Efficacy and Safety of Subcutaneous Ixekizumab Versus Adalimumab in Pediatric Enthesitis-related Arthritis and Juvenile Psoriatic Arthritis

The primary objective of this study is to evaluate the **efficacy** of **ixekizumab** in children with Juvenile Idiopathic Arthritis (JIA) subtypes of Enthesitis-related Arthritis (ERA), including Juvenile-Onset Ankylosing Spondylitis (JoAS), and Juvenile Psoriatic Arthritis (JPsA). The assessment is based on the JIA American College of Rheumatology (ACR) 30 response. This evaluation is clinically relevant as it aims to determine the therapeutic potential of ixekizumab in improving the clinical outcomes for pediatric patients suffering from these specific subtypes of JIA, which are characterized by chronic joint inflammation and can significantly impact the quality of life.

The clinical trial involves a total of **45 participants** diagnosed with **Juvenile Psoriatic Arthritis** and **Enthesitis Related Arthritis**. The study population includes both male and female subjects, with an age range starting from 2 years for those with juvenile psoriatic arthritis and from 6 years for those with enthesitis related arthritis. Participants are required to have a minimum weight of 10 kilograms and must have all immunizations up-to-date according to current guidelines. The trial population was selected based on the presence of active juvenile idiopathic arthritis in the specified categories. The study does not specify any particular lifestyle considerations such as diet or physical activity. The trial includes a vulnerable population, as it involves children with specific health conditions. The sponsor has not provided additional information regarding the general health status or lifestyle habits of the participants.

The clinical trial is designed to evaluate the **efficacy** and safety of **ixekizumab** in children with juvenile idiopathic arthritis (JIA) subtypes, specifically enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA). This is a multicenter, open-label study with a reference arm of **adalimumab**. The trial is structured as a Phase III study, focusing on the JIA American College of Rheumatology (ACR) 30 response as the primary endpoint. The trial is expected to run from April 2021 to January 2029, with participant involvement lasting up to one year.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as active JIA, appropriate age and weight, and up-to-date immunizations. Following the screening, participants will receive subcutaneous injections of the investigational product. Regular follow-up visits will be scheduled to monitor safety, tolerability, and efficacy, with assessments aligned with the primary endpoint. The end-of-study visit will conclude the participant's involvement, ensuring all necessary data is collected and any post-study care is arranged.

Participants may be withdrawn from the study early if they experience significant adverse events, fail to comply with the study protocol, or if the investigator deems it in the participant's best interest. The trial's design does not include a double-blind or placebo-controlled component, as it is open-label. The study aims to provide valuable insights into the treatment of JIA subtypes in a pediatric population, contributing to the understanding of **ixekizumab**'s role in managing these conditions.

The clinical trial involves the use of two experimental medications: **Adalimumab** and **Ixekizumab**. **Adalimumab** is administered as a subcutaneous injection. It is a protein-based medication, classified under the ATC code L04AB04. The pharmaceutical form is identified as PHF00231MIG. The medication is not a pediatric formulation and is used as a comparator in the trial. The maximum treatment period for **Adalimumab** is one unit of time, as defined by the trial protocol. The administration device does not have a CE mark, and the medication is not classified as an orphan drug. The dosage and total dose amounts are not specified, indicating flexibility in dosing as per trial requirements.

**Ixekizumab** is also administered via subcutaneous injection and shares the same pharmaceutical form, PHF00231MIG. It is a protein-based medication with the ATC code L04AC13. **Ixekizumab** is used as the test medication in the trial. Similar to **Adalimumab**, it is not a pediatric formulation and has a maximum treatment period of one unit of time. The administration device for **Ixekizumab** also lacks a CE mark, and it is not designated as an orphan drug. The trial does not specify the maximum daily or total dose amounts, allowing for dosing adjustments based on the study protocol. Both medications are evaluated for their efficacy, safety, tolerability, and pharmacokinetics in children with juvenile idiopathic arthritis subtypes, including enthesitis-related arthritis and juvenile psoriatic arthritis.

The efficacy of ixekizumab in the clinical trial will be assessed in children with **Juvenile Idiopathic Arthritis** (JIA) subtypes of Enthesitis-related Arthritis (ERA), including Juvenile-Onset Ankylosing Spondylitis (JoAS), and Juvenile Psoriatic Arthritis (JPsA). The primary endpoint for evaluating efficacy is the percentage of participants achieving the JIA American College of Rheumatology (ACR) 30 response. This endpoint measures the proportion of participants who experience a 30% improvement in the number of active joints and other criteria defined by the ACR for JIA.

The trial is designed as a multicenter, open-label study with a reference arm using adalimumab. Efficacy assessments will be conducted at specified intervals throughout the study duration, although specific timepoints are not detailed in the provided data. The study will utilize validated scales and criteria established by the ACR to ensure consistent and reliable measurement of efficacy outcomes. The trial aims to provide comprehensive data on the efficacy of ixekizumab in the specified pediatric population, contributing to the understanding of its therapeutic potential in treating these subtypes of JIA.