Clinical trial NCT06668181: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Enthesitis-related Arthritis
Juvenile Psoriatic Arthritis
Keywords: Arthritis
Bimekizumab
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2024-10-31
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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 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.

Primary outcomes:
measure: Plasma bimekizumab concentrations over the Initial Treatment Period
timeFrame: Up to Week 16
Secondary outcomes:
measure: Incidence of Treatment-emergent adverse events (TEAEs)
timeFrame: From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)
measure: Incidence of Serious TEAEs
timeFrame: From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)
measure: Incidence of TEAEs leading to discontinuation of investigational medicinal product (IMP)
timeFrame: From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)
measure: Incidence of TEAEs leading to withdrawal from the study
timeFrame: From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)
measure: Incidence of selected safety events of interest (including infection [serious, opportunistic, fungal, and tuberculosis (TB)], inflammatory bowel disease [IBD], and injection site reactions)
timeFrame: From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)
measure: Change from Baseline in vital signs (systolic and diastolic blood pressure) at Week 16
timeFrame: Baseline and Week 16
measure: Change from Baseline in vital signs (heart rate) at Week 16
timeFrame: Baseline and Week 16
measure: Change from Baseline in biochemistry parameters (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase) at Week 16
timeFrame: Baseline and Week 16
measure: Change from Baseline in biochemistry parameters (glucose, potassium, sodium, calcium) at Week 16
timeFrame: Baseline and Week 16
measure: Change from Baseline in biochemistry parameters (total bilirubin and direct bilirubin, total protein, blood urea nitrogen, and creatinine) at Week 16
timeFrame: Baseline and Week 16
measure: Change from Baseline in hematology parameters (hemoglobin) at Week 16
timeFrame: Baseline and Week 16
measure: Change from Baseline in hematology parameters (hematocrit) at Week 16
timeFrame: Baseline and Week 16
measure: Change from Baseline in hematology parameters (erythrocytes) at Week 16
timeFrame: Baseline and Week 16
measure: Change from Baseline in hematology parameters (platelets, leukocytes neutrophils, lymphocytes, eosinophils, basophils, and monocytes) at Week 16
timeFrame: Baseline and Week 16
measure: Change from Baseline in growth assessments (height) at Week 16
timeFrame: Baseline and Week 16
measure: Change from Baseline in growth assessments (weight) at Week 16
timeFrame: Baseline and Week 16
measure: Acceptability assessments by injection site pain adverse events (AEs) during the Initial Treatment Period (Week 0 to Week 16)
timeFrame: Week 0 to Week 16
measure: American College of Rheumatology pediatric (ACR Pedi) 30/50/70/90/100 response at Week 16
timeFrame: Week 16
measure: Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS27) -high sensitivity C-reactive protein (hs-CRP) at Week 16
timeFrame: Baseline and Week 16
measure: Anti-bimekizumab antibody and neutralizing antibody detection prior to and following IMP administration during the Initial Treatment Period
timeFrame: Up to Week 16
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Ja0005 50646
city: Saskatoon
country: Canada
facility: Ja0005 50645
city: Indre-et-Loire
country: France
facility: Ja0005 40777
city: Le Kremlin-bicetre
country: France
facility: Ja0005 40510
city: Paris
country: France
facility: Ja0005 40778
city: Poitiers
country: France
facility: Ja0005 40776
city: Berlin
country: Germany
facility: Ja0005 40369
city: Sankt Augustin
country: Germany
facility: Ja0005 40787
city: Sendenhorst
country: Germany
facility: Ja0005 40779
city: Sosnowiec
country: Poland
facility: Ja0005 40780
city: Barcelona
country: Spain
facility: Ja0005 40781
city: Madrid
country: Spain
facility: Ja0005 40100
city: Bristol
country: United Kingdom
facility: Ja0005 40786
city: Manchester
country: United Kingdom
facility: Ja0005 40783
city: Nottingham
country: United Kingdom
facility: Ja0005 40785
city: Stroke-on-trent
country: United Kingdom
facility: Ja0005 40784
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References: