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Secukinumab Safety and Efficacy in JPsA and ERA

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ClinicalTrials.gov Identifier: NCT03031782
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : November 17, 2017
Sponsor:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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 : December 30, 2020
Estimated Study Completion Date : December 30, 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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT03031782


Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
United States, California
Novartis Investigative Site Recruiting
Los Angeles, California, United States, 90027
United States, Oregon
Novartis Investigative Site Recruiting
Portland, Oregon, United States, 97232
Belgium
Novartis Investigative Site Recruiting
Bruxelles, Belgium, 1200
Novartis Investigative Site Recruiting
Gent, Belgium, 9000
Novartis Investigative Site Recruiting
Laeken, Belgium, 1020
Germany
Novartis Investigative Site Recruiting
Berlin, Germany, 13125
Novartis Investigative Site Recruiting
Berlin, Germany, 13353
Novartis Investigative Site Recruiting
Bremen, Germany, 28177
Novartis Investigative Site Recruiting
Freiburg, Germany, 79106
Novartis Investigative Site Recruiting
Hamburg, Germany, 22081
Novartis Investigative Site Recruiting
Muenster, Germany, 48149
Novartis Investigative Site Recruiting
Saint Augustin, Germany, 53757
Novartis Investigative Site Recruiting
Sendenhorst, Germany, 48324
Italy
Novartis Investigative Site Recruiting
Genova, GE, Italy, 16147
Poland
Novartis Investigative Site Recruiting
Krakow, Poland, 31503
Russian Federation
Novartis Investigative Site Recruiting
Moscow, Russian Federation, 119991
Novartis Investigative Site Recruiting
Saint-Petersburg, Russian Federation, 194100
Novartis Investigative Site Recruiting
Yekaterinburg, Russian Federation, 620149
Spain
Novartis Investigative Site Recruiting
Esplugues de Llobregat, Barcelona, Spain, 08950
Novartis Investigative Site Recruiting
Santiago de Compostela, Galicia, Spain, 15706
Novartis Investigative Site Recruiting
Madrid, Spain, 28009
Novartis Investigative Site Recruiting
Valencia, Spain, 46026
Turkey
Novartis Investigative Site Recruiting
Istanbul, Halkali, Turkey, 34303
Novartis Investigative Site Recruiting
Istanbul, TUR, Turkey, 34098
Novartis Investigative Site Recruiting
Ankara, Turkey, 06100
United Kingdom
Novartis Investigative Site Recruiting
Bristol, United Kingdom, BS2 8BJ
Novartis Investigative Site Recruiting
Liverpool, United Kingdom, L12 2AP
Novartis Investigative Site Recruiting
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov 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: November 17, 2017
Last Verified: November 2017
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 www.clinicalstudydatarequest.com


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:
Arthritis
Arthritis, Psoriatic
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs