Juvenile Psoriatic ArthritisPhase 3NCT04527380
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
A Phase 3 study testing Ixekizumab and Adalimumab in people with Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis, run by Eli Lilly and Company at 43 sites in 12 countries.
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). Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Juvenile Psoriatic Arthritis, Enthesitis Related Arthritis
- What is being tested?
- Ixekizumab and Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 43 sitesin 12 countries
- Study dates
- 13 Apr 2021to Jan 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
43 sites in 12 countries.
43 sites in 12 countries
Germany7 sites
Helios Klinikum Berlin-Buch
Berlin, 13125
Charité Campus Virchow-Klinikum
Berlin, 13353
Klinikum Bremen-Mitte
Bremen, 28177
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
Hamburg, 22081
Asklepios Klinik Sankt Augustin
Sankt Augustin, North Rhine-Westphalia, 53757
St. Josef-Stift Sendenhorst
Sendenhorst, North Rhine-Westphalia, 48324
United Kingdom7 sites
Bristol Royal Hospital for Children
Bristol, Bristol, City of, BS2 8BJ
Alder Hey Children's Hospital
Liverpool, England, L14 5AB
Queen's Medical Centre, Nottingham University Hospitals
Nottingham, Nottinghamshire, NG7 2UH
Oxford University Hospitals - Nuffield Orthopaedic Centre
Oxford, Oxfordshire, OX3 7HE
Sheffield Children's Hospital
Sheffield, S10 2TH
Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, ST4 6QG
Haywood Community Hospital
Stoke-on-Trent, Staffordshire, ST6 7AG
Italy6 sites
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123
A.O.Universitaria Meyer
Florence, Tuscany, 50139
IRCCS Istituto Giannina Gaslini
Genoa, Liguria, 16147
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
Milan, Lombardy, 20122
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
University of Naples Federico II
Naples, Campania, 80131
France5 sites
Service rhumatologie Loc.
Bron, Auvergne-Rhône-Alpes, 69500
Rhumatologie pediatrique et CEREMAIA Loc. 1
Le Kremlin-Bicêtre, Paris, 94270
Service de consultation pédiatrique Loc. 1
Montpellier, Hérault, 34090
Centre d'Investigation Clinique Loc. 1
Paris, 75015
RHUMATOLOGIE Loc. 1
Poitiers, Vienne, 86021
Spain5 sites
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [Barcelona], 08950
Hospital Infantil Universitario Niño Jesús
Madrid, Madrid, Comunidad de, 28009
H.R.U Málaga - Hospital Materno-infantil
Málaga, 29011
Hospital Universitario Virgen Del Rocio
Seville, 41013
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Belgium3 sites
Cliniques universitaires Saint-Luc
Brussels, Bruxelles-Capitale, Région de, 1200
UZ Gent
Ghent, Oost-Vlaanderen, 9000
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Czechia3 sites
Dětská klinika Loc. 11
Olomouc, 779 00
Oddeleni revmatologie deti a dospelych Loc. 1
Prague, Praha 5, 150 06
Klinika detskeho a dorostoveho lekarstvi Loc. 1
Prague, 12808
Argentina2 sites
Instituto CAICI SRL Loc. 15
Rosario, Santa Fe Province, S2000
Centro Medico Privado de Reumatologia Loc. 20
San Miguel de Tucumán, Tucumán Province, T4000AXL
Switzerland2 sites
Universitäts-Kinderspital beider Basel
Basel, Canton of Basel-City, 4031
Ostschweizer Kinderspital
Sankt Gallen, 9006
Denmark1 site
Aarhus Universitetshospital, Skejby
Aarhus, Central Jutland, 8200
Mexico1 site
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas
Mexico City, Mexico City, 06700
Netherlands1 site
UMC Utrecht - Wilhelmina Kinderziekenhuis
Utrecht, 3584 EA
About this study
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
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).
- Being tested
- Ixekizumab, Adalimumab
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxekizumabDrug
Also called LY2439821
Administered SC
AdalimumabDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Week 16
Secondary outcomes (13)
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%.
Measured: 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%.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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]).
Measured: 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]).
Measured: 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.
Measured: 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.
Measured: 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%.
Measured: 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%.
Measured: Baseline through Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start13 Apr 2021
- Primary completion19 Feb 2024
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Juvenile Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527380
- Sponsor's protocol ID
- 16694
- Other IDs
- I1F-MC-RHCG, 2018-000681-10, 2023-507184-19-00, 2023, 2018
- Status last verified
- Jul 2026
- First submitted
- 24 Aug 2020
- Last updated
- 12 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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 May;8(5):e377-e388. doi: 10.1016/S2665-9913(25)00346-7. Epub 2026 Mar 2.
PubMed 41785908