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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Juvenile Psoriatic Arthritis; Enthesitis Related Arthritis
• Intervention / Treatment: Drug: Ixekizumab; Drug: Adalimumab

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, S2000
      • Instituto CAICI SRL Loc. 15
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
      • Centro Medico Privado de Reumatologia Loc. 20
• Belgium
  • Bruxelles-Capitale, Région de
    • Brussels, Bruxelles-Capitale, Région de, Belgium, 1200
      • Cliniques universitaires Saint-Luc
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • UZ Gent
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • UZ Leuven
• Czechia
  • Olomouc, Czechia, 779 00
    • Dětská klinika Loc. 11
  • Prague, Czechia, 12808
    • Klinika detskeho a dorostoveho lekarstvi Loc. 1
  • Praha 5
    • Prague, Praha 5, Czechia, 150 06
      • Oddeleni revmatologie deti a dospelych Loc. 1
• Denmark
  • Central Jutland
    • Aarhus, Central Jutland, Denmark, 8200
      • Aarhus Universitetshospital, Skejby
• France
  • Paris, France, 75015
    • Centre d'Investigation Clinique Loc. 1
  • Auvergne-Rhône-Alpes
    • Bron, Auvergne-Rhône-Alpes, France, 69500
      • Service rhumatologie Loc.
  • Hérault
    • Montpellier, Hérault, France, 34090
      • Service de consultation pédiatrique Loc. 1
  • Paris
    • Le Kremlin-Bicêtre, Paris, France, 94270
      • Rhumatologie pediatrique et CEREMAIA Loc. 1
  • Vienne
    • Poitiers, Vienne, France, 86021
      • RHUMATOLOGIE Loc. 1
• Germany
  • Berlin, Germany, 13125
    • HELIOS Klinikum Berlin-Buch
  • Berlin, Germany, 13353
    • Charité Campus Virchow-Klinikum
  • Bremen, Germany, 28177
    • Klinikum Bremen-Mitte
  • Hamburg, Germany, 22081
    • Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
  • Baden-Wurttemberg
    • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
      • Universitaetsklinikum Freiburg
  • North Rhine-Westphalia
    • Sankt Augustin, North Rhine-Westphalia, Germany, 53757
      • Asklepios Klinik Sankt Augustin
    • Sendenhorst, North Rhine-Westphalia, Germany, 48324
      • St. Josef-Stift Sendenhorst
• Italy
  • Brescia, Italy, 25123
    • Azienda Ospedaliera Spedali Civili di Brescia
  • Campania
    • Napoli, Campania, Italy, 80131
      • University of Naples Federico II
  • Liguria
    • Genoa, Liguria, Italy, 16147
      • IRCCS Istituto Giannina Gaslini
  • Lombardy
    • Milan, Lombardy, Italy, 20122
      • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
    • Milan, Lombardy, Italy, 20122
      • Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
  • Tuscany
    • Florence, Tuscany, Italy, 50139
      • A.O.Universitaria Meyer
• Mexico
  • Mexico City
    • Mexico City, Mexico City, Mexico, 06700
      • CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas
• Netherlands
  • Utrecht, Netherlands, 3584 EA
    • UMC Utrecht - Wilhelmina Kinderziekenhuis
• Spain
  • Málaga, Spain, 29011
    • H.R.U Málaga - Hospital Materno-infantil
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
  • Barcelona [Barcelona]
    • Esplugues de Llobregat, Barcelona [Barcelona], Spain, 08950
      • Hospital Sant Joan de Déu
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28009
      • Hospital Infantil Universitario Nino Jesus
• Switzerland
  • Sankt Gallen, Switzerland, 9006
    • Ostschweizer Kinderspital
  • Canton of Basel-City
    • Basel, Canton of Basel-City, Switzerland, 4031
      • Universitäts-Kinderspital beider Basel
• United Kingdom
  • Sheffield, United Kingdom, S10 2TH
    • Sheffield Children's Hospital
  • Bristol, City of
    • Bristol, Bristol, City of, United Kingdom, BS2 8BJ
      • Bristol Royal Hospital for Children
  • England
    • Liverpool, England, United Kingdom, L14 5AB
      • Alder Hey Children's Hospital
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
      • Queen's Medical Centre, Nottingham University Hospitals
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 7HE
      • Oxford University Hospitals - Nuffield Orthopaedic Centre
  • Staffordshire
    • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
      • Royal Stoke University Hospital
    • Stoke-on-Trent, Staffordshire, United Kingdom, ST6 7AG
      • Haywood Community Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Ixekizumab; Administered SC; Other Names: LY2439821
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.	Drug: Adalimumab; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 (Ixekizumab - OLT Period)	JIA ACR, is comprised of 6 variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire [CHAQ]), and acute-phase reactants (high-sensitivity C-reactive protein [hsCRP] and erythrocyte sedimentation rate [ESR]). A JIA ACR30 response is defined as at least 30% improvement from baseline in at least 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by more than 30%.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving JIA ACR 30 (Adalimumab - OLT Period)	JIA ACR, is comprised of 6 variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire [CHAQ]), and acute-phase reactants (high-sensitivity C-reactive protein [hsCRP] and erythrocyte sedimentation rate [ESR]). A JIA ACR30 response is defined as at least 30% improvement from baseline in at least 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by more than 30%.	Week 16
Percentage of Participants Achieving JIA ACR 50/70/90/100 (OLT Period)	JIA ACR, is comprised of 6 core set variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire [CHAQ]), and acute-phase reactants (high-sensitivity C-reactive protein [hsCRP] and erythrocyte sedimentation rate [ESR]). A JIA ACR 50/70/90 response is defined as a greater than or equal to (≥) 50/70/90/100% improvement from baseline in at least 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by more than 30%.	Week 16
