NCT06668181招募中3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 41
- 主要终点
- Plasma bimekizumab concentrations over the Initial Treatment Period
研究概览
简要总结
The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Bimekizumab
Experimental
Study participants will receive a bimekizumab dose which is dependent on their weight.
干预措施: Bimekizumab (Drug)
结局指标
主要结局
Plasma bimekizumab concentrations over the Initial Treatment Period
时间窗: Up to Week 16
Plasma samples will be collected at pre-specified timepoints for measurement of plasma bimekizumab concentrations over the Initial Treatment Period.
次要结局
- Incidence of Treatment-emergent adverse events (TEAEs)(From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks))
- Incidence of Serious TEAEs(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)(From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks))
- Incidence of TEAEs leading to withdrawal from the study(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)(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(Baseline and Week 16)
- Change from Baseline in vital signs (heart rate) at Week 16(Baseline and Week 16)
- Change from Baseline in biochemistry parameters (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase) at Week 16(Baseline and Week 16)
- Change from Baseline in biochemistry parameters (glucose, potassium, sodium, calcium) at Week 16(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(Baseline and Week 16)
- Change from Baseline in hematology parameters (hemoglobin) at Week 16(Baseline and Week 16)
- Change from Baseline in hematology parameters (hematocrit) at Week 16(Baseline and Week 16)
- Change from Baseline in hematology parameters (erythrocytes) at Week 16(Baseline and Week 16)
- Change from Baseline in hematology parameters (platelets, leukocytes neutrophils, lymphocytes, eosinophils, basophils, and monocytes) at Week 16(Baseline and Week 16)
- Change from Baseline in growth assessments (height) at Week 16(Baseline and Week 16)
- Change from Baseline in growth assessments (weight) at Week 16(Baseline and Week 16)
- Acceptability assessments by injection site pain adverse events (AEs) during the Initial Treatment Period (Week 0 to Week 16)(Week 0 to Week 16)
- American College of Rheumatology pediatric (ACR Pedi) 30/50/70/90/100 response at Week 16(Week 16)
- Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS27) -high sensitivity C-reactive protein (hs-CRP) at Week 16(Baseline and Week 16)
- Anti-bimekizumab antibody and neutralizing antibody detection prior to and following IMP administration during the Initial Treatment Period(Up to Week 16)
研究者
研究点 (41)
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