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

Juvenile Psoriatic Arthritis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04527380
• Other study ID #: 16694
• Secondary ID: I1F-MC-RHCG2018-
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 13, 2021
• Est. completion date: April 24, 2028

Study information

• Verified date: March 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: April 24, 2028
• Est. primary completion date: February 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Psoriatic
• Enthesitis Related Arthritis
• Enthesopathy
• Juvenile Psoriatic Arthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Ixekizumab
Administered SC
• Adalimumab
Administered SC

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels	Bruxelles-Capitale, Région De
Belgium	UZ Gent	Gent	Oost-Vlaanderen
Belgium	UZ Leuven	Leuven	Vlaams-Brabant
Denmark	Aarhus Universitetshospital, Skejby	Aarhus	Midtjylland
Germany	Charité Campus Virchow-Klinikum	Berlin
Germany	Helios Klinikum Berlin-Buch	Berlin
Germany	Klinikum Bremen-Mitte	Bremen
Germany	Universitaetsklinikum Freiburg	Freiburg	Baden-Württemberg
Germany	Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari	Hamburg
Germany	Asklepios Klinik Sankt Augustin	Sankt Augustin	Nordrhein-Westfalen
Germany	St. Josef-Stift Sendenhorst	Sendenhorst	Nordrhein-Westfalen
Italy	Azienda Ospedaliera Spedali Civili di Brescia	Brescia
Italy	A.O.Universitaria Meyer	Firenze	Toscana
Italy	IRCCS Istituto Giannina Gaslini	Genova	Liguria
Italy	Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO	Milano	Lombardia
Italy	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milano	Lombardia
Italy	University of Naples Federico II	Napoli	Campania
Mexico	CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas	Mexico City	Distrito Federal
Netherlands	UMC Utrecht - Wilhelmina Kinderziekenhuis	Utrecht
Spain	Hospital Sant Joan de Déu	Esplugues de Llobregat	Barcelona [Barcelona]
Spain	Hospital Infantil Universitario Niño Jesús	Madrid	Madrid, Comunidad De
Spain	H.R.U Málaga - Hospital Materno-infantil	Malaga
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Spain	Hospital Universitari i Politecnic La Fe	València
Switzerland	Universitäts-Kinderspital beider Basel	Basel	Basel-Stadt
Switzerland	Ostschweizer Kinderspital	Sankt Gallen
United Kingdom	Bristol Royal Hospital for Children	Bristol	Bristol, City Of
United Kingdom	Alder Hey Children's Hospital	Liverpool	England
United Kingdom	Queen's Medical Centre, Nottingham University Hospitals	Nottingham	Nottinghamshire
United Kingdom	Oxford University Hospitals - Nuffield Orthopaedic Centre	Oxford	Oxfordshire
United Kingdom	Sheffield Children's Hospital	Sheffield
United Kingdom	Haywood Community Hospital	Stoke-on-Trent	Staffordshire
United Kingdom	Royal Stoke University Hospital	Stoke-on-Trent	Staffordshire

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Belgium,  Denmark,  Germany,  Italy,  Mexico,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30	Percentage of Participants Achieving JIA ACR 30	Week 16
Secondary	Percentage of Participants Achieving JIA ACR 30/50/70/90/100	Percentage of Participants Achieving JIA ACR 30/50/70/90/100	Week 0 up to Week 264
Secondary	Change from Baseline in Psoriasis Area and Severity Index (PASI) for JPsA Participants with at Least 3% Body Surface Area (BSA) at Baseline	Change from Baseline in PASI for JPsA Participants with at Least 3% BSA at Baseline	Baseline, up to Week 264
Secondary	Change from Baseline in Leeds Enthesitis Index (LEI) for Participants with Enthesitis at Baseline	Change from Baseline in LEI for Participants with Enthesitis at Baseline	Baseline, up to Week 264
Secondary	Percentage of Participants with Disease Flare (Flare Defined as Worsening of =30% from Baseline in at Least 3 of the 6 JIA ACR Core Set Criteria and an Improvement of =30% in No More than 1 of the Criteria)	Percentage of Participants with Disease Flare (Flare Defined as Worsening of =30% from Baseline in at Least 3 of the 6 JIA ACR Core Set Criteria and an Improvement of =30% in No More than 1 of the Criteria)	Week 0 up to Week 264
Secondary	Pharmacokinetics (PK): Trough Concentrations (Ctrough) of Ixekizumab	Pharmacokinetics (PK): Ctrough of Ixekizumab	Week 16
Secondary	Number of Participants with Anti-Ixekizumab Antibodies	Number of Participants with Anti-Ixekizumab Antibodies	Week 0 up to Week 264

External Links

•   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