NCT06668181RecruitingPhase 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
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
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 30 Oct 2024
- Start date
- 11 Mar 2025
- Primary completion date
- 12 Apr 2028
- Lead sponsor
- UCB Biopharma SRL
- NCT number
- NCT06668181
- EU CT number
- 2023-508845-41-00
- EudraCT number
- 2023-508845-41
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 40
- From 11 Mar 2025 to the primary completion date, 12 Apr 2028
- 23 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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).
Other illness
- Study participant has history of inflammatory bowel disease (IBD) or signs/symptoms suggestive of IBD.
- Study participant has history of active tuberculosis (TB) unless successfully treated, latent TB unless prophylactically treated.
- Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections).
Lab values
- Study participant has laboratory abnormalities at Screening defined in the Protocol.
Other
- 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 active uncontrolled uveitis.
- Presence of active suicidal ideation, or positive suicide behavior.
- Study participant has been diagnosed with severe depression in the past 6 months.
Who the study is looking for
- 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.
Age in the registry: 2 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ja0005 50646 Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| Ja0005 50644 Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Ja0005 50645 Coordinator of this site? Confirm its status | Saskatoon | Canada | Recruiting |
| HELIOS Klinikum Berlin Buch GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Recruiting |
| Hamburger Zentrum Fuer Kinder Und Jugendrheumatologie Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Asklepios-Klinik, Sankt Augustin GmbH Coordinator of this site? Confirm its status | Sankt Augustin | Germany | Recruiting |
| St. Josef Stift GmbH Coordinator of this site? Confirm its status | Sendenhorst | Germany | Recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Recruiting |
| Sant Joan De Deu Barcelona Hospital Coordinator of this site? Confirm its status | Esplugues De Llobregat | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Chambray Les Tours | France | Recruiting |
| Bicetre Hospital Coordinator of this site? Confirm its status | Le Kremlin Bicetre Cedex | France | Recruiting |
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| Ja0005 40786 Coordinator of this site? Confirm its status | Bristol | United Kingdom | Recruiting |
| Ja0005 40783 Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| Ja0005 40785 Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Recruiting |
| Ja0005 40784 Coordinator of this site? Confirm its status | Stoke-on-Trent | United Kingdom | Completed |
| Wojewodzki Specjalistyczny Szpital Dzieciecy Im Sw Ludwika W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o Coordinator of this site? Confirm its status | Sosnowiec | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.