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 Recruiting
Countries Argentina, Belgium, Czechia, Denmark, France, 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

Instituto CAICI SRL, Rosario, Santa Fe, Argentina

Status

Recruiting

Address

Instituto CAICI SRL

Rosario, Santa Fe, S2000

Centro de Investigaciones Médica Tucumán, SAN M. DE Tucuman, Tucumán, Argentina

Status

Recruiting

Address

Centro de Investigaciones Médica Tucumán

SAN M. DE Tucuman, Tucumán, T4000AXL

UZ Gent-Reuma, Gent, East Flanders, Belgium

Status

Recruiting

Address

UZ Gent-Reuma

Gent, East Flanders, 9000

Leuven, Vlaams-Brabant, Belgium

Status

Recruiting

Address

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, Vlaams-Brabant, 3000

UCL- Saint Luc, Bruxelles, Belgium

Status

Recruiting

Address

UCL- Saint Luc

Bruxelles, , 1200

University Hospital Motol, Prague, Praha 5, Czechia

Status

Recruiting

Address

University Hospital Motol

Prague, Praha 5, 150 06

Fakultni nemocnice Olomouc, Olomouc, Czechia

Status

Recruiting

Address

Fakultni nemocnice Olomouc

Olomouc, , 775 20

Vseobecna fakultni nemocnice v Praze, Praha 2, Czechia

Status

Recruiting

Address

Vseobecna fakultni nemocnice v Praze

Praha 2, , 12808

Aarhus Universitetshospital, Aarhus, Midtjylland, Denmark

Status

Recruiting

Address

Aarhus Universitetshospital

Aarhus, Midtjylland, 8200

Bron, Rhône-Alpes, France

Status

Recruiting

Address

Hospices Civils de Lyon - Hôpital Femme Mère Enfant

Bron, Rhône-Alpes, 69500

CHU Poitiers - Hopital Jean Bernard, Poitiers Cedex, Vienne, France

Status

Recruiting

Address

CHU Poitiers - Hopital Jean Bernard

Poitiers Cedex, Vienne, 86021

Le Kremlin Bicetre, France

Status

Recruiting

Address

Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

Le Kremlin Bicetre, , 94275

Montpellier Cedex 5, France

Status

Recruiting

Address

Hôpital Arnaud de Villeneuve - CHU Montpellier

Montpellier Cedex 5, , 34295

GH Necker - Enfants Malades, Paris Cedex 15, France

Status

Recruiting

Address

GH Necker - Enfants Malades

Paris Cedex 15, , 75743

Universitätsklinikum Freiburg, Freiburg im Breisgau, Baden-Württemberg, Germany

Status

Recruiting

Address

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Württemberg, 79106

Hamburg-Nord, Hamburg, Germany

Status

Recruiting

Address

Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari

Hamburg-Nord, Hamburg, 22081

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

Status

Recruiting

Address

Asklepios Klinik Sankt Augustin

Sankt Augustin, Nordrhein-Westfalen, 53757

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

Status

Recruiting

Address

St. Josef-Stift Sendenhorst

Sendenhorst, Nordrhein-Westfalen,

HELIOS Klinikum Berlin-Buch, Berlin, Germany

Status

Recruiting

Address

HELIOS Klinikum Berlin-Buch

Berlin, , 13125

Berlin, Germany

Status

Recruiting

Address

Charité Universitätsmedizin Berlin Campus Buch

Berlin, , 13353

Klinikum Bremen-Mitte, Bremen, Germany

Status

Recruiting

Address

Klinikum Bremen-Mitte

Bremen, , 28 177

Genova, Liguria, Italy

Status

Recruiting

Address

Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini

Genova, Liguria, 16147

Milano, Lombardia, Italy

Status

Recruiting

Address

Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

Milano, Lombardia, 20122

Campania, Napoli, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Federico II

Campania, Napoli, 80131

Azienda Ospedaliero Universitaria Meyer, Firenze, Toscana, Italy

Status

Recruiting

Address

Azienda Ospedaliero Universitaria Meyer

Firenze, Toscana, 50139

Brescia, Italy

Status

Recruiting

Address

ASST Spedali Civili - Università degli Studi

Brescia, , 25123

Milano, Italy

Status

Recruiting

Address

Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

Milano, , 20122

CREA de Guadalajara, S.C., Guadalajara, Jalisco, Mexico

Status

Recruiting

Address

CREA de Guadalajara, S.C.

Guadalajara, Jalisco, 44620

Monterrey, Nuevo León, Mexico

Status

Not yet recruiting

Address

Hospital Univ. "Dr. José Eleuterio González"

Monterrey, Nuevo León, 64460

Medical Care and Research SA de CV, Merida, Yucatán, Mexico

Status

Recruiting

Address

Medical Care and Research SA de CV

Merida, Yucatán, 97070

Investigacion y Biomedicina de Chihuahua, Chihuahua, Mexico

Status

Recruiting

Address

Investigacion y Biomedicina de Chihuahua

Chihuahua, , 31000

Hospital Materno Infantil, Toluca, Mexico

Status

Recruiting

Address

Hospital Materno Infantil

Toluca, , 50010

Utrecht, Netherlands

Status

Recruiting

Address

UMC Utrecht - Wilhelmina Kinderziekenhuis

Utrecht, , 3584

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

Status

Recruiting

Address

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona [Barcelona], 08950

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

Status

Recruiting

Address

H.R.U Málaga - Hospital Materno-infantil

Malaga, Málaga, 29011

Madrid, Spain

Status

Recruiting

Address

Hospital Infantil Universitario Niño Jesús

Madrid, , 28009

Hospital Universitario Virgen Del Rocio, Sevilla, Spain

Status

Recruiting

Address

Hospital Universitario Virgen Del Rocio

Sevilla, , 41013

Hospital Universitario La Fe de Valencia, Valencia, Spain

Status

Recruiting

Address

Hospital Universitario La Fe de Valencia

Valencia, , 46026

Basel, Basel Stadt, Switzerland

Status

Recruiting

Address

Universitäts-Kinderspital beider Basel UKBB

Basel, Basel Stadt, 4056

Ostschweizer Kinderspital, Sankt Gallen, Switzerland

Status

Recruiting

Address

Ostschweizer Kinderspital

Sankt Gallen, , 9006

Nottingham, Nottinghamshire, United Kingdom

Status

Recruiting

Address

Queen's Medical Centre, Nottingham University Hospitals

Nottingham, Nottinghamshire, NG7 2UH

Sheffield Children's Hospital, Sheffield, South Yorkshire, United Kingdom

Status

Recruiting

Address

Sheffield Children's Hospital

Sheffield, South Yorkshire, S10 2TH

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

Status

Not yet recruiting

Address

Royal Stoke University Hospital

Stoke-on-Trent, Staffordshire, ST4 6QG

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

Status

Not yet recruiting

Address

Haywood Community Hospital

Stoke-on-Trent, Staffordshire, ST6 7AG

Bristol Royal Hospital for Children, Bristol, United Kingdom

Status

Recruiting

Address

Bristol Royal Hospital for Children

Bristol, , BS2 8BJ

Liverpool, United Kingdom

Status

Recruiting

Address

Alder Hey Children's NHS Foundation Trust

Liverpool, , L12 2AP

Oxford, United Kingdom

Status

Recruiting

Address

Oxford University Hospitals - Nuffield Orthopaedic Centre

Oxford, , OX3 7LD

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