Clinical Trials in France / NCT06668181
Recruiting
Phase 3
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
NCT06668181 · tracked via the Priya Life Science France tracker
Condition(s) studied
Enthesitis-related ArthritisJuvenile Psoriatic Arthritis
Investigational drug(s) / intervention(s)
Bimekizumab: Bimekizumab will be administered at pre-specified timepoints.
Study summary
The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration.
Eligibility
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, 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:
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 outcome measure(s)
- Plasma bimekizumab concentrations over the Initial Treatment Period — Up to Week 16
Plasma samples will be collected at pre-specified timepoints for measurement of plasma bimekizumab concentrations over the Initial Treatment Period.
Trial sites (23)
| Facility | City | Region | Status |
|---|---|---|---|
| Ja0005 50646 | Calgary | Canada | Recruiting |
| Ja0005 50644 | Montreal | Canada | Recruiting |
| Ja0005 50645 | Saskatoon | Canada | Recruiting |
| Ja0005 40777 | Indre-et-Loire | France | Recruiting |
| Ja0005 40510 | Le Kremlin-Bicêtre | France | Recruiting |
| Ja0005 40778 | Paris | France | Recruiting |
| Ja0005 40776 | Poitiers | France | Recruiting |
| Ja0005 40369 | Berlin | Germany | Recruiting |
| Ja0005 40356 | Dresden | Germany | Recruiting |
| Ja0005 40072 | Freiburg im Breisgau | Germany | Recruiting |
| Ja0005 40852 | Hamburg | Germany | Recruiting |
| Ja0005 40787 | Sankt Augustin | Germany | Recruiting |
| Ja0005 40779 | Sendenhorst | Germany | Recruiting |
| Ja0005 40427 | Tübingen | Germany | Recruiting |
| Ja0005 40720 | Krakow | Poland | Recruiting |
| Ja0005 40780 | Sosnowiec | Poland | Recruiting |
| Ja0005 40781 | Esplugues de Llobregat | Spain | Recruiting |
| Ja0005 40100 | Madrid | Spain | Recruiting |
| Ja0005 40782 | Valencia | Spain | Recruiting |
| Ja0005 40786 | Bristol | United Kingdom | Recruiting |
| Ja0005 40783 | Manchester | United Kingdom | Recruiting |
| Ja0005 40785 | Nottingham | United Kingdom | Recruiting |
| Ja0005 40784 | Stoke-on-Trent | United Kingdom | Completed |
On this site
📄 Bimzelx (bimekizumab) drug profile →More UCB Biopharma SRL trials in France
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06668181 on ClinicalTrials.gov ↗ ← All trials in France