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Study of Ixekizumab and Adalimumab for Children with Juvenile Idiopathic Arthritis, Including Enthesitis-related Arthritis and Juvenile Psoriatic Arthritis

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying two types of juvenile idiopathic arthritis: Enthesitis-related arthritis and Juvenile psoriatic arthritis. These are conditions that cause joint pain and swelling in children. The study will use two treatments: Ixekizumab and Adalimumab. Ixekizumab is a medication that helps reduce inflammation by targeting specific proteins in the body, while Adalimumab, also known by code names like ABP 501, is another treatment that works similarly to reduce joint inflammation.

The purpose of the study is to evaluate how effective Ixekizumab is in treating these types of arthritis in children. The study will involve giving the medications through a subcutaneous injection, which means the medicine is injected under the skin. Children participating in the study will receive either Ixekizumab or Adalimumab, and their progress will be monitored over time to see how well the treatments work in reducing symptoms of arthritis.

Throughout the study, researchers will observe the safety and tolerability of the treatments, ensuring that they are safe for use in children. The study aims to provide valuable information on how these medications can help manage juvenile idiopathic arthritis, potentially improving the quality of life for children affected by these conditions.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of active juvenile idiopathic arthritis, either enthesitis-related arthritis or juvenile psoriatic arthritis.

    The participant's weight must be at least 10 kilograms. The age requirement is at least 2 years for juvenile psoriatic arthritis and at least 6 years for enthesitis-related arthritis.

    All immunizations must be up-to-date according to current guidelines.

  2. Step 2

    Treatment phase

    The treatment phase involves the administration of ixekizumab and adalimumab through subcutaneous injections.

    The specific dosage and frequency of these medications are determined by the study protocol and the participant's condition.

  3. Step 3

    Monitoring and evaluation

    Throughout the study, regular monitoring is conducted to evaluate the efficacy, safety, and tolerability of the treatment.

    The primary goal is to assess the percentage of participants achieving a 30% improvement in symptoms, as defined by the Juvenile Idiopathic Arthritis American College of Rheumatology (ACR) 30 response.

  4. Step 4

    Study completion

    The study is estimated to conclude by January 13, 2029.

    Upon completion, final assessments are conducted to gather data on the long-term effects and overall outcomes of the treatment.

Who can join the trial?

5 criteria

  • Participants must have active juvenile idiopathic arthritis. This includes two types: enthesitis related arthritis and juvenile psoriatic arthritis. These are specific forms of arthritis that affect children.
  • Participants must weigh at least 10 kilograms (about 22 pounds).
  • Participants with juvenile psoriatic arthritis must be at least 2 years old.
  • Participants with enthesitis related arthritis must be at least 6 years old.
  • Participants must have all their vaccinations up-to-date according to current guidelines, as determined by the study doctor.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of arthritis than the ones being studied cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are taking medications that could affect the study results cannot participate.
  • Patients who have had a recent infection or illness that could impact the study cannot participate.
  • Patients who are unable to follow the study procedures or attend study visits cannot participate.
  • Patients who have participated in another clinical trial recently cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have a history of allergic reactions to the study medication cannot participate.
  • Patients who have a history of certain mental health conditions that might affect the study cannot participate.
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Investigated drugs

  • Ixekizumab

    is a medication used in this study to treat children with certain types of juvenile idiopathic arthritis, including enthesitis-related arthritis and juvenile psoriatic arthritis. It is given as an injection under the skin and works by targeting specific proteins in the body that cause inflammation, helping to reduce symptoms like joint pain and swelling.

  • Adalimumab

    is another medication used in this study as a reference treatment. It is also used to treat children with juvenile idiopathic arthritis. Adalimumab is administered through an injection and helps to decrease inflammation by blocking a protein in the body that contributes to the inflammatory process.

What is already known about the treatment

Ixekizumab – This medication is administered through subcutaneous injection and is currently being studied for its effectiveness in treating certain types of juvenile idiopathic arthritis, specifically juvenile psoriatic arthritis and enthesitis-related arthritis. It is an approved treatment in some conditions and is being evaluated for its safety and efficacy in children. Ixekizumab works by targeting and inhibiting a specific protein in the immune system called interleukin-17A, which plays a role in inflammation. It is classified as a monoclonal antibody and is used to reduce inflammation and improve symptoms in autoimmune conditions.

Investigated diseases

  • Juvenile Psoriatic Arthritis

    This is a type of arthritis that affects children and is associated with psoriasis, a skin condition. It causes joint pain, swelling, and stiffness, often in the fingers and toes. Over time, it can lead to joint damage and changes in the nails, such as pitting or separation from the nail bed. The disease may also cause fatigue and affect the eyes, leading to inflammation. Symptoms can vary widely among individuals, with periods of flare-ups and remission.

  • Enthesitis Related Arthritis

    This form of juvenile arthritis primarily affects the areas where tendons and ligaments attach to bones, known as entheses. It often leads to pain and swelling in the joints, particularly in the lower limbs, and can also affect the spine. The disease may cause stiffness, especially in the morning or after periods of inactivity. Over time, it can lead to reduced mobility and changes in posture. Enthesitis related arthritis is more common in boys and may be associated with other conditions like inflammatory bowel disease.

Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2023-507184-19-00Protocol codeI1F-MC-RHCGEstimated enrolment93 patientsSponsorEli Lilly & Co.

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