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Clinical trials
NCT06751238

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).

ClinicalTrials.gov identifier NCT06751238

Novartis reference CAIN457G22101

Show study information as

Condition Juvenile Psoriatic Arthritis

Study status Recruiting

Phase 1

Number of participants 20

Gender All

Age 2 to 17 years

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Study details

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.

Interventions

BIOLOGICAL: Secukinumab

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

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Who can take part?

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.

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

Home
Clinical trials
NCT06751238

Study of Intravenous Investigational Treatment for Juvenile Psoriatic Arthritis

ClinicalTrials.gov identifier NCT06751238

Novartis reference CAIN457G22101

Show study information as

Condition Juvenile Psoriatic Arthritis

Study status Recruiting

Phase 1

Number of participants 20

Gender All

Age 2 to 17 years

Learn More

Study details

This text was simplified by AI to make it easier to read. It may contain mistakes. Switch to Original information for the official version.

The purpose of this research study is to learn about how an investigational treatment moves through the body, and its safety and tolerability, in children and teens with juvenile psoriatic arthritis. Juvenile psoriatic arthritis is a type of childhood arthritis that causes joint swelling and pain and is linked to psoriasis in some people.

Participants will receive multiple doses of an investigational treatment given through a vein (intravenous infusion). This study is open-label, which means all participants will receive the investigational treatment. Participants may be able to continue in an optional extended treatment period, with participation lasting up to about 6 years in total.

This study may be an option for
Children and teens may be able to participate if they:

Are 2 to 17 years old at screening
Have a confirmed diagnosis of juvenile psoriatic arthritis for at least 6 months
Have active disease with at least 3 active joints
Have tried at least 1 non-steroidal anti-inflammatory drug (NSAID) and it did not work well enough or caused difficult side effects
Have tried at least 1 disease-modifying anti-rheumatic drug (DMARD) and it did not work well enough or caused difficult side effects
Meet the study rules for certain background medicines if they are taking them (such as stable doses of methotrexate, a low-dose oral corticosteroid, or 1 NSAID)

Study timeline and visits:
Participation may last up to about 6 years, including an optional extended treatment period.

Interventions

BIOLOGICAL: Secukinumab

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

Who can take part?

This text was simplified by AI to make it easier to read. It may contain mistakes. Switch to Original information for the official version.

You might be able to join if

A parent or legal representative must provide written informed consent, and the child must provide assent if appropriate, before any study-related activities. If the participant reaches the local age of consent during the study, they must also sign the study consent form.
Be male or female and be 2 years old to under 18 years old at screening.
Have a confirmed diagnosis of juvenile psoriatic arthritis based on modified International League of Associations for Rheumatology (ILAR) criteria, with the diagnosis made at least 6 months before screening.
Have active juvenile psoriatic arthritis, defined as at least 3 active joints (swollen, or if not swollen then both tender and with limited range of motion) at baseline.
Have tried at least 1 NSAID for at least 1 month and it did not work well enough, or they could not tolerate it, at screening.
Have tried at least 1 DMARD for at least 2 months and it did not work well enough, or they could not tolerate it, at screening.
If using certain second-line medicines to treat juvenile psoriatic arthritis, meet all of the following requirements:
- Be on a stable dose of methotrexate for at least 4 weeks before the baseline visit (up to 20 mg/m2 body surface area per week), with folic or folinic acid supplementation according to the center’s standard practice.
- Be on a stable dose of an oral corticosteroid for at least 7 days before baseline, at less than 0.2 mg/kg/day prednisone equivalent or up to 10 mg/day maximum (whichever is lower).
- Be on a stable dose of no more than 1 NSAID for at least 1 week before baseline.

You might not be able to join if

Weigh less than 10 kg at screening.
Have used another investigational drug within 4 weeks or within 5 drug half-lives before baseline, or until the expected drug effect has returned to baseline (whichever is longer).
Have a history of allergy (hypersensitivity) to the study treatment or its ingredients (excipients), or to drugs in similar chemical classes.
Have active inflammatory bowel disease or active uveitis at screening or baseline.
Meet diagnostic criteria at baseline for any ILAR juvenile idiopathic arthritis category other than juvenile psoriatic arthritis.
Have been treated with a medication that is not allowed by the study.
Be taking any non-biologic DMARD at screening other than methotrexate.
Have any medical or mental health condition that, in the study doctor’s opinion, would prevent the participant from following the study plan or finishing the study as required.

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