Phase 3 Psoriatic Arthritis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You must be between 2 and 17 years old (inclusive) at the start of the study.
• You must have been diagnosed with enthesitis-related arthritis (a type of arthritis affecting the places where tendons and ligaments attach to bone) and/or juvenile psoriatic arthritis (a type of arthritis linked to psoriasis), for at least 3 months before screening.
• You must have active disease, meaning at least 3 swollen or painful joints, and for enthesitis-related arthritis, at least 1 area of tendon/ligament inflammation either currently or documented in your medical history.
• You must have tried at least one anti-inflammatory painkiller (like ibuprofen or naproxen) for at least 1 month without enough improvement, or been unable to tolerate it.
• You must weigh at least 10 kg (approximately 22 lbs).
• Both males and females may participate.
• If you are female and able to become pregnant, you must not currently be pregnant or breastfeeding, and must agree to use contraception during the study and for at least 20 weeks after the last dose of the study medicine.
• A parent or legal guardian must be able to give signed consent on your behalf (and you may also be asked to give your own agreement, depending on your age).
• If you are already taking methotrexate or sulfasalazine, you may continue if the dose has been stable for the past 4 weeks and is not expected to change in the first 16 weeks of the study (these medications are not required to join).

Who may not be able to join:

• You have been diagnosed with a different type of juvenile arthritis other than enthesitis-related arthritis or juvenile psoriatic arthritis.
• You have a history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), or you currently have symptoms that suggest it.
• You have active, uncontrolled eye inflammation (uveitis) that is not being managed.
• You have a history of active tuberculosis (TB) that was not successfully treated, or latent (inactive) TB that has not been treated preventatively.
• You have had a major surgery (including joint surgery) in the 3 months before the study starts, or are planning major surgery within 6 months of joining.
• You have certain abnormal blood test or lab results at screening, as defined by the study protocol (confirm with trial site).
• You currently have an active infection, or have a history of serious, chronic, or unusual infections.
• You have recently taken certain medications that are not allowed in this study, or are currently taking prohibited medications (confirm with trial site for the specific list).
• You have previously been treated with bimekizumab (the study drug) or any other medicine that targets a protein called IL-17.
• You have previously been treated with more than one type of biologic medication (other than an IL-17 blocker).
• You currently have active thoughts of suicide or recent suicidal behaviour.
• You have been diagnosed with severe depression in the past 6 months.

Important: Always verify eligibility with the trial site directly before applying.