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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hopital Necker Enfants Malades Paris France
Hospital Universitario Y Politecnico La Fe Valencia Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Poitiers Poitiers France
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy
Universitair Ziekenhuis Gent Gent Belgium
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Vseobecni Fakultni Nemocnice V Praze Prague Czechia
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
University Hospital Olomouc Olomouc Czechia
HELIOS Klinikum Berlin-Buch GmbH Berlin Germany
Asklepios Klinik Sankt Augustin GmbH Sankt Augustin Germany
Deutsches Herzzentrum Berlin Berlin Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Klinikum Bremen-Mitte gGmbH Bremen Germany
Bicetre Hospital Le Kremlin-Bicetre France
Cslmycinf Uwgoculaifnxxn Szxzpxqlq Woluwe-Saint-Lambert Belgium
Wlfpgujrww Cgskdbfjm Hiwtawhz Utrecht The Netherlands
Fktourzx naazuublf Mmxvy a Hjxyslz Prague Czechia
Hwdzogsqv Zjgmbqu fmss Kdcpdmf uxb Jveqjdaanpwlnbugnzr Hamburg Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
13.04.2021
Czechia Czechia
Not recruiting
13.04.2021
France France
Not recruiting
13.04.2021
Germany Germany
Not recruiting
13.04.2021
Italy Italy
Not recruiting
13.04.2021
Spain Spain
Not recruiting
13.04.2021
The Netherlands The Netherlands
Not recruiting
13.04.2021

Trial locations

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.

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 ID:
2023-507184-19-00
Protocol code:
I1F-MC-RHCG
Trial Phase:
Therapeutic confirmatory (Phase III)

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