Étude visant à évaluer la pharmacocinétique (PK), l'innocuité et la tolérance jusqu'à 6 ans du sécukinumab intraveineux (i.v.) chez les participants pédiatriques atteints de polyarthrite psoriasique juvénile (JPsA).
Une étude multicentrique ouverte pour évaluer la pharmacocinétique, l'innocuité et la tolérance jusqu'à 6 ans de perfusions intraveineuses de sécukinumab chez des participants pédiatriques atteints de polyarthrite psoriasique juvénile
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Novartis Pharmaceuticals
- Numéro de téléphone: 1-888-669-6682
- E-mail: novartis.email@novartis.com
Sauvegarde des contacts de l'étude
- Nom: Novartis Pharmaceuticals
Lieux d'étude
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California
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Loma Linda, California, États-Unis, 92354
- Recrutement
- Loma Linda University Health
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Contact:
- Monica Pizana
- Numéro de téléphone: +1 909 558 5830
- E-mail: mpizana@llu.edu
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Chercheur principal:
- Wendy De La Pena
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Florida
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Gainesville, Florida, États-Unis, 32610-8068
- Recrutement
- University of Florida
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Chercheur principal:
- Christian Oliveros
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Contact:
- Joel Ravel
- E-mail: Joal.Ravel@UFHelath.ORG
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Illinois
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Chicago, Illinois, États-Unis, 60611
- Recrutement
- Ann and Robert H Lurie Childs Hosp
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Chercheur principal:
- Pooja Patel
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Contact:
- Gabrielle Morgan
- Numéro de téléphone: +1 312 227 4811
- E-mail: gamorgan@luriechildrens.org
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New York
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New York, New York, États-Unis, 10032
- Recrutement
- Col Uni Med Center New York Presby
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Contact:
- Marcela Arizabaleta
- Numéro de téléphone: +1 646 317 1669
- E-mail: ma5005@cumc.columbia.edu
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Chercheur principal:
- Lisa Imundo
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North Carolina
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Charlotte, North Carolina, États-Unis, 28203
- Recrutement
- Levine Childrens Hospital
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Chercheur principal:
- Sheetal Vora
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Contact:
- Haley D Furr
- Numéro de téléphone: +1 800 821 1535
- E-mail: Haley.Furr@advocatehealth.org
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Ohio
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Cincinnati, Ohio, États-Unis, 45229
- Recrutement
- Cincinnati Childrens Hospital
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Chercheur principal:
- Hermine Brunner
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Contact:
- Megan Quinlan-Waters
- Numéro de téléphone: +1 513 636 7261
- E-mail: Megan.Quinlan-Waters@cchmc.org
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Cleveland, Ohio, États-Unis, 44106-5028
- Recrutement
- Univ Hosp Cleveland Medical Center
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Chercheur principal:
- Ezequiel Borgia
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Contact:
- Katrina Gogin
- Numéro de téléphone: +1 216 844 7164
- E-mail: katrina.gogin@uhhospitals.org
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Oregon
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Portland, Oregon, États-Unis, 97232
- Recrutement
- Legacy Emanuel Research Hosp Portland
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Chercheur principal:
- Daniel Joseph Kingsbury
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Contact:
- Brenna Bogle
- Numéro de téléphone: +1 503 413 5447
- E-mail: bbogle@lhs.org
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Pennsylvania
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Pittsburgh, Pennsylvania, États-Unis, 15224
- Recrutement
- Childrens Hosp Pittsburgh UPMC
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Chercheur principal:
- Margalit Rosenkranz
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Contact:
- Vibha Chauhan
- Numéro de téléphone: +1 412 692 6327
- E-mail: vibha.chauhan@chp.edu
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Texas
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El Paso, Texas, États-Unis, 79902
- Recrutement
- Texas Arthritis Center
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Chercheur principal:
- Sanjay Chabra
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Contact:
- Melissa Lopez
- E-mail: melissa.lopez@aara.care
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Utah
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Salt Lake City, Utah, États-Unis, 84113
- Recrutement
- University of Utah
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Contact:
- Tressie Rollins
- Numéro de téléphone: +1 415 515 8212
- E-mail: tressie.rollins@hsc.utah.edu
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Chercheur principal:
- Peter Chiraseveenuprapund
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Key Inclusion Criteria:
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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).
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Males and females ≥2 years old to <18 years old at the time of screening.
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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.
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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).
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Inadequate response (≥1 month) or intolerance to ≥1 Non-Steroidal Anti-Inflammatory Drug (NSAID) at screening.
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Inadequate response (≥2 months) or intolerance to ≥ 1 Disease Modifying Anti-Rheumatic Drug (DMARD) at screening.
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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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Secukinumab
Secukinumab administered intravenously in pediatric participants with JPsA |
Intravenous secukinumab
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Maximum concentration on Day 1
Délai: Pre-infusion and end of infusion (EOI) at Day 1
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Maximum concentration of secukinumab on Day 1 |
Pre-infusion and end of infusion (EOI) at Day 1
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Maximum concentration at steady-state (Cmax, ss)
Délai: 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
|
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)
Délai: 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 |
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
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|
Area under the concentration-time curve at steady-state (AUCtau, ss)
Délai: 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 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)
Délai: 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 |
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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Délai: Up to Week 20
|
Number of participants with AEs and SAEs as a measure of safety and tolerability |
Up to Week 20
|
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Number of participants with clinically significant changes in clinical laboratory measures and vital signs.
Délai: Up to Week 20
|
Number of participants with clinically significant changes in clinical laboratory measures and vital signs as a measure of safety and tolerability |
Up to Week 20
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CAIN457G22101
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Informations sur les médicaments et les dispositifs, documents d'étude
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