Phase 1: testing Secukinumab for Juvenile Psoriatic Arthritis
This study wants to determine the PK, whether it is safe and how hard side effects are to live with of multiple doses of intravenous (i.v.) secukinumab in pediatric participants with JPsA
Official registry: https://clinicaltrials.gov/study/NCT06751238 · Novartis Pharmaceuticals · enrollment listed as 20
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Secukinumab. The registry lists allocation as na. This study wants to determine the PK, whether it is safe and how hard side effects are to live with of multiple doses of intravenous (i.v.) secukinumab in pediatric participants with JPsA
They plan to enroll about 20 people at 11 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.
Official title (unrewritten)
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
Interventions: Secukinumab
Primary outcome (registry wording): Maximum concentration on Day 1
Who it is for (from inclusion criteria)
- Ages 2 Years to 17 Years
- 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)
Who the registry excludes
- 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
Public study contact (from the registry)
Novartis Pharmaceuticals
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
11 listed- Loma Linda University Health — Loma Linda, California (recruiting)
- University of Florida — Gainesville, Florida (recruiting)
- Ann and Robert H Lurie Childs Hosp — Chicago, Illinois (recruiting)
- Col Uni Med Center New York Presby — New York, New York (recruiting)
- Levine Childrens Hospital — Charlotte, North Carolina (recruiting)
- Cincinnati Childrens Hospital — Cincinnati, Ohio (recruiting)
- Univ Hosp Cleveland Medical Center — Cleveland, Ohio (recruiting)
- Legacy Emanuel Research Hosp Portland — Portland, Oregon (recruiting)
- Childrens Hosp Pittsburgh UPMC — Pittsburgh, Pennsylvania (recruiting)
- Texas Arthritis Center — El Paso, Texas (recruiting)
- University of Utah — Salt Lake City, Utah (recruiting)
FAQ about this NCT record
Is NCT06751238 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06751238?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06751238?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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