Not yet recruiting

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

I1F-MC-RHCG - ClinicalTrials.gov - NCT04527380

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).
How long will I be in the trial?
The study will last about 120 weeks and may include up to 32 visits.
Email
Not yet recruiting

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

I1F-MC-RHCG - ClinicalTrials.gov - NCT04527380

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).
How long will I be in the trial?
The study will last about 120 weeks and may include up to 32 visits.
Email

Key Requirements

Age :

2-17

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

2-17

Sex

All

Participants must

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

Participants must NOT

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 Summary

Conditions the trial is for

Enthesitis-Related Arthritis , Juvenile Psoriatic Arthritis

What the trial is testing?

Ixekizumab, Adalimumab

Could I receive a Placebo?

no

Enrollment Goal

100

Trial Dates

May 2021 - February 2025

Trial Phase

3

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

2-17

Sex

All

Participants must

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

Participants must NOT

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 Summary

Conditions the trial is for

Enthesitis-Related Arthritis , Juvenile Psoriatic Arthritis

What the trial is testing?

Ixekizumab, Adalimumab

Could I receive a Placebo?

no

Enrollment Goal

100

Trial Dates

May 2021 - February 2025

Trial Phase

3

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Trial Locations

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Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?