Evaluating the safety and effectiveness of intravenous secukinumab in children with juvenile psoriatic arthritis.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the pharmacokinetics, safety, and tolerability of multiple doses of intravenous secukinumab in pediatric participants diagnosed with juvenile psoriatic arthritis (JPsA). It is a multicenter, open-label study that includes an optional treatment extension period lasting up to six years. Participants will be monitored for their response to the treatment and any adverse effects that may arise during the study period.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Participants parent's or legal representative(s) written informed consent and child's assent, if appropriate, must be obtained before any study related activity or assessment is performed. Of note, if the participant reaches age of consent (as per local law) during the study, they will also need to sign the corresponding study ICF (Informed Consent Form).
* Males and females ≥2 years old to \<18 years old at the time of screening.
* Confirmed diagnosis of JPsA according to the modified International League of Associations for Rheumatology (ILAR) classification criteria that must have occurred at least 6 months prior to screening.
* Active JPsA disease defined as ≥3 active joints (swollen or if not swollen must be both tender and limited range of motion) at baseline (BSL).
* Inadequate response (≥1 month) or intolerance to ≥1 Non-Steroidal Anti-Inflammatory Drug (NSAID) at screening.
* Inadequate response (≥2 months) or intolerance to ≥ 1 Disease Modifying Anti-Rheumatic Drug (DMARD) at screening.
* Concomitant use of the following second-line agents such as disease-modifying and/or immunosuppressive drugs to treat the JPsA will be allowed:

  * Stable dose of methotrexate (MTX) (maximum of 20 mg/ m2 BSA/ week) for at least 4 weeks prior to the BSL visit, with folic/folinic acid supplementation (according to standard medical practice of the center).
  * Stable dose of an oral corticosteroid (CS) at a prednisone equivalent dose of \<0.2 mg/kg/day or up to 10 mg/day maximum, whichever is less, for at least 7 days prior to BSL.
  * Stable dose of no more than one NSAID for at least 1 week prior to BSL.

Key Exclusion Criteria:

* Participants with body weight less than 10 kg at screening.
* Use of other investigational drugs within 4 weeks or 5 half-lives of BSL, or until the expected pharmacodynamic effect has returned to BSL, whichever is longer.
* History of hypersensitivity to study drug or its excipients or to drugs of similar chemical classes.
* Participants with active inflammatory bowel disease or active uveitis at screening or BSL.
* Fulfilling diagnostic criteria for any International League of Associations for Rheumatology (ILAR ) juvenile idiopathic arthritis (JIA) category other than JPsA at BSL.
* Participants treated with prohibited medication
* Participants taking any non-biologic DMARD at screening except for MTX.
* Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.

Other inclusion/exclusion criteria may apply

Where it's running

• Loma Linda University Health
  Loma Linda, California, United States Recruiting
• University of Florida
  Gainesville, Florida, United States Recruiting
• Ann and Robert H Lurie Childs Hosp
  Chicago, Illinois, United States Recruiting
• Col Uni Med Center New York Presby
  New York, New York, United States Recruiting
• Levine Childrens Hospital
  Charlotte, North Carolina, United States Recruiting
• Cincinnati Childrens Hospital
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Secukinumab for moderate-to-severe hidradenitis suppurativa

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.