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).
Recruiting
Phase 1Interventional Study
Juvenile Psoriatic Arthritis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
2 – 17
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for children aged 2 to 17 with juvenile psoriatic arthritis (JPsA) who are having trouble with current treatments. Participants will receive multiple doses of a medication called secukinumab to see how well it works and if it is safe.
Are You a Good Fit for This Trial?
Must be takingMethotrexate
Must not be takingNon-biologic DMARD
Rules you outActive inflammatory bowel diseaseActive uveitis
You may be able to join if
I am between 2 and 17 years old.
I have been diagnosed with juvenile psoriatic arthritis.
My JPsA has been active with multiple swollen or painful joints.
I have not responded well to other arthritis medications.
I have a parent or legal representative who can give consent.
You may not be able to join if
I weigh less than 10 kg.
I have taken other investigational drugs recently.
I have allergies to secukinumab or similar drugs.
I have active inflammatory bowel disease or uveitis.
I do not meet the criteria for juvenile psoriatic arthritis.
I am using prohibited medications.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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
Trial Locations
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Eligibility 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 stu…
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
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