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

Last updated: June 19, 2025
Sponsor: UCB Biopharma SRL
Overall Status: Active - Recruiting

Phase

3

Condition

Joint Injuries

Psoriatic Arthritis

Treatment

Bimekizumab

Clinical Study ID

NCT06668181
JA0005
U1111-1305-2292
2023-508845-41
  • Ages 2-18
  • All Genders

Study Summary

The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration.

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:

  1. Not a woman of childbearing potential (WOCBP) OR

  2. 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

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Bimekizumab
Phase: 3
Study Start date:
March 11, 2025
Estimated Completion Date:
June 24, 2030

Connect with a study center

  • Ja0005 50646

    Calgary,
    Canada

    Active - Recruiting

  • Ja0005 50645

    Saskatoon,
    Canada

    Active - Recruiting

  • Ja0005 40777

    Indre-et-Loire,
    France

    Active - Recruiting

  • Ja0005 40510

    Le Kremlin-bicetre,
    France

    Active - Recruiting

  • Ja0005 40778

    Paris,
    France

    Active - Recruiting

  • Ja0005 40776

    Poitiers,
    France

    Active - Recruiting

  • Ja0005 40369

    Berlin,
    Germany

    Active - Recruiting

  • Ja0005 40072

    Freiburg,
    Germany

    Active - Recruiting

  • Ja0005 40787

    Sankt Augustin,
    Germany

    Active - Recruiting

  • Ja0005 40779

    Sendenhorst,
    Germany

    Active - Recruiting

  • Ja0005 40427

    Tuebingen,
    Germany

    Active - Recruiting

  • Ja0005 40720

    Krakow,
    Poland

    Active - Recruiting

  • Ja0005 40780

    Sosnowiec,
    Poland

    Active - Recruiting

  • Ja0005 40781

    Barcelona,
    Spain

    Active - Recruiting

  • Ja0005 40100

    Madrid,
    Spain

    Active - Recruiting

  • Ja0005 40782

    Valencia,
    Spain

    Active - Recruiting

  • Ja0005 40786

    Bristol,
    United Kingdom

    Active - Recruiting

  • Ja0005 40783

    Manchester,
    United Kingdom

    Active - Recruiting

  • Ja0005 40785

    Nottingham,
    United Kingdom

    Active - Recruiting

  • Ja0005 40784

    Stroke-on-trent,
    United Kingdom

    Active - Recruiting

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