Percentage of Participants Achieving JIA ACR 30/50/70/90/100 (OLE Period)	JIA ACR, is comprised of 6 core set variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire [CHAQ]), and acute-phase reactants (high-sensitivity C-reactive protein [hsCRP] and erythrocyte sedimentation rate [ESR]). A JIA ACR 30/50/70/90 response is defined as a greater than or equal to (≥) 30/50/70/90/100% improvement from baseline in at least 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by more than 30%.	Week 104
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)	The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling (S), redness (R), and plaque induration/infiltration thickness (T) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Severity is rated for each index (R, S, T) on a 0 to 4 scale (0 for no involvement up to 4 for severe involvement): 0 = none; = slight; = moderate; = severe; = very severe The various body regions are weighted to reflect their respective proportion of BSA.	Baseline, Week 16
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)	The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling (S), redness (R), and plaque induration/infiltration thickness (T) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Severity is rated for each index (R, S, T) on a 0 to 4 scale (0 for no involvement up to 4 for severe involvement): 0 = none; = slight; = moderate; = severe; = very severe The various body regions are weighted to reflect their respective proportion of BSA.	Baseline, Week 104
Change From Baseline in Leeds Enthesitis Index (LEI) for Participants With Enthesitis Related Arthritis (ERA) at Baseline (OLT Period)	The LEI was developed specifically for use in psoriatic arthritis (PsA). It measures enthesitis at 6 sites (lateral epicondyle of humerus, right/left (R/L); medial femoral condyle, (R/L); Achilles tendon insertion, (R/L)). Each site is assigned a score of 0 (absent) or 1 (present); the results from each site are then added to produce a total score (range 0 to 6) with the higher scores indicating more severe enthesitis.	Baseline, Week 16
Change From Baseline in Leeds Enthesitis Index (LEI) for Participants With Enthesitis Related Arthritis (ERA) at Baseline (OLE Period)	The LEI was developed specifically for use in psoriatic arthritis (PsA). It measures enthesitis at 6 sites (lateral epicondyle of humerus, right/left (R/L); medial femoral condyle, (R/L); Achilles tendon insertion, (R/L)). Each site is assigned a score of 0 (absent) or 1 (present); the results from each site are then added to produce a total score (range 0 to 6) with the higher scores indicating more severe enthesitis.	Baseline, Week 104
Percentage of Participants With Disease Flare (OLT Period)	Disease flare is 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 one of the criteria. The JIA ACR, is comprised of 6 core set variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire [CHAQ]), and acute-phase reactants (high-sensitivity C-reactive protein [hsCRP] and erythrocyte sedimentation rate [ESR]).	Week 2 through Week 16
Percentage of Participants With Disease Flare (OLE Period)	Disease flare is 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 one of the criteria. The JIA ACR, is comprised of 6 core set variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire [CHAQ]), and acute-phase reactants (high-sensitivity C-reactive protein [hsCRP] and erythrocyte sedimentation rate [ESR]).	Baseline through Week 104
Pharmacokinetics (PK): Trough Concentrations (C-trough) of Ixekizumab (Ixekizumab - OLT Period)	C-trough were measured at specified time points to assess the minimum concentration of ixekizumab in the blood before the next dose was administered.	Week 4, 12 and 16 : Pre-dose
Pharmacokinetics (PK): Trough Concentrations (C-trough) of Ixekizumab (Ixekizumab - OLE Period)	C-trough were measured at specified time points to assess the minimum concentration of ixekizumab in the blood before the next dose was administered.	Week 20, 32, 56, 80 and 104 : Pre-dose
Percentage of Participants With Treatment-emergent Positive Anti-ixekizumab Antibodies (Ixekizumab - OLT Period)	Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.	Baseline through Week 16
Percentage of Participants With Treatment-emergent Positive Anti-ixekizumab Antibodies (Ixekizumab - OLE Period)	Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.	Baseline through Week 104

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Publications and helpful links

General Publications

• Ramanan AV, Ruperto N, Foeldvari I, Vega-Cornejo G, Keller S, Wang R, Araujo J, Sen P, Marulkar K, Tseng J, Pitou C, Quartier P. Ixekizumab in children with active psoriatic and enthesitis-related juvenile idiopathic arthritis (COSPIRIT-JIA): a multicentre, open-label, 16-week, Bayesian trial including a randomised reference group to adalimumab. Lancet Rheumatol. 2026 Mar 2:S2665-9913(25)00346-7. doi: 10.1016/S2665-9913(25)00346-7. Online ahead of print.

Helpful 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

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2021
• Primary Completion (Actual): February 19, 2024
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: August 24, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Juvenile; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Adalimumab; ixekizumab
• Other Study ID Numbers: 16694; I1F-MC-RHCG (Other Identifier: Eli Lilly and Company); 2018-000681-10 (EudraCT Number); 2023-507184-19-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes