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NCT06751238From ClinicalTrials.govRecruiting

Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability up to 6 Years of Intravenous (i.v.) Secukinumab in Pediatric Participants With Juvenile Psoriatic Arthritis (JPsA).

An Open-label, Multicenter Study to Evaluate Pharmacokinetics, Safety and Tolerability up to 6 Years of Intravenous Secukinumab Infusions in Pediatric Participants With Juvenile Psoriatic Arthritis

  • Juvenile Psoriatic Arthritis

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Novartis Pharmaceuticals
Enrolment target
20
Started
24 September 2025
Main results due
31 October 2029
Study sites
11
Registry updated
28 September 2026

Can you take part?

  • Ages 2 years to 17 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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

What this study is about

In the sponsor’s own words, from the registry.

The purpose of this study is to determine the PK, safety and tolerability of multiple doses of intravenous (i.v.) secukinumab in pediatric participants with JPsA

Study sites(11)

  • 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

  • Univ Hosp Cleveland Medical Center

    Cleveland, Ohio, United States

    Recruiting

  • Legacy Emanuel Research Hosp Portland

    Portland, Oregon, United States

    Recruiting

  • Childrens Hosp Pittsburgh UPMC

    Pittsburgh, Pennsylvania, United States

    Recruiting

  • Texas Arthritis Center

    El Paso, Texas, United States

    Recruiting

  • University of Utah

    Salt Lake City, Utah, United States

    Recruiting

Showing 11 of 11 sites. 11 of the 11 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06751238. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability up to 6 Years of Intravenous (i.v.) Secuk | Trialion