Phase
Condition
Psoriatic Arthritis
Joint Injuries
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, each of which needs to be included in the jointsassessed in the JADAS27, and for ERA at least 1 site of enthesitis at Baseline ordocumented 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,
CanadaSite Not Available
Ja0005 50646
Calgary 5913490,
CanadaActive - Recruiting
Ja0005 50644
Montreal 6077243,
CanadaActive - Recruiting
Ja0005 50645
Saskatoon,
CanadaSite Not Available
Ja0005 50645
Saskatoon 6141256,
CanadaActive - Recruiting
Ja0005 40777
Indre-et-Loire,
FranceActive - Recruiting
Ja0005 40510
Le Kremlin-Bicêtre 3003737,
FranceActive - Recruiting
Ja0005 40510
Le Kremlin-bicetre,
FranceSite Not Available
Ja0005 40778
Paris,
FranceSite Not Available
Ja0005 40778
Paris 2988507,
FranceActive - Recruiting
Ja0005 40776
Poitiers,
FranceSite Not Available
Ja0005 40776
Poitiers 2986495,
FranceActive - Recruiting
Ja0005 40369
Berlin,
GermanySite Not Available
Ja0005 40369
Berlin 2950159,
GermanyActive - Recruiting
Ja0005 40356
Dresden 2935022,
GermanyActive - Recruiting
Ja0005 40072
Freiburg,
GermanySite Not Available
Ja0005 40072
Freiburg im Breisgau 2925177,
GermanySite Not Available
Ja0005 40852
Hamburg 2911298,
GermanyActive - Recruiting
Ja0005 40787
Sankt Augustin,
GermanySite Not Available
Ja0005 40787
Sankt Augustin 2841648,
GermanyActive - Recruiting
Ja0005 40779
Sendenhorst,
GermanySite Not Available
Ja0005 40779
Sendenhorst 2833076,
GermanySite Not Available
Ja0005 40427
Tuebingen,
GermanySite Not Available
Ja0005 40427
Tübingen 2820860,
GermanyActive - Recruiting
Ja0005 40720
Krakow,
PolandSite Not Available
Ja0005 40720
Krakow 3094802,
PolandActive - Recruiting
Ja0005 40780
Sosnowiec,
PolandSite Not Available
Ja0005 40780
Sosnowiec 3085128,
PolandSite Not Available
Ja0005 40781
Barcelona,
SpainSite Not Available
Ja0005 40781
Barcelona 3128760,
SpainSite Not Available
Ja0005 40781
Esplugues de Llobregat 3122826,
SpainActive - Recruiting
Ja0005 40100
Madrid,
SpainSite Not Available
Ja0005 40100
Madrid 3117735,
SpainActive - Recruiting
Ja0005 40782
Valencia,
SpainSite Not Available
Ja0005 40782
Valencia 2509954,
SpainActive - Recruiting
Ja0005 40786
Bristol,
United KingdomSite Not Available
Ja0005 40786
Bristol 2654675,
United KingdomSite Not Available
Ja0005 40783
Manchester,
United KingdomSite Not Available
Ja0005 40783
Manchester 2643123,
United KingdomActive - Recruiting
Ja0005 40785
Nottingham,
United KingdomSite Not Available
Ja0005 40785
Nottingham 2641170,
United KingdomActive - Recruiting
Ja0005 40784
Stroke-on-trent,
United KingdomSite Not Available

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