An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
ClinicalTrials.gov lists this study as Recruiting.
Official title: Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants From 2 to Less Than 18 Years of Age With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-Related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
Enrollment: 40 participants (Estimated).
What is being studied
Intervention: bimekizumab
Drug: Bimekizumab
Who may be eligible
Ages
2 Years to 18 Years
Sex
All
Healthy volunteers accepted
No
ClinicalTrials.gov lists the following eligibility criteria.
Inclusion Criteria:
* Study participant must be 2 to \<18 years of age inclusive, at the Baseline Visit.
* Study participants who have confirmed diagnosis of enthesitis-related arthritis (ERA; including juvenile-onset ankylosing spondylitis (JAS)) and/or juvenile psoriatic arthritis (JPsA) according to the juvenile-International League of Associations for Rheumatology (JIA-ILAR) classification criteria of at least 3 months duration prior to the Screening Visit.
* Study participants who have active disease (ERA \[including JAS\] and/or JPsA) defined as having at least 3 active joints, each of which needs to be included in the joints assessed in the JADAS27, and for ERA at least 1 site of enthesitis at Baseline or documented by history.
* Study participants with inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal anti-inflammatory drug (NSAID).
* Study participants taking concomitant methotrexate or sulfasalazine are allowed to continue the medication if it has been used for the past 12 weeks with a stable dose for the 4 weeks prior to Baseline, with no change in dose for the first 16 weeks of treatment foreseen. (Note: prior or concomitant use of methotrexate or sulfasalazine is NOT required for study participation.)
* Study participants with no concomitant use of second line agents such as disease-modifying and/or immunosuppressive drugs with the exception of methotrexate or sulfasalazine.
* Body weight of ≥10kg.
* Male and female.
* A female study participant will be eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
1. Not a woman of childbearing potential (WOCBP) OR
2. A WOCBP who agrees to follow the contraceptive guidance during the Initial Treatment Period, the Open-label Extension (OLE) Period, and for at least 20 weeks after the final dose of investigational medicinal product (IMP; ie, the Safety Follow-up (SFU) Period)
* Capable of giving/having parent(s) or legal representative provide signed informed consent/assent (where appropriate), which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and assent and in this protocol.
Exclusion Criteria:
* Study participants fulfilling any International League of Associations for Rheumatology (ILAR) diagnostic juvenile idiopathic arthritis (JIA) category other than enthesitis-related arthritis (ERA; including juvenile-onset ankylosing spondylitis (JAS)) and/or juvenile psoriatic arthritis (JPsA).
* Study participant has history of inflammatory bowel disease (IBD) or signs/symptoms suggestive of IBD.
* Study participant has active uncontrolled uveitis.
* Study participant has history of active tuberculosis (TB) unless successfully treated, latent TB unless prophylactically treated.
* Study participant has had major surgery (including joint surgery) within the 3 months prior to the Baseline Visit or has planned major surgery within 6 months after entering the study.
* Study participant has laboratory abnormalities at Screening defined in the Protocol.
* Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections).
* Study participant has received drugs listed in the protocol outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments.
* Study participant had previous therapy with bimekizumab or prior treatment with other IL-17 biologic response modifier.
* Study participant had prior treatment with more than one biologic response modifier (other than an IL-17).
* Presence of active suicidal ideation, or positive suicide behavior.
* Study participant has been diagnosed with severe depression in the past 6 months.
Study locations
23 study locations are listed.
Recruiting site status is explicitly provided for 23 locations; 22 are listed as Recruiting.
Countries: Canada, France, Germany, Poland, Spain, United Kingdom
Sample of listed locations
Ja0005 50646 — Calgary, Canada — Recruiting
Ja0005 50644 — Montreal, Canada — Recruiting
Ja0005 50645 — Saskatoon, Canada — Recruiting
Ja0005 40777 — Indre-et-Loire, France — Recruiting
Ja0005 40510 — Le Kremlin-Bicêtre, France — Recruiting
Ja0005 40778 — Paris, France — Recruiting
Ja0005 40776 — Poitiers, France — Recruiting
Ja0005 40369 — Berlin, Germany — Recruiting
Ja0005 40356 — Dresden, Germany — Recruiting
Ja0005 40072 — Freiburg im Breisgau, Germany — Recruiting
Ja0005 40852 — Hamburg, Germany — Recruiting
Ja0005 40787 — Sankt Augustin, Germany — Recruiting
Ja0005 40779 — Sendenhorst, Germany — Recruiting
Ja0005 40427 — Tübingen, Germany — Recruiting
Ja0005 40720 — Krakow, Poland — Recruiting
Ja0005 40780 — Sosnowiec, Poland — Recruiting
Ja0005 40781 — Esplugues de Llobregat, Spain — Recruiting
Ja0005 40100 — Madrid, Spain — Recruiting
Ja0005 40782 — Valencia, Spain — Recruiting
Ja0005 40786 — Bristol, United Kingdom — Recruiting
Ja0005 40783 — Manchester, United Kingdom — Recruiting
Ja0005 40785 — Nottingham, United Kingdom — Recruiting
Ja0005 40784 — Stoke-on-Trent, United Kingdom — Completed
Trial information can change. Confirm current study details with the study team or the registry.
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