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).

NCT06751238 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CAIN457G22101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 7

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Maximum concentration on Day 1

  Maximum concentration of secukinumab on Day 1

  Pre-infusion and end of infusion (EOI) at Day 1

• Maximum concentration at steady-state (Cmax, ss)

  Maximum concentration at steady-state.

  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

  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

  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

  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)

  Up to Week 20

• Number of participants with clinically significant changes in clinical laboratory measures and vital signs.

  Up to Week 20

Study Arms (1)

Secukinumab

EXPERIMENTAL

Secukinumab administered intravenously in pediatric participants with JPsA

Biological: Secukinumab

Interventions

Secukinumab BIOLOGICAL

Intravenous secukinumab

Also known as: AIN457

Secukinumab

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (7)

University of Florida

Gainesville, Florida, 32610 8068, United States

RECRUITING

Ann and Robert H Lurie Childs Hosp

Chicago, Illinois, 60611, United States

RECRUITING

Levine Childrens Hospital

Charlotte, North Carolina, 28203, United States

RECRUITING

Cincinnati Childrens Hospital

Cincinnati, Ohio, 45229, United States

RECRUITING

Univ Hosp Cleveland Medical Center

Cleveland, Ohio, 44106-5028, United States

RECRUITING

Legacy Emanuel Research Hosp Portland

Portland, Oregon, 97232, United States

RECRUITING

Texas Arthritis Center

El Paso, Texas, 79902, United States

RECRUITING

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

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

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: September 24, 2025
• Primary Completion (Estimated): November 30, 2032
• Study Completion (Estimated): December 1, 2032
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (7)