Clinical trial NCT04527380: A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Juvenile Psoriatic Arthritis
Enthesitis Related Arthritis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-08-26
Enrollment: 101
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Participants must not have active or history of inflammatory bowel disease
* Participants must not have active uveitis
* Participants must not have active or latent tuberculosis
* Participants must not have an active infection
* Participants must not have concurrent use of biologic agents for the treatment of the juvenile idiopathic arthritis

Primary outcomes:
measure: Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 (Ixekizumab - OLT Period)
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving JIA ACR 30 (Adalimumab - OLT Period)
timeFrame: Week 16
measure: Percentage of Participants Achieving JIA ACR 50/70/90/100 (OLT Period)
timeFrame: Week 16
measure: Percentage of Participants Achieving JIA ACR 30/50/70/90/100 (OLE Period)
timeFrame: Week 104
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) for Juvenile Psoriatic Arthritis (JPsA) Participants With at Least 3% Body Surface Area (BSA) at Baseline (OLT Period)
timeFrame: Baseline, Week 16
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) for Juvenile Psoriatic Arthritis (JPsA) Participants With at Least 3% Body Surface Area (BSA) at Baseline (OLE Period)
timeFrame: Baseline, Week 104
measure: Change From Baseline in Leeds Enthesitis Index (LEI) for Participants With Enthesitis Related Arthritis (ERA) at Baseline (OLT Period)
timeFrame: Baseline, Week 16
measure: Change From Baseline in Leeds Enthesitis Index (LEI) for Participants With Enthesitis Related Arthritis (ERA) at Baseline (OLE Period)
timeFrame: Baseline, Week 104
measure: Percentage of Participants With Disease Flare (OLT Period)
timeFrame: Week 2 through Week 16
measure: Percentage of Participants With Disease Flare (OLE Period)
timeFrame: Baseline through Week 104
measure: Pharmacokinetics (PK): Trough Concentrations (C-trough) of Ixekizumab (Ixekizumab - OLT Period)
timeFrame: Week 4, 12 and 16 : Pre-dose
measure: Pharmacokinetics (PK): Trough Concentrations (C-trough) of Ixekizumab (Ixekizumab - OLE Period)
timeFrame: Week 20, 32, 56, 80 and 104 : Pre-dose
measure: Percentage of Participants With Treatment-emergent Positive Anti-ixekizumab Antibodies (Ixekizumab - OLT Period)
timeFrame: Baseline through Week 16
measure: Percentage of Participants With Treatment-emergent Positive Anti-ixekizumab Antibodies (Ixekizumab - OLE Period)
timeFrame: Baseline through Week 104
Other outcomes:
Locations:
city: Rosario
country: Argentina
facility: Instituto CAICI SRL Loc. 15
state: Santa Fe
city: San Miguel De Tucumán
country: Argentina
facility: Centro Medico Privado de Reumatologia Loc. 20
state: Tucumán
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
state: Bruxelles-Capitale, Région De
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
city: Praha
country: Czechia
facility: Oddeleni revmatologie deti a dospelych Loc. 1
state: Praha 5
city: Olomouc
country: Czechia
facility: Dětská klinika Loc. 11
city: Praha 2
country: Czechia
facility: Klinika detskeho a dorostoveho lekarstvi Loc. 1
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital, Skejby
state: Midtjylland
city: Montpellier
country: France
facility: Service de consultation pédiatrique Loc. 1
state: Hérault
city: Le Kremlin-Bicêtre
country: France
facility: Rhumatologie pediatrique et CEREMAIA Loc. 1
state: Paris
city: Bron
country: France
facility: Service rhumatologie Loc.
state: Rhône-Alpes
city: Poitiers
country: France
facility: RHUMATOLOGIE Loc. 1
state: Vienne
city: Paris
country: France
facility: Centre d'Investigation Clinique Loc. 1
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
state: Baden-Württemberg
city: Sankt Augustin
country: Germany
facility: Asklepios Klinik Sankt Augustin
state: Nordrhein-Westfalen
city: Sendenhorst
country: Germany
facility: St. Josef-Stift Sendenhorst
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum
city: Bremen
country: Germany
facility: Klinikum Bremen-Mitte
city: Hamburg
country: Germany
facility: Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
city: Napoli
country: Italy
facility: University of Naples Federico II
state: Campania
city: Genova
country: Italy
facility: IRCCS Istituto Giannina Gaslini
state: Liguria
city: Milano
country: Italy
facility: Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
state: Lombardia
city: Firenze
country: Italy
facility: A.O.Universitaria Meyer
state: Toscana
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
city: Mexico City
country: Mexico
facility: CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas
state: Distrito Federal
city: Utrecht
country: Netherlands
facility: UMC Utrecht - Wilhelmina Kinderziekenhuis
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Déu
state: Barcelona [Barcelona]
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesús
state: Madrid, Comunidad De
city: Malaga
country: Spain
facility: H.R.U Málaga - Hospital Materno-infantil
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: València
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Basel
country: Switzerland
facility: Universitäts-Kinderspital beider Basel
state: Basel-Stadt
city: Sankt Gallen
country: Switzerland
facility: Ostschweizer Kinderspital
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
state: Bristol, City Of
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital
state: England
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre, Nottingham University Hospitals
state: Nottinghamshire
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals - Nuffield Orthopaedic Centre
state: Oxfordshire
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital
state: Staffordshire
city: Stoke-on-Trent
country: United Kingdom
facility: Haywood Community Hospital
state: Staffordshire
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM -5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: