Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab With Adalimumab Reference Arm, in Children With Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
Who is this study for? Children with juvenile idiopathic arthritis subtypes of enthesitis-related arthritis and juvenile psoriatic arthritis
What treatments are being studied? Ixekizumab
Status: Active_not_recruiting
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The reason for this study is to see if the study drug ixekizumab is safe and effective in children with juvenile idiopathic arthritis (JIA) categories of enthesitis-related arthritis (ERA) (including juvenile onset ankylosing spondylitis \[JoAS\]) and juvenile psoriatic arthritis (JPsA).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:
• Participants must have active juvenile idiopathic arthritis (categories of enthesitis related arthritis or juvenile psoriatic arthritis)
• Participants must have weight of at least 10 kilograms (Kg), age starting at 2 years for participants with juvenile psoriatic arthritis and starting at 6 years for participants with enthesitis related arthritis
• Participants must have all immunizations up-to-date in agreement with current immunization guidelines, in the opinion of the investigator
Locations
Other Locations
Argentina
Instituto CAICI SRL Loc. 15
Rosario
Centro Medico Privado de Reumatologia Loc. 20
San Miguel De Tucumán
Belgium
Cliniques universitaires Saint-Luc
Brussels
UZ Gent
Ghent
UZ Leuven
Leuven
Denmark
Aarhus Universitetshospital, Skejby
Aarhus
France
Service rhumatologie Loc.
Bron
Rhumatologie pediatrique et CEREMAIA Loc. 1
Le Kremlin-bicêtre
Service de consultation pédiatrique Loc. 1
Montpellier
Centre d'Investigation Clinique Loc. 1
Paris
RHUMATOLOGIE Loc. 1
Poitiers
Germany
Charité Campus Virchow-Klinikum
Berlin
Helios Klinikum Berlin-Buch
Berlin
Klinikum Bremen-Mitte
Bremen
Universitaetsklinikum Freiburg
Freiburg Im Breisgau
Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
Hamburg
Asklepios Klinik Sankt Augustin
Sankt Augustin
St. Josef-Stift Sendenhorst
Sendenhorst
Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia
A.O.Universitaria Meyer
Florence
IRCCS Istituto Giannina Gaslini
Genoa
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
Milan
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan
University of Naples Federico II
Napoli
Mexico
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas
Mexico City
Netherlands
UMC Utrecht - Wilhelmina Kinderziekenhuis
Utrecht
Spain
Hospital Sant Joan de Déu
Esplugues De Llobregat
Hospital Infantil Universitario Niño Jesús
Madrid
H.R.U Málaga - Hospital Materno-infantil
Málaga
Hospital Universitario Virgen Del Rocio
Seville
Hospital Universitari i Politecnic La Fe
Valencia
Switzerland
Universitäts-Kinderspital beider Basel
Basel
Ostschweizer Kinderspital
Sankt Gallen
United Kingdom
Bristol Royal Hospital for Children
Bristol
Alder Hey Children's Hospital
Liverpool
Queen's Medical Centre, Nottingham University Hospitals
Nottingham
Oxford University Hospitals - Nuffield Orthopaedic Centre
Oxford
Sheffield Children's Hospital
Sheffield
Haywood Community Hospital
Stoke-on-trent
Royal Stoke University Hospital
Stoke-on-trent
Time Frame
Start Date: 2021-04-13
Completion Date: 2028-04
Participants
Target number of participants: 101
Treatments
Experimental: Ixekizumab - OLT Period
Participants received subcutaneous (SC) ixekizumab from week 0 to week 16, following dosing regimens based on body weight:~* Greater than (\>) 50.0 kg: Starting dose 160 mg at week 0, then 80 mg SC every 4 weeks (Q4W) from week 2 to week 16.~* 25.0-50.0 kg: Starting dose 80 mg at week 0, then 40 mg SC Q4W from week 2 to week 16.~* 10.0 to less than (\<) 25.0 kg: Starting dose 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16.
Active_comparator: Adalimumab - OLT Period
Participants received SC adalimumab from week 0 to week 16, following dosing regimens based on body weight:~* Greater than or equal to (≥) 30.0 kg: 40 mg SC every 2 weeks (Q2W).~* 10.0 to \<30.0 kg: 20 mg SC Q2W.
Authors
Marisol Comacho Lovillo, Frank Weller-Heinemann, Jonathan Packham, Daniel Philip Hawley, Markus Hufnagel, Satyapal Rangaraj, Kirsten Minden, Alexandre Belot, Liza McCann, Rolando Cimaz, Aurelia Carbasse, Akhila Murthy Kavirayani, Gerd Horneff, Athimalaipet Ramanan, Elisabeth Gervais, Daniel Windschall, Andreas Woerner, Ivan Foeldvari, Ralf Trauzeddel, Elisabeth Solau-Gervais, Christian Huemer, Pavla Dolezalova, Joke Dehoorne, Cecile Boulanger, Maria Alessio, Joost Frans Swart, Giovanni Filocamo, Jordi Anton, Mia Glerup, Roberta Caorsi, Daniel Clemente, Achille Marino, Marco Cattalini, Inmaculada Calvo Penades, Ilaria Pagnini, Cesar Francisco Pacheco-Tena
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company