Recruiting
Phase 1

Secukinumab

Sponsor:

Novartis Pharmaceuticals

Code:

NCT06751238

Conditions

Juvenile Psoriatic Arthritis

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Interventions

Secukinumab

Study Details

Brief 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

Conditions

Juvenile Psoriatic Arthritis

Study ID

NCT06751238

Start date

Sep 24, 2025

Status verified date

Aug, 2026

Completion date

Mar 11, 2031

Anticipated

Primary completion date

Oct 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Secukinumab

Secukinumab administered intravenously in pediatric participants with JPsA

Interventions

Secukinumab

Intravenous secukinumab

Primary outcome measure

  • Maximum concentration on Day 1 [ Time Frame: Pre-infusion and end of infusion (EOI) at Day 1 ]
  • Maximum concentration at steady-state (Cmax, ss) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Locations

Loma Linda University Health

Recruiting

Loma Linda, California, United States, 92354

Contacts

Monica Pizana

+1 909 558 5830mpizana@llu.edu

Principal Investigator:

Wendy De La Pena

University of Florida

Recruiting

Gainesville, Florida, United States, 32610 8068

Contacts

Joel Ravel

Joal.Ravel@UFHelath.ORG

Principal Investigator:

Christian Oliveros

Ann and Robert H Lurie Childs Hosp

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Tyler Sorensen

+1 312 227 4811tsorensen@luriechildrens.org

Principal Investigator:

Pooja Patel

Col Uni Med Center New York Presby

Recruiting

New York, New York, United States, 10032

Contacts

Marcela Arizabaleta

+1 646 317 1669ma5005@cumc.columbia.edu

Principal Investigator:

Lisa Imundo

Levine Childrens Hospital

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Haley D Furr

+1 800 821 1535Haley.Furr@advocatehealth.org

Principal Investigator:

Sheetal Vora

Cincinnati Childrens Hospital

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Megan Quinlan-Waters

+1 513 636 7261Megan.Quinlan-Waters@cchmc.org

Principal Investigator:

Hermine Brunner

Univ Hosp Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106-5028

Contacts

Katrina Gogin

+1 216 844 7164katrina.gogin@uhhospitals.org

Principal Investigator:

Ezequiel Borgia

Legacy Emanuel Research Hosp Portland

Recruiting

Portland, Oregon, United States, 97232

Contacts

Brenna Bogle

+1 503 413 5447bbogle@lhs.org

Principal Investigator:

Daniel Joseph Kingsbury

Childrens Hosp Pittsburgh UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Vibha Chauhan

+1 412 692 6327vibha.chauhan@chp.edu

Principal Investigator:

Margalit Rosenkranz

Texas Arthritis Center

Recruiting

El Paso, Texas, United States, 79902

Contacts

Melissa Lopez

melissa.lopez@aara.care

Principal Investigator:

Sanjay Chabra

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84113

Contacts

Tressie Rollins

+1 415 515 8212tressie.rollins@hsc.utah.edu

Principal Investigator:

Peter Chiraseveenuprapund

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • Pediatric
  • JPsA
  • Pharmacokinetic (PK)
  • safety
  • Intravenous (i.v.)
  • Secukinumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-08-21.