks ]
  3. Change from baseline Juvenile Arthritis Disease Activity Score (JADAS) score [ Time Frame: 12 weeks ]
  4. Change from baseline in total enthesitis count [ Time Frame: 12 weeks ]
  5. Change from baseline in total dactylitis count [ Time Frame: 12 weeks ]
  6. Percentage of participants with JIA ACR 30/50/70/90/100 and inactive disease [ Time Frame: From week 12 to up to week 104 ]
    To evaluate the effect of withdrawal of secukinumab treatment

  7. Secukinumab serum concentration [ Time Frame: 104 weeks ]
    Will assess secukinumab serum concentrations over time

  8. Number of participants with reported Adverse Events [ Time Frame: 104 weeks ]
  9. Percentage of participants with anti-secukinumab anitbodies [ Time Frame: 104 weeks ]
    Will be assessed by immunogenicity techniques from blood samples drawn during the study.

  10. Change from baseline for inactive disease status [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal anti-inflammatory drugs(NSAID)
  4. Inadequate response (at least 2 months) or intolerance to at least 1 Disease-modifying antirheumatic drugs (DMARD)
  5. No concomitant use of second line agents such as disease-modifying and/or immunosuppressive drugs.

Exclusion Criteria:

  1. Patients fulfilling any ILAR diagnostic JIA category other than ERA or JPsA.
  2. Patients who have ever received biologic immunomodulating agents
  3. Patients taking any non-biologic DMARD except for MTX (or sulfasalazine for ERA patients only).
  4. Patients with active uncontrolled inflammatory bowel disease or active uncontrolled uveitis.

Other protocol-defined inclusion/exclusion criteria apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03031782

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Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals Identifier: NCT03031782     History of Changes
Other Study ID Numbers: CAIN457F2304
2016-003761-26 ( EudraCT Number )
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
JIA, JPsA, ERA, Secukinumab, ILAR
Additional relevant MeSH terms:
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Arthritis, Psoriatic
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs