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
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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