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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-18
SponsorUCB Biopharma SRL

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Bimekizumab

    Drug

    Bimekizumab will be administered at pre-specified timepoints.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: BimekizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Plasma bimekizumab concentrations over the Initial Treatment Period

Plasma samples will be collected at pre-specified timepoints for measurement of plasma bimekizumab concentrations over the Initial Treatment Period.

Time frame
Up to Week 16

Secondary outcomes

1

Incidence of Treatment-emergent adverse events (TEAEs)

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP.

Time frame
From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)
2

Incidence of Serious TEAEs

A SAE is defined as any untoward medical occurrence that, at any dose: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent disability/incapacity * Is a congenital anomaly/birth defect * Important medical events

Time frame
From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)
3

Incidence of TEAEs leading to discontinuation of investigational medicinal product (IMP)

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP.

Time frame
From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)
4

Incidence of TEAEs leading to withdrawal from the study

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP.

Time frame
From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)

Other outcomes

Sponsors and contacts

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