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

NCT04527380 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 4 other identifiers: 16694I1F-MC-RHCG2018-000681-102023-507184-19-00
• Study Type: interventional
• Target: 101
• Locations: 12 countries
• Sites: 43

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).

Conditions

Juvenile Psoriatic Arthritis; Enthesitis Related Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Percentage of Participants Achieving JIA ACR 30 (Adalimumab - OLT Period)

  Week 16

• Percentage of Participants Achieving JIA ACR 50/70/90/100 (OLT Period)

  Week 16

• Percentage of Participants Achieving JIA ACR 30/50/70/90/100 (OLE Period)

  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)

  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)

  Baseline, Week 104

Study Arms (2)

Ixekizumab - OLT Period

EXPERIMENTAL

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

Adalimumab - OLT Period

ACTIVE COMPARATOR

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

Interventions

Ixekizumab DRUG

Administered SC

Also known as: LY2439821

Ixekizumab - OLT Period

Adalimumab DRUG

Administered SC

Adalimumab - OLT Period

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (43)

Instituto CAICI SRL Loc. 15

Rosario, Santa Fe Province, S2000, Argentina

Location

Centro Medico Privado de Reumatologia Loc. 20

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

Location

Cliniques universitaires Saint-Luc

Brussels, Bruxelles-Capitale, Région de, 1200, Belgium

Location

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Oddeleni revmatologie deti a dospelych Loc. 1

Prague, Praha 5, 150 06, Czechia

Location

Dětská klinika Loc. 11

Olomouc, 779 00, Czechia

Location

Klinika detskeho a dorostoveho lekarstvi Loc. 1

Prague, 12808, Czechia

Location

Aarhus Universitetshospital, Skejby

Aarhus, Central Jutland, 8200, Denmark

Location

Service rhumatologie Loc.

Bron, Auvergne-Rhône-Alpes, 69500, France

Location

Service de consultation pédiatrique Loc. 1

Montpellier, Hérault, 34090, France

Location

Rhumatologie pediatrique et CEREMAIA Loc. 1

Le Kremlin-Bicêtre, Paris, 94270, France

Location

RHUMATOLOGIE Loc. 1

Poitiers, Vienne, 86021, France

Location

Centre d'Investigation Clinique Loc. 1

Paris, 75015, France

Location

Universitaetsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Asklepios Klinik Sankt Augustin

Sankt Augustin, North Rhine-Westphalia, 53757, Germany

Location

St. Josef-Stift Sendenhorst

Sendenhorst, North Rhine-Westphalia, 48324, Germany

Location

Helios Klinikum Berlin-Buch

Berlin, 13125, Germany

Location

Charité Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

Klinikum Bremen-Mitte

Bremen, 28177, Germany

Location

Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari

Hamburg, 22081, Germany

Location

University of Naples Federico II

Naples, Campania, 80131, Italy

Location

IRCCS Istituto Giannina Gaslini

Genoa, Liguria, 16147, Italy

Location

Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

Milan, Lombardy, 20122, Italy

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy, 20122, Italy

Location

A.O.Universitaria Meyer

Florence, Tuscany, 50139, Italy

Location

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, 25123, Italy

Location

CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas

Mexico City, Mexico City, 06700, Mexico

Location

UMC Utrecht - Wilhelmina Kinderziekenhuis

Utrecht, 3584 EA, Netherlands

Location

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain

Location

Hospital Infantil Universitario Niño Jesús

Madrid, Madrid, Comunidad de, 28009, Spain

Location

H.R.U Málaga - Hospital Materno-infantil

Málaga, 29011, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

Universitäts-Kinderspital beider Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Ostschweizer Kinderspital

Sankt Gallen, 9006, Switzerland

Location

Bristol Royal Hospital for Children

Bristol, Bristol, City of, BS2 8BJ, United Kingdom

Location

Alder Hey Children's Hospital

Liverpool, England, L14 5AB, United Kingdom

Location

Queen's Medical Centre, Nottingham University Hospitals

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Oxford University Hospitals - Nuffield Orthopaedic Centre

Oxford, Oxfordshire, OX3 7HE, United Kingdom

Location

Royal Stoke University Hospital

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

Location

Haywood Community Hospital

Stoke-on-Trent, Staffordshire, ST6 7AG, United Kingdom

Location

Sheffield Children's Hospital

Sheffield, S10 2TH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 41785908 DERIVED

Related 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

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

ixekizumab; Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

08005455979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 26, 2020
• Study Start: April 13, 2021
• Primary Completion: February 19, 2024
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 19, 2026
• Results First Posted: June 5, 2025

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

GB (7); ES (5); ME (1); DK (1); DE (7); CZ (3); NL (1); AR (2); FR (5); CH (2); IT (6); BE (3)