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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).

Novartis Pharmaceuticals · NCT06751238

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 2–17 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1
Target enrollment
20
US sites recruiting
11
Study start
September 24, 2025
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: Secukinumab

Conditions: Juvenile Psoriatic Arthritis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Loma Linda University Health

    Loma Linda, CA 92354

    Site contact: Monica Pizana · +1 909 558 5830 · mpizana@llu.edu

  • University of Florida

    Gainesville, FL 32610-8068

    Site contact: Joel Ravel · Joal.Ravel@UFHelath.ORG

  • Ann and Robert H Lurie Childs Hosp

    Chicago, IL 60611

    Site contact: Gabrielle Morgan · +1 312 227 4811 · gamorgan@luriechildrens.org

  • Col Uni Med Center New York Presby

    New York, NY 10032

    Site contact: Marcela Arizabaleta · +1 646 317 1669 · ma5005@cumc.columbia.edu

  • Levine Childrens Hospital

    Charlotte, NC 28203

    Site contact: Haley D Furr · +1 800 821 1535 · Haley.Furr@advocatehealth.org

  • Cincinnati Childrens Hospital

    Cincinnati, OH 45229

    Site contact: Megan Quinlan-Waters · +1 513 636 7261 · Megan.Quinlan-Waters@cchmc.org

  • Univ Hosp Cleveland Medical Center

    Cleveland, OH 44106-5028

    Site contact: Katrina Gogin · +1 216 844 7164 · katrina.gogin@uhhospitals.org

  • Legacy Emanuel Research Hosp Portland

    Portland, OR 97232

    Site contact: Brenna Bogle · +1 503 413 5447 · bbogle@lhs.org

  • Childrens Hosp Pittsburgh UPMC

    Pittsburgh, PA 15224

    Site contact: Vibha Chauhan · +1 412 692 6327 · vibha.chauhan@chp.edu

  • Texas Arthritis Center

    El Paso, TX 79902

    Site contact: Melissa Lopez · melissa.lopez@aara.care

  • University of Utah

    Salt Lake City, UT 84113

    Site contact: Tressie Rollins · +1 415 515 8212 · tressie.rollins@hsc.utah.edu

Study contacts (from the official record)

  • Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com
  • Novartis Pharmaceuticals
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Study to Evaluate the Pharmacokinetics (PK), Safety and… (NCT06751238) | Bored Studies