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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 2 Years - 17 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04527380
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Eli Lilly and Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

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)
Principal Investigator Affiliation Eli Lilly and Company
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Belgium, Denmark, Germany, Italy, Mexico, Netherlands, Spain, Switzerland, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Juvenile Psoriatic Arthritis, Enthesitis Related Arthritis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Ixekizumab

Ixekizumab given subcutaneously (SC).

Active Comparator: Adalimumab

Adalimumab given SC. Participants may have the option to switch to ixekizumab given SC during the open label extension period.

Interventions

Drug: - Ixekizumab

Administered SC

Drug: - Adalimumab

Administered SC

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Cliniques universitaires Saint-Luc, Brussels, Bruxelles-Capitale, Région De, Belgium

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Address

Cliniques universitaires Saint-Luc

Brussels, Bruxelles-Capitale, Région De, 1200

UZ Gent, Gent, Oost-Vlaanderen, Belgium

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Address

UZ Gent

Gent, Oost-Vlaanderen, 9000

UZ Leuven, Leuven, Vlaams-Brabant, Belgium

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UZ Leuven

Leuven, Vlaams-Brabant, 3000

Aarhus Universitetshospital, Skejby, Aarhus, Midtjylland, Denmark

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Address

Aarhus Universitetshospital, Skejby

Aarhus, Midtjylland, 8200

Universitaetsklinikum Freiburg, Freiburg, Baden-Württemberg, Germany

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Address

Universitaetsklinikum Freiburg

Freiburg, Baden-Württemberg, 79106

Asklepios Klinik Sankt Augustin, Sankt Augustin, Nordrhein-Westfalen, Germany

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Address

Asklepios Klinik Sankt Augustin

Sankt Augustin, Nordrhein-Westfalen, 53757

St. Josef-Stift Sendenhorst, Sendenhorst, Nordrhein-Westfalen, Germany

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Address

St. Josef-Stift Sendenhorst

Sendenhorst, Nordrhein-Westfalen, 48324

Helios Klinikum Berlin-Buch, Berlin, Germany

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Helios Klinikum Berlin-Buch

Berlin, , 13125

Charité Campus Virchow-Klinikum, Berlin, Germany

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Address

Charité Campus Virchow-Klinikum

Berlin, , 13353

Klinikum Bremen-Mitte, Bremen, Germany

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Address

Klinikum Bremen-Mitte

Bremen, , 28177

Hamburg, Germany

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Address

Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari

Hamburg, , 22081

University of Naples Federico II, Napoli, Campania, Italy

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University of Naples Federico II

Napoli, Campania, 80131

IRCCS Istituto Giannina Gaslini, Genova, Liguria, Italy

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IRCCS Istituto Giannina Gaslini

Genova, Liguria, 16147

Milano, Lombardia, Italy

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Address

Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

Milano, Lombardia, 20122

Milano, Lombardia, Italy

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Address

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milano, Lombardia, 20122

A.O.Universitaria Meyer, Firenze, Toscana, Italy

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A.O.Universitaria Meyer

Firenze, Toscana, 50139

Brescia, Italy

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Address

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, , 25123

Mexico City, Distrito Federal, Mexico

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Address

CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas

Mexico City, Distrito Federal, 06700

Utrecht, Netherlands

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Address

UMC Utrecht - Wilhelmina Kinderziekenhuis

Utrecht, , 3584 EA

Hospital Sant Joan de Déu, Esplugues de Llobregat, Barcelona [Barcelona], Spain

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Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona [Barcelona], 08950

Madrid, Madrid, Comunidad De, Spain

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Address

Hospital Infantil Universitario Niño Jesús

Madrid, Madrid, Comunidad De, 28009

H.R.U Málaga - Hospital Materno-infantil, Malaga, Spain

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H.R.U Málaga - Hospital Materno-infantil

Malaga, , 29011

Hospital Universitario Virgen Del Rocio, Sevilla, Spain

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Address

Hospital Universitario Virgen Del Rocio

Sevilla, , 41013

Hospital Universitari i Politecnic La Fe, València, Spain

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Address

Hospital Universitari i Politecnic La Fe

València, , 46026

Universitäts-Kinderspital beider Basel, Basel, Basel-Stadt, Switzerland

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Address

Universitäts-Kinderspital beider Basel

Basel, Basel-Stadt, 4031

Ostschweizer Kinderspital, Sankt Gallen, Switzerland

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Address

Ostschweizer Kinderspital

Sankt Gallen, , 9006

Bristol Royal Hospital for Children, Bristol, Bristol, City Of, United Kingdom

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Address

Bristol Royal Hospital for Children

Bristol, Bristol, City Of, BS2 8BJ

Alder Hey Children's Hospital, Liverpool, England, United Kingdom

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Alder Hey Children's Hospital

Liverpool, England, L14 5AB

Nottingham, Nottinghamshire, United Kingdom

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Queen's Medical Centre, Nottingham University Hospitals

Nottingham, Nottinghamshire, NG7 2UH

Oxford, Oxfordshire, United Kingdom

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Oxford University Hospitals - Nuffield Orthopaedic Centre

Oxford, Oxfordshire, OX3 7HE

Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, United Kingdom

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Royal Stoke University Hospital

Stoke-on-Trent, Staffordshire, ST4 6QG

Haywood Community Hospital, Stoke-on-Trent, Staffordshire, United Kingdom

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Haywood Community Hospital

Stoke-on-Trent, Staffordshire, ST6 7AG

Sheffield Children's Hospital, Sheffield, United Kingdom

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Sheffield Children's Hospital

Sheffield, , S10 2TH

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