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

Официальное название

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

Обзор

The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration.

Вмешательства

• Препарат Bimekizumab
  Bimekizumab will be administered at pre-specified timepoints.

Первичные конечные точки

• Plasma bimekizumab concentrations over the Initial Treatment Period [Срок оценки: Up to Week 16]

Вторичные конечные точки (12)

• Incidence of Treatment-emergent adverse events (TEAEs) [Срок оценки: From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)]
• Incidence of Serious TEAEs [Срок оценки: From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)]
• Incidence of TEAEs leading to discontinuation of investigational medicinal product (IMP) [Срок оценки: From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)]
• Incidence of TEAEs leading to withdrawal from the study [Срок оценки: From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)]
• Incidence of selected safety events of interest (including infection [serious, opportunistic, fungal, and tuberculosis (TB)], inflammatory bowel disease [IBD], and injection site reactions) [Срок оценки: From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)]
• Change from Baseline in vital signs (systolic and diastolic blood pressure) at Week 16 [Срок оценки: Baseline and Week 16]
• Change from Baseline in vital signs (heart rate) at Week 16 [Срок оценки: Baseline and Week 16]
• Change from Baseline in biochemistry parameters (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase) at Week 16 [Срок оценки: Baseline and Week 16]
• Change from Baseline in biochemistry parameters (glucose, potassium, sodium, calcium) at Week 16 [Срок оценки: Baseline and Week 16]
• Change from Baseline in biochemistry parameters (total bilirubin and direct bilirubin, total protein, blood urea nitrogen, and creatinine) at Week 16 [Срок оценки: Baseline and Week 16]
• Change from Baseline in hematology parameters (hemoglobin) at Week 16 [Срок оценки: Baseline and Week 16]
• Change from Baseline in hematology parameters (hematocrit) at Week 16 [Срок оценки: Baseline and Week 16]

Критерии участия

Критерии включения

• 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:

• Not a woman of childbearing potential (WOCBP) OR
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 7 центров

• Ja0005 40369 — Berlin
• Ja0005 40356 — Dresden
• Ja0005 40072 — Freiburg im Breisgau
• Ja0005 40852 — Hamburg
• Ja0005 40787 — Sankt Augustin
• Ja0005 40779 — Sendenhorst
• Ja0005 40427 — Tübingen

Франция · 4 центра

• Ja0005 40777 — Indre-et-Loire
• Ja0005 40510 — Le Kremlin-Bicêtre
• Ja0005 40778 — Paris
• Ja0005 40776 — Poitiers

Великобритания · 4 центра

• Ja0005 40786 — Bristol
• Ja0005 40783 — Manchester
• Ja0005 40785 — Nottingham
• Ja0005 40784 — Stroke-on-trent

Канада · 3 центра

• Ja0005 50646 — Calgary
• Ja0005 50644 — Montreal
• Ja0005 50645 — Saskatoon

Испания · 3 центра

• Ja0005 40781 — Esplugues de Llobregat
• Ja0005 40100 — Madrid
• Ja0005 40782 — Valencia

Польша · 2 центра

• Ja0005 40720 — Krakow
• Ja0005 40780 — Sosnowiec

Идентификаторы

NCT: NCT06668181 · JA0005 · U1111-1305-2292 · 2023-508845-41

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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