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
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ClinicalTrials.gov Identifier: NCT04527380 |
Recruitment Status :
Recruiting
First Posted : August 26, 2020
Last Update Posted : June 23, 2022
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Condition or disease | Intervention/treatment | Phase |
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Juvenile Psoriatic Arthritis Enthesitis Related Arthritis | Drug: Ixekizumab Drug: Adalimumab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | April 13, 2021 |
Estimated Primary Completion Date : | July 31, 2023 |
Estimated Study Completion Date : | April 24, 2028 |

Arm | Intervention/treatment |
---|---|
Experimental: Ixekizumab
Ixekizumab given subcutaneously (SC).
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Drug: Ixekizumab
Administered SC
Other Name: LY2439821 |
Active Comparator: Adalimumab
Adalimumab given SC. Participants may have the option to switch to ixekizumab given SC during the open label extension period.
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Drug: Adalimumab
Administered SC |
- Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 [ Time Frame: Week 16 ]Percentage of Participants Achieving JIA ACR 30
- Percentage of Participants Achieving JIA ACR 30/50/70/90/100 [ Time Frame: Week 0 up to Week 104 ]Percentage of Participants Achieving JIA ACR 30/50/70/90/100
- Change from Baseline in Psoriasis Area and Severity Index (PASI) for JPsA Participants with at Least 3% Body Surface Area (BSA) at Baseline [ Time Frame: Baseline, up to Week 104 ]Change from Baseline in PASI for JPsA Participants with at Least 3% BSA at Baseline
- Change from Baseline in Leeds Enthesitis Index (LEI) for Participants with Enthesitis at Baseline [ Time Frame: Baseline, up to Week 104 ]Change from Baseline in LEI for Participants with Enthesitis at Baseline
- Percentage of Participants with Disease Flare (Flare 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 1 of the Criteria) [ Time Frame: Week 0 up to Week 104 ]Percentage of Participants with Disease Flare (Flare 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 1 of the Criteria)
- Pharmacokinetics (PK): Trough Concentrations (Ctrough) of Ixekizumab [ Time Frame: Week 16 ]Pharmacokinetics (PK): Ctrough of Ixekizumab
- Number of Participants with Anti-Ixekizumab Antibodies [ Time Frame: Week 0 up to Week 104 ]Number of Participants with Anti-Ixekizumab Antibodies

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Ages Eligible for Study: | 2 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04527380
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 | clinicaltrials.gov@lilly.com |

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 |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT04527380 |
Other Study ID Numbers: |
16694 I1F-MC-RHCG ( Other Identifier: Eli Lilly and Company ) 2018-000681-10 ( EudraCT Number ) |
First Posted: | August 26, 2020 Key Record Dates |
Last Update Posted: | June 23, 2022 |
Last Verified: | June 17, 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (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. |
URL: | https://vivli.org/ |
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 |
Spondylitis Arthritis Arthritis, Psoriatic Spondylitis, Ankylosing Arthritis, Juvenile Enthesopathy Joint Diseases Musculoskeletal Diseases Bone Diseases, Infectious Infections Bone Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Psoriasis |
Skin Diseases, Papulosquamous Skin Diseases Ankylosis Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Tendinopathy Muscular Diseases Tendon Injuries Wounds and Injuries Adalimumab Ixekizumab Anti-Inflammatory Agents Antirheumatic Agents |