Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (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. |
ClinicalTrials.gov Identifier: NCT03031782 |
Recruitment Status :
Completed
First Posted : January 26, 2017
Last Update Posted : April 9, 2021
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Juvenile Psoriatic Arthritis Enthesitis-related Arthritis | Drug: AIN457 Other: Matched placebo | Phase 3 |
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 |
Actual Primary Completion Date : | October 7, 2020 |
Actual Study Completion Date : | November 9, 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 |
- 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.
- Change from baseline for Juvenile idiopathic arthritis (JIA) American college of rheumatology (ACR) 30/50/70/90/100 response [ Time Frame: 12 weeks ]
- Change from baseline for JIA ACR core components [ Time Frame: 12 weeks ]
- Change from baseline Juvenile Arthritis Disease Activity Score (JADAS) score [ Time Frame: 12 weeks ]
- Change from baseline in total enthesitis count [ Time Frame: 12 weeks ]
- Change from baseline in total dactylitis count [ Time Frame: 12 weeks ]
- 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
- Secukinumab serum concentration [ Time Frame: 104 weeks ]Will assess secukinumab serum concentrations over time
- Number of participants with reported Adverse Events [ Time Frame: 104 weeks ]
- Percentage of participants with anti-secukinumab anitbodies [ Time Frame: 104 weeks ]Will be assessed by immunogenicity techniques from blood samples drawn during the study.
- Change from baseline for inactive disease status [ Time Frame: 12 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 2 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Other protocol-defined inclusion/exclusion criteria apply.

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
United States, California | |
Novartis Investigative Site | |
Los Angeles, California, United States, 90027 | |
United States, Idaho | |
Novartis Investigative Site | |
Boise, Idaho, United States, 83702 | |
United States, Ohio | |
Novartis Investigative Site | |
Cincinnati, Ohio, United States, 45229 | |
United States, Oregon | |
Novartis Investigative Site | |
Portland, Oregon, United States, 97232 | |
Belgium | |
Novartis Investigative Site | |
Bruxelles, Belgium, 1200 | |
Novartis Investigative Site | |
Gent, Belgium, 9000 | |
Novartis Investigative Site | |
Laeken, Belgium, 1020 | |
Germany | |
Novartis Investigative Site | |
Berlin, Germany, 13353 | |
Novartis Investigative Site | |
Freiburg, Germany, 79106 | |
Novartis Investigative Site | |
Hamburg, Germany, 22081 | |
Novartis Investigative Site | |
Saint Augustin, Germany, 53757 | |
Italy | |
Novartis Investigative Site | |
Genova, GE, Italy, 16147 | |
Novartis Investigative Site | |
Napoli, Italy, 80131 | |
Poland | |
Novartis Investigative Site | |
Krakow, Poland, 31503 | |
Russian Federation | |
Novartis Investigative Site | |
Moscow, Russian Federation, 119991 | |
Novartis Investigative Site | |
Saint-Petersburg, Russian Federation, 194100 | |
Novartis Investigative Site | |
Voronezh, Russian Federation, 394036 | |
Novartis Investigative Site | |
Yekaterinburg, Russian Federation, 620149 | |
South Africa | |
Novartis Investigative Site | |
Cape Town, South Africa, 7925 | |
Novartis Investigative Site | |
Panorama, South Africa, 7500 | |
Spain | |
Novartis Investigative Site | |
Santiago de Compostela, Galicia, Spain, 15706 | |
Novartis Investigative Site | |
Valencia, Spain, 46026 | |
Turkey | |
Novartis Investigative Site | |
Istanbul, Halkali, Turkey, 34303 | |
Novartis Investigative Site | |
Istanbul, TUR, Turkey, 34098 | |
Novartis Investigative Site | |
Ankara, Turkey, 06100 | |
Novartis Investigative Site | |
Istanbul, Turkey, 34766 | |
United Kingdom | |
Novartis Investigative Site | |
Bristol, United Kingdom, BS2 8BJ | |
Novartis Investigative Site | |
Glasgow, United Kingdom, G51 4TF | |
Novartis Investigative Site | |
Liverpool, United Kingdom, L12 2AP | |
Novartis Investigative Site | |
London, United Kingdom, WC1N 3JH | |
Novartis Investigative Site | |
Nottingham, United Kingdom, NG7 2UH |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03031782 |
Other Study ID Numbers: |
CAIN457F2304 2016-003761-26 ( EudraCT Number ) |
First Posted: | January 26, 2017 Key Record Dates |
Last Update Posted: | April 9, 2021 |
Last Verified: | April 2021 |
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 |
JIA JPsA ERA Secukinumab ILAR |
Arthritis Arthritis, Psoriatic Enthesopathy Arthritis, Juvenile Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases Bone Diseases |
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Tendinopathy Muscular Diseases Tendon Injuries Wounds and Injuries Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |