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Tests treatment safety and results for Enthesitis-related Arthritis
Official title 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
ClinicalTrials.gov ID: NCT06668181
What this study is testing
What is Bimekizumab?
Bimekizumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for enthesitis-related arthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 18
You may be able to join if
- 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...
- 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...
- 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...
You likely can't join if
- Study participants fulfilling any International League of Associations for Rheumatology (ILAR) diagnostic juvenile idiopathic arthritis (JIA)...
- 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...
- Study participant has laboratory abnormalities at Screening defined in the Protocol.
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- Study participants fulfilling any International League of Associations for Rheumatology (ILAR) diagnostic juvenile idiopathic arthritis (JIA) category other than enthesitis-related arthritis (ERA; including...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Canada
- Montreal, Canada
- Saskatoon, Canada
- Indre-et-Loire, France
- Le Kremlin-Bicêtre, France
- Paris, France
- Poitiers, France
- Berlin, Germany
- Dresden, Germany
- Freiburg im Breisgau, Germany
- Hamburg, Germany
- Sankt Augustin, Germany
- Sendenhorst, Germany
- Tübingen, Germany
- Krakow, Poland
- Sosnowiec, Poland
- Esplugues de Llobregat, Spain
- Madrid, Spain
- Valencia, Spain
- Bristol, United Kingdom
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Canada; Montreal, Canada; Saskatoon, Canada; Indre-et-Loire, France; Le Kremlin-Bicêtre, France; Paris, France and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.