BIMEKIZUMAB for Juvenile idiopathic arthritis | Enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) | Juvenile psoriatic arthritis

Inclusion criteria

• {"criterion_text":"- Study participant must be 2 to <18 years of age inclusive, at the Baseline Visit."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Study participants with inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal anti-inflammatory drug (NSAID)."}
• {"criterion_text":"- 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.)"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Body weight of ≥10kg."}
• {"criterion_text":"- Male and female."}
• {"criterion_text":"- 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: a)     Not a woman of childbearing potential (WOCBP) OR b)    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)"}

Exclusion criteria

• {"criterion_text":"- 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)."}
• {"criterion_text":"- Study participant had prior treatment with more than one biologic response modifier (other than an IL-17)."}
• {"criterion_text":"- Presence of active suicidal ideation, or positive suicide behavior."}
• {"criterion_text":"- Study participant has been diagnosed with severe depression in the past 6 months."}
• {"criterion_text":"- Study participant has history of inflammatory bowel disease (IBD) or signs/symptoms suggestive of IBD."}
• {"criterion_text":"- Study participant has active uncontrolled uveitis."}
• {"criterion_text":"- Study participant has history of active tuberculosis (TB) unless successfully treated, latent TB unless prophylactically treated."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Study participant has laboratory abnormalities at Screening defined in the Protocol."}
• {"criterion_text":"- Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections)."}
• {"criterion_text":"- Study participant has received drugs listed in the protocol outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments."}
• {"criterion_text":"- Study participant had previous therapy with bimekizumab or prior treatment with other IL-17 biologic response modifier."}

Primary endpoints

• {"endpoint_text":"- Plasma bimekizumab concentrations over the Initial Treatment Period","definition_or_measurement_approach":"Assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration; measured plasma concentrations during the Initial Treatment Period."}

Secondary endpoints

• {"endpoint_text":"- Occurrence of Treatment-emergent adverse events (TEAEs)","definition_or_measurement_approach":"Occurrence and recording of treatment-emergent adverse events during study period."}
• {"endpoint_text":"- Occurrence of Serious TEAEs","definition_or_measurement_approach":"Recording and classification of serious treatment-emergent adverse events."}
• {"endpoint_text":"- Occurrence of TEAEs leading to discontinuation of investigational medicinal product (IMP)","definition_or_measurement_approach":"Recording TEAEs that lead to permanent discontinuation of IMP."}
• {"endpoint_text":"- Occurrence of TEAEs leading to withdrawal from the study","definition_or_measurement_approach":"Recording TEAEs that result in withdrawal from the study."}
• {"endpoint_text":"- Occurrence of selected safety events of interest (including infection [serious, opportunistic, fungal, and tuberculosis (TB)], inflammatory bowel disease [IBD], and injection site reactions)","definition_or_measurement_approach":"Monitoring and recording pre-specified safety events of interest including infections, IBD, and injection site reactions."}
• {"endpoint_text":"- Change from Baseline in vital signs (systolic blood pressure) at Week 16","definition_or_measurement_approach":"Difference from baseline to Week 16 in systolic blood pressure measurements."}
• {"endpoint_text":"- Change from Baseline in vital signs (diastolic blood pressure) at Week 16","definition_or_measurement_approach":"Difference from baseline to Week 16 in diastolic blood pressure measurements."}
• {"endpoint_text":"- Change from Baseline in vital signs (heart rate) at Week 16","definition_or_measurement_approach":"Difference from baseline to Week 16 in heart rate."}
• {"endpoint_text":"- Change from Baseline in protocol planned laboratory analyses (chemistry) at Week 16","definition_or_measurement_approach":"Change from baseline in protocol-specified chemistry laboratory values at Week 16."}
• {"endpoint_text":"- Change from Baseline in protocol planned laboratory analyses (hematology) at Week 16","definition_or_measurement_approach":"Change from baseline in protocol-specified hematology laboratory values at Week 16."}
• {"endpoint_text":"- Change from Baseline in growth assessments (height) at Week 16","definition_or_measurement_approach":"Change from baseline in measured participant height at Week 16."}
• {"endpoint_text":"- Change from Baseline in growth assessments (weight) at Week 16","definition_or_measurement_approach":"Change from baseline in measured participant weight at Week 16."}
• {"endpoint_text":"- Acceptability assessments by injection site pain adverse events (AEs) during the Initial Treatment Period (Week 0 to Week 16)","definition_or_measurement_approach":"Assessment of acceptability based on reports of injection site pain adverse events during Week 0 to Week 16."}
• {"endpoint_text":"- American College of Rheumatology pediatric (ACR Pedi) 30/50/70/90/100 response at Week 16","definition_or_measurement_approach":"ACR Pedi 30/50/70/90/100 responder rates assessed at Week 16 per ACR pediatric criteria."}
• {"endpoint_text":"- Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS27) -high sensitivity C-reactive protein (hs-CRP) at Week 16","definition_or_measurement_approach":"Change from baseline in JADAS27 (using hs-CRP) at Week 16."}
• {"endpoint_text":"- Anti-bimekizumab antibody and neutralizing antibody detection prior to and following IMP administration during the Initial Treatment Period","definition_or_measurement_approach":"Detection of anti-bimekizumab antibodies and neutralizing antibodies before and after IMP administration during the Initial Treatment Period."}

