NCT06751238RecruitingPhase 1
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).
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 20 Dec 2024
- Start date
- 24 Sept 2025
- Primary completion date
- 31 Oct 2029
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Psoriatic arthritis
- NCT number
- NCT06751238
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 24 Sept 2025 to the primary completion date, 31 Oct 2029
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Participants treated with prohibited medication
Other illness
- 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.
- 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
Other
- Participants with body weight less than 10 kg at screening.
- Fulfilling diagnostic criteria for any International League of Associations for Rheumatology (ILAR ) juvenile idiopathic arthritis (JIA) category other than JPsA at BSL.
- Participants taking any non-biologic DMARD at screening except for MTX.
Who the study is looking for
- 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.
Age in the registry: 2 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Levine Childrens Hospital Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| Ann and Robert H Lurie Childs Hosp Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Cincinnati Childrens Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Univ Hosp Cleveland Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Texas Arthritis Center Coordinator of this site? Confirm its status | El Paso | United States | Recruiting |
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
| Loma Linda University Health Coordinator of this site? Confirm its status | Loma Linda | United States | Recruiting |
| Col Uni Med Center New York Presby Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Childrens Hosp Pittsburgh UPMC Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Legacy Emanuel Research Hosp Portland Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.