Phase
Condition
Joint Injuries
Psoriatic Arthritis
Treatment
Bimekizumab
Clinical Study ID
Ages 2-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 juvenilepsoriatic arthritis (JPsA) according to the juvenile-International League ofAssociations for Rheumatology (JIA-ILAR) classification criteria of at least 3months duration prior to the Screening Visit.
Study participants who have active disease (ERA [including JAS] and/or JPsA) definedas having at least 3 active joints and for ERA at least 1 site of enthesitis atBaseline or documented by history.
Study participants with inadequate response (at least 1 month) or intolerance to atleast 1 nonsteroidal anti-inflammatory drug (NSAID).
Study participants taking concomitant methotrexate or sulfasalazine are allowed tocontinue the medication if it has been used for the past 12 weeks with a stable dosefor the 4 weeks prior to Baseline, with no change in dose for the first 16 weeks oftreatment foreseen. (Note: prior or concomitant use of methotrexate or sulfasalazineis NOT required for study participation.)
Study participants with no concomitant use of second line agents such asdisease-modifying and/or immunosuppressive drugs with the exception of methotrexateor 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 InitialTreatment Period, the Open-label Extension (OLE) Period, and for at least 20weeks after the final dose of investigational medicinal product (IMP; ie, theSafety Follow-up (SFU) Period)
- Capable of giving/having parent(s) or legal representative provide signed informedconsent/assent (where appropriate), which includes compliance with the requirementsand restrictions listed in the Informed Consent Form (ICF) and assent and in thisprotocol.
Exclusion
Exclusion Criteria:
Study participants fulfilling any International League of Associations forRheumatology (ILAR) diagnostic juvenile idiopathic arthritis (JIA) category otherthan enthesitis-related arthritis (ERA; including juvenile-onset ankylosingspondylitis (JAS)) and/or juvenile psoriatic arthritis (JPsA).
Study participant has history of inflammatory bowel disease (IBD) or signs/symptomssuggestive of IBD.
Study participant has active uncontrolled uveitis.
Study participant has history of active tuberculosis (TB) unless successfullytreated, latent TB unless prophylactically treated.
Study participant has had major surgery (including joint surgery) within the 3months prior to the Baseline Visit or has planned major surgery within 6 monthsafter 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 seriousinfection, chronic infections, opportunistic infections, unusually severeinfections).
Study participant has received drugs listed in the protocol outside the specifiedtimeframes relative to the Baseline Visit or receives prohibited concomitanttreatments.
Study participant had previous therapy with bimekizumab or prior treatment withother 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.
Study Design
Connect with a study center
Ja0005 50646
Calgary,
CanadaActive - Recruiting
Ja0005 50645
Saskatoon,
CanadaActive - Recruiting
Ja0005 40777
Indre-et-Loire,
FranceActive - Recruiting
Ja0005 40510
Le Kremlin-bicetre,
FranceActive - Recruiting
Ja0005 40778
Paris,
FranceActive - Recruiting
Ja0005 40776
Poitiers,
FranceActive - Recruiting
Ja0005 40369
Berlin,
GermanyActive - Recruiting
Ja0005 40072
Freiburg,
GermanyActive - Recruiting
Ja0005 40787
Sankt Augustin,
GermanyActive - Recruiting
Ja0005 40779
Sendenhorst,
GermanyActive - Recruiting
Ja0005 40427
Tuebingen,
GermanyActive - Recruiting
Ja0005 40720
Krakow,
PolandActive - Recruiting
Ja0005 40780
Sosnowiec,
PolandActive - Recruiting
Ja0005 40781
Barcelona,
SpainActive - Recruiting
Ja0005 40100
Madrid,
SpainActive - Recruiting
Ja0005 40782
Valencia,
SpainActive - Recruiting
Ja0005 40786
Bristol,
United KingdomActive - Recruiting
Ja0005 40783
Manchester,
United KingdomActive - Recruiting
Ja0005 40785
Nottingham,
United KingdomActive - Recruiting
Ja0005 40784
Stroke-on-trent,
United KingdomActive - Recruiting
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