Methods

• Recruitment materials: patient letters (K2) — country-specific (e.g. K2_FR_Recruit_Patient_Letter_fr-FR-public, K2_PL_Recruit-Patient Letter_public-pl-PL).
• Posters (K2) for local site posting — country-specific (e.g. K2_FR_Recruit_Poster_fr-FR-public, K2_PL-Recruit-Poster-public-pl-PL, K2_DE-Recruit-POSTER-public-de-DE).
• Brochures and study brochures (K2 / L1) — country-specific (France, Germany, Poland).
• ICF Flipbook and patient information packs (K2 IC F Flipbook, L1 SIS-ICF) for participant/parent information — country/language specific.
• Recruitment procedure documents (K1) describing site recruitment processes (e.g. K1_ES_recruitment Procedure des_public-en-EN, K1_PL-Recruit-ICF-process-public-pl-PL, K1_DE_Recruit-Proc-des_public-de-DE).
• ScoutPass mailer / ScoutPass brochures and related site scout materials (PL/DE documents listed: SCOUT/ScoutPass items) to identify potential participants.
• Email communications and electronic outreach (L2_JA0005-PL-Email-Commun-pub-pl-PL; L1_JA0005-DE-SC-PFD-email-comm-public-de-DE).
• Home administration materials and guides (L2_JA0005-PL-Home-Admin-Guide-pub-pl-PL) for participant support.
• Video transcript available (L2_JA0005-PL-Video-Transcript-pub-pl-PL) to support multimedia recruitment/participant information.

France

Earliest CTIS Part Ii Submission Date

13-09-2024

Latest Decision Or Authorization Date

27-03-2026

Processing Time Days

560

Number Of Sites

4

Number Of Participants

8

Spain

Earliest CTIS Part Ii Submission Date

07-10-2024

Latest Decision Or Authorization Date

27-03-2026

Processing Time Days

536

Number Of Sites

3

Number Of Participants

6

Germany

Earliest CTIS Part Ii Submission Date

16-09-2024

Latest Decision Or Authorization Date

25-03-2026

Processing Time Days

555

Number Of Sites

7

Number Of Participants

10

Poland

Earliest CTIS Part Ii Submission Date

02-10-2024

Latest Decision Or Authorization Date

27-03-2026

Processing Time Days

541

Number Of Sites

2

Number Of Participants

4

Primary sponsor

Full Name

UCB Biopharma

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

Project Management, Regulatory Expertise, Medical Expertise, Investigator Recruitment, Data Management, Laboratory Analysis, Q/A Auditing, Site Training

Name

4g Clinical LLC

Name

PPD Development LP

Third parties

• {"country":"United States","full_name":"Syner-G Biopharma Group LLC","duties_or_roles":"code:11","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"code:3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Scales & Linguistic validation services","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Project Management, Regulatory Expertise, Medical Expertise, Investigator Recruitment, Data Management, Laboratory Analysis, Q/A Auditing, Site Training","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"BioAgilytix Europe GmbH","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Center For Information And Study On Clinical Research Participation Inc.","duties_or_roles":"code:11","organisation_type":"Patient organisation/association"}