Juvenile Psoriatic ArthritisPhase 1NCT06751238
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).
A Phase 1 study testing Secukinumab in people with Juvenile Psoriatic Arthritis, run by Novartis Pharmaceuticals at 11 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Juvenile Psoriatic Arthritis
- What is being tested?
- Secukinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 11 sitesUnited States
- Study dates
- 24 Sep 2025to 11 Mar 2031
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Levine Childrens Hospital
Charlotte, North Carolina, 28203
Haley D Furr, +1 800 821 1535, Haley.Furr@advocatehealth.org
Sheetal Vora
- Recruiting
Ann and Robert H Lurie Childs Hosp
Chicago, Illinois, 60611
Gabrielle Morgan, +1 312 227 4811, gamorgan@luriechildrens.org
Pooja Patel
- Recruiting
Cincinnati Childrens Hospital
Cincinnati, Ohio, 45229
Megan Quinlan-Waters, +1 513 636 7261, Megan.Quinlan-Waters@cchmc.org
Hermine Brunner
- Recruiting
Univ Hosp Cleveland Medical Center
Cleveland, Ohio, 44106-5028
Katrina Gogin, +1 216 844 7164, katrina.gogin@uhhospitals.org
Ezequiel Borgia
- Recruiting
Texas Arthritis Center
El Paso, Texas, 79902
Melissa Lopez, melissa.lopez@aara.care
Sanjay Chabra
- Recruiting
University of Florida
Gainesville, Florida, 32610-8068
Joel Ravel, Joal.Ravel@UFHelath.ORG
Christian Oliveros
- Recruiting
Loma Linda University Health
Loma Linda, California, 92354
Monica Pizana, +1 909 558 5830, mpizana@llu.edu
Wendy De La Pena
- Recruiting
Col Uni Med Center New York Presby
New York, New York, 10032
Marcela Arizabaleta, +1 646 317 1669, ma5005@cumc.columbia.edu
Lisa Imundo
- Recruiting
Childrens Hosp Pittsburgh UPMC
Pittsburgh, Pennsylvania, 15224
Vibha Chauhan, +1 412 692 6327, vibha.chauhan@chp.edu
Margalit Rosenkranz
- Recruiting
Legacy Emanuel Research Hosp Portland
Portland, Oregon, 97232
Brenna Bogle, +1 503 413 5447, bbogle@lhs.org
Daniel Joseph Kingsbury
- Recruiting
University of Utah
Salt Lake City, Utah, 84113
Tressie Rollins, +1 415 515 8212, tressie.rollins@hsc.utah.edu
Peter Chiraseveenuprapund
About this study
Official title: 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
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
Read the detailed description
This is a multicenter, open-label study with an optional treatment extension period to evaluate pharmacokinetics, safety and tolerability (up to 6 years) of i.v. secukinumab in pediatric patients with JPsA.
- Conditions
- Juvenile Psoriatic Arthritis
- Being tested
- Secukinumab
- Keywords
- Pediatric, JPsA, Pharmacokinetic (PK), safety, Intravenous (i.v.), Secukinumab
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabBiological
Also called AIN457
Intravenous secukinumab
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab | Experimental | Secukinumab administered intravenously in pediatric participants with JPsA Receives: Biological: Secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration on Day 1
Maximum concentration of secukinumab on Day 1
Measured: Pre-infusion and end of infusion (EOI) at Day 1
Maximum concentration at steady-state (Cmax, ss)
Maximum concentration at steady-state.
Measured: Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365
Minimum concentration at steady-state (Cmin, ss)
Minimum concentration at steady-state
Measured: Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365
Area under the concentration-time curve at steady-state (AUCtau, ss)
Area under the concentration-time curve at steady-state during a dosing interval
Measured: Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365
Average concentration at steady-state (Cavg,ss)
Average concentration at steady-state
Measured: Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365
Secondary outcomes (2)
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs as a measure of safety and tolerability
Measured: Up to Week 20
Number of participants with clinically significant changes in clinical laboratory measures and vital signs.
Number of participants with clinically significant changes in clinical laboratory measures and vital signs as a measure of safety and tolerability
Measured: Up to Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start24 Sep 2025
- Primary completion31 Oct 2029 (estimated)
- Study completion11 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751238
- Sponsor's protocol ID
- CAIN457G22101
- Status last verified
- Oct 2026
- First submitted
- 20 Dec 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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